我们决定向甘孜泸定、雅安石棉捐赠300万元现金、300万元物资，目前已成功对接甘孜州红十字会、雅安市红十字会，今天下午已经完成打款，物资根据当地所需正在紧急集结。对于灾区需要的其他支持，我们也当全力以赴。”
9月6日下午，四川科伦药业股份有限公司相关负责人告诉记者，针对四川泸定6.8级地震中受灾严重的泸定县和石棉县，他们紧急启动灾害应急处理方案，并进行现金和物资捐赠。
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2024-05-24
ASCO 2024| Two Abstracts of the Study Results of Kelun-Biotech’s TROP2-ADC SKB2...
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(May 24th, Chengdu and New Jersey) The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago, Illinois, the United States of America from May 31 to June 4, 2024, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) will present two clinical stage study results at ASCO.
1.The Phase 3 OptiTROP-Breast01 study of its anti-TROP2 ADC sacituzumab tirumotecan (sac-TMT) (formerly SKB264/MK-2870) in patients with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC).
? Session: Special clinical science symposium (Abstract #104; Next-Generation Antibody–Drug Conjugates: The Revolution Continues),
? Time: June 2, 2024, 9:45 AM to 11:15 AM local time
2. The Phase 2 OptiTROP-Lung01 study of sac-TMT in combination with KL-A167 (an anti-PD-L1 mAb) as 1L treatment for patients with advanced non-small cell lung cancer (NSCLC)
? Session: oral (Abstract #8502; Lung Cancer—Non-Small Cell Metastatic Oral)
? Time: May 31, 2024, 2:45 PM to 5:45 PM local time.
Sac-TMT is jointly developed by Kelun-Biotech and MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) at clinical stage.
The abstracts for the above studies were published on ASCO’s official website on [May 23, 2024], local time. The study results are summarized as follows:
TNBC
Patients were randomly assigned (1:1) to receive sac-TMT (n = 130) or chemotherapy (n = 133). The median age was 51 years; 87% had visceral metastases; 26% received prior PD-1/PD-L1 inhibitors; 48% received three or more prior lines of chemotherapy for advanced disease. The primary endpoint of progression free survival (PFS) was met based on interim analysis (data cut-off: Jun 21, 2023) with a 69% reduction in risk of progression or death (HR 0.31; 95% CI, 0.22 to 0.45; P <0.00001).
The median PFS, as assessed by BICR, was 5.7 months (95% CI, 4.3 to 7.2) with sac-TMT and 2.3 months (95% CI, 1.6 to 2.7) with chemotherapy; PFS rate at 6 months was 43.4% vs 11.1%. In the subset of patients with trophoblast cell-surface antigen 2 (TROP2) H-score > 200, the median PFS was 5.8 months with sac-TMT and 1.9 months with chemotherapy (HR 0.28; 95% CI, 0.17 to 0.48). At the first planned interim analysis for overall survival (OS) (data cut-off: Nov 30, 2023) with median follow-up of 10.4 months, OS was statistically significant in favor of sac-TMT (HR 0.53; 95% CI, 0.36 to 0.78; P =0.0005); the median OS was not reached (95% CI, 11.2 to NE) with sac-TMT and 9.4 months (95% CI, 8.5 to 11.7) with chemotherapy. The objective response rate (ORR) assessed by BICR was 43.8% with sac-TMT and 12.8% with chemotherapy.
Most common grade ≥ 3 treatment-related adverse events (TRAEs) (sac-TMT vs. chemotherapy) were neutrophil count decreased (32.3% vs. 47.0%), anemia (27.7% vs. 6.1%) and white blood cell count (WBC) decreased (25.4% vs. 36.4%).
A Phase 3 global study led by MSD of sac-TMT plus pembrolizumab versus treatment of physician's choice (TPC) in TNBC who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery (NCT06393374) and a Phase 3 study led by the Company of sac-TMT in China for 1L treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative TNBC (NCT06279364) are ongoing.
NSCLC
Patients with treatment naive advanced NSCLC without actionable genomic alterations were enrolled to receive sac-TMT 5 mg/kg Q3W plus KL-A167 1200 mg Q3W (cohort 1A) or sac-TMT 5 mg/kg Q2W plus KL-A167 900 mg Q2W (cohort 1B) in a non-randomized manner until disease progression or unacceptable toxicity. As of January 02, 2024, 40 and 63 patients have been enrolled in cohort 1A and 1B, respectively. Median ages were 63/63 years (cohort 1A/1B); 97.5%/85.7% had Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 1; 30.0%/33.3%, 32.5%/30.2% and 37.5%/36.5% of patients had programmed death ligand 1 (PD-L1) expression < 1%, 1%-49% and ≥ 50% of tumor cells by IHC 22C3 pharmDx assay, respectively.
After median follow up of 14.0 months for cohort 1A, the ORR was 48.6% (18/37, 2 pending confirmation), disease control rate (DCR) was 94.6% and median PFS was 15.4 months (95% CI: 6.7, NE) with a 6-month PFS rate of 69.2%. After median follow-up of 6.9 months for cohort 1B, the ORR was 77.6% (45/58, 5 pending confirmation), DCR was 100% and median PFS was not reached with a 6-month PFS rate of 84.6%. Additional subgroup analyses of cohort 1B are shown in the following table:
*Including confirmed or unconfirmed response. ORR was calculated based on response evaluable population defined as patients with ≥ 1 on-study scans.
In cohorts 1A and 1B, the most common Grade ≥ 3 TRAEs were neutrophil count decreased (30.0%/30.2%), WBC decreased (5.0%/17.5%), anemia (5.0%/15.9%), rash (5.0%/6.3%) and drug eruption (7.5%/0). Treatment-related adverse events leading to discontinuation of sac-TMT occurred in 1 patient of cohort 1B due to drug hypersensitivity, and there were no treatment-related deaths.
Two Phase 3 global studies led by MSD of sac-TMT in patients with 3L+ EGFR mutant NSCLC (NCT06074588), and 2L EGFR mutant NSCLC (NCT06305754) and a Phase 3 study led by the Company of sac-TMT in China in patients with 2L EGFR mutant NSCLC (NCT05870319) are ongoing. Additionally, Three Phase 3 global studies led by MSD of sac-TMT plus pembrolizumab are ongoing: One in patients with 1L Metastatic Squamous NSCLC (NCT06422143) , a second in patients with metastatic NSCLC expressing PD-L1 ≥ 50% (NCT06170788), and the third in patients with resectable NSCLC not achieving a pathological complete response (NCT06312137) .
2024-04-08
AACR 2024| Two Abstracts of the Study Results of Kelun-Biotech’s TROP2-ADC SKB2...
More2024 American Association for Cancer Research (AACR) Annual Meeting is being held in San Diego, California, the United States of America from April 5th to 10th, 2024, local time.
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK, the “Company”) will present two study results of anti-TROP2 ADC sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) during the AACR meeting scheduled below. The abstracts for the studies have been published on the official website of the AACR on April 5th, 2024, local time (See link below).
1. The updated efficacy and safety results for its anti-TROP2 ADCSKB264/sac-TMT in patients with previously treated advanced non-small cell lung cancer (NSCLC) from a phase 2 study in a poster session scheduled on April 9 2024, 1:30 PM - 5:00 PM local time (Abstract Presentation Number: CT247).
2.The preliminary efficacy and safety results for its anti-TROP2 ADC SKB264/sac-TMT in patients with previously treated advanced gastric or gastroesophageal junction (GEJ) cancer from a phase 2 study as an oral presentation, which is scheduled in a session on April 9 2024, 2:30 PM - 4:30 PM local time (Abstract Presentation Number: CT038).
The study results are summarized as follows:
NSCLC
Patients with previously treated advanced NSCLC were enrolled to receive SKB264/sac-TMT at 5 mg/kg Q2W until disease progression or unacceptable toxicity (KL264-01, NCT04152499). The data cut-off date was November 22, 2023.
Five Phase 3 global studies of SKB264/sac-TMT in patients with NSCLC are ongoing. Including two Phase 3 global studies of SKB264/sac-TMT in patients with 3L+ EGFR mutant NSCLC (NCT06074588), and 2L EGFR mutant NSCLC (NCT06305754) and a Phase 3 study ofSKB264/sac-TMT in China in patients with 2L EGFR mutant NSCLC (NCT05870319). Additionally two Phase 3 global studies of SKB264/sac-TMT plus pembrolizumab in patients with metastatic NSCLC expressing programmed death ligand 1 (PD-L1)≥ 50% (NCT06170788) and resectable NSCLC not achieving pathological complete response (NCT06312137) are ongoing.
As of the Data Cut-off date, 43 NSCLC patients had been enrolled and the median follow-up was 17.2 months. 21 patients with EGFR wild type had received a median of 3 prior regimens of therapy including anti-PD-1/L1 inhibitors. 22 patients with EGFR mutant had progressed on or after TKI therapy, 50% of whom also failed at least one line of chemotherapy. Updated efficacy results are shown in the following:
*Including confirmed or unconfirmed response. Based on response evaluable patients (≥1 on-study scans) with 4 patients (2 EGFR mutant patients with non-squamous histology and 2 EGFR wild type patients with squamous histology) excluded.
The most common Grade ≥3 treatment-related adverse events (TRAEs) were neutrophil count decreased (34.9%), anemia (30.2%), white blood cell (WBC) count decreased (25.6%), stomatitis (9.3%), and rash (7.0%). No TRAEs leading to treatment discontinuation or deaths occurred. No drug-related interstitial lung disease (ILD)/pneumonitis was reported.
Gastric/GEJ cancer
Patients with previously treated inoperable advanced gastric/GEJ adenocarcinoma were enrolled to receive SKB264/sac-TMT monotherapy at 5 mg/kg Q2W until disease progression or unacceptable toxicity in Phase 2 expansion cohort of KL264-01 study (NCT04152499). Patients with heavily pre-treated gastric/GEJ cancer were enrolled first, and then the cohort was amended to enroll patients with only one prior therapy of chemotherapy and anti-PD-1/L1 therapy. The data cut-off date was Nov 22, 2023.
As of the data cut-off date, a total of 48 patients were enrolled and followed up for at least 9 weeks. 24 patients (50.0%) had received one prior line of therapy (2L), while 24 patients (50.0%) had received ≥ 2 prior lines of therapy (3L+). 40 patients (83.3%) had received prior anti-PD-1/L1 inhibitors. Of 41 response-evaluable patients (defined as ≥ 1 on-study scans), the objective response rate (ORR) was 22.0% (9 partial responses, 2 pending confirmation) and disease control rate (DCR) was 80.5%. The ORRs in the 2L and 3L+ setting were 27.3% (including 2 pending confirmation) and 15.8%, respectively. Median duration of response (DoR) was 7.5 months. In the subset of 3L+ patients (n=24 including 54.2% of patients with ≥ 4 prior lines of therapy) with more mature follow-up (median follow up of 14.6 months), the median progression free survival (mPFS) was 3.7 months (95% CI: 2.6, 5.4) and median overall survival (mOS) was 7.6 months (95% CI: 5.3, 15.5).
The most common ≥ Grade 3 TRAEs were anemia (20.8%), neutrophil count decreased (18.8%), WBC decreased (12.5%) and neutropenia (6.3%). No TRAEs leading to treatment discontinuation or deaths occurred. No neuropathy or drug-related ILD/pneumonitis was reported.
A Phase 3 global study of SKB264/sac-TMT monotherapy versus standard of care (SOC) chemotherapy in 3L+ gastric/GEJ adenocarcinoma is being planned.
Press Contact: Xinwei Li, klbio_pr@kelun.com
2024-03-13
The FOURTH BTD! TROP2-ADC SKB264 (MK-2870) Granted Breakthrough Therapy designat...
MoreOn 8th March 2024, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK, Kelun-Biotech)’s innovative core product TROP2-ADC SKB264 (also known as MK-2870) was granted Breakthrough Therapy Designation（BTD） by the Center for Drug Evaluation（ CDE） of the National Medical Products Administration (NMPA) of China for first-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative triple negative breast cancer (TNBC). SKB264 (MK-2870) is jointly developed by Kelun-Biotech and MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA).
This is the fourth Breakthrough Therapy Designation for SKB264 (MK-2870) granted by the NMPA. Previously, SKB264 (MK-2870) was granted BTD for:
July 2022, locally advanced or metastatic TNBC.
January 2023, EGFR-mutant locally advanced or metastatic non-small cell lung cancer (NSCLC) after progression on EGFR tyrosine kinase inhibitor (TKI) therapy.
June 2023, locally advanced or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer in patients who have previously received at least two lines of systematic chemotherapy.
Breast cancer is one of the most common malignant tumors in women, with its incidence showing an increasing trend year by year. The International Agency for Research on Cancer (IARC) and the World Health Organization (WHO) estimated that in 2020, there were over 2.26 million new cases of breast cancer globally, accounting for 11.7% of all tumors, making it the most prevalent cancer [1]. Triple-negative breast cancer (TNBC) is a clinical subtype that is negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2), comprising 10.0% to 20.8% of all breast cancer types. Triple-negative breast cancer is characterized by high heterogeneity, a high rate of recurrence and metastasis, and a poorer prognosis compared to other types of breast cancer. It lacks effective and specific treatment methods [2]. Currently, the primary treatment for PD-L1 negative TNBC is chemotherapy, which offers limited survival benefits, highlighting the urgent need for new treatment plans. For patients with inoperable locally advanced, recurrent, or metastatic PD-L1 negative triple-negative breast cancer, the first-line standard treatment in China still involves chemotherapy, including single-agent or combination chemotherapy [3]. Compared to single-agent chemotherapy, combination chemotherapy has greater toxicity and offers limited survival benefits.
BTD is designed to expedite the development of new drugs for serious diseases that have shown significant efficacy or safety over existing therapies in preliminary clinical trials. For new drugs included in the Breakthrough Therapy List, CDE will prioritize the allocation of resources for communication, enhanced guidance, and promotion of drug development. If the relevant conditions have been assessed to be met, an application for conditional approval and an application for priority review and approval may also be submitted at the time of the application for drug marketing authorization. This will help accelerate the SKB264 (MK-2870) development process and address the unmet clinical needs of Chinese patients as soon as possible.
参考文献：
[1] Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J(Engl).2022 Feb 9; 135(5):584-590.
[2] 三阴性乳腺癌含铂方案临床应用专家共识（2021版）.中华肿瘤防治杂志2021年6月第28卷第12期.
[3] 《中国临床肿瘤学会（CSCO）乳腺癌诊疗指南2023版》.
2024-03-13
Kelun Biotech and Ellipses corporate pipeline A400(EP0031) has been granted Fast...
MoreOur key product A400(EP0031), a small molecule rearranged during transfection (RET) kinase inhibitor program, has been granted Fast Track designation by the United States Food and Drug Administration (FDA) for the treatment of RET fusion-positive non-small cell lung cancer (NSCLC).
A400 (EP0031) is a second-generation selective RET inhibitor (SRI) with broad activity against common RET fusions and mutations.
In March 2021, the Company granted Ellipses Pharma Limited, a U.K.-based international drug development company, an exclusive, royalty-bearing, sub licensable license to develop, manufacture and commercialize A400 (EP0031) in all countries excluding Greater China, North Korea, South Korea, Singapore, Malaysia and Thailand.
In June 2022, the FDA approved an investigational new drug application for A400 (EP0031), and a phase 1/2 trial is ongoing in patients with malignant tumors with RET gene alteration.
In November 2023, A400 was granted Orphan Drug Designation by the FDA for the treatment of RET fusion-positive solid tumors.
In preclinical studies, A400 (EP0031) demonstrated favourable inhibitory activity against key RET kinases in-vitro and in-vivo. A400 (EP0031) also demonstrated good penetration of the blood brain barrier in animal models. Data shared at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting on A400 (EP0031) showed promising anti-tumor efficacy in patients with advanced RET+ solid tumors, highlighted by ORR of 80.8% and 69.7% for 1L and 2L+ advanced RET+ NSCLC, respectively, based on results from its ongoing phase 1/2 trial. In both cases, DCR of over 96% were reported.
At present, the Company is conducting A400 (EP0031) pivotal clinical study in China for RET- positive NSCLC.
About Ellipses Pharma Limited
Ellipses Pharma is a global drug development company based in London, focused on accelerating the development of cancer treatments through an innovative drug development model that combines unbiased vetting to de-risk initial asset selection with an uninterrupted funding flow to minimise the time it takes to advance lead products through clinical trials and reach patients.
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has 33 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including 14 projects in the clinical stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC, and has four ADC projects in the clinical stage (two of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.
2024-03-04
INCLUSION IN STOCK LIST OF STOCK CONNECT SOUTHBOUND TRADING LINK
Morepursuant to the Notice of Adjustment of Stock List of Southbound Trading Link of the Shanghai-Hong Kong Stock Connect ( 关于沪港通下港股通目标调整的通知) made by the Shanghai StockExchange on March 1, 2024, the Company will be included in the list of eligible shares of the Southbound Trading Link of the Shanghai-Hong Kong Stock Connect with effect from March 4, 2024.
2024-02-26
Kelun-Biotech (6990.HK) attended the FinanceAsia 2023 Annual Awards celebration ...
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On February 21, 2024, the prestigious international finance magazine, FinanceAsia, held its 2023 annual achievement awards ceremony in Hong Kong. Kelun-Biotech (6990.HK) was invited to attend the celebration dinner and was awarded the "Best IPO in Asia and Hong Kong for 2023" honor.
FinanceAsia is regarded as one of the most representative professional monthly magazine in Asia's capital market and has significant influence in the investment industry. Founded in 1996, its sponsored "FinanceAsia Achievement Awards" is one of the most influential and credible industry award selections in the Asia-Pacific region, the award ceremony is an significant annual gathering in the investment industry.
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has 33 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including 14 projects in the clinical stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC, and has four ADC projects in the clinical stage (two of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.
2024-01-11
CEO of Kelun-Biotech Dr. Micheal Ge delivered a presentation on The 42nd JPM Ann...
MoreThe 42nd J.P. Morgan Annual Healthcare Conference（“JPMHC”）2024 is taking place on January 8-11 at San Fracisco, USA, members of Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK, Kelun-Biotech) senior management team participated in the conference. Dr. Micheal Ge, CEO of Kelun-Biotech, delivered a presentation about innovation strength and business progress of Kelun-Biotech.
Presentation Title: Dedicated to human health with a caring heart
Presentation Time: Pacific Standard Time (PST) Tuesday 8:00 AM, January 9, 2024
As one of the pioneers in the antibody-drug conjugates (ADC) development company, Kelun-Biotech has established world leading ADC platform “OptiDC?”, as well as a rich and differentiated ADC R&D pipeline covers unmet clinical needs in the field of oncology. Our core product Trops-ADC and Her2 ADC are expected to be approved for NDA in China this year. Meanwhile, Kelun-Biotech is accelerating the development progress of over 10 clinical and pre-clinical ADC and ADC-derivative products. With the support of the Kelun Group, Kelun-Biotech has built mature R&D, manufacturing and quality control system, the company is now building a commercialization team to form the marketing system. Kelun-Biotech’s innovation capability has gained high recognition from global partners, including MSD, and the capital market. Kelun-Biotech is rapidly developing a unique growth curve as an ADC R&D pharmaceutical enterprise.
Dr.Michael Ge said: “It’s our pleasure to meet again with global industry leaders, innovative technology creators and members of the investment community here at JPMHC. Our top priority is to rapidly advance our differentiated pipeline programs into and through the clinic for disease conditions with significant medical needs. We will continue to innovate and optimize our ADC platform, discover novel payloads, linkers, engineer novel ADC designs, and expand clinical application of antibody drug conjugates to non-oncology disease areas. Build upon our end-to-end drug development capabilities, infrastructure, and commercialization readiness. Furthermore, we plan to extend our global footprints through strategic partnerships and maximize our pipeline and portfolio value. We look forward to achieving and updating you on the 2024 milestones in the coming year”.
Presentation Slides is available on the investor relations page of Kelun-Biotech website at: 投资者关系 - 四川科伦博泰生物医药股份有限公司 (kelun-biotech.com)
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has 33 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including 14 projects in the clinical stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC, and has four ADC projects in the clinical stage (two of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.
2023-12-11
First TROP2-ADC in China! CDE Accepted the New Drug Application for SKB264 (MK-2...
MoreSichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”, 6990.HK) announced that the new drug application (the “NDA”) for SKB264 (MK-2870, Brand name: 佳泰莱) in adult patients with unrespectable locally advanced, metastatic triple-negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). SKB264 (MK-2870) is expected to be the first domestic TROP2-ADC to be approved for marketing in China. This SKB264 New Drug Application is based on a multi-center, randomized, controlled phase 3 clinical study of SKB264 (MK-2870) monotherapy for second line or above locally advanced or metastatic
SKB264 new drug application has been included in the priority review and approval process by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). For drugs that included in the priority review, CDE will prioritize the review and verification procedures to effectively shorten the approval timeframe for launching clinical-valuable new drugs to the market. The Company plans to publish the Phase III clinical trial data at the Academic Conference 2024 and promote the early launch of SKB264, to enrich the clinical treatments for patients with second-line and above TNBC.
Breast cancer is the number one malignant tumor that seriously threatens women's health all over the world, and its incidence is increasing year by year. TNBC is a subtype of breast cancer with specific molecular expression characteristics, invasive behavior and metastatic patterns, and has a poorer prognosis than other subtypes of breast cancer, with higher rates of local recurrence and distant metastasis, and the 5-year survival rate is only 13% for advanced TNBC patients (National Cancer Institute 2022). Due to the lack of therapeutic targets such as endocrine and HER2, TNBC is insensitive to both hormonal and targeted therapies, and the current treatment is still based on chemotherapeutic agents. For patients with second-line and above TNBC, the progression-free survival of current clinically available chemotherapy regimens is less than 3 months, and overall survival is about 5-8 months (Kazmi et al. 2020, O'Shaughnessy et al. 2021), and there is a large and urgent unmet clinical need for more effective therapeutic agents
On December 2023, Kelun-Biotech updated efficacy and safety results from a phase II expansion cohort in patients with previously treated metastatic TNBC for SKB264 (MK-2870) have been presented at the 46th San Antonio Breast Cancer Symposium (SABCS). (SABCS 2023 news link here)
About SKB264 (MK-2870)
SKB264 is a representative innovative ADC targeting TROP2, developed by Kelun-Biotech 's internationally renowned ADC research and development platform—OptiDC. It consists of a humanized anti-TROP2 monoclonal antibody with high affinity and targeting, combined with the self-developed small toxin molecule T030 (a topoisomerase I inhibitor) through a stability-optimized CL2A linker. The drug-to-antibody ratio (DAR) averages as high as 7.4. The stability of SKB264 has been enhanced in two main ways, allowing more ADC to effectively reach tumor cells. Firstly, the antibody end of the linker uses a sulfonamide pyrimidine connector, which allows for irreversible coupling with the antibody. Secondly, T030 contains a methyl sulfone structure, which can securely bind with the toxin end of the linker. The linker of SKB264 is affected by both extracellular pH-sensitive cleavage and intracellular enzymatic cleavage within tumor cells, which leads to efficient release of the small toxin molecule to exert its anti-tumor effects. T030 activity is similar to that of DXd and also shows a “bystander effect”. In summary, SKB264 exerts its anti-tumor effect in three ways. Firstly, the pH-sensitive linker can cleave and release T030 in the acidic tumor microenvironment. Secondly, after being engulfed by tumor cells, SKB264 releases T030 via enzymatic cleavage. Thirdly, T030 can also penetrate the cell membrane to exert a "bystander effect" to kill surrounding tumor cells. With a high-affinity monoclonal antibody, highly active toxin molecule, good stability, and high DAR value, the overall design of SKB264 contributes to its robust anti-tumor activity which has been preliminarily demonstrated in clinical studies to date.
In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize SKB264 (MK-2870) in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan).
SKB264 has received 3 BTDs from the CDE of China’s NMPA for the treatment of locally advanced or metastatic TNBC, locally advanced or metastatic EGFR-mutated non-small cell lung cancer which has failed EGFR-TKI therapy, and locally advanced or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer which has received at least second-line systemic therapy.
About Kelun-Biotech
Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs.
At present, the Company has 33 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including 14 projects in the clinical stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC, and has four ADC projects in the clinical stage (two of which are in the Phase III or NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.
References:
1. National Cancer Institute (2022) Cancer Stat Facts: Female Breast Cancer Subtypes.
2.[Kazmi S, Chatterjee D, Raju D, et al. (2020)] Overall survival analysis in patients with metastatic breast cancer and liver or lung metastases treated with eribulin, gemcitabine, or capecitabine. Breast Cancer Research and Treatment; 184(2):559-565.
3.[O'Shaughnessy J, Punie K, Oliveira M, et al. (2021)] Assessment of sacituzumab govitecan (SG) versus treatment of physician’s choice (TPC) cohort by agent in the phase 3 ASCENT study of patients (pts) with metastatic triple-negative breast cancer (mTNBC). (2021): 1077-1077. https://meetinglibrary.asco.org/record/198258/abstract
Forward-Looking Statements
This press release contains certain forward-looking statements. These statements are based on the beliefs of our management as well as assumptions made by and information currently available to our management. When used in this press release, the words “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “going forward,” “intend,” “may,” “might,” “ought to,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “will,” “would” and the negative forms of these words and other similar expressions are intended to identify forward-looking statements. Such statements reflect the current views of our management with respect to future events, operations, liquidity and capital resources, some of which may not materialize or may change.
It is advised not to place any undue reliance on any forward-looking statements contained herein. The Company can give no assurance that these forward-looking statements will prove to have been correct. Expectations reflected in these forward-looking statements are subject to change and the Company undertakes no obligation to update or revise any forward-looking statements herein.
2023-11-27
Kelun-Biotech announced that A400/EP0031 has been granted Orphan Drug Designatio...
MoreKelun-Biotech announces that KL590586 (EP0031) (small molecule RET kinase inhibitor, also named A400) program, licensed to global ex-China partner Ellipses Pharma, has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA) for the treatment of RET fusion-positive solid tumors.
Orphan drugs are drugs used for the prevention, treatment and diagnosis of rare diseases. The FDA grants ODD for investigational treatments for rare diseases, such as RET fusion-positive solid tumours, defined as affecting fewer than 200,000 people in the United States. The designation is an important milestone in the development of innovative drugs, it is expected to accelerate the progress of clinical trials in the United States. ODD qualifies the developer for certain incentives with the goal of accelerating drug development for patients, including tax credits and seven years of market exclusivity in the US upon approval by the FDA.
A400 (EP0031) is a next generation selective RET inhibitor (SRI) with broad activity against common RET fusions and mutations. Therefore, A400 (EP0031) may overcome resistance mechanisms to first generation SRIs. In preclinical studies, A400 (EP0031) demonstrated favourable inhibitory activity against key RET kinases in-vitro and in-vivo. A400 (EP0031) also demonstrated good penetration of the blood brain barrier in animal models. At present, Kelun-Biotech is conducting A400 (EP0031) pivotal clinical study in China for RET-positive non-small cell lung cancer.
In March 2021, Kelun-Biotech granted Ellipses an exclusive license for A400 (EP0031) in certain territories including the US and Europe, with Kelun-Biotech retaining certain rights in Greater China and parts of the Asia-Pacific region such as Korea, Singapore, Malaysia.
In June 2022, the FDA approved an investigational new drug application for A400 (EP0031), and a Phase 1/2 trial is ongoing in patients with malignant tumors with RET gene alteration.
About RET altered malignancies
RET fusions and mutations are present in a wide range of tumors, including non-small cell lung cancer, medullary thyroid cancer and other types of thyroid cancer, as well as colorectal cancer, so targeting RET gene changes is promising as a treatment for all types of cancer. However, for patients with RET gene alteration, the effect of traditional chemotherapy and immunotherapy is limited, especially for patients with drug resistance after first-generation SRI treatment, the acceptable treatment options are limited, and the prognosis is poor, and there are still unmet clinical needs.
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and establishing an globalized drug development and industrialization platform for the unmet medical needs in China and worldwide. The Company is committed to becoming an leading global enterprise in the field of innovation drugs.
At the present, the company has 33 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including 14 projects in the clinical stage with multiple global trials conducted simultaneously in several regions including China, Europe, and the United States. The company has established one of the world’s leading in-house developed ADC platform, OptiDC, and has four ADC projects in the clinical stage (two of which are in the phase III or NDA stage, respectively) and several projects in the preclinical stage.
For more information, please visit https://kelun-biotech.com/.
About Ellipses Pharma Limited
Ellipses Pharma is a global drug development company based in London, focused on accelerating the development of cancer treatments through an innovative drug development model that combines unbiased vetting to de-risk initial asset selection with an uninterrupted funding flow to minimise the time it takes to advance lead products through clinical trials and reach patients. For more information, please visit www.ellipses.life
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2024-09-29
Multiple Study Results of Kelun-Biotech’s TROP2-ADC SKB264 (sac-TMT) At 2024 CSCO Congress
More
From September 25th to 29th, the 27th China Clinical Oncology Congress and the 2024 CSCO Annual Meeting were held in Xiamen. Experts and scholars in the field of oncology from all over China gathered together to discuss the hotspots at the forefront of clinical practice. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”, 6990.HK) presented multiple clinical research results and progress of TROP2 ADC sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) at the conference.
TNBC
【2024 CSCO：Oral report by Academician Binghe Xu 】
On the afternoon of September 27, Academician Binghe Xu from the Cancer Hospital of the Chinese Academy of Medical Sciences gave an oral presentation and paper discussion on the results of the Phase III OptiTROP-Breast01 study of sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC) in the Innovative Drugs Clinical Data Session.
The median PFS assessed by BICR was 6.7 months (95% CI, 5.5 to 8.0) with SKB264 and 2.5 months (95% CI, 1.7 to 2.7) with chemotherapy; The sac-TMT group had a 68% reduction in risk of disease progression or death compared to the chemotherapy group (HR 0.32; 95% CI, 0.22 to 0.44; P <0.00001). In the subset of pts with TROP2 H-score > 200, the median PFS was 8.3 months with SKB264 and 2.3 months with chemotherapy (HR 0.29; 95% CI, 0.19 to 0.46). The median OS was not reached (95% CI, 11.2 to NE) with SKB264 and 9.4 months (95% CI, 8.5 to 11.7) with chemotherapy. The sac-TMT group had a 47% reduction in risk of death compared to the chemotherapy group (HR 0.53; 95% CI, 0.36 to 0.78; P =0.00005). Compared to the investigator's choice of chemotherapy, sac-TMT for metastatic TNBC patients showed statistically and clinically significant improvements in PFS and OS, with a manageable safety profile, and could be a new and effective therapeutic option for this group of patients.
Binghe Xu said, “Breast cancer is a highly prevalent malignant tumor in the world, threatening women's lives and health, among which, triple-negative breast cancer is also known as ‘the most toxic’ breast cancer due to its poor therapeutic effect. The future direction of advanced triple-negative breast cancer treatment is precise and stratified treatment. Sac-TMT can help to meet more treatment needs of patients, and may be expected to become the new standard of second-line treatment for advanced triple-negative breast cancer in the future. For the research and development of ADC, domestic enterprises have gone through the stages of catching up and running parallel to each other, and now they have become an important force in the global ADC innovation technology, and we believe that one day, patients with advanced triple-negative breast cancer can get more effective treatment through ADC innovative drugs.”
NSCLC
【2024 CSCO：Oral report by Prof.Wengfeng Fang】
On the afternoon of September 28, Prof. Wenfeng Fang from the Affiliated Cancer Hospital of Sun Yat-sen University orally reported the results of the Phase II OptiTROP-Lung01study, a first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC) with sac-TMT in combination with KL-A167, an anti-PD-L1 monoclonal antibody, in the session of Clinical Data of Innovative Drugs, with a paper discussion.
Pts with treatment naive advanced NSCLC without actionable genomic alterations were enrolled to receive SKB264 5 mg/kg Q3W + KL-A167 1200 mg Q3W (cohort 1A，130 Pts) or SKB264 5 mg/kg Q2W + KL-A167 900 mg Q2W (cohort 1B,133 Pts) in a non-randomized manner. After median follow up of 14.0 mo and 6.9 mo for cohort 1A and 1B, the ORR was 48.6% (18/37, 2 pending confirmation), DCR was 94.6% and median PFS was 15.4 mo (95% CI: 6.7, NE) with 6-mo PFS rate of 69.2% for cohort 1A ; the ORR was 77.6% (45/58, 5 pending confirmation), DCR was 100% and median PFS was not reached with 6-mo PFS rate of 84.6% for cohort 1B.
Prof. Wenfeng Fang said, “The emergence of ADC drugs is epoch-making. The dual-drug regimen of sac-TMT combined with immunotherapy is leading a new direction in the exploration of first-line treatment for advanced NSCLC, with very stunning efficacy observed in the preliminary study data. In the future, the potential for the application of sac-TMT in the treatment of NSCLC is worth looking forward to, and sac-TMT is expected to provide diversified treatment options and better survival benefits for more patients, both in the driver-negative and EGFR-mutated patient populations.”
CC
【2024 CSCO：Oral report by Pro.Jing Wang】
On the morning of September 28, Professor Jing Wang from Hunan Cancer Hospital orally reported the results of Efficacy and Safety of sac-TMT Plus Pembrolizumab in patients with recurrent or metastatic cervical cancer. Pts with R/M CC who had progressed on or after platinum-doublet chemotherapy and received no more than 2 systemic therapies for R/M disease were enrolled.38 pts were treated and followed up for at least 17 weeks or 2 tumor assessments. The median follow-up was 6.2 mo, The ORR was 57.9% (22/38, 3 unconfirmed), with 3 complete responses. Responses were also observed in pts were pre-treated with anti-PD-1 based therapy. Median PFS was not reached and 6-mo PFS rate was 65.7%.
Professor Jing Wang said, “Cervical cancer highly expresses TROP2, and previous studies have suggested that the overexpression ratio is more than 90%. High TROP2 expression is closely related to the poor prognosis of tumor patients, and it may also be related to the sensitivity of some drug therapies, which makes it a good target to explore. It is believed that with these promising results, more studies will emerge in the field of gynecologic oncology in the future to further validate these findings and bring hope to a wider range of cancer patients.”
EC/OC
【2024 CSCO：Oral report by Dr.Zhuo Yang】
On the morning of September 28, Dr. Zhuo Yang from Liaoning Provincial Cancer Hospital shared the results of safety and efficacy of sac-TMT in pts with previously treated advanced endometrial carcinoma (EC) and ovarian cancer (OC) from a Phase 2 Study. In the endometrial cancer cohort, 44 EC pts were enrolled and median follow-up time was 7.2 mo. 52.3% of pts had received ≥ 2 prior lines of therapy. The ORR was 34.1% (15/44, 12 confirmed) and DCR was 75%. Median PFS was 5.7 mo (95% CI: 3.7, 9.4) with 6-mo PFS rate of 47.5%.
40 OC pts were enrolled and median follow-up time was 28.2 mo. All pts had received ≥ 2 prior lines of therapy (80% of pts ≥ 3 prior lines). 87.5% of pts were platinum-resistant. The ORR was 40% (16/40, 14 confirmed) and DCR was 75%. mPFS was 6.0 mo (95% CI: 3.9, 7.3); mo was 16.5 mo (95% CI: 10.7, NE). In the pts with TROP2 IHC H-score > 200 (n=13) or H-score ≤ 200 (n=22), the ORR was 61.5% (8/13, 7 confirmed) and 27.3% (6/22, 6 confirmed) respectively. In the pts with platinum-resistant (n=35), mPFS was 6.0 mo (95% CI: 5.3, 7.3) and mOS was 16.1 mo (95% CI: 10.5, NE).
Prof Danbo Wang said, “Ovarian cancer and endometrial cancer have their own epidemiological characteristics, and the incidence rate of endometrial cancer in developed cities in China is increasing year by year, and it may become the top gynecological malignant tumor in Chinese women in the future. In contrast, ovarian cancer is characterized by insidious onset, high late detection rate and high mortality rate. Exploring new therapeutic strategies to overcome platinum resistance and improve the survival rate of ovarian cancer patients is a key direction for future research. Sac-TMT shows great potential in the treatment of advanced endometrial and ovarian cancers. It has not only achieved remarkable results in terms of efficacy, but also well controlled safety. I believe that in the future research and application, it will become a leader in the field of ADC innovative drug development and bring new hope to more gynecological oncology patients.”
With a caring heart, Kelun-Biotech is committed to solving unmet clinical needs in China and around the world. By focusing on its own technological strengths, Kelun-Biotech is able to provide patients in China with novel ADC drugs with significant clinical value and excellent cost-effectiveness, and to enhance the benefits for clinical patients. In the future, we will continue to accelerate the R&D and clinical progress of our drug candidates, enhance our integrated drug development capabilities, and contribute to the realization of Healthy China 2030.
2024-09-29
Multiple Study Results of Kelun-Biotech’s TROP2-ADC SKB264 (sac-TMT) At 2024 CSCO Congress
More
From September 25th to 29th, the 27th China Clinical Oncology Congress and the 2024 CSCO Annual Meeting were held in Xiamen. Experts and scholars in the field of oncology from all over China gathered together to discuss the hotspots at the forefront of clinical practice. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”, 6990.HK) presented multiple clinical research results and progress of TROP2 ADC sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) at the conference.
TNBC
【2024 CSCO：Oral report by Academician Binghe Xu 】
On the afternoon of September 27, Academician Binghe Xu from the Cancer Hospital of the Chinese Academy of Medical Sciences gave an oral presentation and paper discussion on the results of the Phase III OptiTROP-Breast01 study of sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC) in the Innovative Drugs Clinical Data Session.
The median PFS assessed by BICR was 6.7 months (95% CI, 5.5 to 8.0) with SKB264 and 2.5 months (95% CI, 1.7 to 2.7) with chemotherapy; The sac-TMT group had a 68% reduction in risk of disease progression or death compared to the chemotherapy group (HR 0.32; 95% CI, 0.22 to 0.44; P <0.00001). In the subset of pts with TROP2 H-score > 200, the median PFS was 8.3 months with SKB264 and 2.3 months with chemotherapy (HR 0.29; 95% CI, 0.19 to 0.46). The median OS was not reached (95% CI, 11.2 to NE) with SKB264 and 9.4 months (95% CI, 8.5 to 11.7) with chemotherapy. The sac-TMT group had a 47% reduction in risk of death compared to the chemotherapy group (HR 0.53; 95% CI, 0.36 to 0.78; P =0.00005). Compared to the investigator's choice of chemotherapy, sac-TMT for metastatic TNBC patients showed statistically and clinically significant improvements in PFS and OS, with a manageable safety profile, and could be a new and effective therapeutic option for this group of patients.
Binghe Xu said, “Breast cancer is a highly prevalent malignant tumor in the world, threatening women's lives and health, among which, triple-negative breast cancer is also known as ‘the most toxic’ breast cancer due to its poor therapeutic effect. The future direction of advanced triple-negative breast cancer treatment is precise and stratified treatment. Sac-TMT can help to meet more treatment needs of patients, and may be expected to become the new standard of second-line treatment for advanced triple-negative breast cancer in the future. For the research and development of ADC, domestic enterprises have gone through the stages of catching up and running parallel to each other, and now they have become an important force in the global ADC innovation technology, and we believe that one day, patients with advanced triple-negative breast cancer can get more effective treatment through ADC innovative drugs.”
NSCLC
【2024 CSCO：Oral report by Prof.Wengfeng Fang】
On the afternoon of September 28, Prof. Wenfeng Fang from the Affiliated Cancer Hospital of Sun Yat-sen University orally reported the results of the Phase II OptiTROP-Lung01study, a first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC) with sac-TMT in combination with KL-A167, an anti-PD-L1 monoclonal antibody, in the session of Clinical Data of Innovative Drugs, with a paper discussion.
Pts with treatment naive advanced NSCLC without actionable genomic alterations were enrolled to receive SKB264 5 mg/kg Q3W + KL-A167 1200 mg Q3W (cohort 1A，130 Pts) or SKB264 5 mg/kg Q2W + KL-A167 900 mg Q2W (cohort 1B,133 Pts) in a non-randomized manner. After median follow up of 14.0 mo and 6.9 mo for cohort 1A and 1B, the ORR was 48.6% (18/37, 2 pending confirmation), DCR was 94.6% and median PFS was 15.4 mo (95% CI: 6.7, NE) with 6-mo PFS rate of 69.2% for cohort 1A ; the ORR was 77.6% (45/58, 5 pending confirmation), DCR was 100% and median PFS was not reached with 6-mo PFS rate of 84.6% for cohort 1B.
Prof. Wenfeng Fang said, “The emergence of ADC drugs is epoch-making. The dual-drug regimen of sac-TMT combined with immunotherapy is leading a new direction in the exploration of first-line treatment for advanced NSCLC, with very stunning efficacy observed in the preliminary study data. In the future, the potential for the application of sac-TMT in the treatment of NSCLC is worth looking forward to, and sac-TMT is expected to provide diversified treatment options and better survival benefits for more patients, both in the driver-negative and EGFR-mutated patient populations.”
CC
【2024 CSCO：Oral report by Pro.Jing Wang】
On the morning of September 28, Professor Jing Wang from Hunan Cancer Hospital orally reported the results of Efficacy and Safety of sac-TMT Plus Pembrolizumab in patients with recurrent or metastatic cervical cancer. Pts with R/M CC who had progressed on or after platinum-doublet chemotherapy and received no more than 2 systemic therapies for R/M disease were enrolled.38 pts were treated and followed up for at least 17 weeks or 2 tumor assessments. The median follow-up was 6.2 mo, The ORR was 57.9% (22/38, 3 unconfirmed), with 3 complete responses. Responses were also observed in pts were pre-treated with anti-PD-1 based therapy. Median PFS was not reached and 6-mo PFS rate was 65.7%.
Professor Jing Wang said, “Cervical cancer highly expresses TROP2, and previous studies have suggested that the overexpression ratio is more than 90%. High TROP2 expression is closely related to the poor prognosis of tumor patients, and it may also be related to the sensitivity of some drug therapies, which makes it a good target to explore. It is believed that with these promising results, more studies will emerge in the field of gynecologic oncology in the future to further validate these findings and bring hope to a wider range of cancer patients.”
EC/OC
【2024 CSCO：Oral report by Dr.Zhuo Yang】
On the morning of September 28, Dr. Zhuo Yang from Liaoning Provincial Cancer Hospital shared the results of safety and efficacy of sac-TMT in pts with previously treated advanced endometrial carcinoma (EC) and ovarian cancer (OC) from a Phase 2 Study. In the endometrial cancer cohort, 44 EC pts were enrolled and median follow-up time was 7.2 mo. 52.3% of pts had received ≥ 2 prior lines of therapy. The ORR was 34.1% (15/44, 12 confirmed) and DCR was 75%. Median PFS was 5.7 mo (95% CI: 3.7, 9.4) with 6-mo PFS rate of 47.5%.
40 OC pts were enrolled and median follow-up time was 28.2 mo. All pts had received ≥ 2 prior lines of therapy (80% of pts ≥ 3 prior lines). 87.5% of pts were platinum-resistant. The ORR was 40% (16/40, 14 confirmed) and DCR was 75%. mPFS was 6.0 mo (95% CI: 3.9, 7.3); mo was 16.5 mo (95% CI: 10.7, NE). In the pts with TROP2 IHC H-score > 200 (n=13) or H-score ≤ 200 (n=22), the ORR was 61.5% (8/13, 7 confirmed) and 27.3% (6/22, 6 confirmed) respectively. In the pts with platinum-resistant (n=35), mPFS was 6.0 mo (95% CI: 5.3, 7.3) and mOS was 16.1 mo (95% CI: 10.5, NE).
Prof Danbo Wang said, “Ovarian cancer and endometrial cancer have their own epidemiological characteristics, and the incidence rate of endometrial cancer in developed cities in China is increasing year by year, and it may become the top gynecological malignant tumor in Chinese women in the future. In contrast, ovarian cancer is characterized by insidious onset, high late detection rate and high mortality rate. Exploring new therapeutic strategies to overcome platinum resistance and improve the survival rate of ovarian cancer patients is a key direction for future research. Sac-TMT shows great potential in the treatment of advanced endometrial and ovarian cancers. It has not only achieved remarkable results in terms of efficacy, but also well controlled safety. I believe that in the future research and application, it will become a leader in the field of ADC innovative drug development and bring new hope to more gynecological oncology patients.”
With a caring heart, Kelun-Biotech is committed to solving unmet clinical needs in China and around the world. By focusing on its own technological strengths, Kelun-Biotech is able to provide patients in China with novel ADC drugs with significant clinical value and excellent cost-effectiveness, and to enhance the benefits for clinical patients. In the future, we will continue to accelerate the R&D and clinical progress of our drug candidates, enhance our integrated drug development capabilities, and contribute to the realization of Healthy China 2030.
2024-08-20
Kelun-Biotech’s TROP2-ADC SKB264 (sac-TMT) Second NDA Accepted by NPMA, locally advanced or metastatic EGFR-mutant NSCLC
More
On August 20, the new drug application (NDA) for the core product sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) based on the positive results from the pivotal OptiTROP-Lung03 study has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”, 6990.HK)
OptiTROP-Lung03 is a multi-center, randomized, pivotal clinical study that evaluates sac-TMT monotherapy 5mg/kg every other week (Q2W) as an intravenous injection versus docetaxel for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) who failed after treatment with EGFR-tyrosine kinase inhibitor (TKI) therapy and platinum-based chemotherapy. At a pre-specified analysis, sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR) and progression-free survival (PFS) compared with docetaxel.
Lung cancer mainly includes non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), of which NSCLC is the most common pathological type, accounting for about 80%-85% of all lung cancers. The molecular typing of NSCLC patients in China is different from that of Western populations, and EGFR mutation is a common variant gene type, accounting for about 40%-50% of lung adenocarcinoma patients in China [1]. According to the 2024 CSCO guidelines, EGFR-TKIs are the preferred treatment for stage IV EGFR-mutant NSCLC [2]; platinum-containing chemotherapy is the main first-line chemotherapy regimen after resistance to EGFR-TKIs; and existing treatment regimens are ineffective in those who have failed EGFR-TKIs and platinum-containing chemotherapy. Single-agent chemotherapy is the current standard of care for this population, and docetaxel is the most commonly used single-agent chemotherapy, with an ORR of 3.2%-10.8%, a median PFS of only about 2 months, and a median OS of about 6-8 months [3,4,5,6,7]. For patients with locally advanced or metastatic EGFR-mutated NSCLC who have failed treatment with EGFR-TKIs and who have failed platinum-containing chemotherapy, the existing treatment regimens are less efficacious, there is a large unmet clinical need, and new drugs are urgently needed to improve patient survival.
Kelun-Biotech has filed the Application for sac-TMT for injection for the treatment of patients with locally advanced or metastatic EGFR-mutant NSCLC who failed after treatment with an EGFR-TKI and platinum-based chemotherapy.
The Application is the second NDA for sac-TMT that has been accepted by the NMPA. On August14, 2024, it was announced on the official website of the CDE that the Application was plannedto be included in the priority review and approval process of the CDE. Previously, an NDA for sac-TMT in patients with locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) was accepted by the NMPA.
Dr. Junyou Ge, CEO of Kelun-Biotech, said, “It is a great honor to have the second NDA of SKB264 accepted. Kelun-Biotech has always adhered to an innovation-driven development strategy, actively exploring cutting-edge technologies and new approaches to the treatment of major diseases. In response to unmet medical needs, we are committed to the original innovation of new drugs with differentiated advantages and international potential. By enhancing our end-to-end innovative drug development capabilities, we continuously improve the efficiency and success rate of drug research and development, and make every effort to move forward our clinical research progress. We are dedicated to continuously exploring and rapidly validating the clinical value of core projects. The company will always be guided by a caring heart, striving for excellence, and contributing to the great global oncology health cause.”
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs.
At present, the Company has more than 30 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including over 10 projects in the clinical stage and 4 projects in the NDA stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC?, and has 5 ADC projects in the clinical stage (2 of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.
References:
[1] [Chinese Society of Clinical Oncology (CSCO)(2024)] Guidelines for the diagnosis and treatment of non-small cell lung cancer.
[2] [Chinese Society of Clinical Oncology (CSCO)(2024)] Guidelines for the diagnosis and treatment of non-small cell lung cancer.
[3] Hanna N,Shepherd FA, Fossella Fv, et al.(2004)
[4] Randomized Phase lll Trial of Pemetrexed, versus Docetaxel in Patients with Non-Small-Cell Lung CancerPreviously Treated with Chemotherapy.Journa otClcaOncology,22:1589-1597.
[5] Jyoti D. Patel, Mleng J, et al. (2023) Clinical charateristics, real-world treatment patterns, and clinicaloutcomes among patients with previously treated metastatic or unresectable EGFR-mutated non-small cellung cancer in the United States. Cancer Research.83:6754.
[6] KawaguchiT, Ando M. Asami K, et a. 2014) Randomized phase ll trlal of erlotnib versus docetaxe assecond- or third-line therapy in patients with advanced non-small-cell lung cancer. Docetaxel and Erlotinibung Cancerlra (DEhA)Journa of cinica32(18):1902-1908.
[7] Krzakowski M, Ramlau R, Jassem J, et al. (2010)] Phase Ⅲ trial comparing vinflunine with docetaxel in second-line advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy. Journal of Clinical Oncology, 28(1.
2024-06-18
Kelun-Biotech ADC Innovator SKB518 for Advanced Solid Tumors Receives CDE Clinical Trial Approval Notification
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("Kelun-Biotech" or the "Company", SEHK: 6990.HK) announces that the Company has received a Notice of Clinical Trial Approval (IND) for SKB518, an innovative ADC drug developed by the Company, in patients with advanced solid tumors from the Center for Drug Evaluation (CDE) of the State Drug Administration (NDA). (CDE) of the National Drug Administration (NMPA) for the approval of the clinical trial application (IND) of SKB518 for injection, an innovative ADC drug developed by the Company, to conduct clinical trials in patients with advanced solid tumors.
SKB518 for injection is an innovative antibody-coupled drug with proprietary intellectual property rights developed by the Company by utilizing the "OptiDC?" platform technology in light of the biological characteristics of the target site, and it has demonstrated good efficacy and safety window in the preclinical stage.
Dr. Junyou Ge, Chief Ｅxecutive Officer of Kelun-Biotech, said, "The entry of SKB518 into clinical trials enriches Kelun-Biotech's clinical product portfolio in the field of oncology ADC therapeutics, and paves a broader path for the company's flexible development of future pipelines in the oncology field. We are simultaneously accelerating the independent research and development of more than 10 preclinical-stage ADCs and novel coupling technology drug assets, and this year we plan to continue to file clinical INDs for a number of preclinical ADC pipelines."
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs.
At present, the Company has more than 30 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including over 10 projects in the clinical stage and 4 projects in the NDA stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC?, and has 5 ADC projects in the clinical stage (2 of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.
2024-05-24
ASCO 2024| Two Abstracts of the Study Results of Kelun-Biotech’s TROP2-ADC SKB264/sac-TMT Published Today–OptiTROP-Breast01 study AND the OptiTROP-Lung01 study
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(May 24th, Chengdu and New Jersey) The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago, Illinois, the United States of America from May 31 to June 4, 2024, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) will present two clinical stage study results at ASCO.
1.The Phase 3 OptiTROP-Breast01 study of its anti-TROP2 ADC sacituzumab tirumotecan (sac-TMT) (formerly SKB264/MK-2870) in patients with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC).
? Session: Special clinical science symposium (Abstract #104; Next-Generation Antibody–Drug Conjugates: The Revolution Continues),
? Time: June 2, 2024, 9:45 AM to 11:15 AM local time
2. The Phase 2 OptiTROP-Lung01 study of sac-TMT in combination with KL-A167 (an anti-PD-L1 mAb) as 1L treatment for patients with advanced non-small cell lung cancer (NSCLC)
? Session: oral (Abstract #8502; Lung Cancer—Non-Small Cell Metastatic Oral)
? Time: May 31, 2024, 2:45 PM to 5:45 PM local time.
Sac-TMT is jointly developed by Kelun-Biotech and MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) at clinical stage.
The abstracts for the above studies were published on ASCO’s official website on [May 23, 2024], local time. The study results are summarized as follows:
TNBC
Patients were randomly assigned (1:1) to receive sac-TMT (n = 130) or chemotherapy (n = 133). The median age was 51 years; 87% had visceral metastases; 26% received prior PD-1/PD-L1 inhibitors; 48% received three or more prior lines of chemotherapy for advanced disease. The primary endpoint of progression free survival (PFS) was met based on interim analysis (data cut-off: Jun 21, 2023) with a 69% reduction in risk of progression or death (HR 0.31; 95% CI, 0.22 to 0.45; P <0.00001).
The median PFS, as assessed by BICR, was 5.7 months (95% CI, 4.3 to 7.2) with sac-TMT and 2.3 months (95% CI, 1.6 to 2.7) with chemotherapy; PFS rate at 6 months was 43.4% vs 11.1%. In the subset of patients with trophoblast cell-surface antigen 2 (TROP2) H-score > 200, the median PFS was 5.8 months with sac-TMT and 1.9 months with chemotherapy (HR 0.28; 95% CI, 0.17 to 0.48). At the first planned interim analysis for overall survival (OS) (data cut-off: Nov 30, 2023) with median follow-up of 10.4 months, OS was statistically significant in favor of sac-TMT (HR 0.53; 95% CI, 0.36 to 0.78; P =0.0005); the median OS was not reached (95% CI, 11.2 to NE) with sac-TMT and 9.4 months (95% CI, 8.5 to 11.7) with chemotherapy. The objective response rate (ORR) assessed by BICR was 43.8% with sac-TMT and 12.8% with chemotherapy.
Most common grade ≥ 3 treatment-related adverse events (TRAEs) (sac-TMT vs. chemotherapy) were neutrophil count decreased (32.3% vs. 47.0%), anemia (27.7% vs. 6.1%) and white blood cell count (WBC) decreased (25.4% vs. 36.4%).
A Phase 3 global study led by MSD of sac-TMT plus pembrolizumab versus treatment of physician's choice (TPC) in TNBC who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery (NCT06393374) and a Phase 3 study led by the Company of sac-TMT in China for 1L treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative TNBC (NCT06279364) are ongoing.
NSCLC
Patients with treatment naive advanced NSCLC without actionable genomic alterations were enrolled to receive sac-TMT 5 mg/kg Q3W plus KL-A167 1200 mg Q3W (cohort 1A) or sac-TMT 5 mg/kg Q2W plus KL-A167 900 mg Q2W (cohort 1B) in a non-randomized manner until disease progression or unacceptable toxicity. As of January 02, 2024, 40 and 63 patients have been enrolled in cohort 1A and 1B, respectively. Median ages were 63/63 years (cohort 1A/1B); 97.5%/85.7% had Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 1; 30.0%/33.3%, 32.5%/30.2% and 37.5%/36.5% of patients had programmed death ligand 1 (PD-L1) expression < 1%, 1%-49% and ≥ 50% of tumor cells by IHC 22C3 pharmDx assay, respectively.
After median follow up of 14.0 months for cohort 1A, the ORR was 48.6% (18/37, 2 pending confirmation), disease control rate (DCR) was 94.6% and median PFS was 15.4 months (95% CI: 6.7, NE) with a 6-month PFS rate of 69.2%. After median follow-up of 6.9 months for cohort 1B, the ORR was 77.6% (45/58, 5 pending confirmation), DCR was 100% and median PFS was not reached with a 6-month PFS rate of 84.6%. Additional subgroup analyses of cohort 1B are shown in the following table:
*Including confirmed or unconfirmed response. ORR was calculated based on response evaluable population defined as patients with ≥ 1 on-study scans.
In cohorts 1A and 1B, the most common Grade ≥ 3 TRAEs were neutrophil count decreased (30.0%/30.2%), WBC decreased (5.0%/17.5%), anemia (5.0%/15.9%), rash (5.0%/6.3%) and drug eruption (7.5%/0). Treatment-related adverse events leading to discontinuation of sac-TMT occurred in 1 patient of cohort 1B due to drug hypersensitivity, and there were no treatment-related deaths.
Two Phase 3 global studies led by MSD of sac-TMT in patients with 3L+ EGFR mutant NSCLC (NCT06074588), and 2L EGFR mutant NSCLC (NCT06305754) and a Phase 3 study led by the Company of sac-TMT in China in patients with 2L EGFR mutant NSCLC (NCT05870319) are ongoing. Additionally, Three Phase 3 global studies led by MSD of sac-TMT plus pembrolizumab are ongoing: One in patients with 1L Metastatic Squamous NSCLC (NCT06422143) , a second in patients with metastatic NSCLC expressing PD-L1 ≥ 50% (NCT06170788), and the third in patients with resectable NSCLC not achieving a pathological complete response (NCT06312137) .
2024-05-20
Twenty-eight years of riding with the wind I grow with Kelun - Kelun Group 28th Anniversary Series Activities Successfully Held
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On May 16, 2024, Kelun Group celebrated the Group's twenty-eighth birthday. On the occasion of the 28th birthday of Kelun Group, Kelun-Biotech (6990.HK), together with Kelun Research Institute, honored the long-serving employees and celebrated with them. The "28 years of riding the wind together, I grow with Kelun" series of staff activities came to a successful conclusion.
Activity 1: "Cultural Symbiosis" Theme Activity
The "Cultural Symbiosis" activity began with the firm and powerful "Elite Oath" of 170 employees from 34 teams. In the "Culture Lecture - Side by Side - Culture Transmission - Working Together - Dedication to Factory Day" competition, colleagues within the team support each other to work together, the teams learn from each other to catch up with each other, in a pleasant and intense atmosphere to promote the corporate culture, enhance the team cohesion, and match the style of the people of Kelun!
Highlights of the event
Activity 2: "All the Way" Long-term Service Employee Recognition Ceremony
To fight for the waves, a group of Kelun people have been working together with great expertise. In order to inspire and thank the long-serving employees of Kelun, on May 16th, the Group's birthday, Kelun-Biotech and Kelun Research Institute honored more than 40 employees who have joined Kelun Group for 15 years and above.
At the recognition ceremony, the company management presented each long-service employee with a certificate of honor and a souvenir. Employees are one of the most valuable assets of Kelun, they have traveled with Kelun all the way, not only witnessed the growth of the company, but also promoted the development of the company so far.
Kelun-Biotech also looks forward to more employees joining the ranks of long-term service in the future, witnessing the growth of Colum, meeting more challenges and opportunities together with the company, and becoming the backbone of promoting the development of the company.
"Twenty-eight years of riding the wind together, I grow up with Kelun", all the staff of Kelun-Biotech will be with good wishes for Kelun, and with the company to sail the waves together to make a new chapter!
2024-05-16
Warmly celebrate the 28th anniversary of Kelun Group
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2024-05-04
Kelun-Biotech X Ellipses | Second Generation Selective RET Inhibitor A400 (EP0031) Receives FDA Approval for Phase 2 Clinical Trial
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(stock code: 6990.HK, hereinafter referred to as "Kelun-Biotech" or the "Company") has received approval from the U.S. Food and Drug Administration (FDA) to conduct Phase 2 clinical trials for its main product, A400 (also known as KL590586 or EP0031). (also known as KL590586 or EP0031), the Company's main product, has been approved by the U.S. Food and Drug Administration (FDA) for Phase 2 clinical trials.
A400 (EP0031) is a second-generation selective RET inhibitor (SRI) with broad activity against common RET gene fusions and mutations, designed to address clinical needs not met by first-generation SRIs. Targeting RET-driven cancers, next-generation SRIs offer potentially more diverse treatment options and may further improve patient prognosis.
In March 2021, Kelun-Biotech granted an exclusive, paid-up license to Ellipses Pharma Limited ("Ellipses"), a UK-based pharmaceutical company, to develop, manufacture and commercialize A400 (EP0031) in all countries outside of Greater China, North Korea, South Korea, Singapore, Malaysia and Thailand. (EP0031) in all countries except Greater China, Korea, South Korea, Singapore, Malaysia and Thailand.
In June 2022, A400 (EP0031) received FDA approval of an Investigational New Drug (IND) application for a Phase 1/2 trial in patients with RET-altered malignancies.
In November 2023,A400 was granted orphan drug status designation by the FDA for the treatment of RET fusion-positive solid tumors.
In March 2024, A400 was granted Fast Track designation by the FDA for the treatment of RET fusion-positive non-small cell lung cancer (NSCLC).
Currently, Kelun-Biotech is conducting a pivotal clinical study of A400 (EP0031) in China in RET-positive NSCLC.
In preclinical studies, A400 (EP0031) demonstrated favorable inhibitory activity against major RET kinases in vitro and in vivo, and A400 (EP0031) also demonstrated good blood-brain barrier penetration in animal models.
Data on A400 (EP0031) shared at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting showed that, based on the results of its ongoing Phase 1/2 trial, A400 (EP0031) demonstrated good anti-tumor efficacy in patients with advanced RET+ solid tumors, particularly in first- and second- or higher-line advanced RET+ NSCLC, with ORRs of 80.8% and 69.7%. The DCR in both cases was reported to be more than 96%.
At the upcoming 2024 ASCO Annual Meeting, the Company's partner Ellipses will report clinical data from the A400 (EP0031) Phase 1 dose-escalation and extension study conducted in patients with advanced RET variant NSCLC and other oncology treatments who have never been treated with an SRI or prior therapy on June 3, 2024 (local time).
Kelun-Biotech is committed to developing innovative medicines with features and advantages to address global unmet clinical needs, and the company will also accelerate the development of the drug in China and work with its partner Ellipses to advance the global development and commercialization of A400 (EP0031) to benefit more oncology patients around the world.
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs.
At present, the Company has more than 30 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including over 10 projects in the clinical stage and 4 projects in the NDA stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC?, and has 5 ADC projects in the clinical stage (2 of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.