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2023 ASCO | Kelun Biotech SKB264 (TROP2-ADC) releases research data of non-small cell lung cancer for the first time

On May 25, US Eastern Time, the official website of the 2023 ASCO Annual Meeting published abstracts of some of the selected studies for the meeting. The innovative TROP2-ADC (SKB264, MK-2870) jointly developed by Kelun-Biotech and MSD (the tradename of Merck & Co., Inc Rahway NJ USA), with the Phase 2 expansion study data for previously treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), has been published on the official website of ASCO.

The data cut-off is February 9, 2023, and the median follow-up time is 11.5 months.

Efficacy: 39 NSCLC patients were evaluable for efficacy (who had received SKB264 at 5 mg/kg, Q2W): the objective response rate (ORR) was 44% (17/39), the disease control rate (DCR) was 95% (37/39), the median duration of response (DoR) was 9.3 months, and the 6-month DoR rate was 77%.

In the EGFR mutant subgroup, all patients were EGFR-TKI resistant, and 50% of the patients had received at least one chemotherapy regimen. Subgroup analysis showed that the ORR was 60% (12/20), the disease control rate (DCR) was 100% (20/20), and the median progression-free survival (PFS) was 11.1 months, with 9-month PFS rate of 66.7%.

In the EGFR wild-type subgroup, all patients had previously failed anti-PD-1/L1 therapy and the median prior lines of therapy was 2. Among this subgroup, the ORR was 26% (5/19), the DCR was 89% (17/19), the median PFS was 5.3 months, and the 9-month overall survival (OS) rate was 80.4%.

Safety: Grade ≥3 treatment-related adverse events (TRAEs) were reported in 67.4% (29/43) of patients. The most common Grade ≥3 TRAEs (≥ 5%) were decreased neutrophil count, anemia, decreased white blood cell count, oral mucositis, rash, and decreased lymphocyte count. Most blood-related adverse events occurred within two months of starting SKB264 treatment and recovered after treatment with granulocyte colony-stimulating factor and erythropoietin. TRAEs led to a dose reduction rate of 23.3%, and no discontinuation or death due to TRAEs occurred. No neurotoxicity or drug-related interstitial lung disease (ILD)/pneumonitis was observed.

In previously treated patients with locally advanced or metastatic NSCLC, SKB264 demonstrated encouraging antitumor activity and a manageable safety profile. A Phase 3 registrational study of SKB264 for the treatment of locally advanced or metastatic NSCLC is in progress.

About SKB264 (TROP2-ADC)
SKB264 is a new generation of antibody-drug conjugates (ADC) composed of a humanized
monoclonal antibody targeting TROP2, an enzymatically cleavable linker and a novel topoisomerase I inhibitor for which Kelun-Biotech has independent intellectual property rights. SKB264 combines the specificity of monoclonal antibodies to target antigens on the surface of tumor cells and the high cell-killing efficiency of cytotoxic drugs. SKB264 has been granted breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic triple-negative breast cancer and locally advanced or metastatic EGFR-mutated non-small cell lung cancer.

Based on preliminary clinical data, SKB264 is currently conducting Phase 2 and Phase 3 clinical trials involving monotherapy and combination therapy for multiple tumor types. In China, the Phase 3 registrational clinical study of SKB264 monotherapy for advanced or metastatic TNBC patients who have failed at least second-line treatment is progressing smoothly, and it is expected to become the first domestic TROP2-ADC approved for marketing. Phase 3 clinical research of SKB264 monotherapy for TKI-resistant EGFR-mutated non-small cell lung cancer patients is also rapidly advancing. Several Phase 2 clinical studies of SKB264 combined with pembrolizumab (KEYTRUDA?, MSD’s anti-PD-1 therapy) or KL-A167 (anti-PD-L1 monoclonal antibody) are under development. In addition, Kelun-Biotech has granted an exclusive license to MSD to manufacture, develop, and commercialize SKB264 (also known as MK-2870) outside of Greater China territories (Greater China includes Mainland China, Hong Kong, Macau and Taiwan). Global clinical research in several major countries, including United States, Canada, Australia, France, Spain, Belgium and Poland, are currently ongoing while additional multi-center clinical studies are also under preparation.

About Kelun-Biotech
Kelun-Biotech is a holding subsidiary of Kelun Pharmaceutical, focusing on the R&D, production, commercialization and international cooperation of innovative biologics and small molecule drugs. Focusing on the unmet clinical needs in China and the rest of world, the company aims to treat major diseases, including solid tumors, autoimmune, inflammatory and metabolic diseases. By building an international drug R&D and industrialization platform, the company strives to become an international leading enterprise in the field of innovation. Significant progress has been made in the field of biologic drugs, including ADC, monoclonal antibody, bispecific antibody, as well as novel targets for innovative small molecule drug discovery, etc. The world-renowned ADC R&D platform, OptiDC, has been successfully established, from which 4 ADCs are in the clinical research stage, and several are in the preclinical research stage. The company currently has 33 innovative projects for the treatment of major diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease, including 14 projects advancing in clinical research, of which 3 are being carried out concurrently in China and the United States.

Business Development Team

Saturday, May 27, 2023

KLUS Pharma will attend 2023 ASCO Annual Meeting in Chicago from June 2-6th.

KLUS Pharma is the US subsidiary of Kelun-Biotech, a mid-sized innovative biopharma company based in Chengdu, China. Kelun-Biotech is committed to the development of innovative therapies to address the unmet needs of patients with advanced cancer and other serious illnesses. Currently, we are advancing several antibody-drug conjugates (ADCs) and immuno-oncology assets in ongoing clinical trials for advanced solid tumors, including lung, breast, gastric, and others. We are excited to share recent progress and review the latest data updates being presented at ASCO and look forward to meeting potential collaborators and colleagues!

Business Development Team

Saturday, May 27, 2023

KLUS Pharma will attend the BIO International Convention partnering event held live in Boston, MA from June 5-8, 2023.

KLUS Pharma is the US subsidiary of Kelun-Biotech, a mid-sized innovative biopharma company based in Chengdu, China. Kelun-Biotech is advancing a broad pipeline of small molecules, monoclonal antibodies, antibody drug conjugates (ADCs), and cell therapies for the treatment of cancer, autoimmune, metabolic, and cardiovascular diseases. With over ten clinical-stage assets and dozens of promising preclinical candidates, we are actively seeking strategic partners to help accelerate the global development of these promising therapeutic candidates. In addition, we are also seeking in-licensing opportunities for the Greater China market, including innovative therapeutics in oncology, autoimmune, metabolic, and cardiovascular diseases areas. Clinical-stage assets with preliminary safety and efficacy data are preferred. We also consider selective generic products suitable for the China market in the following therapeutic spaces: neurology, infectious disease, reproductive health, and fertility treatments.

Click the link below to request a meeting with KLUS Pharma through the BIO partnering system!
https://login.partnering.bio.org/inova-business-platform/webclient/#/bio/12401/hub
We look forward to meeting potential collaborators at the event!

Business Development Team

Friday, April 14, 2023

KLUS Pharma will attend the 2023 AACR Annual Meeting held live in Orlando, Florida from April 14-19.

KLUS Pharma is the US subsidiary of Kelun-Biotech, a mid-sized innovative biopharma company based in Chengdu, China. Kelun-Biotech is advancing a broad pipeline of small molecules, monoclonal antibodies, and antibody-drug conjugates (ADCs) for the treatment of cancer. With multiple programs in late stage clinical trials, such as HER2 ADC to treat HER2+/HR- metastatic breast cancer, and TROP2 ADC for the treatment of a wide range of solid tumors, Kelun-Biotech is aiming to address the unmet needs of cancer patients by bringing novel, safer, and affordable medicines to market. In this current competitive landscape, we believe it is more important than ever to work with potential collaborators to achieve meaningful advances in this field, including exploring combination therapy synergies, leveraging regional/global clinical trial resources, and striving to improve existing discovery and development capabilities.

Therefore, we are looking forward to meeting potential collaborators and exploring all the latest ground-breaking research to be presented at AACR Annual Meeting, which has served as a premier event for scientists, clinicians, industry, and patients to meet and share knowledge for advancing the treatment of cancer.

Business Development Team

Tuesday, April 11, 2023

KLUS Pharma will attend Bio-Europe Spring partnering event held live in Basel, Switzerland from March 20-22 and virtually from March 28-30, 2023. KLUS Pharma is the US subsidiary of Kelun-Biotech, a mid-sized innovative biopharma company based in Chengdu, China. Kelun-Biotech is advancing a broad pipeline of small molecules, monoclonal antibodies, antibody drug conjugates (ADCs), and cell therapies for the treatment of cancer, autoimmune, metabolic, and cardiovascular diseases. With over ten clinical-stage assets and dozens of promising preclinical candidates, we are actively seeking strategic partners to help accelerate the global development of these promising therapeutic candidates. In addition, we are also seeking in-licensing opportunities for the Greater China market, including innovative therapeutics in oncology, autoimmune, metabolic, and cardiovascular diseases areas. Clinical-stage assets with preliminary safety and efficacy data are preferred. We also consider selective generic products suitable for the China market in the following therapeutic spaces: neurology, infectious disease, reproductive health, and fertility treatments.

Click the link below to request a meeting with KLUS Pharma through the BIO partnering system!
https://partneringone.informaconnect.com/event/731/
We look forward to meeting potential collaborators at the event!

Business Development Team

Monday, March 13, 2023

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Kelun-Biotech (a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd), a clinical-stage biotech company focused on biologic and small molecule discovery and development, today announced that the companies have entered into an exclusive license and collaboration agreement to develop seven investigational preclinical antibody-drug conjugates (ADC) for the treatment of cancer.

“Advances in ADC technologies are yielding a new generation of candidates designed to more precisely target and deliver potent anticancer agents to the tumor site,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “We continue to augment our oncology pipeline and look forward to working with the Kelun-Biotech team to advance these candidates to the patients that need them.”
Under the agreement, Kelun-Biotech has granted Merck exclusive global licenses to research, develop, manufacture and commercialize multiple investigational preclinical ADC therapies and exclusive options to obtain additional licenses to ADC candidates. Kelun-Biotech retains the right to research, develop, manufacture and commercialize certain licensed and option ADCs for mainland China, Hong Kong and Macau.

“The further expansion of our collaboration with Merck provides a strong endorsement for our technology from a leader in the development of cancer treatments,” said Dr. Junyou Ge, chief Ｅxecutive officer of Kelun-Biotech. “We are grateful for our partnership with the Merck scientists.” Kelun-Biotech will receive an upfront payment of $175 million from Merck. Kelun-Biotech is also eligible to receive future development, regulatory and sales milestone payments totaling up to $9.3 billion, if Kelun-Biotech does not retain mainland China, Hong Kong and Macau rights for the option ADCs and all candidates achieve regulatory approval, plus tiered royalties on net sales for any commercialized ADC product. Merck also intends to make an equity investment in Kelun-Biotech. The transaction is subject to customary closing conditions including regulatory approval under the Hart-Scott Rodino (HSR) Act and approvals by the shareholders of Kelun-Biotech and Sichuan Kelun Pharmaceutical Co., Ltd.

This announcement follows previously disclosed research collaboration and licensing agreements for two ADC candidates including MK-2870 (also known as SKB-264), an investigational TROP2 targeting ADC currently being evaluated in late-stage clinical trials.

Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.
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About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube, and LinkedIn.
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About Kelun-Biotech
Kelun-Biotech is a clinical-stage biotech company established in 2016, a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd, engaged in biologic therapeutics as well as small molecule discovery and development. The company focuses on unmet medical needs such as oncology and autoimmune conditions and strives to be a leader in novel therapeutic discovery and development. Since its inception, Kelun-Biotech has established multi-modal drug discovery platforms based on global standards and made important development breakthroughs in antibody-drug conjugation, immuno-oncology, bispecific antibody and novel small molecule targeting and designs.

Kelun-Biotech’s current pipeline includes 33 therapeutic programs for the treatment of cancers, autoimmune conditions, infectious diseases, and metabolic syndromes. Fourteen programs are in clinical development in China, two of which have entered into clinical development in the US. Most notably, Kelun-Biotech has built out a proprietary ADC platform which is protected by a complex patent portfolio. Our comprehensive ADC capabilities range from novel target discovery, payload screening, linker design, as well as GMP manufacturing. As of today, Kelun-Biotech is advancing over 10 novel ADC programs in varying stages of development.

For additional information, please contact klbio_bd@kelun.com (China) or bd@kluspharma.com (US).

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2021 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Business Development Team

Thursday, December 22, 2022

The 45th Annual San Antonio Breast Cancer Symposium (SABCS) will commence on December 6th, 2022. A series of groundbreaking study data is expected to be presented at this conference, and the participants will also discuss how to apply the latest findings to clinical practice in order to improve the current treatment paradigm for breast cancer patients.

The efficacy and safety data of Kelun-Biotech’s TROP2-ADC (SKB264, MK-2870) in the Phase II expansion study in patients with locally advanced or metastatic triple-negative breast cancer (TNBC) were presented in a scientific poster, which was released on the official SABCS website and displayed and exchanged at the conference site, and the detailed contents are provided below.


Main contents of the Presented Poster

This was a Phase 2 expansion study that enrolled 59 patients with previously treated locally advanced or metastatic triple-negative breast cancer to receive SKB264 monotherapy (23 patients in the 4 mg/kg group and 36 patients in the 5 mg/kg group) with a 2-week treatment cycle. The data cut-off was October 10th, 2022, with a median follow-up of 12.8 months.

Baseline characteristics: 59 patients were enrolled (23 in 4 mg/kg group, 36 in 5 mg/kg group); 88% had previously received 3 or more regimens, 40.7% had previously received 5 or more regimens, and 28.8% of patients had previously received anti-PD-1/L1 therapy. 57 patients were available for TROP2 testing, and 54.2% had high TROP2 expression (defined as H-score >200-300).
Efficacy: Among 55 patients with evaluable response (21 in 4 mg/kg group, 34 in 5 mg/kg group), confirmed objective response rate (ORR) was 40% (22/55), disease control rate (DCR) was 80% (44/55), and confirmed ORR was 55.2% (16/29) in patients with high TROP2 expression. The confirmed ORR was as high as 62.5% in the high TROP2-expressing group dosed at 5 mg/kg. Median duration of sustained response (DoR) was 11.5 months, median PFS was 5.7 months, median OS was 14.6 months, and 12-month OS was 66.4%.

Safety: Treatment-related adverse events (TRAEs) ≥Grade 3 were reported in 57.6% (34/59) of patients. The most common ≥Grade 3 TRAEs (≥10%) were neutrophil count decrease (25.4%), white blood cell count decrease (23.7%), and platelet count decrease (16.9%). TRAEs led to dose reductions in 10.2% (6/59) of patients. No deaths due to TRAEs occurred and no interstitial lung disease (ILD) was observed.

In patients with metastatic TNBC treated with multiple prior lines of therapy, SKB264 demonstrated a manageable safety and promising antitumor activity. CDE has granted Breakthrough Therapy Designation for SKB264 as a single agent in locally advanced or metastatic TNBC, and this year will mark the debut of SKB264 clinical data being shared at an international conference for breast cancer. Currently, SKB264 monotherapy is rapidly advancing in a Phase III registrational study for the treatment of locally advanced or metastatic TNBC (NCT05347134), and also as a combination therapy with KL-A167 (anti-PD-L1 monoclonal antibody) for metastatic TNBC in the first-line setting (NCT05445908). Further clinical data for SKB264 in the treatment of breast cancer is expected to be shared in the near future.

About SKB264 (TROP2-ADC)
SKB264 is a new generation of antibody-drug conjugates (ADCs) composed of a humanized monoclonal antibody targeting TROP2, an enzymatically cleavable linker, and a new topoisomerase I inhibitor that Kelun-Biotech has independent intellectual property rights, which combines the specificity of monoclonal antibodies to target antigens on the surface of tumor cells and the high efficacy of cytotoxic drugs.

Based on preliminary clinical data, SKB264 is currently conducting Phase II and Phase III clinical trials of single drug/combination for multiple tumor types. In 2022, the research and development of SKB264 is progressing rapidly. Since January, 6 clinical studies have been approved (5 in China and 1 in the United States).


About Kelun-Biotech
Kelun Biotech is a clinical-stage biotech company established in 2016, a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd, engaged in biologic therapeutics as well as small molecule discovery and development. The company focuses on unmet medical needs such as oncology and autoimmune conditions and strives to be a leader in novel therapeutic discovery and development. Since its inception, Kelun-Biotech has established multi-modal drug discovery platforms based on global standards and made important development breakthroughs in antibody-drug conjugation, immuno-oncology, bispecific antibody and novel small molecule targeting and designs.
Kelun-Biotech’s current pipeline includes 55 therapeutic programs for the treatment of cancers, autoimmune conditions, infectious diseases, and metabolic syndromes. Fourteen programs are in clinical development in China, two of which have entered into clinical development in the US. Most notably, Kelun-Biotech has built out a proprietary ADC platform which is protected by a complex patent portfolio. Our comprehensive ADC capabilities range from novel target discovery, payload screening, linker design, as well as GMP manufacturing. As of today, Kelun-Biotech is advancing 10 novel ADC programs in varying stages of development.

Business Development Team

Wednesday, December 14, 2022

KLUS Pharma is Attending BIO Partnering @ JPMorgan Healthcare Conference in San Francisco, CA (January 9-12, 2023).

KLUS Pharma will attend the annual BIO Partnering @ JPM held in San Francisco, CA. KLUS Pharma is the US subsidiary of Kelun-Biotech, a mid-sized innovative biopharma company based in Chengdu, China. Kelun-Biotech is advancing a broad pipeline of small molecules, monoclonal antibodies, antibody drug conjugates (ADCs), and cell therapies for the treatment of cancer, autoimmune, metabolic, and cardiovascular diseases. With over ten clinical-stage assets and dozens of promising preclinical candidates, we are actively seeking strategic partners to help accelerate the global development of these promising therapeutic candidates. In addition, we are also seeking in-licensing opportunities for the Greater China market, including innovative therapeutics in oncology, autoimmune, metabolic, and cardiovascular diseases areas. Clinical-stage assets with preliminary safety and efficacy data are preferred. We also consider selective generic products suitable for the China market in the following therapeutic spaces: neurology, infectious disease, reproductive health, and fertility treatments.

Attending BIO Partnering during JPMorgan Healthcare Conference Week? Click the link below to request a meeting with KLUS Pharma through the BIO partnering system! #JPM2023

https://login.partnering.bio.org/inova-business-platform/webclient/#/bio/11900/company/144762

We look forward to meeting new potential partners at the event!

Business Development Team, KLUS Pharma

Monday, November 14, 2022