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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

KLUS Pharma will attend the annual BioPharm America conference held in Boston, MA from September 28-29 and virtually from October 4-5, 2022. As part of Kelun-Biotech, a mid-sized innovative drug developer based in Chengdu, China, we are advancing a broad pipeline of small molecules, monoclonal antibodies, ADCs, and cell therapies covering various therapeutic areas, including oncology, autoimmune, metabolic, and cardiovascular diseases. With more than 10 projects in clinical trials and dozens of promising preclinical candidates under evaluation, we are seeking strategic partnerships to accelerate the development of these potential drug products on a global scale. We look forward to meeting potential next collaborators at the event!

Business Development Team

Thursday, September 8, 2022

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, announced today that it has entered into a collaboration and exclusive license agreement with MSD (the tradename of Merck & Co., Inc Rahway NJ USA), to develop an investigational antibody drug conjugate (ADC) for the treatment of solid tumors.

Under the terms of the agreement, Kelun-Biotech has granted MSD global, exclusive rights to develop, manufacture and commercialize an investigational ADC. Kelun-Biotech and MSD will also collaborate on the early clinical development of the investigational ADC. In return, Kelun-Biotech will receive an upfront payment of$35mm and is eligible to receive future development, approval and commercial milestone payments totaling up to $901mm, plus tiered royalties on net sales.

This latest transaction follows MSD’s decision earlier this year to exercise an option for worldwide rights, except for the Greater China region (including Mainland China, Hong Kong, Macau, and Taiwan), to SKB-264, an investigational TROP2 targeting ADC. SKB-264 is currently being evaluated in a Phase 3 clinical trial for the treatment of metastatic triple-negative breast cancer and in Phase 2 trials for non-small cell lung cancer and advanced solid tumors. Kelun-Biotech and MSD will collaborate on certain early clinical development plans, including evaluating the potential of SKB-264 as a monotherapy and in combination with KEYTRUDA (pembrolizumab) for advanced solid tumors.

“These collaborations with MSD underscore the sophistication and capabilities of Kelun-Biotech's ADC platform and the potential of our ADC therapeutics,” said Dr. Junyou Ge, Chief Ｅxecutive Officer of Kelun-Biotech. “Incorporating MSD’s deep and broad global expertise with Kelun-Biotech’s innovation power has the potential to generate great development synergy, significantly accelerating the development and commercialization of the collaboration programs. These collaborations will also strengthen our strategic position in building a global, innovative, fully-integrated biopharmaceutical company.”

“The collaboration with Kelun-Biotech strengthens and diversifies MSD’s oncology pipeline as we seek to further the potential of ADCs to provide more treatment options and improve outcomes for people with cancer,” commented Dr. Eric H. Rubin, senior vice president, oncology early development, MSD Research
Laboratories. “We look forward to advancing this collaboration with the Kelun-Biotech team.”

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.

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

Kelun-Biotech Business Development Team
KLUS Pharma Business Development Team

Tuesday, July 26, 2022

Kelun-Biotech announced that the U.S. Food and Drug Administration (FDA) has recently approved the Investigational New Drug Application (IND) of the company’s small molecule RET kinase inhibitor A400 (KL590586) submitted by its collaboration partner Ellipses Pharma (internally named EP0031) for RET gene mutated malignant tumors. The approval is a key step for A400/EP0031 to start a global Phase I/II clinical study.

A400/EP0031 is a next-generation highly specific small-molecule RET kinase inhibitor (SRI). Kelun-Biotech has initiated the clinical study of A400/EP0031 in China and is currently in the dose-escalation stage. This approved Phase I/II clinical study in the U.S. will recruit patients with thyroid cancer and non-small cell lung cancer patients with RET gene mutation, including those who have previously received treatment with first-generation RET inhibitors. The safety, tolerability, and efficacy of A400/EP0031 will be evaluated.

The study is planned to be conducted at sites in the United States and Europe, with the first patient in the dose-escalation phase expected to complete enrollment in the third quarter of 2022. In addition, Ellipses Pharma will soon submit applications to regulators in the U.K. and E.U. to accelerate the launch of clinical research centers outside the U.S.

KLUS Pharma, Business Development
Kelun-Biotech, Business Development

Tuesday, June 28, 2022