Keymed and Lepu Biopharma Jointly Announce Global Exclusive Licence Agreement with AstraZeneca for CMG901

Rhea-AI Summary

Keymed Biosciences Inc. and Lepu Biopharma Co., Ltd have entered into a global exclusive license agreement with AstraZeneca (AZN) for CMG901, a potential first-in-class antibody drug conjugate targeting Claudin 18.2. AstraZeneca will oversee research, development, manufacturing, and commercialization of CMG901, which is currently in Phase I trials for Claudin 18.2-positive solid tumors. The agreement provides Keymed with an upfront payment of $63 million and potential milestone payments up to $1.1 billion, along with low double-digit tiered royalties. Closing is anticipated in the first half of 2023, pending regulatory approvals.

Positive

• Upfront payment of $63 million from AstraZeneca
• Potential milestone payments of up to $1.1 billion
• Encouraging preliminary results for CMG901 in Phase I trials
• AstraZeneca's expertise in commercializing novel anti-cancer therapies

Negative

• None.

CHENGDU, China, Feb. 23, 2023 /PRNewswire/ -- Keymed Biosciences Inc., ("Keymed") (Stock Code: 02162 HK) and Lepu Biopharma Co., Ltd, (Stock Code: 02157.HK) today jointly announce a global exclusive licence agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) for CMG901, a potential first-in-class Claudin 18.2 antibody drug conjugate (ADC). Under the licence agreement, AstraZeneca will be responsible for the research, development, manufacture and commercialisation of  CMG901 globally.

CMG901 is currently in a Phase I clinical trial for the treatment of Claudin 18.2-positive solid tumors. Preliminary results from the Phase 1 trial indicated that CMG901 has a favorable safety and tolerability profile, and encouraging anti-tumor efficacy across the dose levels tested.

Financial Considerations

Under the terms of the agreement, KYM Biosciences, the joint venture established by Keymed and Lepu Biopharma, will receive an upfront payment of $63m on transaction closing and additional development and sales-related milestone payments of up to $1.1bn as well as tiered royalties up to low double-digits. The transaction is expected to close in the first half of 2023, subject to customary closing conditions and regulatory clearances.

Dr. Bo Chen, Chief Executive Officer of Keymed and Board Chairman of KYM said, "We are pleased to have partnered with AstraZeneca, a global biopharmaceutical company with leadership in developing and commercializing novel anti-cancer therapies. This is not only a recognition of CMG901, a potential first-in-class Claudin 18.2 ADC, but also Keymed's internal discovery and development capabilities. The global scope of this agreement has the potential to benefit patients in China, and throughout the world."

Puja Sapra, Senior Vice President, Biologics Engineering & Oncology Targeted Delivery, Oncology R&D, AstraZeneca, said, "We are excited by the opportunity to accelerate the development of CMG901, a potential new medicine for patients with Claudin18.2-expressing cancers. CMG901 strengthens our growing pipeline of antibody drug conjugates and supports our ambition to expand treatment options and transform outcomes for patients with gastrointestinal cancers."

ABOUT CMG901

CMG901 is a novel antibody drug conjugate targeting Claudin 18.2, and consists of an anti-Claudin 18.2 monoclonal antibody, a protease-degradable linker, and a cytotoxic small molecule monomethyl auristatin E (MMAE). CMG901 is being developed for the treatment of solid tumours that express the cell surface protein Claudin 18.2, including gastric cancers. CMG901 is owned by KYM Biosciences Inc. (KYM), a joint venture established by affiliates of Keymed Biosciences (70% of KYM ownership) and Lepu Biopharma (30% of KYM ownership).

ABOUT Keymed Biosciences Inc.

Keymed Biosciences Inc. (Stock Code: 02162 HK) focuses on the urgent unmet clinical needs, and is committed to providing high-quality, affordable, innovative therapies for patients in China and overseas. Keymed was founded by medical and scientific experts from world-renowned universities who have strong experience in the transformation of scientific and technological achievements to commercialization at home and abroad. The core leadership team includes the inventors of the first PD-1 antibody drugs that were pioneered and approved in the United States and China. Developing antibodies with first-in-class and best-in-class therapeutic potential, Keymed has built a diversified pipeline addressing cancer and autoimmune diseases with over 30 self-developed Class I novel drug candidates, 9 of which have already entered clinical trial stages. The Company was listed on the main board of Hong Kong Stock Exchange on July 8, 2021.

For more information, please visit www.Keymedbio.com. 

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SOURCE Keymed

FAQ

What is the CMG901 license agreement between Keymed and AstraZeneca?

Keymed and Lepu Biopharma signed a global exclusive license agreement with AstraZeneca for CMG901, an antibody drug conjugate targeting Claudin 18.2.

What are the financial terms of the agreement with AstraZeneca for CMG901?

Keymed will receive a $63 million upfront payment, milestone payments up to $1.1 billion, and tiered royalties up to low double-digits.

What stage is CMG901 currently in regarding clinical trials?

CMG901 is currently in Phase I clinical trials for Claudin 18.2-positive solid tumors.

When is the transaction expected to close for the agreement with AstraZeneca?

The transaction is expected to close in the first half of 2023, subject to regulatory approvals.

What is the significance of CMG901 for cancer treatment?

CMG901 is considered a potential first-in-class treatment for solid tumors expressing Claudin 18.2, which includes gastric cancers.