ImmunoGen and Hangzhou Zhongmei Huadong Pharmaceutical Co., a wholly-owned subsidiary of Huadong Medicine Co., Chinese pharmaceutical company founded in 1993, have entered into an exclusive collaboration to develop and commercialize mirvetuximab soravtansine (IMGN853) in mainland China, Hong Kong, Macau, and Taiwan (Greater China). ImmunoGen will retain all rights to mirvetuximab in the rest of the world.

The partnership is expected to ccelerates the development of mirvetuximab soravtansine in Greater China and Expands Huadong Medicine’s Oncology Portfolio with Innovative ADC

Mirvetuximab soravtansine is a first-in-class antibody-drug conjugate (ADC) which consists of the maytansinoid DM4 (N2′- Deacetyl-N2′-(4-mercapto-4-methyl-1-oxopentyl)-maytansine conjugated to M9346A, an anti-folate receptor alpha (FRα) antibody, linked via the cleavable N-Succinimidyl 4-(2-pyridyldithio)-2-sulfobutanoate linker (Sulfo-SPDB). Maytansinoids are anti-mitotic agents that inhibit tubulin polymerization and microtubule assembly. In mirvetuximab soravtansine, each antibody molecule is conjugated to an average of 3-4 molecules of maytansinoid DM4.[1]

Market access
This collaboration provides ImmunoGen with access to the second largest pharmaceutical market in the world via Huadong Medicine’s development, regulatory, and commercial capabilities, while supporting Huadong Medicine’s growth strategy to build a deep portfolio of oncology, endocrinology, and autoimmunology candidates.

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Mirvetuximab adds a compelling late-stage oncology asset to Huadong Medicine’s portfolio.

Regional expertese
“With extensive regional experience, the right development and regulatory capabilities, and access to a deep local network of hospitals and clinics across Greater China, Huadong Medicine is an ideal partner for us,” said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer.

“This collaboration reflects mirvetuximab’s potential to deliver meaningful value to ovarian cancer patients as well as our ability to translate our work in ADCs into long-term relationships that create sustainable value for ImmunoGen and our partners. We look forward to working closely with Huadong Medicine to develop and commercialize mirvetuximab in Greater China as we advance the mirvetuximab program and prepare for the first potential commercial launch in the United States in 2022.”

“ImmunoGen is a leader in the development of ADCs for the treatment of cancer and this partnership provides us with a late-stage asset that will enable us to further expand our pipeline of innovative oncology programs,” said Liang Lu, Chairman of Huadong Medicine.

“The compelling clinical data generated to date highlights mirvetuximab’s potential to be a promising therapy for an extremely difficult to treat disease and we look forward to beginning its development as we seek to meet the growing needs of ovarian cancer patients in Greater China.”

Under the terms of the agreement, ImmunoGen will receive an upfront payment of U.S.  $ 40 million and is eligible to receive additional milestone payments of up to $265 million as milestone payment when certain development, regulatory, and commercial objectives are achieved. ImmunoGen is also eligible to receive low double digit to high teen royalties as a percentage of mirvetuximab commercial sales by Huadong Medicine in Greater China.

The companies have agreed that Huadong Medicine will be responsible for the development as well as potential regulatory submissions and commercialization of mirvetuximab in Greater China pursuant to input from a joint steering committee which includes representatives of from both companies. Huadong Medicine will also have the opportunity to participate in global clinical studies of mirvetuximab conducted by ImmunoGen. ImmunoGen will continue to be responsible for the development and commercialization of mirvetuximab in the United States and a number of other countries.

Clinical trials
Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer – NCT03832361
A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (SORAYA) – NCT04296890

[1] Ab O, Whiteman KR, Bartle LM, Sun X, Singh R, Tavares D, LaBelle A et al. IMGN853, a folate receptor-α (FRα)-targeting antibody-drug conjugate, exhibits potent targeted antitumor activity against FRα- expressing tumors. Molecular Cancer Therapeutics 14(7): 1605-1613, 2015.

Featured Image: Map of China. Courtesy: © Fotolia. Used with permission.

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