ImmunoGen said today it has granted exclusive licenses to four compounds using its technology that are being developed by Sanofi, under amendments to the companies’ 14-year-old collaboration.

ImmunoGen, which focuses on antibody–drug conjugates (ADCs), agreed to amend a 2003 agreement between the companies by granting Sanofi a fully paid exclusive license to develop, manufacture, and commercialize four cancer candidates:

  • Isatuximab (SAR650984), a Phase III unconjugated anti-CD38 antibody being developed for relapsed and refractory multiple myeloma;
  • SAR566658, a Phase II ADC targeting CA6 in Phase II development for triple-negative breast cancer (TNBC);
  • SAR408701, an anti-carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) ADC under study for the treatment of unspecified solid tumors; and
  • An additional ADC directed to an undisclosed target.

The ADCs use ImmunoGen’s Targeted Antibody Payload (TAP) technology, through which an antibody is conjugated to one of ImmunoGen's proprietary highly potent cancer-cell killing agents.

For each compound developed under the original 2003 agreement, Sanofi agreed to pay ImmunoGen milestone payments plus royalties on the sales of any resulting product, with ImmunoGen also retaining co-promotion rights. Sanofi-Aventis agreed to oversee product development, clinical testing, manufacturing, and marketing.

Under the amended collaboration, Sanofi has agreed to pay ImmunoGen $30 million while ImmunoGen has agreed to forego a limited co-promotion option in the U.S. for the compounds covered by the 2003 agreement, as well as future milestones or royalties under both license agreements.

ImmunoGen and Sanofi have also amended a separate 2013 exclusive license to grant Sanofi a fully paid exclusive license to develop, manufacture, and commercialize a fifth ImmunoGen compound— SAR428926, an anti-lysosomal-associated membrane protein 1 (LAMP1) ADC being studied for the treatment of unspecified solid tumors.

“We believe Sanofi possesses the right resources to complete the development of these innovative candidates and potentially bring them to patients around the globe,” ImmunoGen president and CEO Mark Enyedy said in a statement.

Enyedy added that the amended agreement would allow ImmunoGen to further focus on developing its lead program, mirvetuximab soravtansine, while advancing its earlier-stage portfolio and further strengthening its cash position.

Mirvetuximab soravtansine is being evaluated in the Phase III FORWARD I study as a treatment for platinum-resistant folate receptor alpha (FRα)-positive ovarian cancer. The first patient in the study was dosed in January. The Phase Ib/II FORWARD II trial is separately evaluating mirvetuximab soravtansine as part of combination therapy for both platinum-resistant and platinum-sensitive disease.

Just last week, ImmunoGen sold its Phase II anti-CD37 ADC candidate IMGN529/DEBIO 1562 to Debiopharm for $25 million upfront, plus $5 million once it has transferred relevant assets to Debiopharm. ImmunoGen is also eligible for an additional $25 million milestone payment tied to the launch of a Phase III trial with IMGN529/DEBIO 1562.

ImmunoGen also cited its focus on mirvetuximab soravtansine in disclosing last September that it was eliminating 17% of its workforce and seeking a partner for its noncore B-cell lymphoma programs, including IMGN529, and coltuximab ravtansine (formerly SAR3419), a CD19-targeting ADC.








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