MGA271 is in Phase I studies against solid tumors expressing B7-H3.

Servier is paying MacroGenics $20M up front for an option to license the latter’s Phase I-stage anticancer candidate MGA271. The B7-H3-targeting Fc-optimized monoclonal antibody is currently in development against solid tumors, in patients with refractory B7-H3-expressing neoplasms identified using a companion diagnostic.

Under terms of the deal, MacroGenics retains full development and commercialization rights to the drug in the U.S., Canada, Mexico, Japan, Korea, and India. Servier has an option to obtain an exclusive license to MGA271 for the rest of the world, at the end of the Phase I study and its expansion into additional cohorts. If Servier takes up its option it will pay MacroGenics a specified fee which, when combined with the up-front payment and early development milestones, will total $60 million. MacroGenics could receive up to an additional $390 million in clinical, regulatory, and commercialization milestones, plus tiered double-digit sales royalties. The firms will carry out additional R&D before Servier considers its option on the drug. If it takes up its license, then both firms will share subsequent development costs.

MacroGenics is exploiting three technology platforms to develop biologics against cancer, autoimmune disorders, and infectious diseases. The DART™ Dual-Affinity Re-Targeting (DART) platform is focused on dual specificity antibody-like therapeutic proteins capable of targeting multiple different epitopes with a single recombinant molecule. The Cancer Stem Cell (CSC) platform is being used to develop novel antibodies that target antigens present on both CSCs and bulk tumor cells, for potential use in therapeutics, diagnostics, and compound screening. MacroGenics’ Fc Optimization platform, meanwhile, allows the engineering of customizable Fc domains into antibody candidates. MGA271 is a humanized IgG1/kappa monoclonal antibody that has been Fc-optimized to boost tumor-killing activity. 

The firm’s development pipeline is headed by lead in-house candidate teplizumab, a humanized anti-CD3 monoclonal antibody in Phase II development for the treatment of type I diabetes.  Also in clinical development is MGAH22, an Fc-optimized anti-HER2 antibody in Phase I development against solid tumors. Preclinical DART and other antibodies are additionally in development either in house or in partnership with firms including Pfizer and Boehringer Ingelheim, for the treatment of solid and liquid tumors, inflammation, autoimmune diseases, and emerging infectious diseases. 

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