MacroGenics and Merck to Collaborate

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The FINANCIAL — MacroGenics, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, autoimmune disorders and infectious diseases, and Merck, known as MSD outside the United States and Canada, on October 22 announced a collaboration to evaluate the combination of MacroGenics’ anti-HER2 product candidate, margetuximab, with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in a Phase 1b/2 clinical trial in patients with advanced gastric cancer.

Margetuximab is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2, which is an antigen critical for the growth of many types of tumors, including breast and gastroesophageal cancers. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, according to Merck.

“The combination of our proprietary Fc-optimized anti-HER2 antibody, with expected enhanced immune-mediated killing properties, and the anti-PD-1 antibody KEYTRUDA, is intended to exploit potentially complementary biology,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “Treatment options for patients with advanced HER2-positive gastric cancer are extremely limited. The combination of mechanisms engaged by margetuximab and KEYTRUDA could provide an important alternative for patients who do not respond to currently available regimens.”

“Today, there is a great opportunity and need to bring forward new scientific breakthroughs for the treatment of gastric cancer,” said Dr. Eric Rubin, vice president and therapeutic area head, oncology early-stage development, Merck Research Laboratories. “Evaluating the potential of combination therapies through strategic collaborations in difficult-to-treat tumor types continues to be an important part of our immuno-oncology clinical development program for KEYTRUDA.” 

The Phase 1b/2 multicenter, open-label clinical trial will be conducted in two parts. The Phase 1b portion is designed to determine the safety and tolerability of margetuximab in combination with KEYTRUDA in patients with advanced gastric cancer, while the Phase 2 portion will evaluate the anti-tumor activity of margetuximab in combination with KEYTRUDA in patients with advanced HER2-positive gastric cancer. Trial startup activities are underway and MacroGenics expects to begin enrolling patients by the first quarter of 2016. The agreement includes a provision where the parties may extend the collaboration to include a potential Phase 3 clinical trial.

The agreement is between MacroGenics and Merck, through a subsidiary.  Additional details were not disclosed. 


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