ROCKVILLE, Maryland—MacroGenics, Inc. and Servier have announced that they have entered into an option for a license agreement for the development and commercialization of MGA271, MacroGenics' proprietary product candidate. The compound is a first-in-class, Fc-optimized monoclonal antibody currently in a Phase I clinical trial as a treatment for solid tumors.
Per the terms of the agreement, MacroGenics will receive $20 million as an upfront payment. MacroGenics will retain full development and commercialization rights for the compound in the United States, Canada, Mexico, Japan, Korea and India, and Servier will have an option to obtain an exclusive license covering the rest of the world. Prior to the exercise of that option, funding will be handling by both parties, and both Servier and MacroGenics will conduct specified research and development activities. If Servier does exercise its option after the Phase I study and its expansion cohorts are complete, both companies will share clinical development costs, and MacroGenics will receive an option exercise fee that when combined with the upfront and early development milestone payments, will total $60 million. An additional $390 million could also be received pending the achievement of clinical, regulatory and commercialization milestones. MacroGenics will also receive tiered, double-digit royalties on future net sales.
"We are delighted to enter into this collaboration with Servier. It will significantly broaden and accelerate our clinical plans for MGA271, enabling us to further investigate the multiple solid tumor types for which MGA271 may have activity," Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics, said in a press release. "This important collaboration highlights the rapidly growing excitement surrounding the B7 family of immune regulators in oncology immunotherapy as well as our Fc engineering platform."
MGA271 is a next-generation monoclonal antibody that targets B7-H3, which is overexpressed in several malignancies. MGA271 incorporates several complementary mechanisms of action, including enhanced immuno-stimulatory properties and targeting of tumor vasculature. The compound is being evaluated in an open-label, multi-dose, single-arm, dose-escalation Phase I study in patients with refractory B7-H3-expressing neoplasms. The trial is using a companion diagnostic for B7-H3 that will enable screening of patients for expression of the target antigen, and enrollment of the first dosing cohort is complete.
"Following very promising pre-clinical results, we will work together to define the clinical indications and the best drug combinations and to identify early biomarkers predictive of response," Stephane Depil, M.D., Ph.D., in charge of Oncology Research & Development at Servier, said in a press release.
"Today's announcement underscores Servier's commitment to develop novel targeted therapies that address significant unmet medical needs for cancer patients," Emmanuel Canet, M.D., Ph.D., President Research & Development at Servier, noted. "MGA271 is a novel immunotherapeutic with a compelling product profile and the potential to treat a broad spectrum of solid tumors. We have been deeply impressed by both the excellence of science being conducted by MacroGenics and their world-class antibody development capabilities. We are looking forward to building a long-term strategic collaboration with MacroGenics."
MacroGenics has several other compounds in its pipeline, including MGAH22 targeting HER2 for solid tumors, mAbs for solid and liquid tumors, Teplizumab for early-onset and at-risk diabetes, and multiple DARTs for solid tumors as well as autoimmune indications. The company's Dual-Affinity Re-Targeting (DART) technology program focuses on "dual specificity 'antibody-like' therapeutic proteins capable of targeting multiple different epitopes with a single recombinant molecule," the company site states. MacroGenics' pipeline candidates currently vary in development from lead optimization to Phase I studies. In addition to Servier, MacroGenics also has partnerships with Pfizer and Boehringer Ingelheim.
"Servier is a world-class pharmaceutical company with a long history of successful innovation and a dedication to research for the benefit of patients," said Koenig in a press release. "They have an expansive global footprint and are an ideal partner to maximize the potential of MGA271."
SOURCE: MacroGenics press release