Date: 2014-02-05
Type of information: Development agreement
Compound: Dual-Affinity Re-Targeting (DART™) products including MGD006
Company: Macrogenics (USA - Md) Servier (France)
Therapeutic area: Cancer - Oncology
Type agreement: development
commercialisation
Action mechanism: MacroGenics’ DART technology is a proprietary, bi-specific antibody platform in which a single recombinant molecule is able to target two different antigens. These DART proteins can be used to redirect the body’s cell-destroying, immune effector cells against tumor cells.
Disease: undisclosed cancers
Details: * On September 20, 2012, MacroGenics and Servier have entered into an option agreement for the development and commercialization of Dual-Affinity Re-Targeting (DART™) products directed at three undisclosed tumor targets. This new agreement is an expansion of their existing relationship. Servier has already partnered with MacroGenics in late 2011 on MGA271, a monoclonal antibody that recognizes B7-H3, a novel member of the B7 family of immune regulators. MacroGenics retains full development and commercialization rights to the three pre-clinical DART programs in the U.S., Canada, Mexico, Japan, Korea and India, while Servier has the option to obtain an exclusive license covering the rest of the world for each of the programs. Prior to the exercise of Servier’s option, both parties will fund and conduct specified research and development activities. Servier may exercise its option for one of the programs prior to IND submission, and for each of the other two programs upon completion of an initial Phase 1 clinical trial.
Financial terms: Under the terms of the agreement, MacroGenics will receive a $20 million upfront payment. If Servier exercises its options, MacroGenics will receive option exercise fees, which, when combined with preclinical milestones, would total an additional $80 million. MacroGenics could also receive up to an additional $1 billion in clinical, regulatory and commercialization milestone payments for the three programs. Both parties will share the clinical development costs for each program following the exercise of such option. Finally, MacroGenics may receive tiered, double-digit royalties on future net sales.
Latest news: * On February 5, 2014, MacroGenics has announced that Servier has exercised its exclusive option to develop and commercialize MGD006, a DART-based product candidate developed by MacroGenics. Servier will gain exclusive development and commercial rights in all countries outside of the U.S., Canada, Mexico, Japan, South Korea and India. In those countries, MacroGenics will retain development and commercialization rights. As a result of the exercise, MacroGenics will receive a $15 million payment from Servier. In addition, the Investigational New Drug (IND) application for MGD006 has cleared the 30 day review period by the FDA, triggering an additional $5M payment to MacroGenics by Servier.MGD006 is a humanized Dual-Affinity Re-Targeting (DART®) molecule in development for hematologic malignancies that recognizes both CD123 and CD3. In pre-clinical studies, the results of which were presented at the 55th Annual Meeting of the American Society of Hematology (ASH) in November 2013, MGD006 was shown to redirect T cells via their CD3 component to kill CD123-expressing leukemia cells at very low concentrations of the DART. MacroGenics expects to initiate a Phase 1 study in the second quarter of 2014 for the treatment of relapsed and refractory acute myeloid leukemia (AML), representing the initial execution of an important strategic effort by the company to apply T-cell directed cancer immunotherapy in significant areas of unmet clinical need, including both hematologic malignancies and solid tumors.
