Date: 2016-09-12
Type of information: Termination of an agreement
Compound: MGD010
Company: Macrogenics (USA - MD) Takeda Pharmaceutical (Japan)
Therapeutic area: Autoimmune diseases
Type agreement: development - commercialisation
Action mechanism:
- bispecific DART. MGD010 is a humanized DART compound that simultaneously targets CD32B and CD79B. In pre-clinical studies, MGD010 was shown to modulate the function of human B cells without B-cell depletion. In normal conditions, B cells utilize CD32B as one of the key negative regulators to ensure that tolerance to self is maintained and autoimmune disease does not occur. MGD010 exploits this mechanism and triggers this inhibitory "immune checkpoint" loop for the inhibition of B-cell function, an approach that may be useful for the treatment of patients with autoimmune disorders.
Disease:
Details:
- • On May 27, 2014, MacroGenics and Takeda Pharmaceutical announced that they have entered into an option agreement for the development and commercialization of MGD010. This product candidate incorporates MacroGenics' proprietary platform for Dual-Affinity Re-Targeting (DART®) to simultaneously engage CD32B and CD79B, which are two B-cell surface proteins. MGD010 is currently in pre-clinical development for the treatment of autoimmune diseases.
Financial terms:
- Under the terms of the agreement, MacroGenics will receive an upfront payment of $15 million and Takeda receives an option to obtain an exclusive worldwide license for MGD010 following the completion of a pre-defined Phase 1a study. MacroGenics will lead all product development activities until that time. If Takeda exercises its option, it will assume responsibility for future development and pay MacroGenics an option exercise fee which, when combined with the upfront payment and an early development milestone, will total $33 million. Assuming successful development and commercialization of MGD010, MacroGenicscould receive up to an additional $468.5 million in clinical, regulatory and commercialization milestone payments. If commercialized, MacroGenics would receive double-digit royalties on any global net sales and has the option to co-promote MGD010 with Takeda in the United States. Finally, MacroGenics may elect to fund a portion of Phase 3 clinical development in exchange for a North American profit share
Latest news:
- • On September 12, 2016, MacroGenics and Takeda Pharmaceutical announced the conclusion of their license and option agreement for MGD010. MacroGenics has regained the worldwide rights to MGD010, a bispecific molecule targeting CD32B and CD79B. Takeda's decision comes earlier than the predefined expiration of its option exercise period and follows Takeda's recently announced therapeutic area re-prioritization. Takeda's decision was not based on the ongoing Phase 1 study with MGD010. MacroGenics plans to continue to advance the development of this product candidate based on the positive study results reported to date.
Is general: Yes
