MacroGenics, Inc. a clinical-stage biopharmaceutical company discovering and developing monoclonal antibody-based cancer therapeutics and various autoimmune disorders and infectious diseases, has formed a global collaboration and license agreement for MGD015, a preclinical bispecific molecule, with Janssen Biotech, Inc. This product candidate incorporates MacroGenics’ proprietary Dual-Affinity Re-Targeting, or DART platform to simultaneously target CD3 and an undisclosed tumor target for the potential treatment of various hematological malignancies and solid tumors.

Under the agreement and subject to the termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act, MacroGenics will receive a $75 million upfront license fee. Janssen will complete investigational new drug-enabling activities and be fully responsible for future clinical development of MGD015. Assuming successful development and commercialization, MacroGenics could receive up to an additional $665 million in clinical, regulatory and commercialization milestone payments. MacroGenics may elect to fund a portion of late-stage clinical development in exchange for a profit share in the US and Canada. If commercialized, MacroGenics would be eligible to receive double-digit royalties on any global net sales and has the option to co-promote MGD015 with Janssen in the US.

MGD015 is designed to redirect T cells, via their CD3 component, to eliminate cells which overexpress an undisclosed antigen in various hematological malignancies and solid tumors. MacroGenics has demonstrated that MGD015 is able to kill these targeted cells both in vitro and in vivo, with high response rates in several mouse tumor xenograft models. In addition, this product candidate and the company’s other DART molecules that redirect T cells against cancer targets are manufactured using a conventional antibody platform without having to genetically modify T cells from individual patients as required by approaches such as chimeric antigen receptor (CAR) T-cells.

Source: MacroGenics