Johnson & Johnson’s Janssen Biotech subsidiary will co-develop MacroGenics' cancer treatment candidate MGD011, which is designed to treat B-cell malignancies by incorporating the latter’s Dual-Affinity Re-Targeting (DART®) platform to simultaneously target CD19 and CD3 proteins. The collaboration could generate as much as $700 million for MacroGenics.

MGD011 is a preclinical, monoclonal antibody-based compound designed to redirect T cells, via their CD3 component, to eliminate CD19-expressing cells found in many blood cancers. MGD011 is among DART molecules manufactured using a conventional antibody platform that, according to MacroGenics, has the advantage of offering the complexity of having to genetically modify T cells from individual patients as required by approaches such as chimeric antigen receptor (CAR) T-cells.

“MGD011 is a promising product candidate and one that we believe is meaningfully differentiated from competing CD19-directed therapies,” MacroGenics President and CEO Scott Koenig, M.D., Ph.D., said in a statement. “Janssen represents the ideal partner for this product candidate, given their track record of successfully developing and commercializing transformative oncology therapies and their experience in the B-cell malignancy area. We look forward to working with Janssen to significantly expand the development of MGD011 and maximize its value.”

Janssen agreed to pay MacroGenics a $50 million upfront license fee, while Johnson & Johnson Innovation will invest $75 million to purchase 1,923,077 new shares of MacroGenics common stock at a price of $39 per share. Janssen will be fully responsible for developing MGD011 following submission of an IND, which is planned for 2015, MacroGenics said.

Should the collaboration prove successful, MacroGenics could receive up to an additional $575 million in payments from Janssen tied to clinical, regulatory and commercialization milestones. MacroGenics can choose to fund a portion of late-stage clinical development in exchange for a profit share in the U.S. and Canada.

If MGD011 is commercialized, MacroGenics added, it would be eligible to receive double-digit royalties on any global net sales and has the option to co-promote the molecule with Janssen in the U.S.

MGD011 is one of more than 100 different DART molecules that MacroGenics says have been successfully produced.

J&J/Janssen is the second biopharma giant to ink a collaboration agreement with MacroGenics in recent months. In September, the company joined Takeda Pharmaceutical in agreeing to develop four additional drugs based on the DART platform, in an up-to-$1.6 billion expansion of a collaboration launched in May. The original partnership was formed to co-develop another MacroGenics preclinical compound MGD010, a B-cell-targeted therapy that simultaneously targets the B-cell surface proteins CD32B and CD79B, and is indicated for lupus and rheumatoid arthritis.

Other biopharma giant partners of MacroGenics include Gilead Sciences (through a collaboration launched in 2013), Servier (2012), Pfizer, and Boehringer Ingelheim (both in 2010).

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