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December 22, 2014
By Mark Terry, BioSpace.com Breaking News Staff

Janssen Biotech Inc., a Johnson & Johnson company, announced today that it had inked a global collaboration and licensing agreement with Rockville, Md.-based MacroGenics, Inc . The deal focuses on MGD011, a humanized CD19 x CD3 bispecific DART protein that has potential for the treatment of B-cell hematological malignancies.

As part of the deal, Janssen will pay MacroGenics a $50 million upfront license fee. In addition, Johnson & Johnson Innovation – JJDC, will repurchase 1,923,077 new shares of MacroGenics common stock at $39.00 per share, totally about $75 million.

MacroGenics focuses on clinical-stage development and discovery of monoclonal antibody-based therapies for cancer, autoimmune disorders and infectious diseases. The company’s proprietary platform is Dual-Affinity Re-Targeting (DART).

Janssen Biotech focuses on immunology, oncology and nephrology. It’s brand name product is Remicade (infliximab), which is used to treat various disorders, including plaque psoriasis, rheumatoid arthritis, Crohn’s disease and ulcerative colitis.

Under the agreement, Janssen will handle development of MGD011 after submission of the IND, planned for 2015. If successful, MacroGenics may receive up to an additional $575 million in various milestone payments. If the company chooses, MacroGenics could help fund late-stage clinical development in exchange for profit sharing in the U.S. and Canada.

“MGD011 is a promising product candidate and one that we believe is meaningfully differentiated from competing CD19-directed therapies,” said Scott Koenig, president and chief executive of MacroGenics 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,” he said. “We look forward to working with Janssen to significantly expand the development of MGD011 and maximize its value.”

Earlier in the month MacroGenics presented pre-clinical data of MGD011 at the 56th Annual Meeting of the American Society of Hematology (ASH) in San Francisco.

The study, presented by Liqin Liu, senior scientist at MacroGenics, indicated that the compound demonstrated significant anti-tumor activity in vitro and in mouse leukemia/lymphoma tumor models. There were high complete response rates with no evidence of relapse.

“CD19-targeted therapies have generated a great deal of excitement and based on our pre-clinical data, we believe that MGD011 has strong potential in the treatment of patients with certain types of hematological malignancies,” said Koenig in a statement. “We are enthusiastic about the initiation of clinical development in 2015.”

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