News Feature | December 26, 2014

Janssen Enters New Collaborations For Cancer And Antibody Research

By C. Rajan, contributing writer

Janssen Biotech has entered into a collaboration with MacroGenics to co-develop the latter’s novel cancer drug candidate, MGD011, which is designed to treat multiple B-cell malignancies. The collaboration and license agreement can net up to $700 million for MacroGenics.

Under the terms of the agreement, Janssen will pay an upfront license fee of $50 million to MacroGenics and will also invest an additional $75 million in MacroGenics through shares purchase. Janssen will be solely responsible for developing MGD011 and plans to submit an Investigational New Drug (IND) application to the FDA in 2015.

Based on the progress of the drug, MacroGenics will be eligible to receive up to $575 million in various clinical, regulatory, and commercialization milestones. It will also have the option to take a profit share of the drug in the U.S. and Canada by funding a portion of late-stage clinical development. If MGD011 is approved, Janssen will also pay double-digit royalties on global net sales to MacroGenics.

MGD011, a monoclonal antibody-based compound, is based on MacroGenics’ proprietary Dual-Affinity Re-Targeting (DART) platform, and can simultaneously target CD19 and CD3 proteins. MGD011 works by redirecting the CD3 component of immune system T cells to attack and eliminate CD19-expressing cells, which are found in many hematological cancers.

“MGD011 is a promising product candidate and one that we believe is meaningfully differentiated from competing CD19-directed therapies,” said Dr. Scott Koenig, president and CEO of MacroGenics. “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.”

Yesterday, another collaboration agreement was struck between Janssen and Sevion Therapeutics, to discover antibodies for multiple targets and diseases.

CNA Development, an affiliate of Janssen, and the Johnson & Johnson Innovation center will work together with Sevion to utilize the latter’s novel antibody discovery platform to develop new drug candidates for several therapeutic areas. Sevion’s platform is different from traditional antibody drug discovery methods, as it allows discovery of antibodies against unpurified protein targets, including difficult transmembrane targets.

Under the terms of the agreement, Sevion will receive an up-front payment from Janssen, as well as funding for research activities conducted in collaboration with Janssen.

Janssen will be able to secure an exclusive license to develop, manufacture, and commercialize any candidates resulting from the joint research. For any candidates licensed by Janssen, Sevion will receive milestone payments of up to $125 million based on achievement of certain development and commercial goals, as well as royalties on product sales.

Just today, Janssen has entered yet another agreement. Janssen will be licensing out its hepatitis drug candidate, tipifarnib, to EB Pharma to develop a treatment for Hepatitis Delta Virus (HDV).