MacroGenics, Janssen Biotech ink license agreement

ROCKVILLE, Md.—Biopharmaceutical company MacroGenics Inc. has announced the signing of a global collaboration and license agreement for MGD011 with Janssen Biotech Inc., a Johnson & Johnson company. Per the agreement, Janssen will pay MacroGenics a $50-million upfront license fee, while Johnson & Johnson Innovation-JJDC Inc. will invest $75 million to purchase 1,923,077 new shares of MacroGenics common stock at $39 per share. Janssen will assume full responsibility for developing MGD011 following IND submission, which is slated for next year. Should the compound be successfully developed and commercialized, MacroGenics could earn up to an additional $575 million in clinical, regulatory and commercialization milestones.

MacroGenics may opt to fund a portion of late-stage clinical development in exchange for a profit share in the United States and Canada, and if MDG011 is successfully commercialized, the company is also eligible to receive double-digit royalties on any global net sales, with the option to co-promote the compound with Janssen in the United States. The agreement is subject to the termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act.

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

MGD011 is a humanized CD19 x CD3 bispecific DART protein under development for the treatment of B-cell hematological malignancies. The compound is designed to redirect T cells, via their CD3 component, to eliminate the cell expressing CD19 that are found in many hematological malignancies. CD19 is a lymphocyte-specific marker expressed from early B-lymphocyte development through mature memory B cells, and is highly present in B-cell malignancies. Given MGD011's Fc domain, it has extended pharmacokinetic properties and a longer half-life, allowing for dosing at a once-weekly or longer interval. The compound incorporates MacroGenics' proprietary Dual-Affinity Re-Targeting (DART) platform.

This collaboration follows a similar partnership announced in late September when MacroGenics signed an agreement with Takeda Pharmaceutical Company Limited for the development and commercialization of up to four product candidates (in addition to MGD010, which is the focus of a prior agreement struck in May of this year). Each product candidate will be directed against jointly selected pairs of molecular targets and incorporate MacroGenics' DART platform.