Date: 2015-01-27
Type of information: Termination of an agreement
Compound: duvortuxizumab -MGD011
Company: Macrogenics (USA - MD) Janssen Biotech, a J&J company (USA - NJ)
Therapeutic area: Cancer - Oncology
Type agreement: licensing
Action mechanism:
- bispecific DART. MGD011, a humanized CD19 x CD3 bispecific DART protein, is being developed for the treatment of B-cell hematological malignancies. CD19, a lymphocyte-specific marker expressed from early B-lymphocyte development through mature memory B cells, is highly represented in B-cell malignancies. This makes it attractive for targeted interventions. MGD011 is designed to redirect T cells, via their CD3 component, to eliminate CD19-expressing cells found in many hematological malignancies. MGD011 has been engineered to address half-life challenges posed by other programs targeting CD19 and CD3. This product candidate has an Fc domain, which allows for extended pharmacokinetic properties and convenient dosing at a once-a-week or longer interval. In addition, MGD011 and the Company\'s other DART molecules that redirect T cells against cancer targets are manufactured using a conventional antibody platform without the complexity of having to genetically modify T cells from individual patients as required by approaches such as chimeric antigen receptor (CAR) T-cells. Last December, Macrogenics has presented preclinical results for MGD011 at the 56th Annual Meeting of the American Society of Hematology (ASH).
Disease: B-cell hematological malignancies
Details:
- • On January 27, 2015, MacroGenics, a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases, announced the closing of the global collaboration and license agreement for MGD011 with Janssen Biotech. The agreement was announced on December 22, 2014 .
Under the terms of the agreement, MacroGenics will receive a $50 million upfront license fee and Johnson & Johnson Innovation - JJDC, has invested $75 million with the purchase of 1,923,077 new shares of MacroGenics common stock at a price of $39.00 per share. Janssen will be fully responsible for developing MGD011 following submission of the IND, which is planned for 2015. Assuming successful development and commercialization, MacroGenics could receive up to an additional $575 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 U.S. 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 the molecule with Janssen in the U.S.
Financial terms:
Latest news:
- • On August 31, 2017, MacroGenics announced that it had been notified by its partner, Janssen Biotech, that Janssen is terminating the collaboration and license agreement with MacroGenics relating to duvortuxizumab. Enrollment of the Phase 1 dose-escalation study of this molecule is being discontinued. Janssen reaffirmed its commitment to MGD015, also known as JNJ-9383, a second DART molecule licensed from MacroGenics. Janssen has indicated that it anticipates initiating a first-in-human study with this molecule in 2018.
Is general: Yes
