On July 28, 2015 MacroGenics, Inc. (Nasdaq:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as various autoimmune disorders and infectious diseases, reported that its partner, Janssen Biotech, Inc. ("Janssen"), has initiated dosing in a Phase 1 trial of MGD011 (also known as JNJ-64052781) (Press release, MacroGenics, JUL 28, 2015, View Source [SID:1234506713]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

MGD011 incorporates MacroGenics’ proprietary platform for Dual-Affinity Re-Targeting (DART) to simultaneously target CD19 and CD3 for the potential treatment of B-cell malignancies. Achievement of this milestone triggers a $10 million payment to MacroGenics by Janssen.

The purpose of this first-in-human, open-label study is to evaluate the safety, tolerability and preliminary clinical activity of MGD011 when administered to patients with relapsed or refractory B-cell malignancies, including diffuse-large B cell lymphoma, follicular lymphoma, mantle-cell lymphoma, chronic lymphocytic leukemia and acute lymphoblastic leukemia.

"Janssen’s use of the DART platform for targeting CD19 provides important validation of our technology," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We continue to be impressed with Janssen’s track record of successfully developing potentially transformative oncology therapies and look forward to the future progress of MGD011 in this Phase 1 study."

About MGD011/JNJ-64052781

MGD011 (also known as JNJ-64052781), 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. MGD011 has been engineered to address half-life challenges posed by other programs targeting CD19 and CD3. This product candidate incorporates an Fc domain, which allows for extended pharmacokinetic properties and convenient dosing at an interval of once-every-two-weeks. In addition, MGD011 and MacroGenics’ 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 cell-based approaches such as chimeric antigen receptor (CAR) T-cells.

About the MGD011 Collaboration and License Agreement with Janssen

In December 2014, MacroGenics entered into a collaboration agreement with Janssen. Under this collaboration, MacroGenics licensed MGD011 to Janssen and received a $50 million upfront license fee and a $75 million equity investment by Johnson & Johnson Innovation – JJDC, Inc. Janssen is fully responsible for developing MGD011. Beyond the upfront consideration and recent $10 million clinical milestone, MacroGenics is eligible to receive up to an additional $565 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.