Date: 2016-12-26
Type of
information: Halting of patient enrollment
phase: 1
Announcement: initiation of the trial
Company: Janssen Biotech, a J&J company (USA - NJ)
Product: MGD011 (JNJ-64052781)
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.
- 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.
Disease: relapsed or refractory B-cell malignancies, including diffuse-large B cell lymphoma, follicular lymphoma, mantle-cell lymphoma, chronic lymphocytic leukemia and acute lymphoblastic leukemia
Therapeutic
area: Cancer - Oncology
Country:
Trial
details:
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. In the Phase 1 dose-escalation study of duvortuxizumab, multiple objective responses were observed in patients treated at various dosing levels tested. However, a number of patients experienced treatment-related neurotoxicity similar to that seen in patients treated with other CD19-targeted T-cell therapies. Given the recent advances in the highly competitive field for the treatment of B cell malignancies, the opportunity for development and commercialization has become less attractive.
• On July 28, 2015, MacroGenics announced that its partner, Janssen Biotech has initiated dosing in a Phase 1 trial of MGD011 (also known as JNJ-64052781). 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.
Is
general: Yes
