MacroGenics Inc. (NASDAQ:MGNX) has reported its Q3 2020 financial results and provided its corporate progress update.
MacroGenics advancing three programs
Scott Koenig, the company’s CEO and president, said that the company continued to advance its portfolio of multiple clinical molecules in Q3. Currently, the company has three experimental programs which include flotetuzumab, margetuximab and retifanlimab in pivotal studies. The PDUFA action date for margetuximab in breast cancer has been set on December 18, 2020. Following the publication of flotetuzumab data in three different journals early this year, the company is looking forward to presenting the clinical data at the ASH meeting next month. The published data highlights the scientific and medical interest in the DART® molecule.
In September at ESMO, the company and its partner Incyte Corp (NASDAQ:INCY) presented MGD019 and retifanlimab clinical data. This came following the company’s presentation of MGC018 clinical data at ASCO, and recently MacroGeneics commenced enrolment of NSCLC, TNBC and mCRPC patients. Koenig confirmed that soon they would offer an update on the combination of tebotelimab and margetuximab in treating HER2-Positive patients at the SITC Annual Meeting.
The FDA is reviewing a Biologics License Application for margetuximab combination with chemotherapy in metastatic HER2-positive breast cancer. The PDUFA action date set on December 18 based in the accrual overall survival rate events in Phase 3 SOPHIA study. The company is anticipating the accrual of the 385th overall survival event triggering the final OS analysis in 2H 2020. Enrolment is ongoing in Phase 2/3 MAHOGANY margetuximab combination study with checkpoint blockade as a front-line treatment in gastric and gastroesophageal junction cancer patients.
In Q3, the company published two manuscripts in Blood and Blood Advance and two publications of the ASH. The company reported flotetuzumab clinical results as of November last year with the most recent publication reporting the potential role of flotetuzumab inTP54-positive acute myeloid leukaemia immunotherapy. MacroGenics is enrolling in the registrational study evaluating around 200 AML patients with early relapse or primary induction failure with partial haematological recovery and complete remission as the primary endpoint.