Allogene Therapeutics in Collaboration with Servier Announces FDA Clearance of the IND for ALLO-501

Allogene Therapeutics (Nasdaq:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, in collaboration with its development partner Servier, an independent international pharmaceutical company, today announced that the U.S. Food & Drug Administration (FDA) has cleared Allogene’s Investigational New Drug (IND) application for ALLO-501 in patients with relapsed/refractory non-Hodgkin lymphoma (NHL). Allogene is the sponsor of the ALLO-501 program.

As quoted in the press release:

The Phase 1 portion of the study is designed to assess the safety and tolerability at increasing dose levels of ALLO-501 in the most common NHL subtypes of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL). ALLO-501 will be administered following lymphodepletion with fludarabine/cyclophosphamide (Flu/Cy) and ALLO-647, Allogene’s proprietary anti-CD52 monoclonal antibody. The ALPHA Phase 1 trial will treat up to 24 patients and is on track for initiation in the first half of 2019.

“I am very pleased with the Allogene team’s ability to accelerate the ALLO-501 program by securing the FDA’s clearance of our IND,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. “This significant milestone for the company, as well as the planned initiation of the ALPHA trial, brings us one step closer to making CAR T therapy ‘on demand’ and more broadly accessible to patients when they are at a critical stage in their disease.”

Click here to read the full press release.