Allogene Therapeutics Announces the FDA Granted Regenerative Medicine Advanced Therapy (RMAT) Designation to ALLO-501A for Large B Cell Lymphoma
- RMAT Designation Follows Positive Data from ALLO-501A ALPHA2 Trial in Heavily Pretreated Patients with Relapsed or Refractory Large B cell Lymphoma (LBCL)
- Data Presented at the
American Society of Hematology(ASH) 2021 Annual Meeting Demonstrated AlloCAR T™ Could be Safe and Effective in Producing Durable Responses
- In the ALPHA Trials with ALLO-501 and ALLO-501A, Treatment was Initiated Approximately 2 Days from Enrollment, Eliminating Any Need for Bridging Therapy
- Data Presented at the
- Company Intends to Initiate a Phase 2 Pivotal Trial in Mid-2022
“The designation for ALLO-501A supports the patient need for access to an off-the-shelf CAR T product that can be delivered faster, more reliably, and at greater scale,” said
Results from the ALPHA2 study were presented at an oral session of the
- ALLO-501A was associated with consistent and manageable safety with no dose limiting toxicities (DLTs) or graft-vs-host disease (GvHD) and minimal Grade 3 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), or Grade 3 cytokine release syndrome (CRS).
- There were no relapses observed in LBCL CAR T naïve patients who were in a complete response (CR) at six months with the longest ongoing CRs with ALLO-501A at 15+ months.
- Nearly all enrolled patients were able to receive therapy with the median time from enrollment to initiation of treatment of two days in ALPHA2.
Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes for promising pipeline products, including cell therapies, that includes all the benefits of Fast Track and Breakthrough designation. An investigational cell therapy is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious or life-threatening disease; and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for that disease. Advantages of the RMAT designation include early interactions with FDA that may be used to discuss potential surrogate or intermediate endpoints and potential ways to satisfy post approval requirements.
Cautionary Note on Forward-Looking Statements for Allogene
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward- looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the timing and ability to progress the ALPHA2 trial of ALLO-501A, including initiating a pivotal clinical trial of ALLO-501A, which remains subject to further patient follow-up and discussions with the
AlloCAR T is a trademark of
Allogene’s AlloCAR T™ programs utilize Cellectis technologies. ALLO-501 and ALLO-501A are anti-CD19 products being jointly developed under a collaboration agreement between
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Chief Communications Officer
Source: Allogene Therapeutics, Inc.