Allogene Advances Off-The-Shelf Mission With Pivotal Trial Progress, Solid Tumor Data

Early Renal Cell Carcinoma Results Offer Proof-Of-Concept

R&D head Zachary Roberts spoke with Scrip about Allogene’s Phase II pivotal trial for ALLO-501A and the firm’s hopes for overcoming challenges with allogeneic CAR-T therapies in solid tumors.

Allogene Therapeutics Inc. achieved a big first for allogeneic chimeric antigen receptor T-cell (CAR-T) therapies last year when it initiated the Phase II ALPHA2 clinical trial of its CD19-targeting ALLO-501A in third-line or later treatment of diffuse large B-cell lymphoma (DLBCL). This year, the company achieved another big milestone when it reported initial results from the ongoing Phase I TRAVERSE trial of ALLO-316, a CD70-targeting candidate, in advanced or metastatic renal cell carcinoma (RCC), providing proof-of-concept data for its allogeneic CAR-T approach in solid tumors.

Executive vice president of research and development, and chief medical officer, Zachary Roberts described in an interview with Scrip how achievement of these and several other upcoming milestones will help Allogene advance its mission of delivering off-the-shelf CAR-T therapies to cancer patients who currently may not be able to

KEY TAKEAWAYS
  • Allogene is at the forefront of developing allogeneic, or off-the-shelf, CAR-T products, and has started the ALPHA2 pivotal trial for ALLO-501A in DLBCL and released Phase I data for ALLO-316 in renal cell carcinoma, offering proof-of-concept for use in solid tumors.

  • Enrollment is paused for trials of the firm’s BCMA-targeting CAR-Ts in development for multiple myeloma while the company reviews manufacturing to make sure outcomes will be similar or improved relative to competing products.

  • Current autologous products are frequently hindered commercially by access and manufacturing issues. Allogene says it can produce 100 doses from a manufacturing run, which would produce only a single dose for an autologous CAR-T

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