From The Editor | July 30, 2021

Fast Track Designation for Relapsed/Refractory Multiple Myeloma


By Erin Harris, Editor-In-Chief, Cell & Gene
Follow Me On Twitter @ErinHarris_1

Blood Cells

Many effective treatments for multiple myeloma exist, but it is currently incurable. This means that even after successful treatment has provided a period of remission or stable disease, myeloma will return. When this happens, it’s called recurrent or relapsed. If the myeloma does not respond to treatment or comes back within 60 days after the last dose of treatment, it is known as refractory. Enter Allogene Therapeutics, a clinical-stage biotech that develops allogeneic CAR therapies for cancer including relapsed/refractory multiple myeloma.

ALLO-605 and Why It Matters

Allogene recently announced the FDA has granted Fast Track designation to ALLO-605, the company’s AlloCAR T therapy targeting BCMA for the treatment of relapsed or refractory multiple myeloma. It is an investigational therapy that targets the B-cell maturation antigen (BCMA) for the treatment of patients with relapsed/refractory multiple myeloma and other BCMA-positive malignancies. This study uses ALLO-647, Allogene's proprietary monoclonal antibody (mAb) as a part of its differentiated lymphodepletion regimen.

ALLO-605 incorporates Allogene’s proprietary TurboCAR technology, which allows for cytokine activation signaling to be engineered selectively into CAR T cells.  The FDA granted Fast Track designation based on the potential of ALLO-605 to address the unmet need for patients who have failed other standard multiple myeloma therapies. The Phase 1 dose escalation portion of the IGNITE trial evaluating ALLO-605 was initiated in Q2 2021.

According to Allogene, ALLO-605 is the biotech’s first TurboCAR clinical candidate. TurboCAR is a proprietary platform technology based upon programmable cytokine signaling designed to improve the function and potency of AlloCAR T cells. These properties may also enable CAR T therapy to succeed in solid tumors and increase efficacy in hematologic malignancies.

Timeline of FDA’s Fast Track Designation

According to the FDA, Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and decide within 60 days based on whether the drug fills an unmet medical need in a serious condition. Now that Allogene’s therapy has received Fast Track designation, early and frequent communication between the FDA and Allogene will be encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

What’s Next for ALLO-605

AlloCAR T therapies for Allogene's clinical trials are manufactured in a dedicated, purpose-built GMP suite by a CMO, which is expected to remain a component of the biotech’s manufacturing strategy. Allogene is building its own new manufacturing facility in Newark, CA. The facility is designed for clinical and commercial manufacturing, analytical testing, and distribution of cell therapies. This facility will provide in-house quality assurance and quality control, per good manufacturing practices (GMPs), to ensure a reliable supply of AlloCARs for our clinical programs and commercial products, pending regulatory approval.