Following Q1 Assessment, Allogene Remains Focused on CAR-T Therapy

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After the market closed on Wednesday, Allogene Therapeutics reported its first-quarter financial results, along with updates to its research programs.

The report marked Allogene's fourth anniversary. The company ended the quarter with $733.1 million in cash, cash equivalents and investments. 

The highlight of Allogene’s quarter was the completion of its now operational commercial-scale manufacturing facility located in Newark, California. The facility is intended to produce the supply of ALLO-501A, a CAR-T cell therapy intended to treat relapsed/refractory Non-Hodgkin Lymphoma (NHL), for its planned pivotal study. The new facility will be able to manufacture approximately 20,000 ALLO-501A  doses annually at scale.

Allogene is also going full steam ahead with its CAR-T therapy trials, which were under a U.S. Food and Drug Administration hold until January 2022.

 “Our clinical teams have been incredibly engaged with clinical trials by investigators as we enroll patients across four active studies. We are keenly focused on initiating our pivotal trial on ALLO-501A in third line Large B Cell Lymphoma around the middle of this year,” executive vice president of research and development and chief medical officer of Allogene Rafael G. Amado, M.D., said during the call.

Allogene is currently enrolling patients in clinical trials evaluating Allo-715 and Allo-605, cell therapies intended to treat multiple myeloma (MM), with Allo-715 drawing attention as a potential monotherapy for MM.

“There is tremendous unmet need in myeloma and despite the recent approvals of autonomous CAR-T therapies, there remains a strong interest in a product that can be delivered in days and without the need of bridging chemotherapy. Allo-715 as a monotherapy is already demonstrating a profile that appears attractive,” emphasized Amado.

Preclinical data was published by Allogene which demonstrated the superior long-term in vitro myeloma-killing activity of allogenic anti-BCMA CAR-T cells which model the approach of Allo-715 and -605.

Allogene also provided an update to its first AlloCAR-T candidate for solid tumors, Allo-316, which is intended to treat patients with advanced or metastatic clear cell renal cell carcinoma (RCC). Preclinical data supported the ongoing evaluation of the drug and the trial is now in its second dose level cohort and is continuing to enroll patients.

“In March, the FDA granted Allo-316 Fast Track designation based on its potential to address the unmet needs for patients with renal cell carcinoma who have failed standard therapy. Metastatic tumors have been a challenge regardless of treatment modality, creating a necessity for scientific innovation. While we still have a long road ahead of us, we continue to make progress and look forward to generating data from our ongoing Phase I trial,” Amado said.

As always, Allogene made sure to note that its goal as a CAR-T product company is to be able to serve tens of thousands of patients in a commercial setting with advancements in manufacturing, clinical development and research.

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