Grant awarded to aid development of allogeneic CAR T treatment for RCC

According to Allogene Therapeutics, the grant will support the ongoing phase 1 TRAVERSE trial (NCT04696731).

Allogene Therapeutics, LLC has been awarded a $15 million grant from the California Institute for Regenerative Medicine (CIRM) to support the clinical development of ALLO-316, an allogeneic CAR T investigational product targeting CD70 that is being developed for the treatment of advanced or metastatic renal cell carcinoma, the company announced.¹

“CAR T has transformed the treatment of hematologic malignancies, but there remains a significant opportunity to apply this innovation to solid tumors,” said Zachary Roberts, MD, PhD, executive vice president, Research & Development and chief medical officer of Allogene, in a news release.¹ “We believe this CIRM award validates the remarkable inroads we have made in our TRAVERSE trial to date and the therapeutic potential ALLO-316 has for patients with advanced RCC who have failed standard therapies. We look forward to advancing this trial with the added support of this grant and are grateful for the recognition from the CIRM reviewers of the potential for ALLO-316 to make a difference for patients.”

According to Allogene Therapeutics, the grant will support the ongoing phase 1 TRAVERSE trial (NCT04696731). The trial is evaluated the safety, tolerability, and preliminary efficacy of ALLO-316 in advanced RCC that has progressed despite receipt of standard therapy. Initial data from TRAVERSE were presented at the 2023 American Association for Cancer Research Annual Meeting indicated promising response rates as well as early anti-tumor activity with deepening responses over time. In the trial, the agent also demonstrated the potency of Dagger technology, “which selectively eliminates CD70 positive, alloreactive host immune cells, thus delaying or preventing premature rejection of AlloCAR T cells by the patient’s immune system,” according to the news release.¹

The trial’s primary outcome measures include the proportion of subjects experiencing dose-limiting toxicities with increasing doses of ALLO-316 (time frame: 28 days) and the proportion of patients experiencing dose-limiting toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-316 (time frame: 33 days).²

Marked expansion and persistence in both preclinical experiments as well as clinical trial as patients has been seen with ALLO-316, even when the agent has been combined with less-intense lymphodepletion regimens.

The CIRM grant is intended to facilitate the completion of the phase 1 portion of the trial. This includes expansion of clinical sites to incorporate diverse patient populations. The grant will also provide support for translational and clinical analyses to inform a recommended phase 2 regimen.

“This clinical study has the potential to demonstrate the value of Chimeric Antigen Receptor (CAR) T cell therapy in solid cancers such as kidney cancer with a high unmet medical need,” said Abla Creasey, PhD, vice president of Therapeutics Development at CIRM, in the news release.¹

Allogene Therapeutics reported that publication of details on a safety algorithm discovered during the initial portion of TRAVERSE is planned for Q2 2024. According to the company, the algorithm may facilitate expanded use of CAR Ts in solid tumors. In addition, the company said it plans a more comprehensive data update from the trial later this year.

REFERENCES

1. Allogene Therapeutics awarded grant from the California Institute for Regenerative Medicine to advance development of an allogeneic CAR T in renal cell carcinoma. News release. Allogene Therapeutics. April 26, 2024. Accessed April 29, 2024. https://www.globenewswire.com/news-release/2024/04/26/2870462/0/en/Allogene-Therapeutics-Awarded-Grant-from-the-California-Institute-for-Regenerative-Medicine-to-Advance-Development-of-an-Allogeneic-CAR-T-in-Renal-Cell-Carcinoma.html

2. Safety and efficacy of ALLO-316 in subjects with advanced or metastatic clear cell renal cell carcinoma (TRAVERSE). ClinicalTrials.gov. Last updated October 31, 2023. Accessed April 29, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT04696731