The California Institute for Regenerative Medicine (CIRM) awarded $15 million to Dr. John Le Gall and his team at Allogene Therapeutics. This funding will support the development of ALLO-316, an innovative anti-CD70 CAR-T cell product designed to treat metastatic clear cell renal cell carcinoma (ccRCC), the most common type of kidney cancer worldwide. 

Metastatic renal cell carcinoma (RCC) presents significant challenges with limited treatment options, especially for patients who have not responded to checkpoint blockers and targeted therapies. The five-year survival rate for advanced kidney cancer is less than 17%, highlighting the urgent need for new therapeutic approaches. 

ALLO-316 is an allogeneic CAR-T cell therapy that targets CD70, a protein highly expressed on ccRCC tumors. By focusing on CD70-positive cancer cells, this therapy offers a promising new approach to treating kidney cancer. Initial data from the Phase 1 TRAVERSE trial, presented at the American Association for Cancer Research (AACR) 2023 Annual Meeting, showed encouraging response rates and early anti-tumor activity, suggesting deepening responses over time. 

Dr. Zachary Roberts, Executive Vice President of Research & Development and Chief Medical Officer of Allogene, emphasized the transformative potential of CAR-T therapy for solid tumors.  

“CAR-T has revolutionized the treatment of hematologic malignancies, and we believe this CIRM award validates the remarkable progress we have made in our TRAVERSE trial,” said Dr. Roberts. “ALLO-316 has shown significant promise for patients with advanced RCC who have exhausted standard therapies. We are grateful for the support from CIRM and look forward to advancing this trial.” 

The Phase 1 TRAVERSE trial aims to assess the safety, tolerability, and preliminary efficacy of ALLO-316 in patients with advanced RCC. The grant from CIRM will facilitate the completion of this phase, including expanding clinical sites to enhance patient access and conducting translational and clinical analyses to inform the Phase 2 regimen. 

Dr. Abla Creasey, Vice President of Therapeutics Development at CIRM, highlighted the potential impact of this research.  

“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, which has a high unmet medical need,” said Dr. Creasey. 

A cornerstone discovery during the initial phase of the TRAVERSE trial is the Dagger® technology, which selectively eliminates CD70-positive, alloreactive host immune cells. This breakthrough helps delay or prevent the patient’s immune system’s premature rejection of AlloCAR T cells, enhancing the therapy’s effectiveness. 

The development of ALLO-316 represents a significant step forward in the fight against metastatic kidney cancer, offering hope to patients and their families.