FDA Grants Fast Track Designation to Potential Treatment for Clear Cell Renal Cell Carcinoma

Updated on July 8, 2024 at 12:26 pm.

The FDA has granted fast track designation to ADI-270, a potential treatment for metastatic/advanced clear cell renal cell carcinoma (ccRCC), for patients who have already been treated with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor.¹

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“We are pleased that ADI-270, our first ever gamma delta 1 CAR T cell therapy candidate to enter clinical trials for solid tumors, has been granted fast track designation by the FDA,” Chen Schor, president and CEO of Adicet Bio, said in a news release. “ccRCC is the most common type of kidney cancer, and this significant milestone underscores our commitment to advancing innovative treatments to these patients as quickly as possible.”¹

In a presentation at the 2023 American Society of Gene and Cell Therapy conference, the drug demonstrated proof-of-concept for an armored allogeneic CD70 γδ CAR T cell therapy, using CD27 natural receptor targeting CD70+ cancers. According to the presentation, ADI-270 showed the ability to enhance functional persistence against renal cell carcinoma cell lines and inhibited tumor growth for renal cell carcinoma xenograft model in NOD scid gamma mice. Furthermore, the presentation showed that host vs graft armoring also showed improved persistence of ADI-270.²

Previously, the FDA also cleared the investigational new drug (IND) application to evaluate ADI-270, with Adicet Bio planning to initiate a phase 1 trial to assess the safety and anti-tumor activity of the drug for patients with relapsed or refractory renal cell carcinoma. The trial will be multicentered and open label, designed to investigate ADI-270 as a monotherapy. After lumphodepleiton, patients will also be eligible to receive a single dose of the drug and a starting dose level of 3E8 CAR+ cells, according to a news release. Patients enrolled in the study might also be eligible to receive a second dose of ADI-270.³

Patients included in the study will have documented evidence of advanced or metastatic disease, previously treated with an immune checkpoint inhibitor and a VEGF inhibitor, at least 1 measurable target lesion according to RECIST 1.1, and at least 3 weeks or 5 half-lives (whichever is shorter) from the last dose of prior line of systemic therapy, according to the clinical trial information.⁴

The dose escalation and dose expansion parts of the trial will also evaluate the safety, tolerability, and pharmacokinetics assessed by the overall response rate, duration of response, and disease control rate.³

“ADI-270 is the first ever gamma delta 1 CAR T cell therapy candidate to enter clinical trials for the treatment of solid tumors,” Schor said. “The FDA’s clearance of our IND application to evaluate ADI-270 in patients with RCC underscores a significant achievement for Adicet. ADI-270 is a third-generation CAR T designed to target CD70+ tumors with high specificity, increased exposure, persistence and tumor infiltration, while addressing immunosuppressive factors in the tumor microenvironment.”³

Reference

1. Adicet Bio Receives FDA Fast Track Designation for ADI-270 in Metastatic/Advanced Clear Cell Renal Cell Carcinoma. News release. Adicet Bio Inc. July 8, 2024. Accessed July 8, 2024. https://www.businesswire.com/news/home/20240708125834/en/Adicet-Bio-Receives-FDA-Fast-Track-Designation-for-ADI-270-in-MetastaticAdvanced-Clear-Cell-Renal-Cell-Carcinoma

2. Lamture G, Teague AG, Smith-Boeck M, et al. ADI-270: an armored allogeneic "off-the-shelf" CAR γδ T cell therapy targeting CD70+ cancers. Presented at: 2023 American Society of Gene + Cell Therapy; May 16-20, 2023; Los Angeles, CA.

3. Adicet Bio Announces FDA Clearance of IND Application for ADI-270 in Renal Cell Carcinoma. News release. Adicet Bio Inc. June 24, 2024. Accessed July 8, 2024. https://investor.adicetbio.com/news-releases/news-release-details/adicet-bio-announces-fda-clearance-ind-application-adi-270-renal

4. A Phase 1/2 trial of ADI-270 in ccRCC. ClinicalTrials.gov. Updated Jun 28, 2024. Accessed July 8, 2024. https://clinicaltrials.gov/study/NCT06480565