FDA fast tracks ADI-270 for clear cell renal cell carcinoma

The FDA has awarded a fast track designation to ADI-270 for the potential treatment of patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC) who have received prior therapy with an immune checkpoint inhibitor and a vascular endothelial growth factor (VEGF) inhibitor, Adicet Bio, the developer of the therapy, announced in a news release.¹

The phase 1/2 trial of ADI-270 in ccRCC is expected to launch in the second half of 2024.

ADI-270 is an investigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting CD70-positive cancers.

Fast track designation is awarded to new drugs and vaccines that are intended to treat or prevent serious conditions and have the potential to address an unmet medical need. With this designation, the development process for ADI-270 can benefit from more frequent engagement with the FDA, eligibility for accelerated approval, and priority review.

“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,” said Chen Schor, president and chief executive officer of Adicet Bio, in the news release.¹ “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.”

This announcement comes on the heels of an FDA acceptance of an investigational new drug (IND) application for ADI-270 in June.² The clearance of the IND application will initiate the launch of a phase 1/2 clinical trial (NCT06480565) of the CAR T cell therapy in adult patients with ccRCC.

Overall, the multicenter, open-label, phase 1/2 dose-escalation/dose-expansion trial will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of ADI-270 in adult patients with relapsed or refractory clear cell RCC. Initial efficacy of the CAR T-cell therapy will be assessed by the overall response rate, duration of response, and disease control rate. The primary outcome measures for the trial are the incidence of dose limiting toxicities and the proportion of patients with treatment-emergent or treatment-related adverse events.

In total, the trial expects to enroll 60 patients.³ Participants are eligible for enrollment in the study if they have histologically or cytologically confirmed ccRCC, documented evidence of advanced or metastatic disease, at least 1 measurable target lesion per RECIST v1.1, and a KPS of 70 or higher. Additionally, patients must have received prior treatment with an immune checkpoint inhibitor and a VEGF inhibitor in the advanced/metastatic setting and be at least 3 weeks, or 5 half-lives, whichever is shorter, from the last dose of prior systemic therapy.

Those enrolled in the trial will receive a single dose of ADI-270 monotherapy following lymphodepletion, starting at the dose level of 3E8 CAR+ cells. Patients may then be eligible to receive a second dose of ADI-270 if they meet the protocol defined criteria.

According to the company, the phase 1/2 trial of ADI-270 in ccRCC is expected to launch in the second half of 2024, with preliminary clinical data expected in the first half of 2025.² Overall study completion is anticipated for 2027.³

References

1. Adicet Bio receives FDA Fast Track Designation for ADI-270 in metastatic/advanced clear cell renal cell carcinoma. News release. Adicet Bio, Inc. Published online and accessed July 8, 2024. https://investor.adicetbio.com/news-releases/news-release-details/adicet-bio-receives-fda-fast-track-designation-adi-270

2. 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

3. A phase 1/​2 trial of ADI-270 in ccRCC. ClinicalTrials.gov. Last updated June 28, 2024. Accessed July 8, 2024. https://clinicaltrials.gov/study/NCT06480565