FDA Clears Adicet Bio’s IND Application for ADI-270 in Renal Cell Carcinoma, Phase I Study to Begin in 2024
CAR T cell therapy candidate will be evaluated in Phase I multicenter, open-label clinical trial.
Adicet Bio has announced that the FDA has cleared its Investigational New Drug (IND) application to evaluate ADI-270, an armored allogeneic “off-the-shelf” gamma delta chimeric antigen receptor (CAR) T cell therapy candidate targeting CD70+ cancers, for the treatment of relapsed/refractory renal cell carcinoma (RCC). Adicet plans to initiate a Phase I clinical trial to assess the safety and anti-tumor activity of ADI-270 in RCC patients later this year.1
The future study evaluating ADI-270 will be a Phase I multicenter, open-label clinical trial that is designed to investigate ADI-270 as monotherapy in adults with relapsed or refractory clear cell RCC. Following lymphodepletion, patients will be eligible to receive a single dose of ADI-270 with a starting dose level of 3E8 CAR+ cells. The trial is set to have dose escalation and dose expansion phases.
According to the American Cancer Society, kidney cancer is one of the 10 most common cancers in both men and women in the United States. In 2024, approximately 81,610 new cases of kidney cancer (52,380 in men and 29,230 in women) will be diagnosed.2
“ADI-270 is the first ever gamma delta 1 CAR T cell therapy candidate to enter clinical trials for the treatment of solid tumors,” Chen Schor, president and CEO of Adicet Bio said in a press release. “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. RCC is the most common type of kidney cancer and has a high unmet need with limited viable treatment options available. With its highly differentiated profile, we believe that ADI-270 has the potential to become an important therapeutic option for patients with RCC and other CD70+ tumors.”
Earlier in April, Adicet shared preclinical data that showed anti-tumor activity of ADI-270 in multiple CD70-positive solid and hematological cancer models.3
According to Adicet, the findings included:
- ADI-270 demonstrated potent in vitro cytotoxicity against multiple CD70 positive tumor cell lines expressing varying levels of CD70.
- ADI-270 demonstrated robust cytotoxicity against heterogeneous CD70 negative and CD70 positive tumor cell cultures, highlighting the potential of gamma delta CAR T cells to be effective against tumors with mixed antigen expression.
- ADI-270’s unique use of CD27-based targeting of CD70 demonstrated robust CAR-mediated killing in multiple cancer models including ccRCC, non-small cell lung cancer and T cell lymphoma, and including those models with lower levels of CD70 expression.
- ADI-270 inhibited tumor growth in the context of suppressive tumor microenvironment attributed to inclusion of dominant-negative transforming growth factor beta receptor and demonstrated resilience to clearance by host T cells attributed to the function of CD27-based CAR targeting of CD70 also expressed on host T cells.
- Robust anti-tumor effects in an in vivo model of ccRCC, such as tumor infiltration, proliferation, and effector function, were observed after administration, resulting in eradication of CD70 positive tumor cells.
References
1. Adicet Bio Announces FDA Clearance of IND Application for ADI-270 in Renal Cell Carcinoma. Adicet Bio. News release. June 24, 2024. Accessed June 25, 2024. https://investor.adicetbio.com/news-releases/news-release-details/adicet-bio-announces-fda-clearance-ind-application-adi-270-renal
2. Key Statistics About Kidney Cancer. American Cancer Society. May 1, 2024. Accessed June 25, 2024. https://www.cancer.org/cancer/types/kidney-cancer/about/key-statistics.html
3. Adicet Bio Highlights Preclinical Data Supporting IND Readiness for ADI-270 in an Oral Presentation at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting. Adicet Bio. News release. April 22, 2024. Accessed June 25, 2024. https://investor.adicetbio.com/news-releases/news-release-details/adicet-bio-highlights-preclinical-data-supporting-ind-readiness
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