Adicet Bio Begins Phase 1 Trial of ADI-270 for Advanced Renal Cell Carcinoma

Adicet Bio, Inc., a notable player in the biotechnology field, recently announced a significant milestone in their ongoing efforts to develop innovative cancer treatments. The company, which focuses on creating gamma delta T cell therapies for autoimmune diseases and cancer, has initiated a Phase 1 clinical trial to evaluate a new therapeutic candidate, ADI-270, for patients suffering from metastatic or advanced clear cell renal cell carcinoma (ccRCC). This news marks the dosing of the first patient in this trial, setting the stage for further advancements in the treatment of solid tumors, a critical area of need in oncology.

Chen Schor, the President and CEO of Adicet Bio, expressed optimism about the potential impact of ADI-270. Given the limited efficacy of existing treatments for ccRCC, Adicet Bio aims to address this gap with their novel therapy. The preclinical studies for ADI-270 have shown promising results, highlighting its ability to penetrate tumors effectively, resist the immunosuppressive environment of tumors, and exhibit substantial activity through CAR and innate-mediated targeting mechanisms. The company is hopeful that these features will translate into meaningful clinical benefits for patients. Preliminary clinical data from this trial is expected to be available in the first half of 2025.

The clinical trial is structured as an open-label, multicenter study focusing on ADI-270 as a standalone treatment for adults with relapsed or refractory metastatic/advanced ccRCC. Eligible patients will receive a single dose of ADI-270 following lymphodepletion, with an initial dose level set at 3E8 CAR+ cells. Depending on specific criteria outlined in the protocol, there is a possibility for patients to receive a second dose. The study aims to assess the safety, tolerability, and pharmacokinetics of ADI-270, alongside its anti-tumor activity, which will be measured by overall response rate, duration of response, and disease control rate.

ADI-270 represents an innovative approach in cancer treatment. As an "off-the-shelf" gamma delta CAR T cell therapy, it targets cancers expressing the CD70 antigen. CD70 is an attractive target due to its significant presence in both solid and blood-related cancers. The therapy incorporates a third-generation CAR, which utilizes the natural receptor CD27 for targeting CD70, and is further enhanced with a dominant negative variant of the transforming growth factor-β receptor II (dnTGFβRII). This design aims to bolster the therapy's resilience against the suppressive environment of tumors and to improve exposure and persistence by reducing the likelihood of host versus graft elimination. The combined properties of ADI-270 are anticipated to enhance the clinical outcomes for patients with RCC and other CD70-positive tumors.

Renal cell carcinoma (RCC) is the predominant form of kidney cancer, making up 80% to 85% of primary renal tumors. Clear cell RCC, the most aggressive subtype, accounts for approximately 80% of RCC cases. This subtype often originates in the proximal nephron's tubular epithelium, with frequent metastasis to organs such as the lungs, liver, and bones. Advanced or locally advanced RCC is present in about 20% of new diagnoses, and post-nephrectomy, up to 30% of patients may develop metastatic disease. The prognosis for advanced RCC remains poor, with a 5-year survival rate of only 15%, compared to 93% for localized cases.

Adicet Bio, Inc., with headquarters in Redwood City, California, and Boston, Massachusetts, is pioneering the development of "off-the-shelf" gamma delta T cell therapies. Their strategic advancements in engineering chimeric antigen receptors (CARs) are set to provide sustained efficacy for patients, particularly those battling complex conditions like cancer. Through its innovative therapies, Adicet Bio is poised to make significant contributions to the field of oncology and beyond.