Adicet Opens Enrollment for ADI-270 Phase 1 Clinical Trial in Metastatic/Advanced Clear Cell Renal Cell Carcinoma

Rhea-AI Summary

Adicet Bio (Nasdaq: ACET) has initiated enrollment for a Phase 1 clinical trial of ADI-270, their gamma delta CAR T cell therapy targeting metastatic/advanced clear cell renal cell carcinoma (ccRCC). This marks the first gamma delta CAR T cell therapy aimed at treating solid tumors. The company's ADI-270 is an armored allogeneic 'off the shelf' gamma delta 1 CAR T cell therapy targeting CD70 positive cancers. Preliminary Phase 1 clinical data is expected in the first half of 2025. Recent preclinical data presented at the ASGCT conference showed ADI-270's potential for significant tumor infiltration, resistance to immunosuppressive tumor microenvironment, and potent activity.

Positive

• First-in-class gamma delta CAR T cell therapy for solid tumors entering clinical trials
• Preclinical data demonstrated significant tumor infiltration and potent activity
• Novel approach to address unmet medical needs in solid tumors

Negative

• Preliminary clinical data not available until first half of 2025
• Early-stage Phase 1 trial with uncertain outcomes

Insights

Medical Research Analyst

The initiation of ADI-270's Phase 1 trial for advanced renal cell carcinoma represents a significant milestone in solid tumor immunotherapy. The study targets CD70-positive cancers using gamma delta CAR T cell therapy, a novel approach that could potentially overcome the limitations of current CAR T treatments in solid tumors.

The preclinical data demonstrates three important advantages:

• Effective tumor infiltration
• Resistance to immunosuppressive environments
• Dual-targeting mechanism through CAR and innate immunity

The 'off-the-shelf' allogeneic nature of ADI-270 could provide significant manufacturing and accessibility advantages over autologous CAR T therapies. However, investors should note that preliminary data won't be available until H1 2025, indicating a lengthy timeline for clinical validation.

First gamma delta CAR T cell therapy with the potential to address solid tumors entering clinical trials

Preliminary Phase 1 clinical data expected in the first half of 2025

REDWOOD CITY, Calif. & BOSTON--(BUSINESS WIRE)-- Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced the opening of enrollment for the Phase 1 clinical trial evaluating ADI-270 in patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC).

“Solid tumors represent one of the highest unmet medical needs in oncology and have yet to benefit from the breakthroughs observed with CAR T cell therapies in hematologic malignancies. Emerging data from ADI-270, our armored allogeneic 'off the shelf' gamma delta 1 CAR T cell therapy targeting CD70 positive cancers, have shown potential in addressing this gap,” said Chen Schor, President and Chief Executive Officer. “At the recent ASGCT conference, we presented preclinical data in which ADI-270 demonstrated significant tumor infiltration, resistance to the immunosuppressive tumor microenvironment, and potent activity via CAR and innate-mediated targeting, highlighting its potential for treating solid tumors. We look forward to enrolling patients and anticipate sharing preliminary clinical data from the trial in the first half of 2025.”

About the Phase 1 Trial

The Phase 1 multicenter, open-label clinical trial is designed to investigate ADI-270 as monotherapy in adults with relapsed or refractory ccRCC. Following lymphodepletion, patients will be eligible to receive a single dose of ADI-270 with a starting dose level of 3E8 CAR+ cells. Subject to meeting protocol defined criteria, patients enrolled in the trial may be eligible to receive a second dose of ADI-270. The dose escalation and dose expansion portions of the trial will evaluate safety, tolerability, and pharmacokinetics as well as anti-tumor activity as assessed by overall response rate, duration of response and disease control rate.

About ADI-270

ADI-270 is an armored allogeneic “off-the-shelf” gamma delta CAR T cell therapy candidate targeting CD70-positive cancers. CD70 is a compelling target due to its high expression in both solid and hematological malignancies. ADI-270 is engineered with a third-generation CAR designed to target CD70 using its natural receptor, CD27, as the binding moiety and is further armored with a dominant negative form of the transforming growth factor-β receptor II (dnTGFβRII) to provide functional resilience to the immunosuppressive tumor microenvironment. ADI-270 is also designed to increase exposure and persistence by reducing susceptibility to host vs. graft elimination. These properties of ADI-270 combined with the potent tumor infiltration demonstrated with gamma delta 1 T cells aim to improve clinical responses of RCC patients and other patients with CD70+ tumors.

About Renal Cell Carcinoma

Renal cell carcinoma (RCC) is the most common tumor of the kidney, constituting 80% to 85% of primary renal neoplasms. Clear cell RCCs (ccRCC) are the most common subtype, accounting for 80% of all RCCs. ccRCC is an aggressive subtype arising from renal stem cells commonly arising in the proximal nephron and tubular epithelium, and often metastasizes to the lungs, liver, and bones. Approximately 20% of newly diagnosed cases of RCC are locally advanced or metastatic and up to 30% of patients will develop metastatic disease following nephrectomy. While the 5-year survival rate for localized RCC is 93%, the 5-year survival rate for advanced disease is 15%.

About Adicet Bio, Inc.

Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.

Forward-Looking Statements

This press release contains "forward-looking statements" of Adicet within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the business and operations of Adicet. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: clinical development of Adicet’s product candidates, including future plans or expectations for ADI-270; the potential safety, durability, tolerability and activity of ADI-270; the expected progress, timing and success of the Phase 1 clinical trial of ADI-270 in ccRCC, including expectations for enrollment and plans to report preliminary clinical data in the first half of 2025, and the potential of ADI-270 to become a treatment for solid tumors and ccRCC.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including without limitation, the effect of global geopolitical conflicts and economic conditions on Adicet’s business and financial results, including with respect to disruptions to Adicet’s preclinical and clinical studies, business operations, employee hiring and retention, and ability to raise additional capital; Adicet’s ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; that positive results, including interim results, from a preclinical or clinical study may not necessarily be predictive of the results of future or ongoing studies; clinical studies may fail to demonstrate adequate safety and efficacy of Adicet’s product candidates, which would prevent, delay, or limit the scope of regulatory approval and commercialization; and regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; and Adicet’s ability to meet production and product release expectations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Adicet’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Adicet’s most recent annual report on Form 10-K and periodic and current reports on Form 10-Q and Form 8-K filed with the U.S. Securities and Exchange Commission (SEC), as well as discussions of potential risks, uncertainties, and other important factors in Adicet’s other filings with the SEC. All information in this press release is as of the date of the release, and Adicet undertakes no duty to update this information unless required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241118405678/en/

Adicet Bio, Inc.

Investor and Media Contacts

Investors:

Anne Bowdidge

abowdidge@adicetbio.com

Janhavi Mohite

Precision AQ

212-362-1200

janhavi.mohite@precisionaq.com

Media:

Kerry Beth Daly

kbdaly@adicetbio.com

Source: Adicet Bio, Inc.

FAQ

What is the purpose of Adicet Bio's ADI-270 Phase 1 clinical trial?

The Phase 1 clinical trial aims to evaluate ADI-270, a gamma delta CAR T cell therapy, in patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC).

When will Adicet Bio (ACET) release preliminary data for the ADI-270 Phase 1 trial?

Adicet Bio expects to share preliminary clinical data from the ADI-270 Phase 1 trial in the first half of 2025.

What makes Adicet Bio's ADI-270 therapy unique for solid tumors?

ADI-270 is the first gamma delta CAR T cell therapy targeting solid tumors, specifically designed as an armored allogeneic 'off the shelf' therapy targeting CD70 positive cancers.

What were the key findings from ADI-270's preclinical data presented at ASGCT?

The preclinical data showed ADI-270 demonstrated significant tumor infiltration, resistance to the immunosuppressive tumor microenvironment, and potent activity via CAR and innate-mediated targeting.