Adicet Bio Announces First Patient Dosed in the Phase 1 Clinical Trial of ADI-270 in Metastatic/Advanced Clear Cell Renal Cell Carcinoma

Rhea-AI Summary

Adicet Bio (Nasdaq: ACET), a clinical stage biotechnology company, has dosed the first patient in its Phase 1 clinical trial of ADI-270 for metastatic/advanced clear cell renal cell carcinoma (ccRCC), marking a significant milestone. ADI-270, an allogeneic gamma delta T cell therapy, aims to address the high unmet need for effective treatments in ccRCC, the most common type of kidney cancer. Preclinical data suggest ADI-270 has significant tumor infiltration capabilities, resistance to the immunosuppressive tumor microenvironment, and potent activity via CAR and innate-mediated targeting. Preliminary clinical data from the trial are expected in the first half of 2025.

Positive

• Dosing the first patient in Phase 1 trial of ADI-270.
• Potential for ADI-270 to offer significant advancement in treating solid tumors.
• Preclinical data shows ADI-270 demonstrates significant tumor infiltration and resistance to immunosuppressive tumor microenvironment.

Negative

• Preliminary clinical data will not be available until the first half of 2025.

Insights

Medical Research Analyst

The initiation of ADI-270's Phase 1 clinical trial represents a strategic advancement in solid tumor therapy, particularly for clear cell renal cell carcinoma (ccRCC).

The gamma delta 1 CAR T cell approach is particularly noteworthy for several reasons:

• Gamma delta T cells can naturally infiltrate solid tumors and maintain functionality in hostile tumor environments
• The dual-targeting mechanism (CAR and innate immunity) could potentially overcome resistance mechanisms that limit current therapies
• The allogeneic ("off-the-shelf") nature of ADI-270 could provide significant manufacturing and accessibility advantages over autologous cell therapies

However, investors should note that while preclinical data shows promise, the 18-month timeline to preliminary data suggests a measured development approach. The solid tumor space has historically been challenging for cell therapies, with many promising preclinical candidates failing to demonstrate significant clinical benefit.

Oncology Expert

The initiation of this trial addresses a critical gap in ccRCC treatment. Current standard therapies - including tyrosine kinase inhibitors and checkpoint inhibitors - typically yield modest results in advanced disease, with median survival rates remaining suboptimal.

Key considerations for this program:

• ccRCC's immunogenic nature makes it a logical target for immunotherapy approaches
• The tumor microenvironment in ccRCC has unique characteristics that have historically treatment efficacy
• ADI-270's demonstrated ability to penetrate tumors and maintain function in preclinical models is particularly relevant

For a company with a market cap of $72.4M, this represents a significant opportunity but also carries substantial execution risk given the complexity of cell therapy development in solid tumors.

Enrollment underway for patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC)

Company expects to share preliminary Phase 1 clinical data 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 that the first patient has been dosed in the Phase 1 clinical trial evaluating ADI-270 in patients with metastatic/advanced ccRCC.

“Dosing the first patient in our Phase 1 trial of ADI-270 in metastatic/advanced ccRCC is a significant milestone for Adicet as we advance our first gamma delta 1 CAR T cell product candidate for the treatment of solid tumors, one of the highest unmet needs in oncology,” said Chen Schor, President and Chief Executive Officer at Adicet Bio. “Patients with ccRCC, the most common type of kidney cancer, have a pressing need for safe and effective treatments, as current therapies offer limited benefits for patients with advanced disease. Based on ADI-270’s encouraging preclinical data generated to date, in which ADI-270 demonstrated significant tumor infiltration, resistance to the immunosuppressive tumor microenvironment and potent activity via CAR and innate-mediated targeting, we believe ADI-270 has the potential to offer a promising advancement for solid tumors. We anticipate reporting 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 metastatic/advanced 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.

For more information about becoming a study site, please email clinicaltrials@adicetbio.com.

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 RCC (ccRCC) is 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 metastatic/advanced ccRCC, including 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/20241219243706/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 focus of Adicet Bio's new clinical trial?

Adicet Bio's new clinical trial is focused on evaluating ADI-270 in patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC).

When was the first patient dosed in the ADI-270 Phase 1 trial?

The first patient was dosed in the ADI-270 Phase 1 trial as announced in the recent press release.

What are the expected benefits of ADI-270 for ccRCC patients?

ADI-270 is expected to offer significant tumor infiltration, resistance to the immunosuppressive tumor microenvironment, and potent activity via CAR and innate-mediated targeting.

When will Adicet Bio share preliminary clinical data for ADI-270?

Adicet Bio expects to share preliminary clinical data for ADI-270 in the first half of 2025.

What type of cancer is ADI-270 targeting in the Phase 1 trial?

ADI-270 is targeting metastatic/advanced clear cell renal cell carcinoma (ccRCC) in the Phase 1 trial.

What preclinical data supports the use of ADI-270?

Preclinical data indicates that ADI-270 demonstrates significant tumor infiltration, resistance to the immunosuppressive tumor microenvironment, and potent activity via CAR and innate-mediated targeting.