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Adicet Bio Announces FDA Clearance of IND Application for ADI-270 in Renal Cell Carcinoma

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Adicet Bio (Nasdaq: ACET) has announced FDA clearance for its IND application for ADI-270, a gamma delta CAR T cell therapy targeting CD70+ cancers, specifically for relapsed/refractory renal cell carcinoma (RCC).

ADI-270 is the first gamma delta 1 CAR T cell therapy to enter clinical development for solid tumors. A Phase 1 clinical trial to evaluate its safety and anti-tumor activity is set to begin in the second half of 2024, with preliminary data expected in the first half of 2025.

The trial will be a multicenter, open-label study focusing on adults with relapsed/refractory clear cell RCC. Participants will receive a single dose of ADI-270 following lymphodepletion, with potential second doses based on meeting specific criteria. The trial aims to assess safety, tolerability, pharmacokinetics, and anti-tumor activity, including overall response rate and disease control rate.

Positive
  • FDA clearance of IND for ADI-270, a significant regulatory milestone.
  • First gamma delta 1 CAR T cell therapy to enter clinical trials for solid tumors.
  • Phase 1 trial to begin in 2H 2024 with preliminary data expected in 1H 2025.
  • ADI-270 targets CD70+ cancers, addressing a high unmet need in RCC treatment.
  • Potential to become an important therapeutic option for RCC and other CD70+ tumors.
Negative
  • Clinical data is only expected by 1H 2025, which may delay market impact.
  • The effectiveness and safety of ADI-270 are still unproven and will depend on Phase 1 results.

The FDA clearance of ADI-270 for renal cell carcinoma (RCC) is a significant development in oncology. RCC is a challenging cancer to treat, with a high unmet need for effective therapies. The introduction of ADI-270, an innovative gamma delta 1 CAR T cell therapy, presents a novel approach. Traditional CAR T therapies have mostly been focused on hematologic malignancies and their application in solid tumors like RCC has been limited due to the complex tumor microenvironment. The use of gamma delta T cells could potentially overcome some of these barriers due to their unique ability to infiltrate solid tumors and their natural cytotoxicity against cancer cells. This therapeutic strategy may lead to more effective and durable responses in RCC patients compared to existing treatments.

FDA clearance of an IND application typically represents a positive catalyst for biotech companies, often leading to increased investor confidence and a potential increase in stock price. For Adicet Bio, this clearance to initiate Phase 1 trials for ADI-270 in RCC is particularly promising. Phase 1 trials focus on safety and initial efficacy signals and positive results could significantly de-risk the development pathway for ADI-270. Importantly, this also expands Adicet Bio's pipeline into solid tumors, potentially opening larger market opportunities. Investors should closely monitor the trial's progression and preliminary data expected in the first half of 2025, as positive outcomes could substantiate further valuation growth for the company.

Adicet Bio's innovative approach with ADI-270 reflects broader trends in cancer treatment where the focus is shifting towards precision medicine and targeted therapies. The candidate's design, targeting CD70+ tumors, highlights an advanced understanding of tumor biology and the importance of addressing immunosuppressive factors in the tumor microenvironment. The success of ADI-270 could establish a new paradigm in CAR T cell therapy, particularly for solid tumors, which have historically been challenging to treat with this modality. Investors should be aware of these technological and clinical aspects, as they underline the transformative potential of ADI-270 within the evolving landscape of oncology treatment.

ADI-270 is the first gamma delta 1 CAR T candidate to enter clinical development for solid tumors

Phase 1 clinical study to evaluate safety and anti-tumor activity of ADI-270 in relapsed/refractory RCC patients

Phase 1 clinical study to be initiated in 2H 2024; preliminary clinical data expected in 1H 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 U.S. Food and Drug Administration (FDA) has cleared the Company’s 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). The Company plans to initiate a Phase 1 clinical trial to assess the safety and anti-tumor activity of ADI-270 in RCC patients in the second half of 2024.

“ADI-270 is the first ever gamma delta 1 CAR T cell therapy candidate to enter clinical trials for the treatment of solid tumors,” said Chen Schor, President and Chief Executive Officer of Adicet Bio. “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.”

The Phase 1 multicenter, open-label clinical trial 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. Subject to meeting protocol defined criteria, patients enrolled in the study 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 design 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) designed 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 the Company’s 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 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: preclinical and 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 potential of ADI-270 to become an important therapeutic option for RCC patients and other patients with CD70+ tumors; and the expected progress, enrollment, timing and success of the Phase 1 study of ADI-270 in relapsed or refractory RCC patients, including expectations around Phase 1 trial initiation in the second half of 2024 and availability of preliminary clinical data in the first half of 2025.

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, economic conditions and public health emergencies on Adicet’s business and financial results, including with respect to disruptions to the Company’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. 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 reports on Form 10-Q and Form 8-K filed with the 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.

Adicet Bio, Inc.

Investor and Media Contacts

Anne Bowdidge

abowdidge@adicetbio.com

Janhavi Mohite

Precision AQ

212-362-1200

janhavi.mohite@precisionaq.com

Source: Adicet Bio, Inc.

FAQ

What is ADI-270?

ADI-270 is an allogeneic gamma delta CAR T cell therapy targeting CD70+ cancers, specifically for relapsed/refractory renal cell carcinoma (RCC).

When will Adicet Bio start the Phase 1 clinical trial for ADI-270?

Adicet Bio plans to start the Phase 1 clinical trial for ADI-270 in the second half of 2024.

What is the expected timeline for preliminary clinical data of ADI-270?

Preliminary clinical data for ADI-270 is expected in the first half of 2025.

What type of cancer is ADI-270 targeting?

ADI-270 is targeting relapsed/refractory renal cell carcinoma (RCC) and other CD70+ tumors.

What are the objectives of the Phase 1 clinical trial for ADI-270?

The Phase 1 trial aims to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of ADI-270.

Why is ADI-270 considered a significant development in cancer therapy?

ADI-270 is the first gamma delta 1 CAR T cell therapy entering clinical trials for solid tumors, offering a potentially important therapeutic option for RCC and other CD70+ cancers.

Adicet Bio, Inc.

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