Adicet Bio Receives FDA Fast Track Designation for ADI-001 for the Treatment of Systemic Sclerosis (SSc)

Rhea-AI Summary

Adicet Bio (Nasdaq: ACET) has received FDA Fast Track Designation for its drug candidate ADI-001 targeting the treatment of adult patients with systemic sclerosis (SSc). The company, which specializes in developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, will benefit from an expedited review process designed for drugs addressing serious conditions with unmet medical needs.

Positive

• FDA Fast Track Designation received for ADI-001
• Potential acceleration of drug development and review process
• Addresses unmet medical need in serious condition

Negative

• None.

Insights

Biotechnology Analyst

The FDA's Fast Track Designation for Adicet Bio's ADI-001 in systemic sclerosis represents a significant regulatory milestone with several important implications. This designation provides tangible benefits including more frequent FDA interactions, rolling review eligibility, and potential priority review - advantages that could accelerate ADI-001's path to market by months or even years.

Systemic sclerosis affects approximately 100,000 Americans with effective treatments. Current options primarily focus on symptom management rather than addressing underlying disease mechanisms, creating a substantial unmet need. The standard of care typically involves immunosuppressants and organ-specific treatments that manage complications rather than modify disease progression.

ADI-001 represents Adicet's application of allogeneic gamma delta T cell therapy to autoimmune conditions - a notable expansion from the platform's initial cancer applications. These cells possess unique immunomodulatory properties that may address the dysregulated immune response and fibrosis characteristic of SSc without broad immunosuppression. This approach could potentially offer superior efficacy and safety profiles compared to current treatments.

For Adicet, with its $73.6 million market capitalization, this regulatory win provides important validation at a critical time. The company has been strategically pivoting toward autoimmune applications for its platform technology, and this designation supports that strategic direction. The expanded FDA interaction opportunities are particularly valuable for smaller biotechs with regulatory resources.

While promising, investors should note that Fast Track Designation, while improving odds, doesn't guarantee approval. Approximately 60% of Fast Track designated therapies eventually reach market. ADI-001 still faces the challenge of demonstrating efficacy in clinical trials for a complex disease with heterogeneous manifestations and notoriously difficult endpoints.

Clinical Development Expert

The FDA's Fast Track Designation for ADI-001 in systemic sclerosis highlights the critical unmet need in SSc treatment and the potential of Adicet's gamma delta T cell approach. SSc affects approximately 75-100,000 patients in the US with a mortality rate 3-5 times higher than the general population, yet lacks disease-modifying therapies.

From a clinical development perspective, this designation offers substantial practical advantages. Beyond the commonly understood benefits of expedited review, the enhanced FDA interaction will be particularly valuable for navigating the complex endpoints required in SSc trials. These typically include composite measures like the modified Rodnan skin score, forced vital capacity, and quality of life metrics - all challenging to demonstrate meaningful improvement upon.

ADI-001 represents an innovative mechanistic approach to SSc. Gamma delta T cells possess unique immunosurveillance capabilities that can potentially address multiple pathological processes in SSc simultaneously: they can modulate overactive adaptive immune responses, recognize and respond to tissue damage signals, and potentially regulate fibroblast activity directly. This multi-modal mechanism could theoretically address both the inflammatory and fibrotic components of SSc pathology.

The development pathway still faces significant hurdles. SSc's heterogeneous presentation - with cutaneous and diffuse cutaneous variants, plus variable organ involvement - complicates trial design and patient stratification. Additionally, the manufacturing complexity of allogeneic cell therapies requires substantial process development to ensure consistent product quality and potency.

In the competitive landscape, ADI-001 would enter a field with several investigational approaches including JAK inhibitors, anti-fibrotics like nintedanib, and other immunomodulatory agents. The cell therapy approach potentially offers advantages in specificity and durability of response, but must demonstrate meaningful clinical differentiation to justify the likely higher cost and complexity of administration.

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 U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of adult patients with systemic sclerosis (SSc).

Fast Track Designation is a process designed to facilitate development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need.

About ADI-001

ADI-001 is an investigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting CD20 for the treatment of autoimmune diseases. ADI-001 has been granted Fast Track Designation by the FDA for the treatment of relapsed/refractory class III or class IV lupus nephritis (LN), systemic lupus erythematosus (SLE) with extrarenal involvement and systemic sclerosis (SSc). The Company is advancing ADI-001 across six autoimmune indications. Patient enrollment is ongoing in the Phase 1 study evaluating ADI-001 for the treatment of LN. Patient enrollment in SLE, SSc, idiopathic inflammatory myopathy (IIM, or myositis), and stiff person syndrome (SPS) is expected to be initiated in the second quarter of 2025. Initiation of enrollment in anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) is expected in the second half of 2025. In the Phase 1 GLEAN trial, ADI-001 was shown to target B-cells via an anti-CD20 CAR and demonstrated robust exposure and complete CD19+ B-cell depletion both in blood and secondary lymphoid tissue.

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 the initiation of patient enrollment for the Phase 1 trial of ADI-001 in SLE, SSc, IIM, SPS and ANCA AAV and potential benefits resulting from the Fast Track Designation.

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/20250227143374/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 significance of FDA Fast Track Designation for ACET's ADI-001?

The Fast Track Designation will expedite ADI-001's development and FDA review process, potentially accelerating its path to market for systemic sclerosis treatment.

What condition will ACET's ADI-001 treat?

ADI-001 is being developed to treat systemic sclerosis (SSc), a serious autoimmune condition in adult patients.

What type of therapy is Adicet Bio (ACET) developing with ADI-001?

ADI-001 is an allogeneic gamma delta T cell therapy being developed for autoimmune diseases and cancer.

Why did ACET receive Fast Track Designation for ADI-001?

The designation was granted because ADI-001 aims to treat a serious condition (systemic sclerosis) and addresses an unmet medical need.