Adicet Provides Corporate Update and Highlights Strategic Priorities for 2024
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Insights
The recent clearance by the FDA of Adicet Bio's IND application for ADI-001 in lupus nephritis signifies a pivotal advancement in the field of autoimmune disease treatment. The design of ADI-001 to preferentially target and deplete B cells in not just the periphery but also secondary lymphoid organs and kidneys aligns with the therapeutic needs in autoimmune conditions where B cells play a critical role. The potential of ADI-001 to be administered as an off-the-shelf therapy contrasts with the personalized nature of autologous therapies, which may streamline the treatment process and reduce associated costs.
Furthermore, the focus on mantle cell lymphoma (MCL) within the ongoing ADI-001 Phase 1 clinical trial is based on early but promising data indicating an 80% complete response rate, which is significant given the refractory nature of MCL to many treatments. The safety profile, absence of severe cytokine release syndrome and potential for outpatient administration could position ADI-001 as a leading therapy in this space if these results are consistent in larger trials.
Adicet Bio's strategic decision to focus on MCL patients in their Phase 1 GLEAN study and the planned initiation of a Phase 1 clinical trial in lupus nephritis are critical factors for investors to consider. The company's projection of a cash runway into the second half of 2025 indicates a solid financial positioning that could support their ongoing trials without immediate need for additional capital raising, which is reassuring for stakeholders. This runway also allows for the potential IND submission for ADI-270 in renal cell carcinoma, which could expand the company's portfolio and address a wider market.
The possibility of ADI-001 advancing to a pivotal study under an accelerated approval pathway could lead to faster market entry and a competitive advantage. However, it is important to monitor the upcoming clinical update in the second half of 2024, as it will provide further insights into the efficacy and safety of ADI-001, potentially impacting the company's valuation and stock performance.
The reported clinical benefits of ADI-001 in the treatment of mantle cell lymphoma, an aggressive form of non-Hodgkin's lymphoma, are noteworthy. The observed CR rates surpass those of many existing treatments and the absence of significant risks such as cytokine release syndrome or neurotoxicity is particularly promising. These elements suggest that ADI-001 could improve the standard of care for MCL patients, offering a potentially efficacious and safer treatment option.
Additionally, the IND clearance for lupus nephritis opens up new avenues in the management of autoimmune diseases, a field where treatment options are often limited and associated with significant side effects. The off-the-shelf availability of ADI-001 could revolutionize the approach to treatment, making it more accessible and convenient for patients.
Expanding clinical development of ADI-001 into autoimmune diseases following clearance of Investigational New Drug Application (IND); plan to initiate Phase 1 clinical study in 2Q 2024
Focusing enrollment on mantle cell lymphoma (MCL) in ongoing ADI-001 Phase 1 clinical trial given favorable complete response (CR) rate, durability, and safety
ADI-001 clinical update expected 2H 2024
ADI-270 IND submission in renal cell carcinoma expected in 2Q 2024
Updated cash runway into 2H 2025
“In 2024, we aim to make significant strides across our pipeline of differentiated gamma delta T cell therapies through our strategic and disciplined approach,” said Chen Schor, President and Chief Executive Officer at Adicet Bio. “The
Mr. Schor continued: “Our internal research and development efforts are focused in areas where we believe we have a high probability of success and opportunity for significant differentiation. In our ongoing Phase 1 clinical trial of ADI-001 in relapsed or refractory NHL, we have decided to focus our current patient enrollment on the MCL population, which demonstrated the greatest clinical benefit in our June 2023 clinical update. With projected cash runway into the second half of 2025, multiple upcoming milestones, and a disciplined approach, we believe we are well-positioned to advance our pipeline of allogeneic T cell therapy candidates to address substantial unmet needs in oncology and autoimmune diseases.”
Program Updates and Expected Milestones for 2024
ADI-001 is an investigational allogeneic gamma delta CAR T cell therapy targeting CD20 for the potential treatment of relapsed or refractory B-cell non-Hodgkin’s Lymphoma (NHL) and autoimmune diseases.
Autoimmune diseases
- IND cleared for lupus nephritis. In December 2023, the FDA cleared Adicet’s IND application for ADI-001 in lupus nephritis.
- Initiate Phase 1 clinical trial of ADI-001 for the treatment of lupus nephritis in the second quarter of 2024. The Company plans to initiate a Phase 1 clinical trial to assess the safety and efficacy of ADI-001 in lupus nephritis and may provide a clinical update from the trial in the second half of 2024. Adicet expects to expand into additional autoimmune indications in the near future.
Hematologic malignancies
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Focus enrollment on MCL patients in ongoing Phase 1 GLEAN study. Adicet will focus on the MCL patient population in the ongoing Phase 1 GLEAN study (at dose level 4), which experienced the greatest clinical benefit in the June 2023 update. While these were early data, an
80% CR rate and60% 6-month CR rate in late line MCL patients were reported in the June 2023 clinical update, Cmax and exposure by area under the curve (AUC) exceeded that of approved autologous CD19 CAR T therapies, and a favorable safety profile was observed with no significant risk of cytokine release syndrome, immune effector cell associated neurotoxicity syndrome or T-cell malignancies. These initial clinical results, coupled with the potential to dose off-the-shelf in a community setting, support ADI-001 as a potentially attractive therapy for MCL patients. The Company is evaluating the option of advancing ADI-001 to a potentially pivotal study in MCL patients under an accelerated approval pathway. - The Company remains on track to provide an ADI-001 clinical update in the second half of 2024.
ADI-270 is an investigational allogeneic gamma delta CAR T cell therapy targeting CD70 via the CD27-ligand for the treatment of renal cell carcinoma with potential in other solid tumor indications. ADI-270 is designed to home to solid tumors, with a highly specific targeting moiety for CD70 and an armoring technology of TGF beta dominant- negative receptor to address immunosuppressive factors in the tumor microenvironment. Building on gamma delta 1 tissue tropism to solid tumors and three mechanisms of anti-tumor activity (CAR, innate and adaptive), CAR gamma delta 1 T cells may be well positioned to address solid tumors.
Renal cell carcinoma
- Plan to file IND for ADI-270 in 2Q 2024. Following positive feedback from a pre-IND meeting with the FDA, the Company remains on track to file an IND application for ADI-270 in the second quarter of 2024.
Financial Outlook
- The Company expects cash and cash equivalents on hand as of December 31, 2023, to enable funding for current and planned operations into the second half of 2025.
Webcast/ Conference Call Information
The live webcast of the presentation can be accessed by registering under “Presentations & Events” in the investors section of the Company’s website at https://www.adicetbio.com. Upon registration, all participants will receive a confirmation email with a unique passcode to provide access to the webcast event. To participate via telephone, please join by dialing 888-788-0099 (domestic) or 312-626-6799 (international) and referencing the conference ID 918 2940 8885. An archived replay will be available for 30 days following the presentation. The archived webcast will be available on the Company's website beginning approximately two hours after the event.
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and autoimmune diseases. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to enhance selective tumor targeting and facilitate innate and adaptive immune response for 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: preclinical and clinical development of Adicet’s product candidates, including future plans or expectations for ADI-001 and ADI-270 and the potential safety, durability, tolerability and efficacy of these product candidates; the expected progress, timing and success of the Phase 1 clinical trial of ADI-001, including continued enrollment and expectations around a clinical update in the second half of 2024; the Company’s plan to initiate a Phase 1 clinical trial of ADI-001 in lupus nephritis and expand into other autoimmune indications in the future; the Company’s expectations regarding the submission of an IND for ADI-270 in renal cell carcinoma in the second quarter of 2024; and expectations regarding its uses of capital, expenses and financial results, including the expected cash runway. 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 economic conditions and public health emergencies on Adicet’s business and financial results, including with respect to disruptions to our 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 our 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.
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Adicet Bio, Inc.
Investor and Media Contacts
Anne Bowdidge
abowdidge@adicetbio.com
Janhavi Mohite
Stern Investor Relations, Inc.
212-362-1200
janhavi.mohite@sternir.com
Source: Adicet Bio, Inc.
FAQ
What is Adicet Bio, Inc.'s plan for the clinical development of ADI-001?
What is the focus of Adicet Bio, Inc.'s ongoing ADI-001 Phase 1 clinical trial?
What is the expected IND submission for ADI-270 by Adicet Bio, Inc.?
What is Adicet Bio, Inc.'s updated cash runway?
