Adicet Bio sets 2026 readout after SLE trial milestone
Rhea-AI Filing Summary
Adicet Bio, Inc. (ACET) reported multiple pipeline milestones, highlighted by completion of the last patient visit for the planned Phase 1 safety and efficacy analysis of prulacabtagene leucel (prula-cel) in systemic lupus erythematosus with or without lupus nephritis. The planned analysis covers 22 SLE patients with at least 6 months of follow-up, including 13 patients with at least 12 months of follow-up. Topline data are expected in September 2026, with an investor webcast planned to review results and outline a potential registrational trial design.
Adicet also announced that the FDA cleared its IND for ADI-212 for metastatic castration-resistant prostate cancer, with a Phase 1 trial expected to begin enrollment in the fourth quarter of 2026. The company is progressing a diversified in vivo CAR-T portfolio for hematologic malignancies and solid tumors and expects its first in vivo CAR-T candidate to enter clinical development in the second half of 2027.
Positive
- None.
Negative
- None.
Filing Explained
This September 1 Form 8-K furnishes a press release under Item 7.01; the company states that the release is not deemed filed under Section 18 or incorporated by reference into other filings except by specific reference.
8-K Event Classification
Key Figures
Key Terms
prulacabtagene leucel medical
systemic lupus erythematosus medical
lupus nephritis medical
metastatic castration-resistant prostate cancer medical
in vivo CAR-T medical
Investigational New Drug Application regulatory
FAQ
What did Adicet Bio (ACET) announce regarding its prula-cel lupus trial?
How many patients are included in Adicet Bio’s prula-cel Phase 1 analysis?
When will Adicet Bio (ACET) report topline data for prula-cel in SLE?
What regulatory milestone did Adicet Bio achieve for ADI-212?
What is Adicet Bio’s timeline for its in vivo CAR-T portfolio?
When is Adicet Bio planning a clinical update in systemic sclerosis?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: ( |
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
The |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure.
On September 1, 2026, Adicet Bio, Inc. (Adicet or the Company) issued a press release titled “Adicet Bio Announces Completion of Last Patient Visit for Planned Analysis of prula-cel (formerly ADI-001) Study in Patients with Systemic Lupus Erythematosus With or Without Lupus Nephritis and Provides Corporate Update,” a copy of which is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
|
Description |
99.1 |
|
Press Release of Adicet Bio, Inc. dated September 1, 2026, furnished herewith. |
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
ADICET BIO, INC. |
|
|
|
|
|
Date: September 1, 2026 |
|
By: |
/s/ Nick Harvey |
|
|
Name: |
Nick Harvey |
|
|
Title: |
Chief Financial Officer |
Adicet Bio Announces Completion of Last Patient Visit for Planned Analysis of prula-cel (formerly ADI-001) Study in Patients with Systemic Lupus Erythematosus With or Without Lupus Nephritis and Provides Corporate Update
Prula-cel topline results from planned analysis expected September 2026
FDA clearance of IND for ADI-212 in mCRPC; Phase 1 clinical study expected to initiate in 4Q 2026
Unveiling next-generation in vivo CAR-T platform and pipeline targeting hematological malignancies and solid tumors; first candidate expected to enter clinical development in 2H 2027
REDWOOD CITY, Calif. – September 1, 2026 – Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta CAR T cell and in vivo CAR T therapies for autoimmune diseases, hematologic malignancies and solid tumors, today announced completion of the last patient visit for the planned Phase 1 safety and efficacy analysis of prulacabtagene leucel (prula-cel) in patients with systemic lupus erythematosus (SLE) with or without lupus nephritis (LN). The Company expects to report topline data in September 2026.
The Company plans to host an investor webcast upon release of the topline data to discuss the results and next steps for the program.
“We are pleased with the level of interest from investigators and patients in our study evaluating prula-cel in patients with SLE with or without LN and look forward to the planned readout later this month,” said Chen Schor, President and Chief Executive Officer of Adicet Bio. “As we advance this program, we are also executing across our broader pipeline, including initiating start up activities for our Phase 1 study of ADI-212 in mCRPC, following the recent IND clearance by the FDA, while continuing to progress our differentiated in vivo CAR-T platform, with our first candidate expected to enter clinical development in the second half of 2027.”
Prula-cel Autoimmune Program on Track for 3Q 2026 Data Readout
ADI-212 IND Cleared by FDA; Program Advancing into Clinic
Advancing the Company’s Diversified In Vivo CAR-T Portfolio Towards Clinical Development
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical-stage biotechnology company discovering and developing a broad pipeline of allogeneic gamma delta T cell therapies, engineered with chimeric antigen receptors (CARs), alongside differentiated in vivo CAR-T therapies with the potential to redefine treatment across autoimmune diseases, hematologic malignancies and solid tumors. 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 prula-cel in autoimmune diseases and the potential safety, tolerability and efficacy for the treatment of autoimmune diseases and cancer; expectations regarding future alignment with the FDA on regulatory path to approval; timing and success of the Phase 1 clinical trial of prula-cel in multiple autoimmune indications, including timing and expectations for enrollment and future data releases;
expectations regarding the timing and initiation of a pivotal study for prula-cel in patients with SLE with or without LN; the timing of a clinical update in the Company’s ongoing Phase 1 trial of prula-cel in systemic sclerosis; the preclinical and clinical development of ADI-212, including the timing of regulatory filings, clinical startup activities, clinical updates and future data releases; the timing of initiation of enrollment of a Phase 1 trial for ADI-212 in mCRPC; expectations regarding the potential potency of ADI-212; expectations regarding the potential to optimize in vivo T cell transduction to yield highly cytolytic CAR T therapy; timing of updates to the Company’s in vivo CAR T platform pipeline; and ongoing preclinical programs and activities relating to autoimmune diseases, hematological malignancies and solid tumors.
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 U.S. Food and Drug Administration and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; and the production and product release processes necessary to commercialize Adicet's product candidates are similarly 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 titled “Risk Factors” in Adicet’s most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Adicet’s other filings with the U.S. Securities and Exchange Commission, including its quarterly report on Form 10-Q. 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
Penelope Belnap
Precision AQ
Penelope.belnap@precisionaq.com