UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
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:
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
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 April 22, 2024, Adicet Bio, Inc. (the Company) issued a press release titled “Adicet Bio Highlights Preclinical Data Supporting IND Readiness for ADI-270 in an Oral Presentation at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting,” 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 8.01 Other Events.
On April 22, 2024, the Company issued a press release on preclinical data on ADI-270, an armored allogeneic “off-the-shelf” gamma delta chimeric antigen receptor (CAR) T cell therapy candidate targeting CD70+ cancers. The preclinical findings indicate:
Forward-Looking Statements
The disclosure under this Item 8.01 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-270, its unique use of CD27-based targeting of CD70 and the potential potency, safety, durability, tolerability and efficacy of the product candidate; the Company’s expectations regarding regulatory filings and clearances; and the Company’s expectations regarding ADI-270’s potential to be effective in other indications, such as tumors with mixed antigen expression.
Any forward-looking statements in this Item 8.01 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; that 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 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 titled "Risk Factors" in Adicet's most recent Annual Report on Form 10-K subsequent filings 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 disclosure under this Item 8.01 is as of the date of this Form 8-K, and Adicet undertakes no duty to update this information unless required by law.
Item 9.01 Exhibits.
(d) Exhibits
Exhibit No. |
|
Description |
99.1 |
|
Press release issued by Adicet Bio, Inc. on April 22, 2024, 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 hereunto duly authorized.
|
|
ADICET BIO, INC. |
|
|
|
|
|
Date: April 22, 2024 |
|
By: |
/s/ Nick Harvey |
|
|
Name: |
Nick Harvey |
|
|
Title: |
Chief Financial Officer |
Adicet Bio Highlights Preclinical Data Supporting IND Readiness for ADI-270 in an Oral Presentation at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting
Preclinical findings showed robust anti-tumor activity of ADI-270 in multiple CD70-positive solid and hematological cancer models
ADI-270 demonstrated enhanced functional potency and resilience in tumor microenvironment
On track to file an investigational new drug (IND) application for ADI-270 in 2Q 2024
Preclinical data will be featured in oral presentation on May 10, 2024
REDWOOD CITY, Calif. & BOSTON – April 22, 2024 – 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 an abstract featuring new preclinical data highlighting ADI-270, an armored allogeneic “off-the-shelf” gamma delta CAR (chimeric antigen receptor) T cell therapy candidate targeting CD70 positive cancers, has been selected for an oral presentation at the ASGCT 27th Annual Meeting taking place from May 7-11, 2024, in Baltimore, MD. The oral presentation will take place on May 10, 2024 in the Targeted Gene and Cell Therapy session, co-chaired by Adicet Bio’s Chief Scientific Officer, Blake Aftab, Ph.D.
“We look forward to sharing new preclinical data at ASGCT further illustrating ADI-270’s robust anti-tumor activity with a differentiated method for targeting CD70 across multiple solid and hematologic cancers,” said Blake Aftab, Ph.D., Chief Scientific Officer of Adicet Bio. “ADI-270 is a next-generation CAR T cell therapy candidate designed to capitalize on potent tumor infiltration associated with the gamma delta T cell platform. ADI-270 is further enhanced with armoring to address suppressive tumor microenvironments and to address clearance by host T cells. In preclinical studies, ADI-270 demonstrated enhanced functional persistence and potency, including unique contribution of innate anti-tumor immunity, compared to multiple clinically relevant benchmarks in cancers expressing CD70. Supported by these encouraging data, we look forward to advancing ADI-270’s clinical development and remain on track to file an IND in renal cell carcinoma this quarter.”
Findings from this study have further characterized and have provided comparative benchmarking for the mechanisms by which ADI-270 provides enhanced functionality and potency in CD70 positive expressing tumors such as clear cell renal cell carcinoma (ccRCC) and facilitates a robust anti-tumor effect that supports its continued development. The preclinical findings indicate:
Details for the oral presentation are as follows:
Title: ADI-270: An Armored Allogeneic Anti-CD70 CAR γδ T cell Therapy Designed for Multiple Solid and Hematological Cancer Indications
Oral Session: Targeted Gene and Cell Therapy Session I
Presenting Author: Shon Green, Ph.D.
Date & Time: May 10, 2024 at 5:00 PM EST
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: preclinical and clinical development of Adicet’s product candidates, including
future plans or expectations for ADI-270, its unique use of CD27-based targeting of CD70 and the potential potency, safety, durability, tolerability and efficacy of the product candidate; the Company’s expectations regarding regulatory filings and clearances, including the submission of an IND for ADI-270 in renal cell carcinoma in the second quarter of 2024; and the Company’s expectations regarding ADI-270’s potential to be effective in other indications, such as tumors with mixed antigen expression.
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 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 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.
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