UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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 May 18, 2023, Adicet Bio, Inc. (the Company) issued a press release titled “Adicet Bio Presents Positive Preclinical Data on ADI-270 at the American Society of Gene and Cell Therapy (ASGCT) 26th 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 May 18, 2023, the Company issued a press release and presented on preclinical data on ADI-270, an armored CD70-targeted allogeneic gamma delta chimeric antigen receptor (CAR) T cell development candidate. Data highlights are as follows:
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 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 potential ability of ADI-270 for use as an armored allogeneic gamma delta CAR T cell therapy candidate; the potential tolerability, safety and efficacy profile of ADI-270; and the expected progress, timing and success of the preclinical development of ADI-270, including any future studies.
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 events or results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including without limitation, Adicet's ability to execute on its strategy, including obtaining the requisite regulatory approvals on the expected timelines, 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. 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 for the year ended December 31, 2022 and subsequent filings with the Securities and Exchange Commission. 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. |
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Description |
99.1 |
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Press release issued by Adicet Bio, Inc. on May 18, 2023, furnished herewith. |
104 |
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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.
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ADICET BIO, INC. |
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Date: May 18, 2023 |
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By: |
/s/ Nick Harvey |
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Nick Harvey |
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Title: |
Chief Financial Officer |
Adicet Bio Presents Positive Preclinical Data on ADI-270 at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting
ADI-270 includes Adicet’s proprietary armoring technology and enhancements designed for improved persistence and durability within a solid tumor microenvironment (TME)
ADI-270 demonstrated potent anti-tumor activity in CD70+ cancers and improved resilience to clearance from host immune targeting
REDWOOD CITY, Calif. & BOSTON – May 18, 2023 – Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, today announced preclinical data highlighting ADI-270, an armored allogeneic “off-the-shelf” gamma delta CAR (chimeric antigen receptor) T cell therapy candidate targeting CD70+ cancers, at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) taking place from May 16-20, 2023, in Los Angeles, CA.
“We believe that ADI-270, combined with a third generation CAR and armoring technologies designed to improve persistence and resilience within the TME, may be able to overcome multiple barriers for realizing efficacy for cell therapies in solid tumors. Together with both innate and adaptive immune targeting and tumor infiltration, we believe ADI-270 can potentially improve clinical outcomes for patients,” said Dr. Blake Aftab, Ph.D., Chief Scientific Officer of Adicet. “These findings provide critical groundwork to support the continued clinical development of ADI-270 as a potentially meaningful therapeutic option.”
In this study, gamma delta T cells modified to express CD70 CAR were successfully generated and expanded without evident hindrances from CD70-mediated fratricide in the process. Data being presented included the following findings:
Details for the poster presentations are as follows:
Title: ADI-270: An Armored Allogeneic “Off-the-Shelf” CAR gamma delta T Cell therapy Targeting CD70+ Cancers
Abstract Number: 1023
Poster Session: Thursday Poster Session
Date & Time: May 18, 2023 at noon
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs) and chimeric antigen adaptors (CAds), to enhance selective tumor targeting and facilitate innate and adaptive anti-tumor 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-270.
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, 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; regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; Adicet’s ability to meet production and product release expectations; the effect of COVID-19 on Adicet’s business and financial results, including with respect to disruptions to our preclinical and clinical trials, business operations, employee hiring and retention, and ability to raise
additional capital. 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.
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