8-K
NONEfalse000172058000017205802022-05-052022-05-05

 

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): May 05, 2022

 

 

Adicet Bio, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-38359

81-3305277

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

200 Clarendon Street

Floor 6

 

Boston, Massachusetts

 

02116

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 650 503-9095

 

 

(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:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

ACET

 

The Nasdaq Global Market

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 5, 2022, Adicet Bio, Inc. (the “Adicet”) issued a press release titled “Adicet Presents Preclinical Data at the ISCT Annual Meeting Highlighting Potential Advantages of the Non-Gene-Edited Approach for its Investigational Allogeneic Gamma Delta CAR T Cell Therapy Targeting CD20 for B Cell Malignancies,” 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.

 

 

99.1

Press release issued by Adicet Bio, Inc. on May 5, 2022, 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:

May 5, 2022

By:

/s/ Chen Schor

 

 

   Name:

    Title:

Chen Schor
President and Chief Executive Officer

 


EX-99.1

Adicet Presents Preclinical Data at the ISCT Annual Meeting Highlighting Potential Advantages of the Non-Gene-Edited Approach for its Investigational Allogeneic Gamma Delta CAR T Cell Therapy Targeting CD20 for B Cell Malignancies

 

ADI-001 exhibited robust in vitro and in vivo tumor growth inhibition in multiple human lymphoma cell lines, with adaptive and innate mechanisms contributing to its anti-tumor activity

 

Non-gene-edited ADI-001 gamma delta CAR T cells demonstrated superior resilience to host versus graft targeting when compared to common gene-edited approaches

 

MENLO PARK, Calif. & BOSTON--(BUSINESS WIRE)—May 5, 2022-- Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing first-in-class allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapies for cancer, today announced data from a preclinical evaluation of ADI-001 at the International Society for Cell and Gene Therapy (ISCT) Annual Meeting taking place in San Francisco, May 4-7, 2022. ADI-001 is currently being evaluated in an ongoing dose escalation Phase 1 study evaluating the safety and tolerability of ADI-001 for the potential treatment of relapsed or refractory B-cell Non-Hodgkin’s lymphoma (NHL).

 

The extensive preclinical evaluation reported at ISCT observed that ADI-001 exhibited a predominantly naïve-like T cell memory phenotype, expressed multiple chemokine and innate-activating cell receptors and exhibited robust in vitro and in vivo tumor growth inhibition against multiple human lymphoma cell lines, with adaptive and innate activation pathways contributing to the anti-tumor activity of ADI-001.

 

Susceptibility to host versus graft targeting was also evaluated using mixed-lymphocyte reactions incorporating up to 13 different allogeneic lymphocyte samples. Non-gene-edited ADI-001 gamma delta CAR T cells demonstrated high levels of endogenous HLA-E expression in the unmodified state and were associated with superior resilience to lymphocyte-mediated clearance when compared to approaches commonly deployed in gene-edited allogenic cell therapy platforms (β2MKO with or without HLA-E overexpression).

 

“In this first view comparing Adicet’s non-gene-edited gamma delta CAR T cells to alternative and popularly-reported gene editing strategies, we appreciate the lower preclinical susceptibility to host versus graft targeting demonstrated by non-gene-edited ADI-001,” said Blake Aftab, Ph.D., Chief Scientific Officer at Adicet. “Together, the results of this extended characterization highlight potential advantages of our allogeneic gamma delta T cell platform, with adaptive and innate mechanisms contributing to the anti-tumor activity of ADI-001.”


Poster Presentation Details

 

Title: Evaluation of non-gene edited allogeneic “off-the-shelf” Vδ1 gδ (gamma delta) CAR T cells targeting CD20 for B cell malignancies

 

ePoster Presentation: Thursday, May 5 at 4:00 p.m. PT

 

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 CAR and T cell receptor-like targeting moieties to enhance selective tumor targeting, facilitate innate and adaptive anti-tumor immune response, and

 

ACTIVE/116845050.1

 


improve persistence for durable activity in patients. For more information, please visit our website at http://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 business and operations of Adicet. These forward-looking statements include, but are not limited to, express or implied statements regarding data from the preclinical evaluation of ADI-001, including Adicet’s beliefs and expectations regarding the potential therapeutic effects, design and success of ADI-001.

 

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 COVID-19 on Adicet’s business and financial results, including with respect to disruptions to Adicet’s preclinical evaluations and clinical trials, business operations, and ability to raise additional capital; Adicet's ability to execute on its strategy; that positive results from a preclinical or clinical study may not necessarily be predictive of the results of future or ongoing studies; future preclinical or 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; and regulatory developments in the United States and foreign countries. 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, 2021 as filed with the U.S. Securities and Exchange Commission (SEC) and subsequent filings 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. Media and Investor Contacts:

Anne Bowdidge
abowdidge@adicetbio.com

Janhavi Mohite
Stern Investor Relations, Inc.
212-362-1200
janhavi.mohite@sternir.com

 

ACTIVE/116845050.1