Adicet Bio Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
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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).
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Item 7.01 Regulation FD Disclosure.
On October 16, 2024, Adicet Bio, Inc. (the “Company”) issued a press release titled “Adicet Bio Announces FDA Clearance of IND Amendment to Evaluate ADI-001 in Idiopathic Inflammatory Myopathy and Stiff Person Syndrome,” 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 October 16, 2024, the Company announced that the U.S. Food and Drug Administration cleared the Company’s Investigational New Drug amendment to evaluate ADI-001 in idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS). The Company plans to initiate enrollment for IIM and SPS patients as part of the ongoing Phase 1 trial in autoimmune diseases in the first quarter of 2025. The ADI-001 Phase 1 program in autoimmune diseases will have four separate arms, enrolling lupus nephritis and systemic lupus erythematosus patients into one arm, systemic sclerosis patients into a second arm, anti-neutrophil cytoplasmic autoantibody-associated vasculitis patients into a third arm, and IIM and SPS patients into a fourth arm. The fourth cohort combines several rare autoimmune muscle diseases into a single dose-finding population, including SPS and the following IIM subtypes: dermatomyositis, anti-synthetase syndrome, immune-mediated necrotizing myopathy, polymyositis, and overlap myositis.
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 October 16, 2024, 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 thereunto duly authorized.
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ADICET BIO, INC. |
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Date: |
October 16, 2024 |
By: |
/s/ Nick Harvey |
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Name: Title: |
Nick Harvey |