false0001720580NONE00017205802024-05-102024-05-10

 

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 10, 2024

 

 

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.)

 

 

 

 

 

131 Dartmouth Street, Floor 3

 

Boston, Massachusetts

 

02116

(Address of Principal Executive Offices)

 

(Zip Code)

 

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

 

Not applicable

(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 10, 2024, Adicet Bio, Inc. (the Company) presented at the 27th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT ) The Company’s presentation was posted to the “Presentations & Events” section of the Company’s website at investor.adicetbio.com and 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 Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1

Adicet Bio, Inc. Presentation, dated May 10, 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:

May 10, 2024

 By:

/s/ Nick Harvey

 Name:

 Title:

Nick Harvey
Chief Financial Officer

 


Slide 1

ADI-270: An Armored Allogeneic Anti-CD70 CAR γδ T cell Therapy Candidate Designed for Multiple Solid and Hematological Cancer Indications 27th ASGCT Annual Meeting 2024 Baltimore, MD Shon Green, PhD VP, Nonclinical Development


Slide 2

ADI-270: Designed to address multiple refractory cancers CAR utilizes CD27 as the binding domain and contains CD27 and 4-1BB costimulatory domains plus CD3ζ (3rd gen) Inactive form of TGFβ receptor II to mitigate the immunosuppressive effects of TGFβ within the tumor microenvironment Host vs graft armoring against alloreactive activated CD70+ T cells to increase persistence Combines endogenous γδ innate and adaptive mechanisms to recognize and kill malignant cells


Slide 3

High expression in multiple solid and heme malignancies Beyond ccRCC and NPC, multiple solid tumors are of interest when paired with CD70 screening Minimal expression on normal tissues (activated lymphocytes) Target has clinical safety experience CD70 is expressed on multiple solid and hematological cancers with limited expression in normal tissues Representative images from a normal tissue array stained for CD70 Adicet Bio internal data ccRCC= Clear cell renal cell carcinoma; NPC= Nasopharyngeal carcinoma Lung Liver Kidney Ovary Lymph Node Tonsil Spleen Small Intestine Solid tumors Hematological malignancies


Slide 4

ADI-270 highly enriched for Vd1 and memory phenotype % cells positive D o n o r L e u k a p h e r e s i s T r a n s d u c t i o n E x p a n s i o n a ß T C e l l D e p l e t i o n F i n a l F o r m u l a t i o n S e l e c t i v e A c t i v a t i o n o f V δ 1 T C e l l s Adicet Bio internal data ADI-270 is highly pure for Vd1 T cells ADI-270 is highly pure for Vd1 T cells


Slide 5

ADI-270 is resilient to the inhibitory effects of TGFβ Adicet Bio internal data ADI-270 showed resilience to transcriptional changes driven by TGFb signaling ADI-270 maintained proliferation in the presence of TGFb ADI-270 maintained cytotoxicity in the presence of TGFb


Slide 6

CD70-targeting armors ADI-270 against alloreactive host T cells Proposed MoA for enhanced persistence of ADI-270 Host Adicet Bio internal data test materials from same donor PBMCs ADI-270 persisted in culture with primed alloreactive T cells derived from 3 donors


Slide 7

ADI-270 exhibited potent in vitro cytotoxicity against a range of CD70 levels in a diverse set of solid and heme malignancies Adicet Bio internal data CD70 Ag density E:T ratio = 1:1


Slide 8

ADI-270 retained potent activity in the context of CD70-low tumors compared to clinically relevant CD70-targeting αβ CAR T cell benchmarks Adicet Bio internal data


Slide 9

ADI-270 contributed CAR-dependent and CAR-independent mechanisms of tumor targeting CD70+/- tumor mixture model Increased killing of CD70neg tumors within tumor mixture CAR T cell Ag activation A498 tumors and CD70 KO A498 E:T ratio = 1:1, N=2 donors, ****p<0.0001 Adicet Bio internal data test materials derived from same donor PBMCs


Slide 10

ADI-270 demonstrated higher innate cytolytic activity against CD70 negative tumor cells compared to CAR-T cell references ***p<0.001, ****p<0.0001 CD70 KO A498 tumors ADI-270 αβ CAR T references Higher killing Lower killing Adicet Bio internal data test materials derived from same donor PBMCs


Slide 11

ADI-270 associated with a lower potential for macrophage activation syndrome and CRS compared to αβ CAR T cell benchmarks Lower inflammatory profile Higher inflammatory profile CAR T cell activation A498 tumors + macrophages ADI-270 αβ CAR T Benchmarks Adicet Bio internal data


Slide 12

ADI-270 did not demonstrate activation-induced off-target toxicity compared to clinically relevant αβ CAR T cell benchmarks Maintained endothelial growth Reduced endothelial growth CAR T cell activation A498 tumors + HUVEC cells ADI-270 αβ CAR T Benchmarks Adicet Bio internal data


Slide 13

A single dose of ADI-270 showed potent regression and sustained systemic anti-tumor activity in ccRCC xenograft models ADI-270 (5, 10, or 15 x 106 I.V.) ADI-270 (5 or 10 x 106 I.V.) Small tumor ~100mm3 Medium tumor ~500mm3 Monitor tumor volume Monitor tumor volume Monitor tumor volume ****p<0.0001 Tx Tx Tumor regression (right flank) Rechallenge with tumor (left flank) 4 x 106 A498 cells Adicet Bio internal data Opposite Flank Tumor Rechallenge D18 post initial treatment 42 days post rechallenge


Slide 14

ADI-270 demonstrated rapid homing, activation and killing kinetics in ccRCC xenografts resulting in tumor and target eradication Adicet Bio internal data A single dose of ADI-270 showed potent efficacy in A498 tumors, rapidly eradicating CD70+ cells ADI-270 infiltrated and proliferated with effector function as early as Day 3


Slide 15

ADI-270 anti-tumor activity extended to multiple hematologic tumor xenografts associated with lower CD70 expression Adicet Bio internal data A single dose of ADI-270 was administered IV into NSG mice harboring SC tumor xenografts


Slide 16

Next steps: ADI-270 ADI-270 represents potential evolution of γδ CAR T-cell based therapeutics CD27-based 3rd gen CAR demonstrated significant potency advantages1,2,3,4 Armoring against TGFβ and alloreactive T cells confirmed and characterized preclinically Robust efficacy maintained across multiple relevant tumor models of varying stringency Desirable preclinical safety profile with lower potential for CRS and macrophage activation syndrome IND submission in ccRCC expected Q2 2024 1Shaffer et al., Blood 2011 2Acharya et al., Blood 2023 3Leick et al., Cancer Cell 2022 4Kasap et al., BioRxiv 2024

v3.24.1.1.u2
Document And Entity Information
May 10, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date May 10, 2024
Entity Registrant Name Adicet Bio, Inc.
Entity Central Index Key 0001720580
Entity Emerging Growth Company false
Entity File Number 001-38359
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 81-3305277
Entity Address, Address Line One 131 Dartmouth Street, Floor 3
Entity Address, City or Town Boston
Entity Address, State or Province MA
Entity Address, Postal Zip Code 02116
City Area Code (650)
Local Phone Number 503-9095
Entity Information, Former Legal or Registered Name Not applicable
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.0001 per share
Trading Symbol ACET
Security Exchange Name NONE

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