IDYA IDEAYA Biosciences Inc

 

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): November 29, 2023

IDEAYA Biosciences, Inc.

(Exact name of registrant as specified in its charter)

Delaware		001-38915		47-4268251
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification Number)

7000 Shoreline Court, Suite 350

South San Francisco, California 94080
(Address of principal executive offices, including Zip Code)

 

Registrant’s telephone number, including area code: (650) 443-6209

 

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		Name of each exchange on which registered
Common Stock, $0.0001 par value per share		IDYA		The Nasdaq Global Select 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. 

 

 

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Item 1.01 Entry into a Material Definitive Agreement.

On December 4, 2023, IDEAYA Biosciences, Inc. (the “Company”) announced that it had entered into a Clinical Study Collaboration and Supply Agreement (the “Agreement”), dated November 29, 2023, with Gilead Sciences, Inc. (“Gilead”), pursuant to which the Company and Gilead will collaborate on a portion of the Company’s Phase 1 study for the clinical evaluation of the Company’s IDE397 compound in combination with Gilead’s Trop2-ADC, Trodelvy (the “Combination Study”). Pursuant to the Agreement, the Company is the sponsor of the Combination Study and the Company will provide the Company’s IDE397 compound and will pay for the costs of the Combination Study. Gilead will provide Trodelvy for the Combination Study at no cost to the Company. The Company and Gilead will jointly own clinical data from the Combination Study and all inventions relating to the combined use of IDE397 and Trodelvy. Each party retains commercial rights to its respective compounds, including with respect to use as a monotherapy or combination agent. The Company and Gilead will form a joint steering committee responsible for coordinating all regulatory and other activities under the Agreement.

 

The foregoing is only a summary description of the terms of the Agreement, does not purpose to be complete and is qualified in its entirety by reference to the Agreement, which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2023.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Press Release dated December 4, 2023
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	IDEAYA BIOSCIENCES, INC.
Date: December 4, 2023	By: /s/ Yujiro Hata Yujiro Hata President and Chief Executive Officer

 

 

 

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Exhibit 99.1

IDEAYA Announces Clinical Study Collaboration with Gilead Sciences to Evaluate Trodelvy® and IDE397 Combination in MTAP-Deletion Bladder Cancer

- Entered into Clinical Study Collaboration and Supply Agreement with Gilead to evaluate IDE397, IDEAYA’s MAT2A inhibitor, in combination with sacituzumab-govitecan-hziy (“Trodelvy”) Gilead’s Trop-2 directed ADC, in MTAP-deletion bladder cancer

- Potential first-in-class MAT2A-Trop2 ADC clinical combination targets two distinct, mechanistically complementary, nodes of MTAP-deletion bladder cancer pathway

- MTAP-deletion prevalence in bladder cancer is estimated to be approximately 26%

- IDEAYA will sponsor the clinical trial and Gilead will provide Trodelvy

 

South San Francisco, CA, December 4, 2023 – IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced it has entered into a clinical study collaboration and supply agreement with Gilead Sciences, Inc. (Gilead) to evaluate the efficacy and safety of IDE397, its investigational, potential first-in-class, small molecule MAT2A inhibitor, in combination with Gilead’s sacituzumab-govitecan-hziy (“Trodelvy”), a Trop-2 directed antibody-drug conjugate (ADC), in a Phase 1 clinical trial.

“We are pleased to collaborate with Gilead to evaluate this potential first-in-class Trop-2 directed ADC and MAT2A clinical combination in MTAP-deletion bladder cancer. MTAP-deletion prevalence in bladder cancer is approximately 26% and this patient population represents a high unmet medical need, as there are no approved therapies for MTAP-deletion bladder cancer,” said Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.

“We are delighted to enter into this clinical collaboration with Gilead that advances our multi-pronged strategy designed to deliver maximal benefit to MTAP-deletion solid tumor patients. We believe the strong mechanistic rationale of this combination, and the monotherapy efficacy observed by both agents in MTAP-deletion bladder cancer, may enable this combination to be differentiated and studied in an earlier-line clinical setting,” said Yujiro Hata, President and Chief Executive Officer, IDEAYA Biosciences.

IDE397 is a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2a (MAT2A), in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion. The MTAP deletion patient population is estimated to represent approximately 15% of solid tumors, including approximately 19% of squamous NSCLC and 26% of bladder cancer. Sacituzumab govitecan, commercialized under the brand name Trodelvy, is a Trop-2 directed antibody-drug conjugate currently approved in the U.S. for the treatment of HR+/HER2- metastatic breast cancer, metastatic triple-negative breast cancer and metastatic urothelial cancer.

IDEAYA is evaluating IDE397 in an ongoing Phase 1/2 clinical trial. The company has initiated and is actively enrolling patients into monotherapy expansion in squamous NSCLC and bladder cancer and collaborating with Amgen in a Phase 1 combination study with AMG 193, Amgen’s MTA-Cooperative PRMT5 inhibitor.

 

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Exhibit 99.1

Under the clinical study collaboration and supply agreement, Gilead will provide drug supply to IDEAYA, which will be the sponsor of the Phase 1 clinical combination trial. IDEAYA and Gilead each retain all commercial rights to their respective compounds, including as monotherapy or as combination therapies.

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About IDEAYA Biosciences

IDEAYA is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA’s approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets.

 

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related (i) the prevalence of MTAP-deletion and (ii) the potential therapeutic benefits of the combination of IDE397 and Trodelvy. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA’s recent Quarterly Report on Form 10-Q filed on November 7, 2023 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

 

Investor and Media Contact

IDEAYA Biosciences
Andres Ruiz Briseno

SVP, Head of Finance and Investor Relations
investor@ideayabio.com

 

 

 

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Document Type	8-K
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Entity Registrant Name	IDEAYA Biosciences, Inc.
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Entity Address, Address Line One	7000 Shoreline Court
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Title of 12(b) Security	Common Stock, $0.0001 par value per share
Trading Symbol	IDYA
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