IDEAYA Biosciences Announces First-Patient-In for Phase 1 Clinical Trial Evaluating IDE397 and Trodelvy® Combination in MTAP-Deletion Bladder Cancer
IDEAYA Biosciences has initiated a Phase 1 clinical trial for IDE397, its MAT2A inhibitor, in combination with Gilead's Trodelvy (sacituzumab govitecan-hziy) for treating MTAP-deletion bladder cancer. IDE397 targets methionine adenosyltransferase 2 alpha (MAT2A), while Trodelvy is a Trop-2 directed antibody-drug conjugate. This trial will assess safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy. MTAP-deletion is present in approximately 26% of bladder cancer patients. IDEAYA and Gilead will retain commercial rights to their respective compounds, and the trial is part of an ongoing IDEAYA-sponsored study. A data update for the IDE397 Phase 2 monotherapy expansion is expected in late 2024.
- Initiation of Phase 1 trial evaluating IDE397 and Trodelvy combination in MTAP-deletion bladder cancer.
- Potential first-in-class treatment targeting MAT2A and Trop-2 for improved clinical outcomes.
- Collaboration with Gilead, enhancing resource and expertise sharing.
- IDEAYA retains commercial rights to IDE397, optimizing future revenue potential.
- IDE397 and Trodelvy combination has not been approved by regulatory agencies.
- Efficacy and safety of the combination treatment is still unestablished.
- Clinical trial results are pending, indicating uncertainty and risk.
Insights
MTAP-deletion in bladder cancer is a significant biomarker. Approximately
IDE397 is a MAT2A inhibitor, critical because MAT2A is involved in methionine metabolism, a pathway often upregulated in cancers. Inhibition of MAT2A can potentially decrease the growth rate of cancer cells.
Trodelvy, on the other hand, is a Trop-2 directed antibody-drug conjugate (ADC). ADCs are designed to deliver cytotoxic drugs directly to cancer cells, minimizing damage to healthy cells. Trodelvy has already shown efficacy in other cancers, such as metastatic triple-negative breast cancer.
The ongoing trial will assess the safety and efficacy of this combination. If successful, it could provide a novel therapeutic option for a subgroup of patients with poor prognosis, where current treatments are limited.
The initiation of this Phase 1 clinical trial brings IDEAYA closer to potentially offering a new treatment option for bladder cancer. As early clinical trials are inherently risky, the success or failure of such trials can significantly influence a company's stock price.
Given that IDEAYA and Gilead will retain their respective commercial rights, IDEAYA stands to gain if the trial progresses successfully. Licensing and collaboration agreements often positively impact smaller biotech companies due to shared costs and risks.
However, investors should note that the path from Phase 1 trials to commercial approval is long and fraught with uncertainty. Gilead providing Trodelvy supply indicates a strong partnership, which might bolster investor confidence.
The bladder cancer treatment landscape is evolving and the introduction of a novel combination like IDE397 and Trodelvy could potentially disrupt current therapeutic paradigms. While current treatments for MTAP-deletion bladder cancer are limited, a successful new combination therapy could capture significant market share.
Understanding patient demographics and the competitive landscape is key. The MTAP-deletion segment of the bladder cancer market, although niche, represents a substantial portion of patients with specific unmet needs.
Investors should watch for interim data releases and updates to gauge the trial's progress and potential market impact. This trial represents a forward-looking growth opportunity, albeit with the inherent risks of clinical development.
- First-Patient-In (FPI) for Phase 1 combination treatment with IDE397, IDEAYA's MAT2A inhibitor, and Trodelvy®, Gilead's Trop-2 directed antibody-drug conjugate (ADC)
- The global Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE397 in combination with Trodelvy
- MTAP-deletion is found in approximately
26% of patients with bladder cancer
"We are pleased to have dosed our first patient with MTAP-deletion bladder cancer in this Phase 1 trial evaluating combination treatment with IDE397 and Trodelvy. The MAT2A-Trop2 ADC combination targets two distinct, yet complementary nodes in patients with MTAP-deleted urothelial cancer and has first-in-class potential to improve clinical outcomes for bladder cancer patients with poor prognosis associated with MTAP-deletion," commented Dr. Darrin M. Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.
The IDE397 and Trodelvy combination Phase 1 trial is included as an arm of an ongoing IDEAYA-sponsored clinical trial (NCT04794699), which includes a Phase 2 expansion arm of IDE397 monotherapy in MTAP-deletion solid tumors. The global Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE397 in combination with Trodelvy. IDE397 is a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2 alpha (MAT2A) in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion.
Gilead's Trodelvy is currently approved in nearly 50 countries for 2L metastatic triple-negative breast cancer and in more than 30 countries for pre-treated HR+/HER2- metastatic breast cancer (mBC). In the
Pursuant to the clinical study collaboration and supply agreement, IDEAYA and Gilead retain the commercial rights to its respective compounds, including with respect to use as a monotherapy or combination agent. IDEAYA is the study sponsor and Gilead will provide the supply of Trodelvy to IDEAYA.
There is separately an Amgen-sponsored Phase 1/2 trial of IDE397 and AMG 193 combination in MTAP-Deletion NSCLC (NCT05975073) for which the companies intend to develop a joint publication strategy in 2024. The Company is targeting a clinical data update for the IDE397 Phase 2 monotherapy expansion dose in MTAP-deletion bladder and lung cancer in over ~15 evaluable patients in the second half of 2024. The Company is also advancing multiple preclinical stage MTAP-deletion programs to enable wholly-owned combinations with IDE397, including a program targeting a Development Candidate nomination in the second half of 2024.
IDE397 monotherapy or in combination with Trodelvy has not been approved by any regulatory agency and the efficacy and safety of this combination has not been established.
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 to (i) the timing and content of clinical program updates and (ii) the timing for the development of a joint Amgen/IDEAYA publication strategy. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of existing cash to fund operations. 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 Annual Report on Form 10-K dated February 20, 2024 and any current and periodic reports filed with the
Investor and Media Contact
IDEAYA Biosciences
Andres Ruiz Briseno
SVP, Head of Finance and Investor Relations
investor@ideayabio.com
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SOURCE IDEAYA Biosciences, Inc.
FAQ
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