IDEAYA Biosciences Announces IND Clearance for IDE034, a Potential First-in-Class Bispecific B7H3/PTK7 TOP1 ADC Targeting Multiple Solid Tumor Types

Rhea-AI Summary

IDEAYA Biosciences (NASDAQ: IDYA) announced FDA IND clearance for IDE034, a potential first-in-class bispecific B7H3/PTK7 TOP1 antibody-drug conjugate, clearing the way for a Phase 1 trial. The company expects to begin enrolling patients in Q1 2026, initially in solid tumors with B7H3/PTK7 expression including lung, colorectal, head and neck, and ovarian/gynecological cancers. Based on the Human Protein Atlas, B7H3/PTK7 co-expression is reported at ~30% in lung, ~46% in colorectal, and ~27% in head and neck cancers. Preclinical in vivo models showed deep, durable regressions with IDE034 monotherapy and enhanced durability when combined with IDE161 (PARG inhibitor). Additional preclinical combination data is planned for a medical conference in H1 2026.

Positive

• FDA IND clearance secured for IDE034
• Phase 1 enrollment expected in Q1 2026
• Preclinical deep, durable tumor regressions observed
• B7H3/PTK7 co-expression: ~30%, ~46%, ~27% in listed cancers
• Planned H1 2026 data presentation on combination rationale

Negative

• Efficacy limited to preclinical models; no human data yet
• IDE034 clinical benefit in patients unproven until trial readouts
• B7H3/PTK7 co-expression present in a subset (27–46%) of tumors

News Market Reaction

-3.68%

1 alert

-3.68% News Effect

-$119M Valuation Impact

$3.12B Market Cap

2K Volume

On the day this news was published, IDYA declined 3.68%, reflecting a moderate negative market reaction. This price movement removed approximately $119M from the company's valuation, bringing the market cap to $3.12B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Lung cancer co-expression: 30% Colorectal co-expression: 46% Head & neck co-expression: 27% +3 more

6 metrics

Lung cancer co-expression 30% B7H3/PTK7 co-expression in lung cancers (Human Protein Atlas)

Colorectal co-expression 46% B7H3/PTK7 co-expression in colorectal cancers (Human Protein Atlas)

Head & neck co-expression 27% B7H3/PTK7 co-expression in head and neck cancers (Human Protein Atlas)

Phase 1 start Q1 2026 Planned enrollment start for IDE034 Phase 1 trial

Data timing H1 2026 Target timing to share additional preclinical combination data

Solid tumor types Multiple Lung, colorectal, head and neck, ovarian/gynecological cancers targeted

Market Reality Check

Price: $34.75 Vol: Volume 585,285 is below 2...

low vol

$34.75 Last Close

Volume Volume 585,285 is below 20-day average 947,163 (relative volume 0.62). low

Technical Price 33.56 is trading above 200-day MA at 23.72, indicating a pre-news uptrend.

Peers on Argus

While IDYA was down 1.29% pre-news, key biotech peers like GLPG, BLTE, FOLD and ...

While IDYA was down 1.29% pre-news, key biotech peers like GLPG, BLTE, FOLD and TVTX were modestly positive (up to 1.71%), suggesting stock-specific dynamics rather than a sector-wide move.

Common Catalyst Same-day peer news centered on BLTE’s underwritten offering and positive Phase 3 clinical data, not on TOP1 ADC or B7H3/PTK7 mechanisms.

Historical Context

5 past events · Latest: Dec 10 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 10	IND submission	Positive	-1.3%	Filed IND for IDE574 KAT6/7 dual inhibitor targeting breast and lung cancers.
Dec 04	IND clearance	Positive	+4.7%	FDA IND clearance for IDE034 bispecific B7H3/PTK7 TOP1 ADC licensed from Biocytogen.
Dec 01	IND clearance	Positive	-3.7%	Announced FDA IND clearance for IDE034 targeting multiple solid tumor types.
Nov 28	Inducement grant	Neutral	-0.7%	Granted 17,600 non-qualified stock options to a new hire under inducement plan.
Nov 24	Investor events	Positive	+2.0%	Planned CEO fireside chats at Citi and Evercore healthcare investor conferences.

Pattern Detected

Recent R&D catalysts, including IND clearance for IDE034 and IND submission for IDE574, have produced mixed reactions, with both notable gains and selloffs around ostensibly positive pipeline updates.

Recent Company History

Over late 2025, IDEAYA reported multiple pipeline and corporate milestones. The company secured IND clearance for IDE034 and later submitted an IND for IDE574, both positioned as potential first-in-class oncology agents aiming for Phase 1 starts in Q1 2026. It also issued stock options under its 2023 Inducement Plan and participated in December investor conferences. Today’s IDE034 IND announcement echoes the December 1 clearance news, reinforcing a theme of broadening its targeted oncology and TOP1 ADC-focused portfolio.

Market Pulse Summary

This announcement adds IDE034, a bispecific B7H3/PTK7 TOP1 ADC, to IDEAYA’s clinical portfolio follo...

Analysis

This announcement adds IDE034, a bispecific B7H3/PTK7 TOP1 ADC, to IDEAYA’s clinical portfolio following FDA IND clearance and a planned Phase 1 start in Q1 2026. Preclinical models showed deep, durable regressions in tumors co-expressing B7H3/PTK7 and a mechanistic rationale for combining IDE034 with PARG inhibitor IDE161. Investors can track upcoming preclinical combination data in H1 2026, enrollment progress in solid tumor cohorts, and any early safety or activity signals once human data emerge.

Key Terms

antibody-drug conjugate, adc, parg inhibitor, phase 1 clinical trial, +2 more

6 terms

antibody-drug conjugate medical

"a potential first-in-class bispecific B7H3/PTK7 TOP1 antibody-drug conjugate (ADC)"

An antibody-drug conjugate is a targeted medicine that combines an antibody, which can identify specific cells, with a powerful drug designed to destroy those cells. This approach allows for precise treatment, minimizing damage to healthy tissue. For investors, developments in this area can signal advances in cancer therapies and potential growth opportunities in the biotech sector.

adc medical

"bispecific B7H3/PTK7 TOP1 antibody-drug conjugate (ADC)"

An antibody-drug conjugate (ADC) is a targeted cancer medicine that pairs an antibody that recognizes specific markers on tumor cells with a potent cell-killing drug, connected so the toxic payload is delivered directly to the cancer. For investors, ADCs matter because successful ADCs can improve patient outcomes and reduce side effects compared with traditional chemotherapy, shaping clinical trial success, regulatory approval chances, commercial demand, and a company’s valuation much like a guided missile versus a general bomb.

parg inhibitor medical

"combining IDE034 with IDEAYA's PARG inhibitor, IDE161"

A PARG inhibitor is a drug that blocks the enzyme poly(ADP‑ribose) glycohydrolase (PARG), which normally helps cells remove chemical tags used to signal and repair DNA damage. By stopping that cleanup crew, the drug can make damaged cells—often cancer cells—less able to fix themselves and more likely to die when exposed to chemotherapy or other treatments; for investors, successful PARG inhibitors can meaningfully raise a developer’s commercial and clinical value but carry high scientific and regulatory risk.

phase 1 clinical trial medical

"for the initiation of a Phase 1 clinical trial to evaluate IDE034"

A phase 1 clinical trial is the first stage of testing a new drug or treatment in people, typically involving a small group to assess safety, how the body handles the treatment, and appropriate dosing. For investors, phase 1 results are an early risk check — like a test drive that can reveal fatal flaws or promising signals — and they often cause big changes in a drug’s perceived value and the company’s prospects.

monotherapy medical

"deep and durable tumor regressions with IDE034 monotherapy"

Monotherapy is a treatment approach that uses only one type of medicine or therapy to address a condition, instead of combining multiple options. For investors, understanding monotherapy matters because it can influence a company's development strategy, risk profile, and potential market size, especially if the single-treatment approach proves effective or faces limitations compared to combination therapies.

dna damage medical

"TOP1 inhibition induces replication stress and DNA damage"

DNA damage is harm to the chemical code inside cells—like scratches or smudges on a blueprint—that can stop cells working properly or cause them to change behavior. For investors, DNA damage matters because therapies, diagnostics and safety tests often aim to detect, prevent or repair that harm; findings about DNA damage can affect drug development success, regulatory approval, product liability and the commercial outlook for biotech and healthcare companies.

AI-generated analysis. Not financial advice.

• B7H3 and PTK7 is co-expressed in multiple solid tumor types, including lung, colorectal, and head and neck cancers, at approximately 30%, 46%, and 27%, respectively
• Deep and durable regressions observed with IDE034 monotherapy in multiple preclinical in-vivo models with B7H3 and PTK7 co-expression
• Enhanced durability with IDE034 and IDE161 PARG inhibitor combination in preclinical in vivo models; targeting to share additional preclinical data supporting mechanistic rationale at a medical conference in H1 2026

SOUTH SAN FRANCISCO, Calif. and SHANGHAI, Dec. 1, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial to evaluate IDE034, a potential first-in-class bispecific B7H3/PTK7 TOP1 antibody-drug conjugate (ADC).  IDEAYA expects to begin enrolling the study in Q1 2026, initially evaluating patients with solid tumors known to express B7H3 and PTK7, including lung, colorectal, head and neck and ovarian/gynecological cancers.  Based on the Human Protein Atlas database, B7H3/PTK7 has been reported to be co-expressed in lung, colorectal, and head and neck cancers at approximately 30%, 46% and 27%, respectively.

"IND clearance for IDE034 is an important step in expanding our potential first-in-class TOP1 ADC clinical pipeline into bispecific, precision-guided approaches," said Darrin M. Beaupre, M.D., Ph.D., Chief Medical Officer of IDEAYA Biosciences. "IDE034 has demonstrated robust antitumor activity and selective targeting of B7H3- and PTK7-expressing solid tumor models. The high prevalence of B7H3/PTK7 co-expression in solid tumors such as lung, colorectal, and head and neck cancers underscores its broad indication potential."

"We are excited to advance our differentiated clinical strategy with now three potentially first-in-class clinical-stage programs focused on enhancing the efficacy of TOP1 ADCs through the PARG DDR combination mechanism.  We believe this approach addresses a key unmet need by improving the durability of response to TOP1 payload-based ADC therapies.  We are targeting to share additional preclinical data to support the PARG and TOP1 ADC combination rationale at a major medical conference in H1 2026," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.

Preclinical studies have demonstrated strong anti-tumor activity in B7H3/PTK7-positive tumor models, including deep and durable tumor regressions with IDE034 monotherapy, supporting advancement into clinical development. This co-expression pattern supports the potential for broad monotherapy activity, while the TOP1 payload provides a strong mechanistic rationale for combining IDE034 with IDEAYA's PARG inhibitor, IDE161.  TOP1 inhibition induces replication stress and DNA damage, which can increase reliance on the PARG pathway; therefore, a IDE034 and IDE161 combination approach may enhance anti-tumor activity in patients with solid tumors that co-express B7H3 and PTK7, consistent with the results that were observed preclinically with this combination.

About IDEAYA Biosciences

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer.  Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease.  We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications.  Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to: (i) the timing of the initiation of and enrollment of subjects for  the Phase 1 clinical trial to evaluate IDE034; (ii) the potential frequency of B7H3/PTK7 co-expressed in solid tumors types, including lung, colorectal, and head and neck cancers; (iii) the potential therapeutic benefit of IDE034 as monotherapy and in combination with IDE161, a PARG inhibitor; and (iv) the timing of a data presentation related to the  IDE034 and IDE161, PARG inhibitor, combination at a medical conference.  Preclinical study results are not necessarily predictive of future clinical trial results and/or approval.  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 18, 2025 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

Investor and Media Contact
Joshua Bleharski, Ph.D.
Chief Financial Officer 
investor@ideayabio.com

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SOURCE IDEAYA Biosciences, Inc.

FAQ

What did IDEAYA announce about IDE034 (IDYA) on December 1, 2025?

IDEAYA announced FDA IND clearance for IDE034, a bispecific B7H3/PTK7 TOP1 ADC, to begin a Phase 1 trial.

When will IDEAYA start enrolling patients in the IDE034 (IDYA) Phase 1 trial?

IDEAYA expects to begin enrolling patients in Q1 2026.

Which tumor types will IDE034 (IDYA) initially target in the Phase 1 study?

Initial enrollment will include lung, colorectal, head and neck, and ovarian/gynecological cancers with B7H3/PTK7 expression.

How common is B7H3/PTK7 co-expression in tumors relevant to IDE034 (IDYA)?

Reported co-expression is approximately 30% in lung, 46% in colorectal, and 27% in head and neck cancers.

What preclinical activity supports IDE034 (IDYA) moving to clinical trials?

Preclinical in vivo models showed deep and durable tumor regressions with IDE034 monotherapy and enhanced durability with IDE161 combination.

When will IDEAYA share additional preclinical data on the IDE034 and IDE161 combination?

The company is targeting to present additional preclinical combination data at a medical conference in H1 2026.