IDE034 / Biocytogen, Ideaya Biosci - LARVOL DELTA

Selected Pipeline Developments and Corporate Updates: IDE034 (B7H3/PTK7 bispecific TOP1 ADC): (PRNewswire) - "IDEAYA plans to provide initial clinical data from its ongoing Phase 1 dose escalation trial by the end of 2026 or early 2027, which is expected to include preliminary safety and efficacy data."

P1 data • Solid Tumor

IDE034 (B7H3/PTK7 bispecific TOP1 ADC): achieved FPI in Phase 1 dose escalation trial to evaluate IDE034 in solid tumors, and is targeting to provide a clinical data update by the end of 2026. (IDEAYA Biosciences Press Release) - "Patient dosing triggered a $5 million milestone payment from IDEAYA to Biocytogen, pursuant to the Option and License Agreement between the companies."

Financing • P1 data • Solid Tumor

IDE034, A bispecific antibody-drug conjugate co-targeting PTK7 and B7-H3, exhibits avidity-driven selectivity and enhanced antitumor activity versus mono-specific ADCs (AACR 2026) - "Given the reported frequency of detection of B7H3 and PTK7 protein expression across numerous tumor samples, double positive disease is anticipated to be prevalent in colorectal, non-small cell lung, and breast cancers. Together, these findings support IDE034 as a potential first-in-class bispecific TOP1i-ADC with broad opportunity across disease indications as a monotherapy and in combination with IDE161."

ADC • Bispecific • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD276 • PTK7

A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: IDEAYA Biosciences

New P1 trial • Breast Cancer • Castration-Resistant Prostate Cancer • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Genito-urinary Cancer • Head and Neck Cancer • High Grade Serous Ovarian Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • CD276 • ER • HER-2 • PGR • PTK7

IDEAYA Biosciences Announces Upcoming Presentations at AACR 2026 Highlighting Multiple Clinical Stage Pipeline Programs (PRNewswire) - "The presentations will highlight preclinical data from three potential first-in-class programs from IDEAYA's clinical stage pipeline: IDE034, a PTK7/B7H3 bi-specific topoisomerase-1 (TOP1) antibody-drug conjugate (ADC); IDE574, a potent dual inhibitor of the lysine acetyltransferase (KAT) 6 and 7; and IDE892, an MTA-cooperative inhibitor of PRMT5."

Preclinical • Oncology

IDEAYA Biosciences Announces First-Patient-In for Phase 1 Trial of IDE034, a Potential First-In-Class B7H3/PTK7 Bispecific TOP1 ADC (PRNewswire) - "The company is planning to evaluate safety, tolerability and PK of IDE034 as a monotherapy in the Phase 1 trial, and also plans to test combinations with agents that target the DNA damage response (DDR) pathway, such as their proprietary PARG inhibitor, IDE161. Dosing of the first patient with IDE034 triggers a $5 million milestone payment from IDEAYA to Biocytogen, pursuant to the Option and License Agreement between the companies."

Financing • Trial status • Solid Tumor

Antibody-drug Conjugates (ADC) / DNA Damage Response (DDR) Combinations (PRNewswire) - "IDE849 (DLL3 TOP1 ADC): targeting to provide a preliminary clinical data update from IDEAYA-sponsored global Phase 1 trial and initiate a monotherapy registrational study in the second line/refractory setting (2L+) of SCLC and/or NEC by the end of 2026; IDE034 (B7H3/PTK7 bispecific TOP1 ADC)...expect to achieve first-patient-in (FPI) in Phase 1 dose escalation trial in Q1 '26; Dosing of the first patient with IDE034 will trigger a $5 million milestone payment from IDEAYA to Biocytogen, pursuant to the Option and License Agreement between the companies."

Financing • New P1 trial • P1 data • Trial status • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Neuroendocrine Carcinoma • Ovarian Cancer • Small Cell Lung Cancer

2026 Corporate Objectives:…Antibody-drug Conjugate (ADC) + DNA damage response (DDR) combinations (PRNewswire) - "(i) IDE849 (DLL3 TOP1 ADC): target to initiate a monotherapy registrational study in the second line/refractory setting (2L+) of small cell lung cancer (SCLC) and/or neuroendocrine carcinomas (NEC) by the end of 2026; (ii) IDE034 (B7H3/PTK7 bispecific TOP1 ADC): initiate Phase 1 dose escalation trial in Q1 '26; (iii) IDE161 (PARG): initiate clinical combination studies with IDE849 in SCLC, NEC and other DLL3-overexpressing solid tumors in Q2 '26."

New trial • Neuroendocrine Carcinoma • Small Cell Lung Cancer

IDEAYA Biosciences…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) (PRNewswire) - "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."

IND • New P1 trial • Colorectal Cancer • Head and Neck Cancer • Non Small Cell Lung Cancer • Ovarian Cancer

In the fourth quarter IDEAYA submitted an IND for IDE034, a potential first-in-class B7H3/PTK7 bispecific TOP1i ADC, and is on track to file an IND for IDE574, a potential first-in-class KAT6/7 dual inhibitor, by the end of the year. (PRNewswire)

IND • Solid Tumor

IDEAYA Biosciences, Inc. Reports First Quarter 2025 Financial Results and Provides Business Update (PRNewswire) - "IDE892: a potential best-in-class MTA-cooperative PRMT5 inhibitor to enable wholly-owned combination with IDE397. IND filing targeted for mid-year 2025....IDE034: a potential first-in-class B7H3/PTK7 TOP1i bispecific ADC with combination potential with IDE161. IND filing targeted for the second half of 2025. IDE574: a potential first-in-class KAT6/7 dual inhibitor development candidate with combination opportunities with multiple programs in the Company's pipeline. IND filing targeted for the second half of 2025."

IND • Oncology

IDEAYA Announces Agenda for Investor R&D Day Webcast on December 16, 2024 (PRNewswire) - "The presentations by IDEAYA management and key opinion leaders will showcase scientific insights and clinical development opportunities across IDEAYA's precision medicine oncology pipeline. In addition, IDEAYA will highlight its next-generation precision medicine pipeline programs, including IDE275 / GSK959, a potential first-in-class and best-in-class Phase 1 Werner Helicase inhibitor, IDE892, a potential best-in-class MTA-cooperative PMRT5 inhibitor, IDE034, a potential first-in-class B7H3/PTK7 topo-I-payload bispecific antibody drug conjugate (BsADC), and a potential first-in-class lysine acetyltransferase 6/7 (KAT6/7) development candidate."

Clinical • Oncology • Solid Tumor

Biocytogen Announces IDEAYA’s Nomination of Development Candidate IDE034, a Potential First-in-Class B7H3/PTK7 Topo-I-Payload Bispecific ADC and Option Exercise (Businesswire) - "Biocytogen Pharmaceuticals (Beijing) Co., Ltd...announced that IDEAYA Biosciences, Inc...has exercised the option for an exclusive worldwide license for Biocytogen's B7H3/PTK7 BsADC program, IDE034, and has nominated it as a development candidate....IDEAYA is targeting an Investigational New Drug (IND) submission to the U.S. FDA in 2025 for IDE034, pending the completion of ongoing preclinical and IND-enabling studies, to facilitate the initiation of first-in-human trials....Under the option and license agreement between Biocytogen and IDEAYA, Biocytogen will receive upfront and option exercise fees, along with additional development and regulatory milestone payments, commercial milestone payments, and royalties on net sales, totaling $406.5 million, including up to $100 million in development and regulatory milestone payments."

IND • Licensing / partnership • New molecule • Oncology • Solid Tumor

Biocytogen Announces Option and License Agreement with IDEAYA Biosciences for Potential First-in-Class B7H3/PTK7 Topo-I-Payload Bispecific ADC Program (Businesswire) - "Biocytogen granted IDEAYA an option for an exclusive worldwide license for potential first-in-class B7H3/PTK7 topo-I-payload bispecific antibody drug conjugate (BsADC) program; Rational combo opportunities with IDEAYA’s DNA Damage Repair (DDR) pipeline, including IDE161 (PARG); A development candidate nomination for the B7H3/PTK7 topoisomerase-I-inhibitor payload BsADC program is targeted for the second half of 2024."

Licensing / partnership • Colorectal Cancer • Head and Neck Cancer • Lung Cancer