IDE849 / Jiangsu Hengrui Pharma, Ideaya Biosci, Biocytogen - LARVOL DELTA

A First-In-Human Phase 1 Study of SHR-4849 (IDE849), a DLL3-Directed Antibody-Drug Conjugate, in Relapsed SCLC (IASLC-WCLC 2025) - P1 | "Conclusions : SHR-4849 (IDE849) demonstrated manageable safety and preliminary anti-tumor activity in relapsed SCLC. Dose expansion is ongoing to determine RP2D."

First-in-human • P1 data • Anemia • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Small Cell Lung Cancer • Solid Tumor • DLL3

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

IDE849: “IDE849 (SHR-4849) demonstrated compelling initial efficacy in SCLC”; Small cell lung cancer (44th Annual J.P. Morgan Healthcare Conference, IDEAYA Biosciences)

P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer

IDE849: “IDE849 (SHR-4849) demonstrated compelling initial efficacy in SCLC”; Small cell lung cancer (44th Annual J.P. Morgan Healthcare Conference, IDEAYA Biosciences)

P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer

A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=400 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

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

A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=208 | Recruiting | Sponsor: IDEAYA Biosciences | N=90 ➔ 208

Enrollment change • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Oncology • Small Cell Lung Cancer • Solid Tumor

A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=400 | Not yet recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

New P2 trial • Oncology • Solid Tumor

IDE849 (DLL3 TOP1i ADC) (PRNewswire) - "The company continues to enroll SCLC patients with plans to expand into patients with neuroendocrine tumors (NETs) and other DLL3-overexpressing tumors by the end of 2025."

Enrollment status • Neuroendocrine Tumor • Small Cell Lung Cancer

IDEAYA plans to initiate a Phase 1 combination trial of IDE849 and IDE161 by the end of 2025. (PRNewswire)

New P1 trial • Solid Tumor

Hengrui Pharma (600276.SH) announced that its subsidiaries, Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Hengrui Pharmaceutical Co., Ltd., and Shanghai Shengdi Pharmaceutical Co., Ltd., have received the ’Clinical Trial Approval Notice’ (FUTU) - "...issued by the National Medical Products Administration for SHR-7787 Injection, SHR-4849 Injection, Bevacizumab Injection, and Adebrelimab Injection."

New trial • Solid Tumor

A Trial of SHR-4849 Combined With Other Antitumor Drugs in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=90 | Recruiting | Sponsor: IDEAYA Biosciences

New P1/2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

IDEAYA Biosciences Announces Agenda for 10-Year Anniversary R&D Day on September 8, 2025 (PRNewswire) - "Members of IDEAYA's senior leadership team will provide an overview of the company's progress to date, including presentation of new clinical data on darovasertib in neoadjuvant uveal melanoma (UM), IDE849 (DLL3 TOP1 ADC) and IDE397 (MAT2A)..."

Clinical data • Uveal Melanoma

IDEAYA Biosciences and Hengrui Pharma Present Positive Phase 1 Data for IDE849 (SHR-4849), a Potential First-in-Class DLL3 TOP1 ADC, in Small Cell Lung Cancer at the IASLC 2025 World Conference on Lung Cancer (PRNewswire) - "80.0% (8/10) ORR and 70.0% (7/10) confirmed ORR in 2L SCLC; a 73.7% (14/19) ORR and 57.9% (11/19) confirmed ORR (1 pending confirmation) were observed across all lines of SCLC at the 2.4 mg/kg expansion dose of IDE849. 77.1% (27/35) ORR and 60.0% (21/35) confirmed ORR (4 pending confirmation) in 2L SCLC; a 73.2% (52/71) ORR and 47.9% (34/71) confirmed ORR (10 pending confirmation) were observed across all lines of SCLC at all expansion doses of IDE849."

P1 data • Small Cell Lung Cancer

IDEAYA Biosciences, Inc. Reports Second Quarter 2025 Financial Results and Provides Business Update (PRNewswire) - "IDEAYA will provide initial Phase 1 safety and efficacy data from two expansion cohorts in the IDE397 and Trodelvy (sacituzumab govitecan-hziy) combination trial in MTAP-deletion UC patients at the company's R&D Day September 8th, with additional data targeted for a medical conference in the first half of 2026. IDEAYA's partner, Hengrui Pharma, is conducting a multi-site, open label Phase 1 clinical trial for IDE849 in China for patients with small-cell lung cancer (SCLC). Hengrui will present clinical safety and efficacy data from over 70 patients in the trial at the International Association for the Study of Lung Cancer ('IASLC) 2025 World Conference on Lung Cancer (WCLC) taking place from September 6-9, 2025 in Barcelona, Spain. The presentation will include data from the dose escalation and multiple expansion doses. In May 2025, IDEAYA initiated a Phase 1 trial in the U.S. in SCLC. Patient dosing in NETs and other DLL3-expressing tumors is targeted by year-end 2025."

P1 data • Trial status • Neuroendocrine Tumor • Small Cell Lung Cancer • Urothelial Cancer

IDEAYA Biosciences and Hengrui Pharmaceuticals Announce Oral Presentation at IASLC 2025 World Conference on Lung Cancer for IDE849 (SHR-4849), a Potential First-in-Class DLL3-TOP1 ADC (PRNewswire) - "IDEAYA Biosciences...announced the publication of an abstract for an oral presentation on IDE849 (SHR-4849) at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (WCLC)....The presentation will cover efficacy and safety results in SCLC from the Phase 1 trial Hengrui is conducting in China for IDE849 (SHR-4849)....Clinical efficacy and safety data will be presented from over 70 small-cell lung cancer (SCLC) patients in Hengrui's ongoing, multi-site, open label Phase 1 trial. Data will include patients from the dose escalation and at multiple expansion doses. U.S. Phase 1 trial of IDE849 in SCLC patients initiated in 3Q 2025....IDEAYA will also have a poster presentation with data from a second published abstract providing combination mechanism and pre-clinical synergy data between TOP1-payload based ADCs and IDE161, the company's proprietary, potentially first-in-class PARG inhibitor."

P1 data • Preclinical • Small Cell Lung Cancer

A Trial of SHR-4849 Combined With Other Antitumor Drugs in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P2 trial • Oncology • Solid Tumor

IDEAYA Biosciences, Inc. Reports First Quarter 2025 Financial Results and Provides Business Update (PRNewswire) - "IDEAYA plans to enable the wholly-owned IDE397 and IDE892 (PRMT5MTA) combination in patients with MTAP-deletion non-small cell lung cancer (NSCLC) in the second half of 2025....Initiation of evaluation of IDE849 and IDE161 combination targeted in the second half of 2025....Targeting to present preclinical combination mechanism and synergy efficacy data of IDE161 with TOP1-payload based ADCs at a medical conference in the third quarter of 2025."

New trial • Preclinical • Non Small Cell Lung Cancer

IDEAYA Biosciences Announces US FDA IND-Clearance for IDE849, a Potential First-in-Class DLL3 TOP1 ADC, for a Phase 1 Study in Solid Tumors (PRNewswire) - "IDEAYA Biosciences, Inc...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 IDE849 (SHR-4849), a potential first-in-class delta-like ligand 3 (DLL3)-targeting Topo-I-payload antibody drug conjugate (ADC) program, in solid tumors....In addition, IDEAYA is targeting to present preclinical combination mechanism and synergy efficacy data of IDE161/PARG with TOP1-payload based ADCs at a medical conference in the third quarter of 2025....Targeting to present clinical data of over 40 SCLC patients, including the dose escalation and expansion, from partner Hengrui at medical conference in Q3 2025."

IND • P1 data • Preclinical • Small Cell Lung Cancer • Solid Tumor

IDEAYA Biosciences, Inc. Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (PRNewswire) - "Initiation of the Phase 3 registration-enabling trial for darovasertib in neoadjuvant UM is targeted for the first half of 2025...Targeting Phase 1/2 expansion in the first quarter of 2025 and clinical data update for IDE397 in combination with Trodelvy in MTAP-deletion UC in 2025...IDEAYA and Amgen mutually agreed to wind down the IDE397 and AMG 193 clinical combination study in February 2025, and will not pursue dose expansion...IDEAYA plans to submit a U.S. IND for the evaluation of IDE849 as a monotherapy in SCLC in the first half of 2025. Targeting to initiate the evaluation in combination with IDE161 and in NETs in the second half of 2025. Clinical data update targeted in 2025."

Clinical data • IND • New trial • Trial completion • Neuroendocrine Tumor • Small Cell Lung Cancer • Urothelial Cancer • Uveal Melanoma

…SHR-4849, a Novel Phase 1 DLL3 Topo-I-Payload ADC Targeting SCLC and NET Solid Tumors (PRNewswire) - P1 | N=80 | NCT06443489 | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | "In the ongoing Phase 1 dose escalation, SHR-4849 has reached therapeutic dose levels where multiple partial responses have been observed as of the data cut-off date of December 10, 2024. Among 11 evaluable small cell lung cancer (SCLC) subjects treated at therapeutic dose levels, 8 partial responses by RECIST 1.1 were observed, resulting in an overall response rate of ~73% (including both confirmed and unconfirmed responses, all unconfirmed responses were pending further evaluation). As of the data cut-off date, treatment related adverse events (TRAEs) were predominantly Grade 1 or 2, and the Phase 1 dose escalation is ongoing with no reported drug-related discontinuations, and the maximum tolerated dose has not yet been reached...IDEAYA is targeting to file a US IND for SHR-4849 in the first half of 2025."

IND • P1 data • Neuroendocrine Tumor • Small Cell Lung Cancer

2024 AACR｜Hengrui Medicine reveals research data on a new DLL3-ADC drug HRA00130-C004 [Google translation] (Jiangsu Hengrui Press Release) - "At this AACR conference, Hengrui Medicine reported research data on a new DLL3-ADC drug HRA00130-C004 with bystander effect, high DAR (drug to antibody ratio) and good safety...HRA00130-C004 can better inhibit the proliferation of cells with different DLL3 expression levels...In human small cell lung cancer DMS53 and H1184 models, HRA00130-C004 at a dose of 1.5 mg/kg showed strong anti-tumor activity, and no weight loss was observed in mice during the experiment. Moreover, in the DMS53 model, HRA00130-C004 showed an obvious dose effect...HRA00130-C004 has good pharmacokinetic characteristics and molecular integrity in rats and cynomolgus monkeys. HRA00130-C004 was well tolerated by rats and cynomolgus monkeys, and no toxin-related adverse reactions were noted."

Preclinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

IDEAYA Biosciences Enters Exclusive License with Hengrui Pharma for SHR-4849… (PRNewswire) - "IDEAYA Biosciences...announced that it has entered into an exclusive license agreement for SHR-4849, a novel DLL3-targeting Topo-I-payload ADC program with Jiangsu Hengrui Pharmaceuticals..., an innovative global pharmaceutical company headquartered in China focused on unmet clinical needs. Under the terms of the agreement, IDEAYA will develop and commercialize SHR-4849 worldwide outside of Greater China....Under the terms of the agreement, Hengrui Pharma is eligible to receive upfront and milestone payments totaling $1.045 billion, including a $75m upfront fee, up to $200m in development and regulatory milestone payments, plus commercial success-based milestones. Hengrui is also eligible to receive mid-single to low-double digit royalties on net sales outside of Greater China....Rational combination opportunities with IDEAYA's DNA Damage Repair (DDR) clinical pipeline, including Phase 1 PARG inhibitor IDE161."

Licensing / partnership • Solid Tumor

SHR-4849-101: A Trial of SHR-4849 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor