DM002 / Doma Pharma, Biocytogen - LARVOL DELTA

First-in-human study of DM002, an anti-MUC1/HER3 bispecific antibody-drug conjugate, in patients with advanced solid tumors. (ASCO 2026) - P1 | "DM002 is safe and tolerable up to 4.5 mg/kg dose level. In pancreatic cancer, prostate cancer and ovarian cancer, DM002 has demonstrated an encouraging efficacy with a manageable safety profile. The putative RDEs are 3.0 and 3.5 mg/kg which will be further evaluated in phase II trials."

ADC • Bispecific • Clinical • First-in-human • Metastases • P1 data • Endocrine Disorders • Febrile Neutropenia • Genito-urinary Cancer • Heart Failure • Infectious Disease • Leukopenia • Neutropenia • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Thrombocytopenia • ERBB3 • MUC1

Preclinical Efficacy of DM002, a bispecific HER3×MUC1 antibody-drug conjugate with a novel DNA topoisomerase I inhibitor, in solid tumor models (AACR 2024) - "More recently, HER3-targeted ADCs, such as Patritumab deruxtecan, have shown encouraging early clinical activity in a variety of tumors. DM002-BLD1102 also showed strong anti-tumor activity in DM002-vcMMAE resistant PDX models, suggesting the superiority of this new DNA topoisomerase I inhibitor linker/payload over the classical vcMMAE linker/payload. In conclusion, the HER3×MUC1 bsAb is a promising agent for the treatment of HER3 and MUC1 positive tumors."

ADC • Bispecific • Preclinical • Oncology • Solid Tumor • MUC1

R&D News丨Dorma Pharmaceutical: HER3/MUC1-C bispecific antibody obtained IND approval from the FDA [Google translation] (bydrug.pharmcube.com) - "On January 12, DM002, HER3/MUC1-C bispecific antibody ADC, a Class 1 innovative drug independently developed by Doma Pharmaceutical, a company in BioBAY, was officially approved by the US FDA for New Drug Clinical Research Application (IND), and the Phase I clinical trial will start soon. DM002 is the third bispecific antibody ADC product approved by the FDA for a new drug investigation....The upcoming global Phase 1 clinical study will enroll patients with multiple types of solid tumors, including prostate cancer, ovarian cancer, endometrial cancer, pancreatic cancer, small cell lung cancer, colorectal cancer and breast cancer, among others, aiming to explore the safety, tolerability and anti-tumor activity of DM002 at different doses in humans. The results of this phase of the study will provide key data for subsequent clinical research and development, and promote DM002 to benefit more cancer patients as soon as possible."

IND • New P1 trial • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor

Preclinical evaluation of fully human bispecific antibody-drug candidates targeting HER3 and the juxtamembrane region of MUC1 (SITC 2023) - "Conclusions We generated novel bispecific antibodies targeting HER3 and the juxtamembrane domain of MUC1 and demonstrate their ability to function as effective antibody-drug conjugates with MMAE payloads in vivo, with other payloads under investigation. Thus, DM002 is a promising novel therapeutic with potential to treat cancers co-expressing HER3 and MUC-1."

IO biomarker • Preclinical • Oncology • ERBB3 • MUC1

A first-in-class bispecific antibody-drug conjugate (DM002) targeting HER3 and the juxtamembrane domain of MUC1 (AACR 2023) - "DM002 candidates showed robust anti-tumor activity in multiple CDX and PDX models of lung, breast, gastric and pancreatic cancer; most notably, DM002 candidates outperformed benchmark ADCs in BP0508 lung PDX models. Together, these data indicate that DM002 will be a promising therapeutic drug for patients with HER3 and MUC1 co-expressing tumors."

Late-breaking abstract • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • ERBB3 • MUC1