MHB036C / Minghui Pharma - LARVOL DELTA

Minghui Pharmaceuticals received two more CDE clinical implied approval notices [Google translation] (bydrug.pharmcube.com) - "MHB036C for injection is a TROP-2 ADC candidate drug developed by Minghui based on its self-developed new generation Topo I ADC technology platform (SuperTopoi), with complete independent intellectual property rights."

Non-US regulatory • Oncology

Results of a phase 1/2 study of MHB036C: A potential best-in-class TROP2 antibody-drug conjugate (ADC) incorporating a potent DNA topoisomerase I inhibitor in locally advanced or metastatic solid tumors. (ASCO 2024) - "In preclinical studies, MHB036C demonstrated superior tumor killing activities (5~10 times more potent than the DS-1062a analog) and a favorable safety profile with no unique toxicities as compared to other TROP2 ADCs and no occurrences of interstitial lung disease (ILD). MHB036C demonstrated a manageable safety profile without either major hematologic side effects or ILDs and encouraging efficacy in NSCLC and HER2- breast cancer, representing a potential best-in-class TROP2 ADC. The dose optimization and expansion study is ongoing to establish the RP2D for MHB036C. Clinical trial information: CTR20231246."

Metastases • P1/2 data • Anemia • Breast Cancer • Dental Disorders • Fatigue • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Stomatitis • Triple Negative Breast Cancer • HER-2

A Study of MHB036C for Advanced Solid Tumor (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

Metastases • New P1/2 trial • Oncology • Solid Tumor

Minghui Pharmaceutical Inc. Announces First Patient Dosing in Phase 1 Clinical Studies of Both the Antibody-Drug Conjugate Programs Targeting TROP-2 or B7-H3 Respectively, for Treatment of Advanced or Metastatic Solid Tumors (PRNewswire) - "Minghui Pharmaceutical, Inc...announced today that the first dosing has been completed in two phase 1 clinical studies evaluating MHB036C and MHB088C. The studies aim to determine the maximum tolerated dose (MTD), the recommended phase 2 dose (RP2D), as well as assess the pharmacokinetics and preliminary efficacy of the ADCs in patients with selected types of advanced or metastatic solid tumors....'MHB036C and MHB088C hold great promise in the fight against various human solid tumors and we look forward to the results from the phase 1 studies, anticipated to conclude in early 2024'."

P1 data • Trial status • Oncology • Solid Tumor

Study of MHB036C in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=400 | Not yet recruiting | Sponsor: Minghui Pharmaceutical Pty Ltd

New P1/2 trial • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • TACSTD2 • TROP2