MBRC-101 / MBrace Therap - LARVOL DELTA

First-generation and preclinical evaluation of an EphA5-targeted antibody-drug conjugate in solid tumors. (PubMed, J Clin Invest) - P1/2 | "Preclinical Good Laboratory Practice-compliant toxicology studies in rats and nonhuman primates demonstrated that MBRC-101 is well tolerated, with observed toxicities limited to known MMAE off-target effects. These findings establish EphA5 as a therapeutic target in cancer and support the translational development of MBRC-101 as a promising ADC candidate for clinical evaluation, currently in a first-in-human multicenter investigational trial for patients with advanced solid tumors (ClinicalTrials.gov, NCT06014658)."

Journal • Preclinical • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • EPHA5

Safety, PK, and Preliminary Efficacy of MBRC-101 in Advanced Refractory Solid Tumors (clinicaltrials.gov) - P1/2 | N=130 | Recruiting | Sponsor: MBrace Therapeutics | Phase classification: P1 ➔ P1/2 | N=90 ➔ 130 | Trial completion date: Nov 2025 ➔ Nov 2026 | Trial primary completion date: Jul 2025 ➔ Jul 2026

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • EPHA5 • HER-2

Phase 1/1b Trial of MBRC-101, An Anti-EphA5 Monomethyl Auristatin (MMAE) Antibody Drug Conjugate, In Advanced Refractory Solid Tumors (IASLC-WCLC 2024) - "Expression of EphA5 in primary or metastatic tumor tissue will not be required for enrollment into Phase 1 or 1b but will be assessed retrospectively. A Safety Review Committee will monitor safety at each dose escalation in Phase 1 and at regular intervals throughout Phase 1b."

Metastases • P1 data • Breast Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Triple Negative Breast Cancer • EPHA5 • HER-2

A multi-center, open-label phase 1/1b dose finding, safety, and pharmacokinetic study of MBRC-101, an Anth-EphA5 monomethyl auristatin (MMAE) antibody drug conjugate, in advanced refractory solid tumors. (ASCO 2024) - P1 | "Secondary endpoints for Ph1 and 1b include PK analytes and EphA5 expression as determined by immunohistochemistry (IHC). A Safety Review Committee will monitor safety at each dose escalation in Phase 1 and at regular intervals throughout Phase 1b."

Clinical • Metastases • P1 data • PK/PD data • Breast Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • EPHA5 • HER-2

MBrace Therapeutics Presents Trial in Progress Poster for Lead Antibody-Drug Conjugate Program at 2024 ASCO Annual Meeting (Businesswire) - "MBrace Therapeutics...announced that the Company will be presenting a Trial in Progress (TIP) poster at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held from May 31-June 4, 2024, in Chicago, Illinois...The poster will highlight the trial design, dosing regimen and study protocol for the Company's ongoing Phase 1/1b clinical trial of MBRC-101. This first-in-human, multicenter, open-label study (NCT06014658) is examining the safety and efficacy of MBRC-101 in patients with advanced metastatic solid tumors refractory to standard treatment. The Company expects to report initial clinical data from this trial in the first half of 2025."

P1 data • Trial status • Oncology • Solid Tumor

MBRC-101: a novel antibody-drug conjugate (ADC) targeting the tyrosine kinase receptor EphA5 (AACR 2024) - P1 | "EphA5 is a new and promising molecular target for the development of ADC-based therapies against many human cancers. A Phase 1/1b study of MBRC-101 is currently recruiting (NCT06014658)."

Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Triple Negative Breast Cancer • EPHA5

Safety & PK of MBRC-101 in Advanced Refractory Solid Tumors (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: MBrace Therapeutics

Metastases • Trial completion date • Trial initiation date • Trial primary completion date • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • EPHA5 • HER-2

MBrace Therapeutics Announces Initiation of Patient Dosing in Phase 1 Clinical Trial Evaluating Investigational Antibody-Drug Conjugate MBRC-101 (Businesswire) - "MBrace Therapeutics...announced the successful initiation of patient dosing in its Phase 1/1b study evaluating MBRC-101 in patients with advanced metastatic solid tumors refractory to standard treatment. This first-in-human Phase 1/1b clinical trial (NCT06014658) is a multicenter, open-label, dose-escalation and dose-expansion study of MBRC-101 in patients with advanced metastatic solid tumors refractory to standard treatment. The primary objectives of the study are to determine the following parameters for MBRC-101: potential optimal biologically relevant doses (OBRD), maximum tolerated dose (MTD), safety profile, and anti-tumor activity."

Trial status • Solid Tumor

MBRC-101: a novel antibody-drug conjugate (ADC) targeting the membrane-associated tyrosine kinase receptor EphA5 in breast cancer (SABCS 2023) - "These results support EphA5 as a new and promising membrane-associated molecular target for the design and development of ADC-based therapies against hormone-positive breast cancer and TNBC and support the conduct of a Phase 1/1b study of MBRC-101 in patients with breast cancer."

Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • EPHA5

MBrace Therapeutics Presents Preclinical Data Demonstrating Potential of Novel Antibody Drug Conjugate at 2023 San Antonio Breast Cancer Symposium (Businesswire) - "MBrace Therapeutics, Inc...announced new preclinical data supporting ongoing development for lead investigational ADC therapeutic, MBRC-101, at the San Antonio Breast Cancer Symposium taking place December 5-9, 2023, in San Antonio, Texas....Additionally, extensive in vitro testing showed that MBRC-101 binds to EphA5 exclusively, is rapidly internalized and is cytotoxic to cells expressing EphA5. Dramatic preclinical efficacy was observed in vivo, with weekly administration of intravenous MBRC-101 showing dose-dependent, robust, and reproducible anti-tumor activity in patient-derived xenograft murine models of TNBC."

Preclinical • Breast Cancer • Oncology • Solid Tumor

MBrace Therapeutics Raises $85 Million Series B Financing to Advance Oncology Pipeline of Innovative Antibody Drug Conjugate Candidates (Businesswire) - "MBrace™ Therapeutics, Inc...announced the completion of an $85 million Series B financing, bringing the company’s total raised to $110 million. Funds will be used to support clinical development programs, including a first-in-human clinical trial of lead investigational ADC, MBRC-101....MBRC-101 targets the EphA5 receptor tyrosine kinase, which is present in multiple cancers including, but not limited to, breast, non-small cell lung (NSCLC), colorectal, gastric, and pancreatic cancers. The MBrace team will present preclinical data for MBRC-101 at the San Antonio Breast Cancer Symposium on December 7, 2023."

Financing • Preclinical • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Safety & PK of MBRC-101 in Advanced Refractory Solid Tumors (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: MBrace Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • EPHA5 • HER-2

Safety & PK of MBRC-101 in Advanced Refractory Solid Tumors (clinicaltrials.gov) - P1 | N=90 | Not yet recruiting | Sponsor: MBrace Therapeutics

Metastases • New P1 trial • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • EPHA5 • HER-2