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MBrace Therapeutics Initiates Patient Dosing in Phase 1 Clinical Trial to Evaluate Investigational Antibody-Drug Conjugate MBRC-101

Wednesday, December 20, 2023

MBrace™ Therapeutics, Inc. (MBrace), a clinical-stage biopharmaceutical company focused on enhancing the lives of cancer patients through the development of innovative antibody-drug conjugates (ADCs), has announced the successful commencement of patient dosing in its Phase 1/1b study assessing MBRC-101 in individuals with advanced metastatic solid tumors resistant to standard treatments.

The groundbreaking Phase 1/1b clinical trial (NCT06014658) is a multicenter, open-label investigation involving dose-escalation and dose-expansion of MBRC-101 in patients with advanced metastatic solid tumors refractory to standard treatment. The primary objectives of the study include determining potential optimal biologically relevant doses (OBRD), maximum tolerated dose (MTD), safety profile, and anti-tumor activity of MBRC-101.

"Developed utilizing our proprietary SPARTA platform, MBRC-101 represents our inaugural drug candidate with the potential to address various commonly occurring cancers," stated Isan Chen, M.D., President and CEO at MBrace. "The SPARTA platform, a robust antibody and target discovery platform, overcomes previous limitations and expedites translation into clinical applications. The initiation of patient dosing in our first clinical trial with the first four patients marks a significant milestone as MBrace strives to provide new and effective ADCs for patients grappling with challenging-to-treat cancers."

MBRC-101, a novel targeted ADC, is in development for treating multiple cancers. Preclinical studies have demonstrated its robust anti-tumor activity in patient models of non-small cell lung cancer (NSCLC), breast cancer, and squamous cell carcinoma of the head and neck. MBRC-101 targets the EphA5 receptor tyrosine kinase found in various cancers, including NSCLC, breast, colorectal, gastric, pancreatic, and hepatocellular, while being absent in corresponding normal, non-malignant tissues.

"Despite the availability of newer cancer therapies, many patients with advanced cancer develop tumors that become non-responsive to these treatments," commented Shiraj Sen, M.D., Ph.D., Director of Clinical Research at NEXT Oncology-Dallas and an investigator in the Phase 1/1b study of MBRC-101. "We need novel efficacious therapies, including new ADCs, to benefit patients with advanced cancer resistant to prior treatments. I believe that MBRC-101 has the potential to bridge these current treatment gaps for patients with solid tumor cancers and look forward to our involvement in this clinical trial."

"As we enter this next exciting phase of clinical development at MBrace, our commitment to improving outcomes for patients dealing with difficult-to-treat cancers remains steadfast," added Wadih Arap, M.D., Ph.D., Director of Rutgers Cancer Institute of New Jersey at University Hospital, Chief of Hematology/Oncology, and Founder and Scientific Advisor at MBrace. "MBRC-101 serves as a proof point of our emerging pipeline and broader vision."



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