MBrace Therapeutics Announces Initiation of Patient Dosing in Phase 1 Clinical Trial Evaluating Investigational Antibody-Drug Conjugate MBRC-101

  • Study will assess the safety, anti-tumor activity and PK profile for MBRC-101 in the treatment of multiple solid tumor cancers, including breast, non-small cell lung and other solid tumors

  • MBRC-101 targets the EphA5 receptor tyrosine kinase, represents first of Company’s innovative ADC pipeline to enter clinical trials

SAN DIEGO (December 19, 2023) – MBrace™ Therapeutics, Inc. (“MBrace”), a clinical-stage biopharmaceutical company devoted to improving the lives of patients with cancer by developing novel antibody-drug conjugates (ADCs), today 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.

“Developed using our proprietary SPARTA platform, MBRC-101 is our first drug candidate and has the potential to treat a variety of very commonly occurring cancers,” said Isan Chen, M.D., president and chief executive officer at MBrace. “SPARTA is a robust antibody and target discovery platform which, by overcoming several limitations of previous approaches, accelerates translation into clinical applications. The dosing of the first four patients in our first clinical trial marks an important milestone as MBrace works to deliver new and effective ADCs to patients facing difficult-to-treat cancers.”

MBRC-101 is a novel, targeted ADC in development for the treatment of several cancers. In preclinical studies, it has demonstrated robust anti-tumor activity in several 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, which is present in multiple cancers (including, but not limited to, NSCLC, breast, colorectal, gastric, pancreatic and hepatocellular) but is not observed 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,” said 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.”

“At MBrace, as we move into this next exciting phase of clinical development, we remain dedicated to improving outcomes for patients who are living with difficult-to-treat cancers,” said Wadih Arap, M.D., Ph.D., director of Rutgers Cancer Institute of New Jersey at University Hospital and chief of hematology/oncology, and founder and scientific advisor at MBrace. “MBRC-101 is a proof point of our emerging pipeline and broader vision.”

About MBrace Therapeutics

MBrace is a clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutic agents for patients with cancer. MBrace develops innovative treatments for cancer patients by developing novel antibody-drug conjugates using the SPARTA technology pioneered by its founders. MBrace is headquartered in San Diego, CA, with research facilities at The Thomas O. Daniel Research Incubator in Summit, NJ. For additional information, please visit MBrace’s website at www.mbracetrx.com.

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