Mustang Bio Announces $9.28-Million Grant to Fund Phase 1 Trial

Mustang Bio, Inc. recently announced that City of Hope has received a $9.28-million grant from the California Institute for Regenerative Medicine (CIRM) to fund an ongoing Phase 1 clinical trial of MB-103 (HER2‐specific CAR T cells) for the treatment of HER2-positive breast cancer with brain metastases. City of Hope patents covering the HER2 CAR were licensed to Mustang Bio in 2017.

The City of Hope research team led by Saul Priceman, PhD, Assistant Professor in the Department of Hematology & Hematopoietic Cell Transplantation, along with the clinical lead Jana Portnow, MD, Associate Clinical Professor in the Department of Medical Oncology & Therapeutics Research, will use the funds to support the Phase 1 trial. The trial is expected to enroll 21 patients at City of Hope. The trial’s primary objective is to determine the safety and recommended Phase 2 dosing of intraventricular delivery of HER2-specific CAR T cells. Secondary objectives include assessing cerebrospinal fluid (CSF) and peripheral blood for HER2-CAR T cell persistence and endogenous immune system activation, describing changes in cytokine levels in the CSF and peripheral blood and describing changes in circulating tumor cells in the CSF.

According to the American Cancer Society, about 1 in 5 patients with breast cancer have HER2-positive cancer cells. Nearly half of patients with HER2-positive breast cancer ultimately develop brain metastases.

Manuel Litchman, MD, President and Chief Executive Officer of Mustang, said “We congratulate City of Hope on receipt of this prestigious grant to fund the Phase 1 MB-103 trial. When infused into the ventricular system through the brain, MB-103 has the potential to target and destroy HER2-expressing tumors that metastasized from breast cancer. We look forward to continuing to work with the City of Hope team to advance this program and bring hope to patients with breast-cancer-related brain metastases, who have very few treatment options available.”

Additional information on the Phase 1 trial can be found on www.ClinicalTrials.gov using identifier NCT03696030.

Mustang Bio, Inc. is a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market. Mustang has partnered with top medical institutions to advance the development of CAR T and CRISPR/Cas9-enhanced CAR T therapies across multiple cancers, as well as a lentiviral gene therapy for X­SCID. Mustang is registered under the Securities Exchange Act of 1934, as amended, and files periodic reports with the U.S. Securities and Exchange Commission. Mustang was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.mustangbio.com.