First dose occurred in trial currently underway at the University of Alabama at Birmingham
NEW YORK, Oct. 24, 2019 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (MBIO), 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, announced today that the first participant has been dosed in a Phase 1 clinical trial to determine the safety and efficacy of MB-108 (oncolytic virus C134), an attenuated herpes simplex virus type 1, in recurrent glioblastoma multiforme.
The first dosing took place at the University of Alabama at Birmingham (“UAB”), where the trial is led by James Markert, M.D., Ph.D., Chairman of the Department of Neurosurgery at UAB. Kevin Cassady, M.D., Principal Investigator for the Center for Childhood Cancer and Blood Diseases in the Abigail Wexner Research Institute at Nationwide Children’s Hospital (“Nationwide Children’s”), developed C134 in collaboration with Dr. Markert and advanced it for therapeutic use. Nationwide Children’s has exclusively licensed oncolytic virus C134 to Mustang.
The trial will enroll up to 24 participants who will receive escalating doses of MB-108. Safety will be assessed at each dose level before proceeding to the next. Other study objectives include characterizing MB-108’s activity after inoculation into the tumor, as well as the local and systemic immune responses to MB-108. The trial will also follow participants with MRI scans to monitor for potential clinical response to MB-108.
“Dosing the first participant in this trial represents an important step in evaluating MB-108’s potential to treat patients with glioblastoma,” Dr. Markert said. “We are pleased to have achieved this milestone and look forward to sharing more information as the trial progresses.”
Mustang and Nationwide Children’s intend to conduct a subsequent clinical trial that will investigate the combination treatment of MB-101 (IL13Rα2-specific CAR T) and MB-108 to potentially enhance efficacy in treating glioblastoma. Preclinical studies have demonstrated the synergistic potential of an oncolytic virus’ ability to induce an anti-tumor immune response when it is combined with CAR T therapy to target solid tumors.
Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, “We congratulate UAB and Nationwide Children’s on dosing the first participant in this trial evaluating MB-108 in recurrent glioblastoma multiforme, which is one of the most common forms of malignant brain cancer in adults and is often difficult to treat. We are optimistic that MB-108 will provide a strong treatment option, particularly when combined with MB-101.”
In May, the U.S. Food and Drug Administration (“FDA”) granted Orphan Drug Designation to MB-108 for the treatment of malignant glioma.
About Mustang Bio
Mustang Bio, Inc. (“Mustang”) 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. (FBIO). For more information, visit www.mustangbio.com.
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.