Fortress Biotech Surged After Reporting Big Success With CAR-T Cancer Approach

Published: Dec 30, 2016

Fortress Bio Surged After Reporting Big Success With CAR-T Cancer Approach December 29, 2016
By Alex Keown, BioSpace.com Breaking News Staff

NEW YORK – Shares of Fortress Biotech (formerly known as Coronado Biosciences) surged after the company announced Wednesday that a glioblastoma patient who showed no response to standard of care treatments, had a remarkable turnaround after being treated with the company’s Phase I drug candidate, MB-101.

Fortress said the 50-year-old patient with recurrent multifocal glioblastoma and spinal tumors began taking the experimental CAR-T treatment after standard care tumor resection, radiation therapy and temozolomide failed. The patient then received multiple infusions of MB-101, which was developed from his own genetically modified T cells. The drug was first administered intravenously into the resected tumor cavity as part of the Phase 1 study, and then, following tumor growth distal to the resected cavity, under a compassionate use protocol the patient received MB-101 infusions into the ventricular system. The approach used on this patient had not been previously tested, the company said in its Wednesday announcement.

After Wednesday’s announcement, shares spiked 75 percent, hitting a high of $3.21. This morning the stock has dipped some to $2.80 per share.

MB-101 is the lead development candidate of Mustang Bio, Inc., a Fortress subsidiary. Mustang is developing MB-101 as an optimized CAR T product incorporating enhancements in CAR design and T cell engineering to improve antitumor potency and T cell persistence, the company said.

After undergoing the intraventricular treatment, Fortress said regression of all intracranial and spinal tumors was observed in the patient, along with corresponding increases in levels of cytokines and immune cells in the cerebrospinal fluid. As a result, the patient was able to “return to normal life and work activities.” The clinical response continued for 7.5 months after the initiation of MB-101. Infusions of MB-101 were well tolerated and not associated with any toxic effects of grade three or higher, Fortress said.

“We are excited to share this unprecedented research conducted by Mustang’s partners at City of Hope, which confirms the potential of MB-101 to be a breakthrough immunotherapeutic targeted against GBM, an almost universally fatal brain tumor. MB-101’s compelling clinical activity adds to the growing pipeline of therapies developed by our Fortress Companies that have the potential to transform the treatment of life-threatening diseases,” Lindsay Rosenwald, Fortress Biotech’s chairman, president and chief executive officer, said in a statement.

Michael Weiss, chairman of Mustang, said the patient’s response is proof of concept that CAR-T therapies can be used for patients with brain tumors. As a result of the patient’s response, Weiss said the company will expand its Phase I study to evaluate intraventricular administration in a larger cohort of patients.

“Given the poor outcomes for patients with GBM, we believe if we see additional patients with this type of response that we can explore a possible accelerated approval pathway, similar to that proposed by some of the other CAR T companies, which are targeting different forms of cancer,” Weiss said in a statement.

Fortress will publish the patient case study on Friday in the New England Journal of Medicine.

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