NCI awards $2.9M to study RedHill drug with CAR T-cell therapy

The University of Oklahoma has received a five-year, $2.9 million grant from the National Cancer Institute to study whether RedHill Biopharma's (NASDAQ: RDHL) investigational drug opaganib, used after CAR T-cell therapy, may help immune cells fight multiple myeloma more effectively.

The grant will fund two phases of clinical trials. A Phase 1b trial plans to enroll up to 18 patients to evaluate the safety of combining CAR T-cell therapy with opaganib and to determine appropriate dosing. A subsequent Phase 2 trial plans to enroll up to 21 additional patients to seek preliminary evidence of effectiveness.

CAR T-cell therapy genetically modifies a patient's immune cells to recognize and attack cancer cells before returning them to the patient. The university said it plans to manufacture the CAR T cells on its own campus rather than through a commercial manufacturer, which it said could reduce both time and cost.

Yubin Kang, M.D., a hematologist-oncologist at OU Health Stephenson Cancer Center and the grant's lead awardee, said preclinical studies spanning 10 years suggest opaganib may help modified immune cells remain active longer. "Opaganib works by blocking a protein called sphingosine kinase-2 (SPHK2), which appears to act as a kind of brake on the immune system's cancer-fighting T cells," Kang said.

RedHill is expected to supply opaganib for the trials. Lentigen Technology, a Miltenyi Biotec company, will provide the CAR construct and produce GMP-grade lentiviral vector for CAR T manufacturing.

Opaganib is an investigational drug not approved for commercial distribution. It has been evaluated in more than 470 participants across multiple clinical studies. The drug has received Orphan Drug designation from the FDA for neuroblastoma and cholangiocarcinoma, and is also being evaluated in an ongoing Phase 2 study for prostate cancer in combination with Bayer's darolutamide.

The research is supported under NCI award No. R01CA293516-01A1, according to a company press release.

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