On July 14, 2021 City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases, and Osel, Inc., a company developing live biotherapeutic products (LBPs) for diseases linked to the disruption of the human microbiome, reported that City of Hope has granted an exclusive worldwide license to Osel for intellectual property on the novel use of a LBP CBM588 to enhance efficacy of checkpoint inhibitors to treat cancer, including metastatic renal cell carcinoma (Press release, City of Hope, JUL 14, 2021, View Source [SID1234584851]). The experimental treatment was evaluated in a City of Hope investigator-initiated Phase 1b trial.
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Data from the study demonstrated that an LBP – Clostridium butyricum MIYAIRI 588 strain (CBM588) – plus nivolumab/ipilimumab improved overall response rate (ORR) and progression-free survival (PFS) compared to nivolumab/ipilimumab alone in patients with metastatic renal cell carcinoma (RCC).
Data from the Phase 1b study were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting by City of Hope’s Luis Meza, a postdoctoral fellow, and Sumanta K. Pal, M.D., clinical professor, Department of Medical Oncology & Therapeutics Research. Abstract no. 4513 titled "First results of a randomized phase IB study comparing nivolumab/ipilimumab with or without CBM588 in patients with metastatic renal cell carcinoma" is available here.
"The results from this trial demonstrate that CBM588 has the potential to enhance immune checkpoint inhibitor efficacy and suggests that disruption of the human microbiome (dysbiosis) plays an integral role in cancer treatment response," said Thomas Parks, Ph.D., head of development at Osel. "We look forward to working with City of Hope to further investigate how CBM588 can improve the lives of cancer patients."
CBM588 is a spore forming anaerobe that produces short chain fatty acids, mainly butyric acid, which is a well-known energy source of intestinal epithelium. The bacterial strain exerts several beneficial effects through multiple modes of action, including inhibition of pathogenic microorganisms, immunomodulatory activities and restorative effects on intestinal dysbiosis. City of Hope is expected to initiate a study of CBM588 plus recently-approved nivolumab/cabozantinib combination therapy in advanced RCC in July, and expansion to the treatment of other tumor types is planned. In addition, CBM588 is being evaluated in a clinical trial for the prevention of graft-vs-host disease (GVHD) in recipients of allogeneic hematopoietic stem cell transplantation.
"To my knowledge, this is the first data in a randomized study demonstrating clinical benefit with the addition of a live bacterial product to immunotherapy," Pal said. "The signal here, with a dramatic improvement in progression-free survival and response rate, is very compelling and warrants rapid evaluation in a larger study."
CBM588 is manufactured under GMP and marketed in Japan by Miyarisan Pharmaceutical as a prescription product known as Clostridium butyricum MIYAIRI 588 strain for the treatment of gastrointestinal (GI) indications. It has an excellent safety profile in all age groups and immunocompromised patients, as confirmed by post-marketing surveillance.