City of Hope and Osel Announce Exclusive License for Intellectual Property on the Use of Live Biotherapeutic Product CBM588 for Oncology Therapeutic Applications

Positive Phase 1b data recently presented at ASCO 2021 show clinical benefit of CBM588 plus checkpoint inhibitor therapy in patients with metastatic renal cell carcinoma

DUARTE, Calif. & MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–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, today announced 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. The experimental treatment was evaluated in a City of Hope investigator-initiated Phase 1b trial.

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) 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.

About Osel Inc.

Osel Inc., a privately held biopharmaceutical company based in Mountain View, California, is focused on the development and commercialization of a portfolio of LBPs to prevent or treat medical conditions resulting from disruption of the human microbiome (dysbiosis). The company is a pioneer in the field of LBPs and is actively pursuing multiple indications in cancer and women’s health.

About City of Hope

City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies, and numerous breakthrough cancer drugs are based on technology developed at the institution. Translational Genomics Research Institute (TGen) became a part of City of Hope in 2016. AccessHope^TM, a wholly owned subsidiary, was launched in 2019, dedicated to serving employers and their health care partners by providing access to City of Hope’s exceptional cancer expertise. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona. For more information about City of Hope, follow us on Facebook, Twitter, YouTube or Instagram.

About Miyarisan

Miyarisan Pharmaceutical Co., Ltd., is a live biotherapeutic pharmaceutical company based in Tokyo, Japan. The company was founded in 1947 and its main portfolio, Clostridium butyricum MIYAIRI 588^® strain (CBM588), is the most prescribed pharmaceutical product containing live microorganisms in Japan and other Asian countries.

Contacts

Osel:

Chris Lieu

Bioscribe, Inc.

Tel: (310) 528-7486

Email: [email protected]

City of Hope:

Letisia Marquez

Tel: (626) 476-7593

Email: [email protected]