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

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DUARTE, CA & MOUNTAIN VIEW, CA – (COMMERCIAL THREAD) – 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 biotherapeutics (LBP) for diseases related to blood disruption. human microbiome, today announced that City of Hope has granted an exclusive worldwide license to Osel for the intellectual property on the new use of a CBM588 LBP to improve the effectiveness of checkpoint inhibitors to treat cancer, including including metastatic renal cell carcinoma. The experimental treatment was evaluated in a phase 1b trial initiated by a City of Hope researcher.

Data from the study showed that low back pain – Clostridium butyricum MIYARI 588® (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 (CRC).

Data from the Phase 1b study was presented at the 2021 American Society of Clinical Oncology (ASCO) annual meeting by Luis Meza of City of Hope, a postdoctoral fellow, and Sumanta K. Pal, MD, Clinical Professor, Department of Medical Oncology and Therapeutic Research. Abstract no. 4513 entitled “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 of this trial demonstrate that CBM588 has the potential to improve the efficacy of immune checkpoint inhibitors and suggest that disruption of the human microbiome (dysbiosis) plays a critical role in the response to cancer treatment,” said Thomas Parks, Ph.D., development manager 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 sporulated anaerobic that produces short chain fatty acids, primarily butyric acid, which is a well-known energy source for the 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 launch a study of CBM588 and the recently approved nivolumab / cabozantinib combination therapy in advanced RCC in July, and expansion to treatment of other types of tumors is planned. Additionally, CBM588 is being evaluated in a clinical trial for the prevention of graft versus host disease (GVHD) in allogeneic hematopoietic stem cell transplant recipients.

“To my knowledge, this is the first data from a randomized study demonstrating clinical benefit with the addition of a living bacterial product to immunotherapy,” said Pal. “The signal here, with a dramatic improvement in progression-free survival and response rate, is very convincing and warrants rapid assessment in a larger study.”

CBM588 is manufactured under GMP and marketed in Japan by Miyarisan Pharmaceutical as a prescription product known as Clostridium butyricum MIYARI 588® strain for the treatment of gastrointestinal (GI) indications. It has an excellent safety profile in all age groups and in immunocompromised patients, as confirmed by post-marketing surveillance.

About Osel inc.

Osel Inc., a private biopharmaceutical company based in Mountain View, Calif., Is focused on developing and commercializing a portfolio of PSLs to prevent or treat medical conditions resulting from disruption of the human microbiome (dysbiosis). The company is a pioneer in the field of low back pain and actively pursues multiple indications in the field of cancer and women’s health.

About City of Hope

City of Hope is an independent center for biomedical research and treatment of cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader in a bone marrow transplant and immunotherapy like CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols are advancing care around the world. Human synthetic insulin, monoclonal antibodies and many revolutionary cancer drugs are based on the technology developed in the establishment. Translational Genomics Research Institute (TGen) became a part of City of Hope in 2016. AccessHopeMT, a wholly owned subsidiary, was launched in 2019, dedicated to serving employers and their healthcare partners by giving them access to City of Hope’s exceptional cancer expertise. A comprehensive cancer center designated by the National Cancer Institute and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the “Best Hospitals” in the country for cancer by US News & World Report. Its main campus is located near Los Angeles, with additional locations throughout Southern California and Arizona. For more information on City of Hope, follow us on Facebook, Twitter, Youtube or Instagram.

About Miyarisan

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



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