Osel, Inc.

City of Hope developed a novel use of biotherapeutic product CBM588 in the treatment of cancer; new research suggests the agent adjusts people’s microbiome, possibly leading to enhanced effectiveness of Food and Drug Administration-approved cancer immunotherapies Scientists are in discussions to translate City of Hope’s promising phase 1 trial results into a global phase 2/3 trial sponsored by the SWOG Cancer Research Network LOS ANGELES--(BUSINESS WIRE)-- Physician scientists from City of Hope, one of the largest cancer research and treatment organizations in the United States, found that people with metastatic kidney cancer who orally took a live biotherapeutic product called CBM588 while in treatment with immunotherapy and enzymatic tyrosine kinase inhibitors experienced improved health outcomes. The phase 1 trial was published today in Nature Medicine. Microorganisms in the gut modulate the immune system. City of Hope researchers are now in discussions with the global SWOG Cancer Research Network to design a phase 2/3 trial to assess the City of Hope-identified novel use of CBM588 and microbiome modulation in people with advanced cancer. Sumanta Pal, M.D., professor and vice chair of academic affairs in City of Hope’s Department of Medical Oncology & Therapeutics Research, is slated to be co-leader of the potential phase 2/3 SWOG trial. “We at City of Hope are the first to demonstrate a live bacterial product’s ability to improve clinical outcomes for patients with kidney cancer treated with immunotherapy. CBM588 could be exciting in cancer treatment because of its potential to enhance the efficacy of immune checkpoint inhibitor-based treatment, improve patient outcomes and modulate the gut microbiota in beneficial ways,” said Pal, a City of Hope medical oncologist and corresponding author of the new study. “Ongoing and larger clinical trials are crucial to validate these benefits and address current challenges. If the positive results observed in this small trial and a previous trial with nivolumab and ipilimumab are confirmed, CBM588 could become a valuable supplement in the treatment of various cancers, particularly for patients treated with immune checkpoint inhibitors." An estimated 44% of U.S. patients with cancer in 2018 were eligible for checkpoint inhibitor drugs, according to a JAMA Network Open article that flags the increasing trend of this percentage. In the single-center, phase 1 trial, 30 people with metastatic kidney cancer were randomized to receive cabozantinib, an inhibitor of vascular endothelial growth factor receptor, and targeted immunotherapy nivolumab with or without CBM588 as first-line treatment. Participants’ gut microbiome were analyzed via stool samples in the beginning for a baseline and then 13 weeks into treatment. City of Hope has granted an exclusive worldwide license to Osel for intellectual property on the novel use of CBM588 to enhance the efficacy of checkpoint inhibitors used to treat cancer, including metastatic renal cell carcinoma. Scientists from Osel and Miyarisan Pharmaceutical Co. Ltd, the manufacturer of CBM588, collaborated on the study. To date, many studies on lung cancer, melanoma and metastatic kidney cancer, among other diseases, have shown that the composition of the gut microbiome could predict immunotherapy outcomes for patients with cancer. Current guidelines for metastatic renal cell carcinoma (kidney cancer) recommend that newly diagnosed patients receive either dual checkpoint inhibitor therapy or a combination of immunotherapy and tyrosine kinase inhibitor, but most patients eventually experience disease progression while on treatment. Positive patient outcomes usually do not last, and subsequent treatments are largely palliative rather than curative. So, physician scientists are looking to combine current strategies with new treatments that do not introduce toxic side effects, such as through microbiome modulation. In the trial, City of Hope researchers observed an increase in the abundance of unclassified Ruminococcaceae genera, which has been linked with improved clinical outcomes with immune checkpoint inhibitors in recent studies. Clostridium butyricum MIYAIRI 588, the bacterium in CBM588, produces butyric acid, which is critical for intestinal health and is a well-known immunomodulator. “While not yet part of standard cancer treatment protocols, microbiome modulation is a promising area of research with the potential to enhance the efficacy of cancer therapies, particularly immunotherapies. Current applications are primarily within clinical trials, but the growing body of evidence suggests that microbiome-based interventions may soon become a valuable component of cancer treatment strategies,” said Hedyeh Ebrahimi, M.D, M.P.H., City of Hope postdoctoral medical oncology fellow and first author of the study. City of Hope is accelerating its research on the direct link between a healthy gut and the effectiveness of immune therapies, such as CAR T cell therapy. Its enhanced microbiome program spans from basic to clinical research and includes studying the gut microbiome’s role in protecting transplant patients from complications experienced during their recovery. “This study demonstrates again that the microbiome has an important role in the efficacy and toxicity of cancer immunotherapy and can be targeted to improve outcome,” said Marcel van den Brink, M.D., Ph.D., president of City of Hope Los Angeles and City of Hope National Medical Center, and the Deana and Steve Campbell Chief Physician Executive Distinguished Chair. The Nature Medicine study entitled “Cabozantinib and nivolumab with or without live bacterial supplementation in metastatic renal cell carcinoma: a randomized phase 1 trial” was supported by Exelixis Inc. (XL184-IST123). CBM588 was supplied by Miyarisan Pharmaceutical Co., Ltd. and Osel Inc. About City of Hope City of Hope's mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest cancer research and treatment organizations in the U.S. and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center at its core, City of Hope brings a uniquely integrated model to patients spanning cancer care, research and development, academics and training, and innovation initiatives. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHopeTM. For more information about City of Hope, follow us on Facebook, X, YouTube, Instagram and LinkedIn. View source version on businesswire.com: Contacts Zen Logsdon 626-409-9367 zlogsdon@coh.org Source: City of Hope View this news release online at:

DUBLIN, March 15, 2024 /PRNewswire/ -- The "HIV Point of Care (POC) Tests Pipeline by Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies" report has been added to ResearchAndMarkets.com's offering. The report provides comprehensive information about the HIV Point of care (POC) Tests pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress. HIV Point of care (POC) Tests is defined as medical diagnostic testing performed outside the clinical laboratory in close proximity to where the patient is receiving care. POC is typically performed by non-laboratory personnel and the results are used for clinical decision making. POC has a range of complexity and procedures that vary from manual methodologies to automated analyzers. POC devices are often 'handheld' or may be small portable analyzers. Scope Extensive coverage of the HIV Point of care (POC) Tests under development The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities The report reviews the major players involved in the development of HIV Point of care (POC) Tests and list all their pipeline projects The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage The report provides key clinical trial data of ongoing trials specific to pipeline products Recent developments in the segment / industry Reasons to Buy Formulate significant competitor information, analysis, and insights to improve R&D strategies Identify emerging players with potentially strong product portfolio and create effective counter strategies to gain competitive advantage Identify and understand important and diverse types of HIV Point of care (POC) Tests under development Develop market-entry and market expansion strategies Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline In-depth analysis of the product's current stage of development, territory and estimated launch date Key Topics Covered: 1 Table of Contents 1.1 List of Tables 1.2 List of Figures 2 Introduction 2.1 HIV Point of care (POC) Tests Overview 3 Products under Development 3.1 HIV Point of care (POC) Tests - Pipeline Products by Stage of Development 3.2 HIV Point of care (POC) Tests - Pipeline Products by Territory 3.3 HIV Point of care (POC) Tests - Pipeline Products by Regulatory Path 3.4 HIV Point of care (POC) Tests - Pipeline Products by Estimated Approval Date 3.5 HIV Point of care (POC) Tests - Ongoing Clinical Trials 4 HIV Point of care (POC) Tests - Pipeline Products under Development by Companies 4.1 HIV Point of care (POC) Tests Companies - Pipeline Products by Stage of Development 4.2 HIV Point of care (POC) Tests - Pipeline Products by Stage of Development 5 HIV Point of care (POC) Tests Companies and Product Overview 6 HIV Point of care (POC) Tests- Recent Developments 6.1 Oct 10, 2023: Trinity Biotech Welcomes the Decision of the High Court of Kenya to Strike Out the Applications to Prevent the Procurement of Trinscreen HIV by the Kenyan Ministry of Health 6.2 Sep 27, 2023: Update on MedMira's Regulatory Path in Canada and the USA 6.3 Jun 14, 2023: Atomo and Newfoundland Sign Agreement for HIV Testing in Europe 6.4 Mar 22, 2023: Trinity Biotech welcomes TrinScreen HIV's inclusion in the New Kenyan HIV Testing Algorithm 6.5 Feb 28, 2023: Significant purchase order for HIV self-tests for Europe 7 Appendix A selection of companies mentioned in this report includes Abbott Rapid Diagnostics GmbH Aldatu Biosciences Inc Altratech Ltd Atomo Diagnostics Ltd Baebies Inc BBB Technologies Inc Beijing Wantai Biological Pharmacy Enterprise Co Ltd Binx Health Inc Bio-AMD Inc Biocartis Group NV BioHelix Corp Bluejay Diagnostics Inc Calypte Biomedical Corporation Centre International de Reference Chantal Biya Cepheid Inc ChipCare Corp CrossLife Technologies Inc Cue Inc Daktari Diagnostics, Inc. Diagnostics For All Inc Diagnostics for the Real World (Europe) Ltd Endeavor Sciences Inc Epinex Diagnostics Inc ERBA Molecular Ltd Fluxergy LLC GAIA Medical Institute LLC genedrive plc Group K Diagnostics Guangzhou Wondfo Biotech Co Ltd HA TECH Pty Ltd HeatFlow Technologies Inc Identifysensors LLC Imperial College London Integrated Diagnostics Inc (Inactive) Intuitive Biosciences Inc Jan Biotech Inc Jinvator Bio Med GmbH Johns Hopkins University Lynntech Inc Maxim Biomedical Inc MedMira Inc Micronics Inc Molbio Diagnostics Pvt Ltd MyMD Pharmaceuticals Inc Nanobiosym Inc Newmark Diagnostics LLC Northwestern University Osel Inc Philmedi Co Ltd Prenetics Ltd QuantuMDx Group Ltd Quidel Corp Radisens Diagnostics Ltd Rheonix Inc Roche Diagnostics International Ltd Sedia Biosciences Corp Sensible Diagnostics Inc Senzo Inc TheoremDx Inc Trinity Biotech Plc University of Connecticut University of Minnesota UrSure Inc Ustar Biotechnologies (Hangzhou) Ltd. Virax Biolabs Group Ltd Wave 80 Biosciences Inc Yaathum Biotech Pvt Ltd For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

DUBLIN--( BUSINESS WIRE )--The "Microbiome-Targeting Therapeutics in Infectious Diseases - Thematic Research" report has been added to ResearchAndMarkets.com's offering. Microbiome-targeting drugs aim to alter the microbial composition of the gut through the administration of live microbes with the intention of regulating the human microbiome composition in a beneficial way that may effectively treat a wide variety of infectious diseases (ID) ranging from cancer to psychiatric disorders, and even COVID-19. There are currently 23 drugs in clinical development that target the microbiome for ID indications in the 7MM. Ten out of the 23 drugs (43%) are in in clinical development for Clostridioides difficile infections (CDI). Currently, only one successful microbiome-based intervention, fecal microbiota transplantation (FMT), is used in clinical practice to treat CDI. Rebiotix Inc currently holds the most potential in the microbiome space for infectious diseases, with two drug candidates under development across 4 different indications. With most of the pipeline dominated by gastrointestinal (GI) tract infections, other indications remain a largely untapped market in the microbiome space, leaving ample opportunities for companies to invest in this novel therapeutic area. Reasons to Buy What impact will late-stage pipeline agents have on the market? Which class of IO drugs will have the highest peak sales, and why? What are the current unmet needs and which pipeline drugs or strategies are positioned to counter these unmet needs? What are the opportunities for R&D in the microbiome-targeting in ID space? How is the field of microbiome-targeting therapies in ID going to move forward? Which indications are the most promising for combination therapy? What is the regulatory landscape for live biotherapeutic products (LBP) in the US and 5EU? What is the current and future outlook for microbiome-targeting therapeutics according to KOLs? Key Topics Covered: 1. Preface 2. Executive Summary 3. Overview 3.1. What is the Microbiome? 3.2. Microbiome of the Gut 3.3. Microbiome of the Respiratory Tract 3.4. Microbiome of the Skin 4. Trends 4.1. Industry Trends 4.2. Regulatory Trends 4.3. Deal-Making Trends 5. Value Chain 5.1. Microbiome Value Chain 6. Marketed Products 6.1. Fecal Microbiota Transplants 6.2. Fecal Microbiota Transplants - Clinical Trial Mapping in the 7MM 6.3. Current Therapies - KOL Perspectives 7. Pipeline Products 7.1. Pipeline Microbiome-Targeting Drugs for Infectious Diseases in the 7MM 7.2. Clinical Trials - Pipeline Microbiome Targeting Drugs 7.3. Overview of Phase III Pipeline Drugs Targeting the Microbiome for ID in the 7MM 7.4. Late-Stage Pipeline Products - FDA Review Designations 7.5. Pipeline Therapies - KOL Perspectives 8. Market Analysis 8.1. Anticipated Key Launch Dates - Phase III Pipeline Agents 8.2. Market Outlook for Rebiotix Inc's RBX-2660 8.3. Market Outlook for Finch Therapeutic's CP-101 8.4. Market Outlook for Infant Bacterial Therapeutics' IBP-9414 8.5. Market Outlook for Evelo Biosciences' EDP-1815 9. Opportunities, Challenges, and Unmet Needs 9.1. Unmet Needs in Microbiome Targeting Therapies for Infectious Diseases 9.2. Unmet Needs - KOL Perspectives 9.3. Challenges in Immuno-oncology Clinical Trials - KOLs Perspective 10. Company Profiles 10.1 Rebiotix Inc 10.2 Nexbiome Therapeutics 10.3 Finch Therapeutics Group 10.4 Evelo Biosciences 10.5 Infant Bacterial Therapeutics 10.6 Osel Inc 10.7 Mikrobiomik Healthcare 10.8 Seres Therapeutics 11. Drug Development Thematic Scorecard 12. Appendix For more information about this report visit https://www.researchandmarkets.com/r/dngnh5 Source: GlobalData About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.