NEWS
Osel filed a new IND for CBM588 oncology indications in early 2024 and has begun a Phase 1 dose escalation trial in advanced kidney cancer with a new capsule formulation of CBM588 at the City of Hope Comprehensive Cancer Center. The study is now enrolling patients. See clinicaltrials.gov NCT06399419 for contact information.
PRESS RELEASE
JUNE 28, 2024
City of Hope Study Suggests Changing the Gut Microbiome Improves Health Outcomes for People Newly Diagnosed With Metastatic Kidney Cancer
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 FDA-approved cancer immunotherapies
June 28, 2024 — Los Angeles, Calif. — 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.
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.
Media Contact
City of Hope:
Zen Vuong
Tel: (626) 409-9367
Email: zvuong@coh.org
PRESS RELEASE ARCHIVES
PRESS RELEASE FEBRUARY 28, 2022
City of Hope and Osel Announce Live Biotherapeutic Product CBM588 May
Enhance Efficacy of Immunotherapy for Patients With Metastatic Kidney Cancer
Additional Phase 1 clinical trial of CBM588 plus immune checkpoint and tyrosine kinase inhibitors to treat renal cell carcinoma ongoing
February 28, 2022 — Los Angels, Calif. and Mountain View, Calif. — City of Hope, one of the largest cancer research and treatment organizations in the United States, and Osel Inc., a company developing live biotherapeutic products for modulation of the human microbiome, today announced Phase 1 trial data showing that use of the live biotherapeutic CBM588 (Clostridium butyricum MIYAIRI 588® strain) plus immunotherapy medicine nivolumab/ipilimumab significantly improved progression-free survival in patients with metastatic kidney cancer when compared to use of nivolumab/ipilimumab alone. The study was published in Nature Medicine today.
“Compared to microbiome modulation using fecal transplants, CBM588 given orally is potentially a more effective, reproducible, scalable and safer method to treat patients. We look forward to supporting the world-class team at City of Hope as they advance CBM588 in additional clinical trials.”
“To our knowledge, this is the first randomized clinical trial to demonstrate that a live bacterial product can modulate the gastrointestinal microbiome and enhance immunotherapy response in cancer patients. These results can help improve treatment options for patients with kidney cancer and is an important foundational step to bring about more effective targeted therapies for cancer treatment,” said Sumanta K. Pal, M.D., a professor in the Department of Medical Oncology & Therapeutics Research at City of Hope and senior author of the study.
CBM588 is a nonpathogenic bacteria that has multiple documented beneficial effects on the human microbiome. It produces short-chain fatty acids (mainly butyric acid), a well-known energy source for the lining of the GI tract, and has immunomodulatory properties. The bacterial strain appears to exert additional beneficial effects, including inhibiting pathogenic microorganisms and helping to restore the GI lining and decrease intestinal imbalance.
Last summer, City of Hope granted an exclusive worldwide license to Osel for intellectual property on the novel use of CBM588 to enhance the efficacy of checkpoint inhibitors to treat cancer.
In the clinical trial, 30 patients with metastatic kidney cancer (renal cell carcinoma) who had never received treatment before were randomized to receive either CBM588 orally in combination with nivolumab/ipilimumab or nivolumab/ipilimumab alone. Data showed a significant improvement in progression-free survival in patients treated with CBM588 plus nivolumab/ipilimumab (12.7 months) compared to nivolumab/ipilimumab alone (2.5 months). Additionally, use of CBM588 in combination therapy was linked to an increase in response rate when compared to use of nivolumab/ipilimumab therapy alone (58% vs. 20%).
While there was no significant difference between the treatment groups in terms of the amount of the Bifidobacterium genus bacteria, patients who responded to the CBM588 with nivolumab/ipilimumab treatment had significant increases in the Bifidobacterium species. There were no significant differences in treatment-related toxicity reported between the two groups.
“Over the last several years, the immunotherapy field has been closely studying how the GI microbiome can enhance immune checkpoint efficacy for the treatment of cancer,” said Thomas Parks, Ph.D., director of product development at Osel. “Compared to microbiome modulation using fecal transplants, CBM588 given orally is potentially a more effective, reproducible, scalable and safer method to treat patients. We look forward to supporting the world-class team at City of Hope as they advance CBM588 in additional clinical trials.”
Osel licensed the rights for the pharmaceutical use of CBM588 in the United States, Canada and Europe from Miyarisan Pharmaceutical Co., Ltd. CBM588 is manufactured under GMP (good manufacturing practice) and marketed in Japan by Miyarisan Pharmaceutical as a prescription product known as MIYA-BM (Clostridium butyricum MIYAIRI 588® strain) to treat GI indications.
“City of Hope is currently conducting another Phase 1 clinical trial of CBM588 in combination with nivolumab and tyrosine kinase inhibitor cabozantinib for the treatment of advanced or metastatic kidney cancer,” said Pal, co-director of the Kidney Cancer Program at City of Hope. “We are working to open a large, randomized Phase 3 trial of CBM588 in the future.”
Jeffrey Trent, Ph.D., Translational Genomics Research Institute (TGen) president and research director, a contributor to the study, said, “The field of microbiome research is exploding as evidenced by the clinical importance of this study, which points to the continued growth of clinical research and scientific understanding of the microbiome’s connection to disease and recovery.” TGen is an affiliate of City of Hope.
Nazli Dizman, M.D., and Luis Meza, M.D., who were both postdoctoral fellows at City of Hope when the study was conducted, were lead researchers on the trial and co-primary authors.
Funding for the study, “Nivolumab plus ipilimumab with or without live bacterial supplementation in metastatic renal cell carcinoma: a randomized phase 1 trial,” was provided by a grant from the Gateway for Cancer Research (Grant 449 ID: G-20-100).
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. AccessHopeTM, 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 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.
Media Contact
City of Hope:
Zen Vuong
Tel: (626) 409-9367
Email: zvuong@coh.org
Osel:
Michelle Linn
Bioscribe
Tel: (774) 696-3803
Email: michelle@bioscribe.co
PRESS RELEASE JULY 14, 2021
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
July 14, 2021 — Duarte, Calif. and Mountain View, Calif. — 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. AccessHopeTM, 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.
Media Contact
Osel:
Chris Lieu
Bioscribe, Inc.
Tel: (310) 528-7486
Email: chris@bioscribe.com
City of Hope:
Letisia Marquez
Tel: (626) 476-7593
Email: lemarquez@coh.org
PRESS RELEASE JUNE 7, 2021
Osel Announces Positive Results from Phase 1b Trial of Live Biotherapeutic Product CBM588 in Combination with Checkpoint Inhibitor (CPI) Therapy in Metastatic Renal Cell Carcinoma
— CBM588 plus nivolumab/ipilimumab improved ORR and PFS compared to nivolumab/ipilimumab alone —
— First randomized study to prospectively assess a live bacterial product to modulate the GI microbiome in combination with CPIs —
June 07, 2021 — Mountain View, Calif. — Osel Inc., a company developing live biotherapeutic products (LBPs) for diseases linked to the disruption of the human microbiome, announced today that City of Hope, a world-renowned independent cancer and diabetes research and treatment center, presented data from a Phase 1b trial showing that an LBP, CBM588 (Clostridium butyricum MIYAIRI 588® strain), 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).
Osel licensed the rights for the pharmaceutical use of CBM588 in the United States, Canada and Europe from Miyarisan Pharmaceutical Co., Ltd., and has a clinical trial agreement for the CBM588 study with City of Hope.
The data 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. The presentation titled First results of a randomized phase IB study comparing nivolumab/ipilimumab with or without CBM588 in patients with metastatic renal cell carcinoma (Abstract #4513) is part of the session titled Genitourinary Cancer – Kidney and Bladder.
“We are very pleased with results generated from this clinical study,” said Thomas Parks, Ph.D., Head of Development at Osel. “There is considerable interest in microbiome modulation to enhance immune checkpoint inhibitor efficacy that is more consistent and scalable than fecal transplants. These data are an encouraging indicator of potential patient benefit in an initial indication of metastatic RCC.”
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. “Adjunctive treatment with CBM588 is associated with improvements in response rate and PFS in patients treated in combination with standard of care versus standard of care alone – there is also a compelling trend favoring overall survival early on,” Pal said. “These results warrant further investigation in a larger multi-center trial.”
CBM588 is manufactured 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.
“Microbiome analysis showed a statistically significant increase in Bifidobacteria in CBM588 treated clinical responders compared to CBM588 treated non-clinical responders or standard of care patients,” said Motomichi Takahashi, Ph.D., Executive Senior Director, Miyarisan Pharmaceutical. “These preliminary data support the GI microbiome being successfully modulated as a mechanism of clinical efficacy.”
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 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.
Media Contact
Osel:
Chris Lieu
Bioscribe, Inc.
Tel: (310) 528-7486
Email: chris@bioscribe.com
PRESS RELEASE FEBRUARY 3, 2021
Osel Obtains Exclusive License from Danish Research Consortia for IP Related to Osel’s LACTIN-V in Women Undergoing In-Vitro Fertilization
— LACTIN-V, a live biotherapeutic product, previously demonstrated clinical efficacy in reducing bacterial vaginosis recurrence —
February 03, 2021 — Mountain View, Calif. — Osel, Inc., a company developing live biotherapeutic products (LBPs) for diseases linked to the disruption of the human microbiome, today announced that it has entered into a definitive agreement with a consortia comprising Aarhus University, Skive Hospital and Statens Serum Institut of Denmark, and obtained the exclusive worldwide license to inventions resulting from an investigator-initiated Phase 2 trial of Osel’s investigational LBP, LACTIN-V, in women undergoing in-vitro fertilization (IVF). Financial terms were not disclosed.
Osel is developing LACTIN-V, a proprietary formulation of Lactobacillus crispatus being studied in IVF, in addition to bacterial vaginosis (BV) and pre-term birth. Last year, Osel and colleagues published data in The New England Journal of Medicine demonstrating that LACTIN-V significantly reduced the recurrence of BV versus placebo in a Phase 2b trial.
“Dysbiosis, or disruption of the vaginal microbiome, can lead to many problems in women’s health including BV and decreasing the success rate of IVF,” said Peter P. Lee, MD, Founder and Executive Chairman of Osel. “LACTIN-V, which contains the protective vaginal bacterial strain L. crispatus CTV-05, could help promote a healthier vaginal microbiome for IVF.”
Under the agreement, the ongoing Phase 2 IVF trial is being conducted at four fertility clinics in Denmark and led by Professor Peter Humaidan, MD, Aarhus University and Skive Regional Hospital. The primary endpoint of the trial is clinical pregnancy at seven weeks post-embryo transfer in women with documented abnormal vaginal microbiota, which lowers the probability of successful IVF.
“The vaginal microbiome and its importance for fertility is an intriguing new field of research. In the near future we hope to be able to define the most optimal vaginal microbiome – and importantly, to be able to modify the abnormal to normal,” said Professor Humaidan. “The ultimate goal of our research is to improve success rates of not only IVF, but also spontaneous pregnancy.”
“LACTIN-V holds promise as the first treatment to increase the possibility of pregnancy from IVF, especially in women with vaginal dysbiosis,” said Thomas Parks, PhD, Director of Product Development at Osel. “While the trial’s progress was impacted by COVID-19, we expect to complete enrollment by the end of 2021/early 2022.
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 live biotherapeutic products (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, with a primary focus in women’s health. While many current microbiome treatments involve microbial transplants that are collected and processed from donor pools, Osel focuses on rigorously selected single strain products that are highly reproducible, scalable, and safe.
Media Contact
Osel:
Chris Lieu
Bioscribe, Inc.
Tel: (310) 528-7486
Email: chris@bioscribe.com
Danish Consortia:
Morten Faester
SSI
Tel: +45 6137 0414
Email: mofr@ssi.dk
PRESS RELEASE MAY 13, 2020
Osel’s Live Biotherapeutic Product Demonstrates Efficacy in Phase 2b Study of Bacterial Vaginosis
— LACTIN-V is the first live biotherapeutic product to demonstrate significant efficacy in a randomized double-blind, placebo-controlled Phase 2b trial conducted in the United States —
— Results published in the New England Journal of Medicine —
May 13, 2020 — Mountain View, Calif. — Osel, Inc., a company developing live biotherapeutic products (LBPs) for diseases linked to the disruption of the human microbiome, today announced clinical data showing that the company’s LACTIN-V LBP significantly reduced the recurrence of bacterial vaginosis (BV) vs. placebo in a Phase 2b trial. Results were published in the New England Journal of Medicine: “Randomized Trial of LACTIN-V to Prevent Recurrence of Bacterial Vaginosis.” The study was conducted with the support of the National Institute of Allergy and Infectious Diseases (NIAID), contracts HHSN2722013000141 and HHSN27200007.
“We believe this study represents a landmark in the microbiome field, particularly for women’s health,” said Thomas Parks, Director of Product Development at Osel.
BV is one of the most frequent vaginal infections and affects approximately 30% of reproductive-aged women in the U.S. While antibiotic treatment is effective in some women, up to 75% relapse within three months. BV has been associated with increased risk of acquiring and spreading sexually transmitted infections, including HIV, as well as increased risk for premature birth.
LACTIN-V is a topically-administered LBP containing the protective vaginal bacterial strain Lactobacillus crispatus CTV-05, which helps combat the pathogenic bacteria and dysbiosis observed in BV and urinary tract infections. The product is designed to promote a healthy L. crispatus-dominant bacterial community following standard antibiotic treatment with vaginal 0.75% metronidazole (MetroGel®).
In the trial, 228 women were randomized to receive either LACTIN-V or placebo. At the 12-week visit in the intent-to-treat population, BV recurrence was significantly less in women treated with LACTIN-V (30%) compared to placebo (45%) (p=0.01). L. crispatus CTV-05 was detected in 79% of the women treated with LACTIN-V at the 12 week visit. The treatment benefit vs. placebo persisted through an additional 12 weeks following the last dose, despite over half of the enrolled patients having been previously diagnosed with BV five or more times. Adverse events were similar in both groups.
“The initial indication for LACTIN-V is for the prevention of BV recurrence, which tens of millions of women around the world suffer from each year,” said principal investigator and first author Craig R. Cohen, MD, Professor of obstetrics, gynecology & reproductive sciences at the University of California San Francisco. “LACTIN-V is the first major advance to treat women with BV since the introduction of antibiotics to treat this condition. It also has the potential to be an effective intervention to prevent HIV infection and preterm birth through optimization of the vaginal microbiome.”
Peter P. Lee, founder and executive chairman of Osel, added, “We currently have ongoing LACTIN-V clinical studies for in vitro fertilization (IVF) and preterm birth.”
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 live biotherapeutic products (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, with a primary focus in women’s health. While many current microbiome treatments involve microbial transplants that are collected and processed from donor pools, Osel focuses on rigorously selected single strain products that are highly reproducible, scalable, and safe.
Contact:
Mary Coyle
Bioscribe
917-975-6615
mary@bioscribe.com