Osel Inc. and March of Dimes Announce Groundbreaking Phase 2b Trial of Microbiome-based Therapy Targeting Preterm Birth Prevention
Osel Inc., a clinical‑stage biopharma leader in live biotherapeutic products (LBPs), in partnership with the Imperial Clinical Trials Unit at Imperial College London, and March of Dimes, a national leader in maternal and infant health research, today announced the launch of FLIP‑2, a Phase 2b clinical trial that will evaluate the efficacy and safety of LACTIN‑V in pregnant women at high risk of preterm birth (PTB).
Osel Enters Agreement with SWOG Cancer Research Network for First-Ever Pivotal Trial of a Microbiome-Based Therapy in Oncology
Osel Inc., a clinical-stage biopharma company pioneering live biotherapeutic products (LBPs), today announced a clinical trial agreement with SWOG Cancer Research Network for a pivotal Phase 3 clinical trial of its lead oncology candidate, MO-03, in combination with standard immuno-oncology (IO) regimens for advanced and metastatic renal cell carcinoma (mRCC). This marks the first-ever pivotal trial of a microbiome-based oral therapy in oncology.
City of Hope and Osel Announce Exclusive License for Intellectual Property on the Use of Live Biotherapeutic Product CBM588 for Oncology Therapeutic Applications
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.
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
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).
