Osel Enters Agreement with SWOG Cancer Research Network for First-Ever Pivotal Trial of a Microbiome-Based Therapy in Oncology

Pivotal Phase 3 trial of MO-03 builds on prior studies that demonstrated enhanced immunotherapy benefit without added toxicity

Excerpt from the Press Release:

MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–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.

The BIOFRONT trial will build on promising results from two prior clinical studies led by Dr. Sumanta Kumar Pal, MD, FASCO at City of Hope. In those studies, prior formulations of the product were added to nivolumab and ipilimumab or to cabozantinib and nivolumab and showed statistically significant improvements in response rates and progression free survival, without added toxicity.^1,2 A recent dose-escalation study confirmed favorable safety across higher dose levels, with no increase in immune-related adverse events, leading to a new high-potency capsule formulation, MO-03, specific for oncology.

“The study represents a major advance for patients with advanced RCC,” said Dr. Pal. “While other combination approaches in the front-line setting add significant toxicity, MO-03 could possibly augment the efficacy of immunotherapy-based regimens without compromising quality of life.”

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