TREOS Bio Ltd., a clinical-stage biotechnology company developing next-generation off-the-shelf peptide cancer immunotherapies, announced the execution of clinical collaboration agreements with Charité – Universitätsmedizin Berlin and Junshi Biosciences for the initiation of OBERTO-202, a potentially registration-enabling Phase II clinical trial evaluating PolyPEPI1018 in combination with toripalimab (Junshi Biosciences' PD-1 inhibitor) and standard of care in microsatellite stable (MSS) metastatic colorectal cancer (CRC). The company also completed a $2.1 million bridge financing from existing investors, bringing total financing raised to date to $47M, not counting non-dilutive support from grants and clinical collaborations.
The OBERTO-202 study will be conducted as an investigator-led trial at Charité – Universitätsmedizin Berlin, one of Europe's largest university hospitals, with Prof. Sebastian Stintzing as principal investigator and in collaboration with 14 other leading academic hospitals. The trial will evaluate PolyPEPI1018 and toripalimab in combination with standard of care (Lonsurf + Avastin) versus standard of care alone in approximately 140 patients with relapsed/refractory MSS CRC.
"The collaboration with Charité Berlin and Junshi Biosciences represents a significant milestone as we work toward demonstrating the potential of our precision immunotherapy approach in one of the largest oncology markets with significant unmet medical need," said Dr. Christopher Gallen, Chairman and CEO of TREOS Bio. "The bridge financing provides us with the runway to advance our lead program toward what we anticipate will be a registration-enabling Phase II study."
“This randomized, controlled clinical trial represents a logical next step in the development of PolyPEPI1018,” said Dr. Hagop Youssoufian, Chair of Medical Strategy of TREOS Bio and Adjunct Professor of Medicine at Brown University. “Leveraging the built-in antigenic diversity of this unique active immunotherapy that can dampen multiple immunosuppressive mechanisms, in combination with toripalimab and chemotherapy, provides an exciting opportunity to overcome the well-known resistance to immunotherapies in MSS CRC.”
PolyPEPI1018 is TREOS Bio's lead off-the-shelf multi-peptide active cancer immunotherapy designed to convert immunologically "cold" tumors to "hot" tumors. The therapy has demonstrated encouraging clinical activity across three Phase I/II trials (44 patients in total) in advanced MSS CRC conducted in partnership with the Mayo Clinic, with consistent correlations between immune activation and clinical benefit.
MSS CRC represents approximately 85% of all colorectal cancer cases and affects an estimated 130,000 new patients annually in the US alone and over 1.6 million new patients globally. Current immunotherapies, including checkpoint inhibitors, have shown limited efficacy in this patient population.
