Lead Product DUO-207 Completes Clean GLP Toxicology Studies.
Clean Safety Results in Final Animal Studies Pave the Way for DUO-207 to Start Clinical Testing.
PITTSBURGH (PRWEB) August 14, 2025 – Duo Oncology, a clinical-stage biotech company pioneering dual-therapy carrying cancer nanomedicine, today announced the successful completion of Good Laboratory Practice (GLP) toxicology studies for its lead candidate, DUO-207. The studies revealed a clean safety profile across multiple preclinical species, enabling the company to proceed with its first-in-human clinical trial.
“This is a major milestone for Duo Oncology and for DUO-207,” said Dr. Sam Rothstein, Co-founder and CEO of Duo Oncology. “The clean toxicology results reinforce our belief that DUO-207 could transform cancer care by providing a safer, patient-centric alternative to traditional chemotherapies. We are now one step closer to delivering a much-needed treatment option for patients with metastatic pancreatic cancer and other advanced solid tumors.”
The GLP toxicology studies, conducted in accordance with regulatory standards, showed dose-limiting hematotoxicity at doses higher than standard of care nano-albumin paclitaxel and gemcitabine, supporting a favorable safety margin for clinical testing. Animals receiving DUO-207 had more favorable clinical observations than standard of care and all biomarkers returned to baseline by the end of the recovery period. Duo Oncology plans to initiate its Phase I trial in Q4 of 2025, evaluating the safety, tolerability, and initial signs of efficacy in patients, with the goal of significantly improving quality of life compared to conventional chemotherapy.
DUO-207, the lead candidate in Duo Oncology’s pipeline, exemplifies our commitment to replacing toxic chemotherapies with innovative nanomedicines that protect healthy organs and concentrate highly active within tumors, transforming known standards of care. Preclinical models have demonstrated potent anti-tumor activity and durability of response, even in tumors resistant to standard-of-care therapies.
“The rigor and reproducibility of these results give us confidence as we move into the clinic,” said Dr. Katherine Eichinger, Chief Operations Officer at Duo Oncology. “We are grateful to our team, partners, and investors who have helped us reach this point.”
Duo Oncology will initiate its Phase I clinical trial at multiple sites in Australia and will be registering its study and filing the required paperwork with the Human Research Ethic Committee.
