Duo Oncology accepted into NCI Nanotechnology Characterization Program.
The NCI Nanotechnology Characterization Laboratory’s Assay Cascade Characterization Program will Provide Critical Support for Duo Oncology’s Lead Program, DUO-207.
PITTSBURGH (PRWEB) March 25, 2025 – Duo Oncology, a clinic-ready biotech company is pleased to announce its acceptance into the Nanotechnology Characterization Laboratory’s (NCL) Assay Cascade characterization program, an extramural support service provided by the National Cancer Institute (NCI). The NCL is located at the Frederick National Laboratory for Cancer Research, currently operated for NCI by Leidos Biomedical Research, Inc. This prestigious initiative will provide in-depth analytical and preclinical testing for Duo Oncology’s novel cancer nanomedicine, DUO-207.
Scientists at the NCL will work closely with Duo Oncology to guide nanomedicine candidate, DUO-207, through multiple stages of rigorous characterization. The planned studies should generate key data to help expand DUO-207’s clinical translation and accelerate regulatory filings, including a New Drug Application.
“NCL’s Assay Cascade program offers a wealth of technical expertise and in-kind support to our DUO-207 development program,” said Dr. Sam Rothstein of Duo Oncology. “The planned studies will be invaluable for advancing DUO-207 toward clinical trials, regulatory approval, and, ultimately, improving outcomes for cancer patients.”
Duo Oncology’s acceptance into the free, NCI-funded, characterization program underscores its commitment to scientific rigor and innovation in oncology drug development. The company’s platform – capable of creating nanomedicines that enhance drug delivery, increase tumor drug exposure, and minimize systemic toxicity – uses an innovative biomimetic chemistry, making it an ideal fit for the interdisciplinary analytic approach developed at NCL.
The NCL was established as a collaborative effort between the NCI, the U.S. Food and Drug Administration (FDA), and the National Institute of Standards and Technology (NIST). Since its inception, the program has characterized hundreds of nanomedicines by providing researchers with high-quality, standardized data to facilitate regulatory approval.
About Duo Oncology: Duo Oncology, founded by oncologists, is building a stronger, safer foundation for cancer medicine by replacing toxic chemotherapy with patient-responsive therapeutics. Duo’s proprietary drug chemistry assembles potent molecules into complex nanomedicines to penetrate hard-to-treat tumors, such as those found in patients with pancreatic cancer. Their lead product, DUO-207, has demonstrated superior efficacy and safety compared to standard therapies in GLP toxicology studies. Supported by early investments from BeiGene Pharma, which acquired a 40% stake in Duo’s seed round, and an $8M follow-on term sheet from Prevail Partners, Duo Oncology is well-positioned to initiate clinical trials for DUO-207 in early 2025. The company’s potential is further underscored by a Prix Galien nomination and two Orphan Drug designations.
About the Nanotechnology Characterization Lab (NCL): NCI founded NCL in 2004, in collaboration with the US Food and Drug Administration and National Institute of Standards and Technology, as a public–private partnership to advance the science needed to expedite the development of promising nanotech therapies and diagnostics. The NCL’s initial mission was to develop an “Assay Cascade” of scientific tests that would help determine the reproducibility, safety, and efficacy of nanomedicines to facilitate regulatory review. NCL is the only lab with experience testing the wide variety of platforms used in nanomedicine. Since its founding, the NCL has tested more than 500 unique nanomaterials, including almost every type of nanoparticle used in biomedical research and development (e.g., metallic, liposomes, polymers, proteins, micelles, DNA and RNA nanostructures, carbon nanotubes) with nearly every type of active pharmaceutical ingredient (e.g., small molecules, peptides, proteins, nucleic acids, plasmids).
