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Omni Nano chief says nanoparticle combo boosts tumor delivery, outlines IND timeline
Summary
Dr. Leslie Sloan, CEO of Omni Nano, briefed the CPRIT oversight committee on OMP00001, a polymeric micelle co‑encapsulating cyclopamine and paclitaxel that the company says raises tumor drug concentrations and extended survival in multiple preclinical models; Sloan reported dose‑finding, impurity remediation, ongoing toxicology and a planned pre‑IND meeting with FDA.
Dr. Leslie Sloan, chief executive officer of Omni Nano, told the Cancer Prevention and Research Institute of Texas oversight committee that the company's lead program, OMP00001, pairs a stroma‑modulating agent with paclitaxel in a polymeric micelle to improve tumor access and exposure, particularly in pancreatic cancer. She said preclinical studies across multiple models show substantially higher tumor concentrations and statistically significant survival gains versus controls.
Sloan described the drug as a small polymeric micelle that releases two complementary agents: one that reduces stroma formation and another that kills tumor cells, and she argued the combination creates tumor access and a more favorable therapeutic window. "We see about 150‑fold higher tumor versus blood concentrations in a genetically engineered mouse model," Sloan said during the presentation, adding that in an orthotopic syngeneic model she saw much higher tumor paclitaxel levels versus the best‑in‑class formulation.
Omni Nano reported dose‑finding work that identified a minimally efficacious dose and an optimized schedule. Sloan said a surprising drop in efficacy at the highest tested dose led the team to discover an in‑process impurity in polymer production; after removing the impurity and redoing confirmatory studies, the company observed consistent survival improvements. "We found an in‑process impurity that was confounding the data. We figured out how to remove it and then redid the confirmatory study," Sloan told the committee.
On manufacturing and chemistry, Sloan summarized a three‑step polymer synthesis, progress scaling from 100 milligrams to 100 grams, and selection of a nanomedicine‑specialized CDMO. She said Omni Nano has agreements to reference an API drug master file and has identified a feasible GMP route to obtain clinical‑grade cyclopamine via a protection/crystallization approach rather than a lengthy total synthesis. Sloan said the team has tightened critical‑to‑quality attributes (size, polydispersity, drug loading, release) across consecutive batches.
Sloan also discussed regulatory planning. She said the company plans a pre‑IND meeting with FDA in summer 2026, and that FDA indicated the polymers are being treated as novel excipients for this program, which Sloan described as helpful for development. "They recommended adding a couple arms to our toxicology plan but said the proposed plan appeared sufficient," she said. Sloan added that the agency authorized quantifying total plasma CPA and PTX in nonclinical studies, a simplification for bioanalytics.
On safety and next steps, Sloan said a non‑GLP acute toxicology screening study began in May with four dose levels (5, 10, 15, 20 mg/kg) and results were expected the following month; the repeat‑dose toxicology program is planned next. She also outlined capital‑raising activity (seed round and non‑dilutive grants including NCI and DoD applications) to fund IND‑enabling studies and set an internal timeline targeting IND filing and first‑in‑human studies in 2027, subject to fundraising and confirmatory IND material.
The presentation generated technical questions from oversight committee members about metastasis endpoints and whether efficacy was tested in models with established metastases. Sloan said she had tested metastatic potential in genetically engineered mouse models and reported a statistically significant reduction in metastases in treated animals, but she acknowledged the team had not yet treated animals with preexisting lung metastases. "We can delay or prevent metastases, but I can't tell you what happens when we treat animals that already have metastases," she said.
The oversight committee received Sloan's update during the grantee‑presentation portion of the meeting; Omni Nano was among companies discussed later in the product development supplemental awards decisions.
