Onselex has developed a nanomedicine platform engineered to transform oncology treatment through precision drug delivery to tumors, dramatically lower systemic toxicity, and enable repeated, sustained treatment.

Pancreatic cancer remains one of the most difficult cancers to treat, particularly in metastatic disease. Despite FOLFIRINOX, gemcitabine-Abraxane, and the approval of RASONQUE (daraxonrasib), long-term survival remains limited. Current treatments frequently cause treatment-related toxicities requiring dose reductions, treatment delays, or discontinuation, while RASONQUE also carries a significant toxicity burden.

Onselex’s ONX-1006 encapsulates paclitaxel (PTX), a widely used chemotherapy drug, in a stable polymeric nanoparticle designed to limit systemic exposure of normal cells to paclitaxel while enabling precision drug delivery to tumors.

ONX-1006 has been evaluated in more than 30 preclinical studies, generating about 4,000 pages of study data.

Because paclitaxel’s anticancer activity is already established in humans, ONX-1006 does not depend on validation of a new cytotoxic mechanism. Across its preclinical program, ONX-1006 has demonstrated preserved antitumor activity, sustained tumor-tissue exposure, substantially higher tolerated PTX-equivalent exposure, and repeated weekly dosing across two species. Together, these findings provide compelling translational evidence for a differentiated therapeutic profile built on the established anticancer activity of paclitaxel.

ONX-1006 established No Observed Adverse Effect Levels (NOAELs) in both male and female animals in repeat-dose GLP studies. In the 4-week rat study, the highest NOAEL, when converted to a 60 kg adult, was equivalent to more than 750 mg of paclitaxel, about 3.8 times the about 200 mg of paclitaxel delivered in a typical single dose of Abraxane for pancreatic cancer. The Abraxane-gemcitabine regimen at this dose is associated with substantial Grade 3 or higher toxicities. No treatment-related adverse effects were observed at the respective ONX-1006 NOAELs, supporting a broad preclinical therapeutic window and sustained weekly PTX exposure.

In pancreatic cancer xenograft models, ONX-1006 achieved 20% greater tumor reduction than Abraxane at the same weekly paclitaxel dose, with the highest tumor-cell death by TUNEL analysis. Published Abraxane plus gemcitabine data showed about 30% to 36% median tumor target-lesion reduction after at least three treatment cycles, supporting ONX-1006’s strategy of building on established paclitaxel activity through higher tolerated exposure and sustained weekly treatment.

Based on extrapolation of these preclinical findings and the established clinical activity of paclitaxel-based treatment, Onselex has established development goals of 90% to 100% tumor elimination and a 70% one-year survival rate.

Furthermore, Onselex has established a standardized manufacturing SOP for ONX-1006 and produced 15 kg of nanoparticles, demonstrating reproducible multi-kilogram-scale manufacturing.

Onselex’s nanoparticle platform extends across solid tumors and neurological diseases, aiming to provide effective treatment while preserving quality of life and normal daily living.

We invite investors and strategic partners to join Onselex on our journey to transform cancer treatment and improve outcomes for patients worldwide.

We welcome the opportunity to discuss an investment in Onselex or a strategic partnership. To learn more, please contact us by email.

We look forward to welcoming you as part of Onselex’s journey.
Ernest Shin