Pancreatic cancer remains one of the most difficult cancers to treat, with limited therapeutic options and poor outcomes, particularly in metastatic disease. Despite available treatment regimens, including FOLFIRINOX and gemcitabine-Abraxane, improvements in survival remain limited, and a significant unmet medical need persists.

Onselex’s lead drug candidate, ONX-1006, is designed to encapsulate paclitaxel within a chemically stable polymeric nanoparticle structure. This design is intended to minimize nonspecific exposure of paclitaxel to the bloodstream and healthy tissues while enhancing drug delivery and accumulation within tumors.

Across an extensive program of GLP toxicology and preclinical studies, ONX-1006 established a high No Observed Adverse Effect Level, or NOAEL, under repeat-dose conditions. When the highest preclinical NOAEL is converted to a human-equivalent estimate, it corresponds to more than approximately 750 mg of paclitaxel for a 60 kg adult.

Importantly, this represents a preclinical human-equivalent estimate of a dose level at which treatment-related adverse toxicological findings were not observed, rather than simply an administered dose. By comparison, the typical single dose of Abraxane used in metastatic pancreatic cancer is approximately 200 mg of paclitaxel for an average adult, and clinically significant toxicities—including myelosuppression, peripheral neuropathy, dose reductions, treatment delays, and treatment discontinuation—may occur at that dose.

Accordingly, ONX-1006 demonstrated a preclinical NOAEL at a paclitaxel-equivalent level more than approximately 3.75 times the typical single clinical dose of Abraxane. In repeat-dose animal studies, all animals survived without treatment-related serious toxicological findings. These results support the potential for ONX-1006 to provide a substantially improved safety margin and enable repeated, continuous treatment at meaningful paclitaxel-equivalent dose levels.

ONX-1006 also demonstrated strong efficacy signals in validated pancreatic cancer xenograft models. At the same total weekly paclitaxel dose, ONX-1006 produced statistically significant and superior tumor reduction compared with Abraxane and demonstrated the highest level of tumor-cell death in TUNEL analyses.

Together, these preclinical efficacy and safety findings provide a strong scientific foundation for advancing ONX-1006 into human clinical development. Onselex is currently preparing to initiate clinical evaluation of ONX-1006 in patients with metastatic pancreatic cancer.

A central objective of Onselex’s clinical strategy is to enable patients to continue treatment without prolonged interruptions caused by cumulative toxicity. Existing chemotherapy regimens often require dose reductions, treatment delays, or discontinuation, limiting the duration and potential effectiveness of therapy. Based on its favorable preclinical safety profile, ONX-1006 is being developed to support longer-term, continuous treatment.

Based on the company’s extrapolation of its preclinical findings to extended continuous treatment, Onselex has established development goals of achieving the potential for 90% to 100% tumor elimination and a 70% one-year survival rate. These figures represent the company’s clinical development objectives and have not yet been demonstrated in human clinical trials. Their safety and efficacy will be evaluated through the planned clinical program.

Onselex’s vision extends beyond a single indication. Its nanoparticle platform has the potential to expand across multiple solid tumors and, over the longer term, into additional therapeutic areas, including neurological diseases.

At Onselex, we are committed to rigorous scientific validation, disciplined development, and responsible execution. Our goal is to develop new treatment options that allow patients to preserve greater stability, quality of life, and continuity in their daily lives throughout treatment.

We welcome the interest and participation of investors and strategic partners who share our vision and wish to join us in creating long-term value.

To learn more about Onselex or discuss an investment or strategic partnership opportunity, please contact us by email.

Thank you for your consideration. Ernie Shin