We took an effective chemotherapy drug and made it much safer, with no side effects.

ONX-1006 uses paclitaxel (PTX), a widely used chemotherapy drug. The problem with conventional PTX treatment is that the drug also reaches normal cells throughout the body, causing toxicities that can limit how much treatment patients can receive and how long treatment can continue.

ONX-1006 is designed to address this problem by changing how paclitaxel is delivered, rather than introducing a new anticancer mechanism. It incorporates PTX into a stable polymeric nanoparticle designed to protect normal cells from PTX exposure while delivering PTX to tumors.

The objective is straightforward: preserve the established anticancer activity of paclitaxel while allowing treatment to continue for a much longer period without side effects.

This is particularly important in pancreatic cancer, where treatment related toxicities frequently require lower doses, treatment delays, or discontinuation. Despite FOLFIRINOX, gemcitabine-Abraxane, and the recent approval of RASONQUE (daraxonrasib), long term survival remains limited.

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

In repeat dose GLP toxicity tests, ONX-1006 demonstrated an excellent safety profile and a wide safety margin. In the 4-week rat GLP test, the highest dose with no side effects corresponded to more than 750 mg of paclitaxel for a 60 kg adult, more than 3.8 times a typical Abraxane dose of about 200 mg PTX for pancreatic cancer.

The 3.8 times comparison represents the preclinical safety margin. It does not mean that Onselex intends to give patients 3.8 times more chemotherapy.

Our goal is to deliver PTX much more safely, protect normal cells from PTX exposure, and enable treatment to continue without side effects until the tumor is eliminated.

Published Abraxane plus gemcitabine clinical data showed tumor reductions of about 30% to 36% after at least three treatment cycles. In a direct head-to-head pancreatic cancer xenograft test at the same weekly PTX dose, ONX-1006 achieved 20% greater tumor reduction than Abraxane and demonstrated the highest level of tumor cell death.

These findings are important because paclitaxel already has established anticancer activity in humans. ONX-1006 does not depend on proving an entirely new cytotoxic mechanism. Instead, Onselex has developed a safer way to deliver an effective and well established cancer drug.

Concentrates PTX in tumors while protecting normal cells from PTX exposure. No side effects. Continued treatment beyond one year.

Based on these preclinical findings and the established clinical activity of paclitaxel, Onselex has established development goals of continuous treatment for one year or longer without side effects , 90% to 100% tumor elimination , and a 70% one year survival rate .

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

Onselex’s nanoparticle platform extends across solid tumors and neurological diseases, aiming to provide innovative treatment options 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, bring a new generation of therapies to patients worldwide, and ultimately help extend and save millions of lives.

We welcome the opportunity to discuss an investment in Onselex or a strategic partnership. For investment or partnership inquiries, please visit our Investment & Partner Inquiry page and complete the inquiry form.

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