Onselex is a pioneering biotechnology company developing a novel class of therapeutics based on advanced nanoparticle delivery systems to treat cancer and neurological diseases. The Company has developed proprietary nanoparticle encapsulation technology designed to enable targeted administration of oncology medications.

By leveraging this platform, Onselex aims to significantly reduce adverse reactions associated with chemotherapy toxicity—potentially by more than 95 percent compared with conventional chemotherapy—while enhancing therapeutic effectiveness and improving patient quality of life.

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Onselex’s nanoparticle delivery platform is designed to directly impact critical oncologic cellular functions by enabling more precise drug delivery. Extensive in vitro and in vivo research supports the development of Nanoparticle-Loaded Drug candidates, including ONX-1006, a paclitaxel-based formulation.

Numerous studies conducted at leading academic institutions—including research published by MIT and corroborated by independent laboratories associated with the National Cancer Institute and other global research centers—have demonstrated that nanoparticle drug systems can effectively deliver anti-cancer agents to tumor tissue, provided that manufacturing scalability and toxicity challenges are successfully addressed.

Despite decades of medical progress, pancreatic cancer remains one of the most aggressive malignancies, with approximately 75 percent mortality within one year and nearly 90 percent within five years. Most cases are diagnosed at advanced metastatic stages. Current frontline therapies include FOLFIRINOX and Abraxane.

The standard Abraxane regimen (125 mg/m² in combination with gemcitabine 1,000 mg) provides only modest survival benefit, extending median life expectancy by approximately 1.8 months.

In xenograft efficacy studies, ONX-1006 demonstrated a statistically significant and markedly superior anti-tumor effect—greater than 3x—compared with Abraxane. Based on preclinical findings, the Company believes ONX-1006 has the potential to substantially reduce pancreatic cancer mortality with minimal or no observable side effects.

Outstanding ONX-1006 Efficacy and Toxicology Results

GLP toxicology studies indicate that ONX-1006 can be administered at doses exceeding 20 times those of conventional paclitaxel (PTX) without observed harmful side effects.

The lethal paclitaxel dose in rats is approximately 12 mg/kg. In single-dose IV GLP rat toxicity studies, ONX-1006 (PTX 500 mg/kg) demonstrated an approximate lethal dose (ALD) 40-50 times higher than standard PTX lethal dosing, without adverse toxic findings.

The maximum tolerated dose (MTD) of PTX in dogs is 8.25 mg/kg. ONX-1006 remained well tolerated at PTX 25 mg/kg or greater—approximately three times the conventional MTD.

Traditional Taxol-based chemotherapy agents do not establish a clear No Observed Adverse Effect Level (NOAEL) due to toxicity limitations. In contrast, ONX-1006 achieved measurable and favorable NOAEL values across GLP studies in both rats and Beagle dogs, including a 13-week repeated IV dose study (once weekly, total 13 doses) followed by a 4-week recovery and toxicokinetic evaluation.

These data support a strong safety profile, suggesting that patients receiving ONX-1006 may be able to maintain normal daily activities during treatment. Full GLP study reports and protocols are available upon request.

Five xenograft efficacy studies were conducted at Korean FDA-certified research facilities (DT&C and Chemon). Both institutions reported statistically significant tumor reduction and growth suppression using ONX-1006. AsPC-1 and PANC-1 pancreatic cancer cell lines were utilized in these studies.

Experts believe the strong correlation between ONX-1006’s preclinical safety and efficacy data may translate favorably into human clinical outcomes.

Over the past three decades, more than twenty companies have attempted to develop nanoparticle-based oncology therapeutics. Most candidates failed due to safety, toxicity, efficacy, or manufacturing scalability challenges. ONX-1006 has demonstrated the ability to overcome these barriers while achieving scalable nanoparticle production.

The Company has already produced approximately 15 kg of ONX-1006, sufficient for an estimated 30,000 IV injections.

All required preclinical testing has been completed. The Company is preparing to initiate its pancreatic cancer clinical trial program. Approximately 500 clinical vials (saline 10 ml containing ONX-1006 PTX 100 mg) will be manufactured under cGMP conditions for human trials.

The planned Phase I/II trial is expected to enroll approximately 8-24 Stage IV pancreatic cancer patients, with weekly administration of ONX-1006 for 3-12 months.

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Contact: CureCancer@OnSelex.com