Onselex Executive Summary

Onselex is a biotechnology company developing advanced nanoparticle based therapeutics for cancer and neurological diseases. The Company’s proprietary nanoparticle encapsulation platform is designed to improve the delivery, safety, and therapeutic effectiveness of oncology medications.

Onselex’s lead drug candidate, ONX-1006, is being developed as an intravenous anti-cancer drug for Stage IV pancreatic cancer, one of the most aggressive and difficult to treat cancers. ONX-1006 is designed to deliver chemotherapy more precisely to tumor tissue while reducing systemic toxicity associated with conventional chemotherapy.

Company Promotional Video:

https://onselex.com/en/sub/sub04_01.php?boardid=newsen&mode=view&idx=7

Technology Platform

The Company’s nanoparticle delivery platform is designed to encapsulate anti-cancer drugs and enable more targeted delivery to tumor tissue. This approach may reduce damage to normal cells while improving drug exposure at the tumor site.

Extensive in vitro and in vivo research supports the development of nanoparticle loaded drug candidates, including ONX-1006. The platform may also support future applications beyond pancreatic cancer, including other solid tumors and neurological diseases.

ONX-1006 Lead Program

Pancreatic cancer remains one of the deadliest cancers, with most patients diagnosed at advanced metastatic stages. Current frontline therapies include FOLFIRINOX and Abraxane, but treatment options remain limited and survival benefit is modest.

In xenograft efficacy studies, ONX-1006 demonstrated statistically significant and markedly superior anti-tumor activity compared with Abraxane. Based on these preclinical findings, the Company believes ONX-1006 has the potential to substantially improve treatment outcomes in pancreatic cancer.

Preclinical Efficacy and Safety

ONX-1006 is supported by a comprehensive preclinical package, including GLP toxicology, pharmacokinetic, safety pharmacology, and efficacy studies. These studies demonstrated strong tumor growth suppression and favorable safety findings across multiple preclinical models.

GLP toxicology studies indicate that ONX-1006 can be administered at substantially higher tolerated doses than conventional paclitaxel. ONX-1006 also achieved favorable No Observed Adverse Effect Level findings across studies in both rats and Beagle dogs, supporting an expanded safety profile and sustained treatment potential.

Five xenograft efficacy studies were conducted at Korean FDA certified research facilities. These studies demonstrated statistically significant tumor reduction and growth suppression using ONX-1006 in pancreatic cancer models, including AsPC 1 and PANC 1 cell lines.

Manufacturing and Clinical Readiness

One of the major challenges in nanoparticle oncology drug development is scalable and reproducible manufacturing. Onselex has demonstrated the ability to manufacture ONX-1006 at meaningful scale and has already produced approximately 15 kg of ONX-1006, sufficient for an estimated 30,000 IV injections.

All required preclinical testing has been completed, and the Company is preparing to initiate its pancreatic cancer clinical trial program. Approximately 500 clinical vials containing ONX-1006 are expected to be manufactured under cGMP conditions for human trials.

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

Company Positioning

Over the past three decades, many companies have attempted to develop nanoparticle based oncology therapeutics, but most candidates faced limitations related to safety, efficacy, toxicity, or manufacturing scalability. ONX-1006 has demonstrated the potential to overcome these barriers through strong preclinical efficacy, favorable toxicology results, and scalable nanoparticle production.

Onselex is advancing ONX-1006 toward human clinical trials with the goal of developing a safer and more effective treatment option for patients with Stage IV pancreatic cancer and other serious diseases.

Contact:

CureCancer@OnSelex.com