본문 바로가기 주메뉴 바로가기

News & Media

Press Releases


Onselex Presentation

Admin 2026-10-06 00:00:00 Views 3,523
attachment(1)attachment

Updated Corporate Presentation

1. ONX-1006: Safer Chemotherapy

  • Uses proven paclitaxel (PTX) chemotherapy.
  • Designed to concentrate PTX in tumors while protecting normal cells.

2. Outstanding Results and Development Goals

  • Continuous Treatment: One year or longer of continuous ONX-1006 (PTX) chemotherapy treatment (goal).
  • Without Side Effects: No Side Effects at the tested dose levels in key animal toxicity studies. Our goal is continuous treatment without side effects, enabling ongoing tumor reduction.
  • Outstanding Antitumor Efficacy: 20% greater tumor reduction than Abraxane at the same weekly PTX dose in preclinical studies.
  • Tumor Elimination Goal: 90–100%.
  • One-Year Survival Goal: 70%.
  • Outstanding Results With No Side Effects (Slides 5 and 6).

Treatment duration, tumor elimination, and survival figures are future clinical development goals based on preclinical results.

3. FDA IND Package and SEND Completion

  • November 6, 2026: Completed the FDA IND application package for ONX-1006.
  • 15 SEND-applicable studies and 199 electronic datasets: All passed Pinnacle 21 validation, a tool used by the U.S. FDA.
  • Remaining Major Step: cGMP clinical manufacturing batch. Onselex is raising capital to fund this batch and the first human trial.

The IND has not yet been submitted. FDA submission will follow completion of the cGMP clinical batch.

4. Pancreatic Cancer Market Benchmark

RASONQUE (Daraxonrasib) – Revolution Medicines (RVMD)

  • FDA Approval: Stage IV pancreatic cancer, August 2026.
  • One Drug, $45 Billion: Market cap, October 2026.
  • Survival Benefit: ~6.5 months longer.
  • One-Year Survival Rate: 53.2%.
  • Severe Side Effects: 43.6% (Grade ≥3).
  • See Slide 12 for the benchmark.

5. Near-Term Objectives

  • Complete cGMP clinical manufacturing.
  • Submit the IND application to the FDA.
  • Advance ONX-1006 into Phase I/IIa human clinical evaluation for Stage IV pancreatic cancer.

For investment or strategic partnership opportunities, visit our Investor & Partner page and submit the inquiry form.

List
Prev
No previous posts.
Next
No next article.