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Onselex Completes FDA IND Package and SEND Datasets for ONX-1006 in Stage IV Pancreatic Cancer
Onselex Completes FDA IND Package and SEND Datasets for ONX-1006, Its Safer Chemotherapy Drug for Stage IV Pancreatic Cancer
November 6, 2026
Onselex Pharmaceuticals announced today that it has completed the Investigational New Drug (IND) application package for ONX-1006, including the complete nonclinical summaries, Investigator's Brochure, and Phase I/IIa clinical trial protocol for stage IV pancreatic cancer.
Supported by more than 30 preclinical studies, the company has also completed the FDA-required SEND (Standard for Exchange of Nonclinical Data) conversion for 14 applicable studies, comprising 185 electronic datasets, in the format required for FDA submission. All 185 electronic datasets successfully passed Pinnacle 21 validation.
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14
SEND-applicable studies
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185
Electronic Datasets
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The only major component remaining before FDA submission is the cGMP clinical manufacturing batch. The capital the company is now raising funds that batch and the first human trial.
“We took an effective chemotherapy drug and made it much safer, with no side effects,”
said Ernest Shin, Founder and CEO of Onselex Pharmaceuticals.
“The science and the regulatory package are done. What remains is manufacturing the clinical batch — a capital step, not a science step — and then filing with the FDA.”
ONX-1006 delivers paclitaxel, a proven chemotherapy drug, in polymeric nanoparticles designed to target tumors. Onselex is preparing ONX-1006 for a Phase I/IIa trial in stage IV pancreatic cancer.
The IND has not yet been submitted. Submission will follow completion of the cGMP clinical batch.
Media / Investor Contact
Ernie Shin
Founder & CEO
Onselex Pharmaceuticals
CureCancer@onselex.com
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하단영역
Phone: +1-917-994-1228 E-mail: CureCancer@OnSelex.com
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