Onco-Innovations Announces Completion of Analytical Method Development for Monomer Intermediate 1 Supporting ONC010 Program
Rhea-AI Summary
Onco-Innovations (OTCQB:ONNVF) announced completion of analytical method development for its monomer intermediate supporting ONC010. A robust RP-HPLC method was developed and pre-validated with high sensitivity, linearity, and consistent chromatographic behavior to support impurity detection, quality control and future GMP activities.
Process development yielded intermediary scale batches of ~20 g and ~181 g, each confirmed at not less than 98% purity by HPLC; the method will form the basis for formal CMC analytical procedures as the company advances toward IND-enabling work.
Positive
- RP-HPLC method developed and pre-validated for impurity detection
- Intermediary scale batches of ~20 g and ~181 g produced
- Batch purity confirmed at not less than 98% by HPLC
- Method designated to support GMP activities and formal CMC tests
Negative
- Scale remains at intermediary level (181 g), not full clinical supply
- Final polymer and intermediate quality specifications still being defined
VANCOUVER, BC / ACCESS Newswire / April 21, 2026 / Onco-Innovations Limited (CBOE CA:ONCO)(OTCQB:ONNVF)(Frankfurt:W1H, WKN: A3EKSZ) ("Onco" or the "Company") announces the successful completion of a significant milestone with Dalton Pharma Services ("Dalton"), focused on analytical method development for purity determination of Intermediate 1 (monomer) of its proprietary polymer platform supporting ONC010. The completed work includes development of a robust reverse-phase high-performance liquid chromatography (RP-HPLC) analytical method designed to support impurity detection and quality control of the monomer used in the Company's nanoparticle-based drug delivery system. Pre-validation data generated during the program demonstrated strong analytical performance, including high sensitivity for impurity detection at low thresholds, excellent linearity across the tested range, and consistent chromatographic behavior suitable for routine analytical application.
Dalton's development program supports the establishment of a fit-for-purpose method for use in ongoing development and future GMP manufacturing activities. The method will form the basis for formal analytical test procedures as part of the Company's broader chemistry, manufacturing, and controls (CMC) program. Process development for the monomer has been completed, with successful isolation of intermediary scale-up batches at approximately 20 grams and 181 grams, each achieving high purity levels of not less than
"Completion of this analytical method development program represents an important step forward in strengthening the quality and control framework for our polymer platform," said Dr. Islam Mohamed, Chief Medical Officer of Onco-Innovations. "Establishing reliable and sensitive analytical methods is critical to supporting reproducible manufacturing and advancing our program toward IND-enabling studies and clinical development."
Additional process improvements have been implemented, including refinement of synthesis conditions and impurity control strategies through optimized purification techniques. The Company continues to define final quality specifications for the polymer and associated intermediates as part of its ongoing CMC development program.
About Onco-Innovations Limited
Onco-Innovations is a Canadian-based company dedicated to cancer research and treatment, specializing in oncology. Onco's mission is to pursue the prevention and treatment of cancer through pioneering research and innovative solutions. The company has secured an exclusive worldwide license to patented technology that targets solid tumours.
ON BEHALF OF ONCO-INNOVATIONS LIMITED,
"Thomas O'Shaughnessy"
Chief Executive Officer
For more information, please contact:
Thomas O'Shaughnessy
Chief Executive Officer
Tel: + 1 888 261 8055
investors@oncoinnovations.com
Forward-Looking Statements Caution. This news release contains forward-looking statements, including in relation to the Company's business and plans generally, and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "potential", "should", "anticipate", "expects" and similar expressions. All statements, other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties, including (but not limited to) in relation to: the Company's ability to carry out its planned research and development activities; its ability to further pursue or initiate human or other further clinical trials; and its ability to qualify for or maintain any favorable treatment for research and development activities. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.
SOURCE: Onco-Innovations Limited
View the original press release on ACCESS Newswire