Arizona Tribune - Onco-Innovations Completes Analytical Reference Standard Preparation Program for ONC010’s API

The reference standard program, which was completed in collaboration with Dalton Pharma Services, included the preparation, purification, analytical evaluation and quality assessment of highly characterized A83B4C63 material intended for use as a reference standard in future analytical testing programs. Reference standards serve as foundational tools within pharmaceutical development and quality control systems, enabling consistent evaluation of identity, purity, potency, stability, impurity profiles and batch-to-batch comparability throughout the development lifecycle.

Completion of the program establishes an important analytical benchmark for future manufacturing campaigns and supports the Company's broader strategy of building a comprehensive quality infrastructure for ONC010.

"A qualified reference standard provides an essential foundation for maintaining analytical consistency and scientific rigour throughout the drug development process. This milestone strengthens the quality systems supporting ONC010 and contributes to the generation of reliable analytical data that will be used to support future manufacturing, regulatory, and clinical activities," Dr. Islam Mohamed, Chief Medical Officer of Onco-Innovations, stated.

The completion of the reference standard program follows several recent chemistry, manufacturing and controls (CMC) achievements within the ONC010 development program, including successful precursor scale-up activities, API manufacturing advancements, analytical method development, chiral purity testing and continued progress toward manufacturing scale-up and regulatory readiness.

"The successful completion of our analytical reference standard program represents another important advancement in the maturation of the ONC010 development platform. Establishing qualified reference materials is a foundational element of pharmaceutical quality systems and supports consistency across manufacturing, analytical testing, regulatory documentation and future clinical development. This milestone further strengthens our chemistry, manufacturing and controls framework as we continue advancing ONC010 toward clinical readiness," Thomas O'Shaughnessy, Chief Executive Officer of Onco-Innovations, commented.

The reference standard preparation program forms part of a broader analytical development strategy currently underway at Onco-Innovations. Additional activities include analytical method qualification, stability-indicating methodologies, residual solvent testing, impurity profiling, forced degradation studies, formulation characterization and quality control system development.

About ONC010

ONC010 is a novel nanoparticle-formulated inhibitor of Polynucleotide Kinase Phosphatase (PNKP), a key DNA damage repair enzyme. The program is being developed to exploit vulnerabilities in cancer cells dependent on DNA repair pathways and is intended to provide a differentiated therapeutic approach for patients with difficult-to-treat malignancies.

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
[email protected]

Forward-Looking Statements Caution. This news release contains forward-looking statements, including with respect to the anticipated advancement of the Company's ONC010 program. Forward-looking statements are often identified by terms such as 'will', 'may', 'potential', 'should', 'anticipate', 'expects' and similar expressions. These forward-looking statements are subject to specific risks and uncertainties, including risks relating to the Company's ability to successfully scale manufacturing processes beyond current levels; maintain API quality, purity and reproducibility in future batches; complete analytical qualification, formulation development and GMP manufacturing on anticipated timelines; obtain required regulatory approvals to commence clinical studies; secure sufficient funding to support ongoing development; and retain key scientific, technical and operational personnel. In addition, preclinical results, including manufacturing and analytical outcomes, may not be predictive of clinical performance or regulatory acceptance. 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 due to these and other risks and uncertainties, many of which are beyond the Company's control. The reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are made as of the date hereof and the Company undertakes no obligation to update such statements except as required by applicable law.

SOURCE: Onco-Innovations Limited

View the original press release on ACCESS Newswire

S.Jackson--AT