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Onco-Innovations Advances Optimization and Scale-Up of Its PNKP Inhibitor Technology with Dalton Pharma Services to Support Future Phase 1 Clinical Studies
VANCOUVER, BC / ACCESS Newswire / November 20, 2025 / Onco-Innovations Limited (CBOE CA:ONCO)(OTCQB:ONNVF)(Frankfurt:W1H, WKN:A3EKSZ) ("Onco" or the "Company") is pleased to announce that its manufacturing partner, Dalton Pharma Services ("Dalton"), ...

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[{"type":"text","content":"VANCOUVER, BC / ACCESS Newswire / November 20, 2025 / Onco-Innovations Limited (CBOE CA:ONCO)(OTCQB:ONNVF)(Frankfurt:W1H, WKN:A3EKSZ) ("Onco" or the "Company") is pleased to announce that its manufacturing partner, Dalton Pharma Services ("Dalton"), has initiated process optimization and intermediate scale-up activities for A83B4C63, the Company's proprietary PNKP Inhibitor Technology. This phase of work is designed to refine and scale the synthesis process under non-GMP conditions as part of Onco's ongoing manufacturing development program, supporting future clinical material production.","length":633,"tagName":"p"},{"type":"text","content":"Building on the manufacturing activities previously initiated by Dalton for preclinical testing material (see Company press release dated May 26, 2025), the Company has now advanced to the optimization and intermediate-scale production (for research purposes) of A83B4C63. This next phase focuses on process scale-up and analytical method qualification, which is intended to ensure a robust, reproducible, and scalable manufacturing process suitable for future GMP production and subsequent manufacturing of clinical material to support Onco's IND enabling and Phase 1 studies. The work will be performed using dedicated pilot-scale equipment at Dalton's FDA- and Health Canada-approved facility in Toronto, Canada.","length":723,"tagName":"p"},{"type":"text","content":"As part of this optimization phase, Dalton will conduct intermediary scale-up batches targeting approximately 500 g of precursor A83 and 1,000 g of precursor B4 to evaluate reaction performance under scale-up conditions in preparation for pre-clinical production of A83B4C63.","length":275,"tagName":"p"},{"type":"text","content":"The A83B4C63 active pharmaceutical ingredient (API) will be used to support the development of Onco's encapsulated nanoparticle micelle formulation, which is designed with the goal of enhancing tumor-targeted delivery of the PNKP inhibitor, and with the ultimate goal of potentially improving therapeutic efficacy in cancer treatment.","length":338,"tagName":"p"},{"type":"text","content":"The manufacturing program also includes comprehensive analytical method development and stability testing conducted in accordance with International Council for Harmonisation (I...