Onco-Innovations Advances Optimization and Scale-Up of Its PNKP Inhibitor Technology with Dalton Pharma Services to Support Future Phase 1 Clinical Studies
Onco-Innovations (OTCQB:ONNVF) said Dalton Pharma Services began optimization and intermediate scale-up for its proprietary PNKP inhibitor A83B4C63 on November 20, 2025. The program advances from prior preclinical manufacturing to pilot-scale, non‑GMP synthesis using Dalton's FDA- and Health Canada‑approved Toronto facility.
Key activities include intermediary batches targeting approximately 500 g of precursor A83 and 1,000 g of precursor B4, analytical method qualification, ICH‑guided stability testing, and a formal safety and risk assessment to support future GMP production and IND‑enabling work toward Phase 1 studies.
Onco-Innovations (OTCQB:ONNVF) ha dichiarato che Dalton Pharma Services ha avviato l'ottimizzazione e la scala intermedia per il suo inibitore PNKP proprietario A83B4C63 il 20 novembre 2025. Il programma avanza dalla precedente produzione preclinica alla sintesi pilota su scala non GMP, utilizzando l'impianto di Toronto di Dalton, approvato dalla FDA e Health Canada.
Le attività chiave includono batch intermedi mirati a circa 500 g di precursore A83 e 1.000 g di precursore B4, qualificazione del metodo analitico, test di stabilità guidati dall'ICH e una valutazione formale di sicurezza e rischio per supportare la futura produzione GMP e il lavoro abilitante IND volto agli studi di Fase 1.
Onco-Innovations (OTCQB:ONNVF) afirmó que Dalton Pharma Services inició la optimización y la ampliación intermedia para su inhibidor PNKP propietario A83B4C63 el 20 de noviembre de 2025. El programa avanza desde la fabricación preclínica anterior hacia una síntesis a escala piloto, no GMP, utilizando la instalación de Toronto de Dalton, aprobada por la FDA y Health Canada.
Las actividades clave incluyen lotes intermedios destinados a aproximadamente 500 g de precursor A83 y 1.000 g de precursor B4, calificación del método analítico, pruebas de estabilidad guiadas por ICH y una evaluación formal de seguridad y riesgo para respaldar la futura producción GMP y el trabajo habilitante IND hacia los estudios de Fase 1.
Onco-Innovations (OTCQB:ONNVF)는 Dalton Pharma Services가 2025년 11월 20일 독점적 PNKP 억제제 A83B4C63의 최적화 및 중간 규모 확장을 시작했다고 말했다. 이 프로그램은 이전의 전임상 제조에서 파일럿 규모의 비-GMP 합성으로 발전하며 Dalton의 FDA 및 Health Canada 승인 토론토 시설을 사용한다.
주요 활동으로는 대략 500 g의 전구체 A83 및 1,000 g의 전구체 B4를 대상으로 하는 중간 배치, 분석 방법 자격, ICH 지침의 안정성 시험, 그리고 향후 GMP 생산 및 Phase 1 연구를 위한 IND 지원 작업을 위한 형식적 안전성 및 위험 평가가 포함된다.
Onco-Innovations (OTCQB:ONNVF) a indiqué que Dalton Pharma Services a commencé l'optimisation et la montée en échelle intermédiaire de son inhibiteur PNKP propriétaire A83B4C63 le 20 novembre 2025. Le programme passe de la fabrication préclinique précédente à une synthèse pilote à l'échelle non GMP utilisant l'installation de Toronto de Dalton, approuvée par la FDA et Santé Canada.
Les activités clés comprennent des lots intermédiaires ciblant environ 500 g du précurseur A83 et 1 000 g du précurseur B4, la qualification de la méthode analytique, des tests de stabilité guidés par l'ICH et une évaluation formelle de sécurité et de risque pour soutenir la future production GMP et les travaux habilitants IND en vue des essais de Phase 1.
Onco-Innovations (OTCQB:ONNVF) sagte, Dalton Pharma Services habe am 20. November 2025 mit der Optimierung und der Zwischen-Skalierung für den proprietären PNKP-Inhibitor A83B4C63 begonnen. Das Programm schreitet von der bisherigen präklinischen Herstellung zur Pilot-Skala, non-GMP-Synthese, über und nutzt Dalton's FDA- und Health-Canada-genehmigte Toronto-Einrichtung.
Zu den wichtigsten Aktivitäten gehören Zwischenchargen mit Ziel von ca. 500 g des Vorläufers A83 und 1.000 g des Vorläufers B4, Qualifizierung analytischer Methoden, ICH-gesteuerte Stabilitätstests und eine formale Sicherheits- und Risikobewertung, um die zukünftige GMP-Herstellung und IND-fördernde Arbeiten in Richtung Phase-1-Studien zu unterstützen.
Onco-Innovations (OTCQB:ONNVF) قالت إن Dalton Pharma Services بدأت عملية التحسين والتدرج على المستوى المتوسط للمثبط PNKP الملكي A83B4C63 في 20 نوفمبر 2025. يتقدم البرنامج من التصنيع قبل السريري السابق إلى تصنيع على نطاق تجريبي، غير GMP، باستخدام منشأة تورونتو المعتمدة من FDA و Health Canada الخاصة بدالتون.
تشمل الأنشطة الرئيسية دفعات وسيطة تستهدف تقريباً 500 g من المُسبّب A83 و 1,000 g من المُسبّب B4، تأهيل الطريقة التحليلية، اختبارات الاستقرار الموجهة وفق ICH، وتقييم سلامة ومخاطر رسمي لدعم الإنتاج GMP المستقبلي والعمل المُمكّن لـ IND نحو دراسات المرحلة 1.
- Intermediary batches target 500 g precursor A83
- Intermediary batches target 1,000 g precursor B4
- Work performed at Dalton's FDA- and Health Canada‑approved Toronto facility
- Analytical method qualification and ICH-guided stability testing included
- Current optimization conducted under non‑GMP conditions
- Intermediate-scale production described as for research purposes, not clinical supply
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.
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.
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.
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.
The manufacturing program also includes comprehensive analytical method development and stability testing conducted in accordance with International Council for Harmonisation (ICH) guidelines, as well as a formal safety and risk assessment of A83B4C63 prior to full-scale synthesis. The optimization work encompasses precursor synthesis refinement, process scale-up, and analytical method development in accordance with international quality standards to ensure a robust and reproducible manufacturing process suitable for future GMP production.
"This milestone marks a pivotal transition from lab-scale synthesis to scalable pre-clinical manufacturing of our lead PNKP inhibitor," said Thomas O'Shaughnessy, Chief Executive Officer of Onco-Innovations. "Dalton's deep expertise and regulatory credentials make them an ideal partner as we continue to move towards clinical development. This phase is intended to lay the groundwork for meeting the rigorous standards required for future GMP production and clinical trial readiness."
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.
About Dalton Pharma Services
Dalton Pharma Services, established in 1986 and based in Toronto, Canada, is a Health Canada-approved and FDA-inspected GMP contract provider of integrated chemistry, drug development, and manufacturing services to the pharmaceutical and biotechnology industries. With over 35 years of experience, Dalton offers a comprehensive range of in-house services, including drug discovery, flow chemistry, formulation and process development, custom synthesis, cGMP sterile fill/finish, cGMP API manufacturing, and dosage form manufacturing. This integration at a single location enhances adaptability, flexibility, and cost-effectiveness, accelerating drug discovery and development programs. Dalton's commitment to quality, speed, and flexibility has been recognized with CMO Leadership Awards from Life Science Leader in 2016, 2017, and 2018 across categories such as Quality, Reliability, Capabilities, Expertise, Compatibility, and Development.1
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 expectation that it will be able to continue to pursue and progress its research and development plans, and the Company's ability to move forward with its plans for regulatory approvals and the conduct of clinical and other further testing of its Technologies, the prospects of the Company, and 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. 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.
1https://www.dalton.com/pharmaceutical-manufacturing
SOURCE: Onco-Innovations Limited
View the original press release on ACCESS Newswire
FAQ
What did Onco-Innovations announce on November 20, 2025 about A83B4C63 (ONNVF)?
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