Onco-Innovations Announces Start of Manufacturing of Preclinical Testing Material for Its PNKP Inhibitor Technology by Dalton Pharma
Onco-Innovations (ONNVF) has initiated manufacturing of preclinical testing material for its PNKP inhibitor technology through Dalton Pharma Services. The project aims to produce 50 grams of their proprietary inhibitor A83B4C63 for preclinical studies and IND submission preparation.
Previous research from 2021 demonstrated promising results: the nanoparticle-formulated PNKP inhibitor significantly extended median survival in PTEN-deficient colorectal cancer-bearing mice to 60 days vs. 23 days in untreated controls. Additionally, when combined with radiation therapy, it enhanced tumor growth delay without significant toxicity to healthy tissues.
Onco-Innovations (ONNVF) ha avviato la produzione di materiale per test preclinici della sua tecnologia inibitrice PNKP tramite Dalton Pharma Services. Il progetto prevede la produzione di 50 grammi del loro inibitore proprietario A83B4C63 per studi preclinici e la preparazione della domanda IND.
Ricerche precedenti del 2021 hanno mostrato risultati promettenti: l'inibitore PNKP formulato in nanoparticelle ha prolungato significativamente la sopravvivenza mediana nei topi con cancro colorettale carente di PTEN, raggiungendo 60 giorni rispetto ai 23 giorni dei controlli non trattati. Inoltre, in combinazione con la radioterapia, ha aumentato il ritardo nella crescita tumorale senza tossicità significativa nei tessuti sani.
Onco-Innovations (ONNVF) ha iniciado la fabricación de material para pruebas preclínicas de su tecnología inhibidora de PNKP a través de Dalton Pharma Services. El proyecto tiene como objetivo producir 50 gramos de su inhibidor patentado A83B4C63 para estudios preclínicos y la preparación de la solicitud IND.
Investigaciones previas de 2021 demostraron resultados prometedores: el inhibidor de PNKP formulado en nanopartículas extendió significativamente la supervivencia media en ratones con cáncer colorrectal deficiente en PTEN a 60 días frente a 23 días en controles no tratados. Además, combinado con radioterapia, mejoró el retraso en el crecimiento tumoral sin toxicidad significativa en tejidos sanos.
Onco-Innovations (ONNVF)는 Dalton Pharma Services를 통해 PNKP 억제제 기술의 전임상 시험용 물질 생산을 시작했습니다. 이 프로젝트는 전임상 연구 및 IND 제출 준비를 위해 독자적인 억제제 A83B4C63 50그램을 생산하는 것을 목표로 합니다.
2021년 이전 연구에서는 유망한 결과가 나타났습니다: 나노입자 형태로 제조된 PNKP 억제제는 PTEN 결손 대장암 마우스의 중앙 생존 기간을 대조군의 23일에서 60일로 크게 연장시켰습니다. 또한 방사선 치료와 병용 시 건강한 조직에 큰 독성 없이 종양 성장 지연 효과를 향상시켰습니다.
Onco-Innovations (ONNVF) a lancé la fabrication de matériel pour tests précliniques de sa technologie inhibitrice PNKP via Dalton Pharma Services. Le projet vise à produire 50 grammes de leur inhibiteur propriétaire A83B4C63 pour des études précliniques et la préparation du dépôt IND.
Des recherches antérieures de 2021 ont montré des résultats prometteurs : l’inhibiteur PNKP formulé en nanoparticules a significativement prolongé la survie médiane chez des souris porteuses d’un cancer colorectal déficient en PTEN, passant à 60 jours contre 23 jours chez les témoins non traités. De plus, en combinaison avec la radiothérapie, il a amélioré le retard de croissance tumorale sans toxicité significative pour les tissus sains.
Onco-Innovations (ONNVF) hat mit der Herstellung von Material für präklinische Tests seiner PNKP-Inhibitor-Technologie über Dalton Pharma Services begonnen. Das Projekt zielt darauf ab, 50 Gramm ihres proprietären Inhibitors A83B4C63 für präklinische Studien und die Vorbereitung der IND-Einreichung herzustellen.
Frühere Forschungen aus dem Jahr 2021 zeigten vielversprechende Ergebnisse: Der nanopartikel-formulierte PNKP-Inhibitor verlängerte das mediane Überleben bei PTEN-defizienten Mäusen mit kolorektalem Krebs signifikant auf 60 Tage gegenüber 23 Tagen bei unbehandelten Kontrollen. Zudem verbesserte die Kombination mit Strahlentherapie die Tumorwachstumsverzögerung ohne signifikante Toxizität für gesundes Gewebe.
- Transition from early-stage R&D to process scale-up and production marks progress toward clinical development
- Previous studies showed significant survival benefit in preclinical models (60 days vs 23 days)
- Research demonstrated enhanced tumor growth delay when combined with radiation therapy, without significant toxicity
- Partnership with established CDMO (Dalton Pharma) brings technical expertise and regulatory compliance capabilities
- Still in early preclinical stage, far from market approval
- IND submission pending, regulatory approval not guaranteed
- Manufacturing just beginning, potential for delays or technical challenges
VANCOUVER, BC / ACCESS Newswire / May 26, 2025 / Onco-Innovations Limited (CBOE:ONCO) (Frankfurt:W1H, WKN:A3EKSZ) ("Onco" or the "Company") is pleased to announce that Dalton Pharma Services ("Dalton") has commenced activities to manufacture material for preclinical testing of the Company's exclusively-licensed nanoparticle-formulated Polynucleotide Kinase 3'-Phosphatase (PNKP) inhibitor technology. This important step marks the beginning of the transition from early-stage research and development to process scale-up and production for preclinical testing, enabling the generation of material needed for preclinical testing and planned future regulatory submissions which are key activities on the path toward clinical translation.
The current phase of work includes process optimization and scale-up manufacturing aimed at producing 50 grams of Onco's proprietary PNKP inhibitor, known as A83B4C63. This material will be used in preclinical studies, including in-vitro and in-vivo testing, and is intended to support regulatory preparations for an Investigational New Drug (IND) submission in the United States, which the Company plans on making this year. Dalton, a leading Canadian contract development and manufacturing organization (CDMO), brings deep technical expertise and regulatory compliance capabilities to the project.
In 2021, researchers from the University of Alberta published two peer-reviewed studies evaluating Onco-Innovations' nanoparticle-formulated PNKP inhibitor, A83B4C63, in preclinical models of colorectal cancer. The June study[1] demonstrated that treatment with the nanoparticle-encapsulated PNKP inhibitor significantly extended median survival in PTEN-deficient colorectal cancer-bearing mice to 60 days, compared to 23 days in untreated controls. The December study[2] found that combining the nanoparticle-formulated PNKP inhibitor with radiation therapy enhanced tumor growth delay in colorectal cancer models, without significant toxicity to healthy tissues. These findings support further development of the PNKP inhibitor as a targeted therapeutic approach in oncology.
"This marks an important inflection point in our development roadmap, as manufacturing now begins to generate the material necessary to support future preclinical evaluation. We are now taking another tangible step toward translating a novel scientific approach towards potential therapeutic development, setting the stage for the next critical phases ahead," stated Thomas O'Shaughnessy, CEO of the Company.
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.[3]
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 relating to the further development, potential commercialization and benefits of the Company's technologies, including its PKNP Inhibitor Technology, the Company's ability to complete further preclinical or other research and development activities, and the Company's plans with respect to pursuing an IND, and 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. Important factors that could cause actual results to differ materially from the Company's expectations include the failure to further develop, prove out or commercialize its technologies (including its PKNP Inhibitor Technology), the failure to submit an NDA or to pursue further regulatory or preclinical trials, the failure to receive regulatory approval in respect of its research and development activities, and other risks detailed from time to time in the filings made by the Company with securities regulators. 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.
[1] Sadat et al. A synthetically lethal nanomedicine delivering novel inhibitors of polynucleotide kinase 3′-phosphatase (PNKP) for targeted therapy of PTEN-deficient colorectal cancer. J Control Release. 2021 Jun 10;334:335-352. doi:10.1016/j.jconrel.2021.04.034
[2] Sadat et al. Nano-Delivery of a Novel Inhibitor of Polynucleotide Kinase/Phosphatase (PNKP) for Targeted Sensitization of Colorectal Cancer to Radiation-Induced DNA Damage. Front Oncol. 2021 Dec 23;11:772920. doi: 10.3389/fonc.2021.772920
[3] https://www.dalton.com/pharmaceutical-manufacturing
SOURCE: Onco-Innovations Limited
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