Onco-Innovations Advances Progress Towards First-in-Human Trial with Avance Clinical Start-Up Agreement
Onco-Innovations (OTCQB:ONNVF) has signed a Start-Up Agreement with Avance Clinical to prepare for its first-in-human trial of their novel PNKP inhibitor therapy. The agreement focuses on developing crucial regulatory and clinical documentation required for human testing approvals.
Under the partnership, Avance will provide comprehensive support including: development of an Investigator's Brochure, creation of clinical trial protocols, conducting nonclinical gap analysis, and preparation for a pre-IND meeting with the FDA. The therapy targets advanced-stage cancers with PTEN1 or SHP-12 deficiency.
Onco-Innovations (OTCQB:ONNVF) ha firmato un accordo di start-up con Avance Clinical per preparare il suo primo trial clinico sull'uomo della nuova terapia inibitrice di PNKP. L'accordo si concentra sullo sviluppo della documentazione regolatoria e clinica essenziale per ottenere le approvazioni necessarie ai test sull'uomo.
Nel quadro della collaborazione, Avance fornir脿 un supporto completo che include: la stesura del Investigator's Brochure, la creazione dei protocolli per il trial clinico, l'analisi dei gap non clinici e la preparazione per un incontro pre-IND con la FDA. La terapia 猫 indirizzata ai tumori in stadio avanzato con carenza di PTEN1 o SHP-12.
Onco-Innovations (OTCQB:ONNVF) ha firmado un Acuerdo de Start-Up con Avance Clinical para preparar su primer ensayo en humanos de su novedosa terapia inhibidora de PNKP. El acuerdo se centra en desarrollar la documentaci贸n regulatoria y cl铆nica crucial para obtener las aprobaciones para pruebas en humanos.
Dentro de la colaboraci贸n, Avance proporcionar谩 un apoyo integral que incluye: el desarrollo de un Investigator's Brochure, la creaci贸n de protocolos para el ensayo cl铆nico, la realizaci贸n de un an谩lisis de brechas no cl铆nicas y la preparaci贸n para una reuni贸n pre-IND con la FDA. La terapia est谩 dirigida a c谩nceres en etapa avanzada con deficiencia de PTEN1 o SHP-12.
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Onco-Innovations (OTCQB:ONNVF) a sign茅 un accord de d茅marrage avec Avance Clinical pour pr茅parer son premier essai clinique chez l'humain de leur nouvelle th茅rapie inhibitrice de PNKP. L'accord porte sur le d茅veloppement des documents r茅glementaires et cliniques essentiels pour obtenir les autorisations n茅cessaires aux essais humains.
Dans le cadre de ce partenariat, Avance fournira un soutien complet incluant : l'茅laboration d'un Investigator's Brochure, la cr茅ation des protocoles d'essais cliniques, la r茅alisation d'une analyse des lacunes non cliniques et la pr茅paration d'une r茅union pr茅-IND avec la FDA. La th茅rapie cible les cancers avanc茅s pr茅sentant une d茅ficience en PTEN1 ou SHP-12.
Onco-Innovations (OTCQB:ONNVF) hat eine Start-Up-Vereinbarung mit Avance Clinical unterzeichnet, um die erste klinische Studie am Menschen f眉r ihre neuartige PNKP-Inhibitor-Therapie vorzubereiten. Die Vereinbarung konzentriert sich auf die Entwicklung wichtiger regulatorischer und klinischer Dokumentationen, die f眉r die Zulassung von Humanstudien erforderlich sind.
Im Rahmen der Partnerschaft wird Avance umfassende Unterst眉tzung leisten, darunter die Erstellung eines Investigator's Brochure, die Entwicklung von Studienprotokollen, die Durchf眉hrung einer nichtklinischen L眉ckenanalyse und die Vorbereitung auf ein Pre-IND-Meeting mit der FDA. Die Therapie richtet sich gegen fortgeschrittene Krebserkrankungen mit PTEN1- oder SHP-12-Mangel.
- None.
- Additional preclinical work may be required following gap analysis
- Multiple regulatory approvals still needed before human trials can begin
VANCOUVER, BC / / August 4, 2025 / Onco-Innovations Limited (CBOE CA:ONCO)(OTCQB:ONNVF)(Frankfurt:W1H)(WKN:A3EKSZ) ("Onco" or the "Company") is pleased to announce it has entered into a Start-Up Agreement with Avance Clinical Pty Ltd ("Avance"), a leading contract research organization, to initiate key regulatory and clinical documentation, such as the scientific summaries and trial plans required to eventually apply for approvals for human testing, for the Company's lead candidate, the exclusively licensed Polynucleotide Kinase Phosphatase (PNKP) inhibitor (the "Technology"), a first-in-class, polymer-encapsulated therapy. The work is expected to lay the groundwork for regulatory clearance and clinical trial readiness.
Under the agreement, Avance will provide expert clinical and regulatory support to Onco as the Company pursues trials targeting advanced-stage cancers with PTEN1 or SHP-12 deficiency. Deliverables include the development of an Investigator's Brochure summarizing the drug's preclinical performance, the authorship of a detailed clinical trial protocol, and independent medical and statistical review related to a Phase I clinical study. These documents are essential prerequisites for regulatory agencies to evaluate the safety and scientific merit of an investigational therapy.
Additionally, Avance will perform a nonclinical gap analysis, reviewing existing data to identify any remaining preclinical work required for a future Investigational New Drug (IND) application. The agreement also covers the planning and preparation of a pre-IND meeting with the with the U.S. Food and Drug Administration (FDA), a critical regulatory milestone aimed at aligning Onco's trial design with agency expectations and reducing development risk.
"This collaboration with Avance is another example of our progress as we continue to move towards discovery to clinical development. It's about turning promising science into a real clinical opportunity for patients. Their regulatory and operational expertise will be essential in shaping a trial that is not only scientifically sound but also built for execution. We're excited to enter this collaboration with Avance," stated Thomas O'Shaughnessy, CEO of Onco-Innovations.
About Avance Clinical
Avance Clinical is a full-service Contract Research Organization (CRO) with clinical operations spanning Australia, New Zealand, Asia, North America, and Europe.3 The company is recognized for delivering high-quality clinical trials for international biotechs, with deep experience across oncology, rare diseases, CNS, cell and gene therapies, and infectious diseases.4 In the past five years, Avance has successfully completed over 60 trials in rare and orphan disease populations and more than 67 oncology studies globally, highlighting their strong specialty track record.5
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 in relation to the benefits expected to be realized under the agreement with Nucro-Technics, and the Company's ability to move forward with its plans for regulatory approvals and the conduct of human 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.
1 PTEN is a tumor suppressor gene that helps prevent uncontrolled cell growth by regulating signals that control cell division and survival. Mutations or loss of PTEN function can disrupt this balance and lead to tumor formation. See PTEN gene - MedlinePlus Genetics:
2 SHP-1 is a protein that helps control cell signaling, acting as a "brake" on pathways that promote cell growth and survival. When SHP-1 is missing or inactive, these signals can become overactive, contributing to cancer development. See SHP-1 - National Center for Biotechnology Information (NCBI):
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SOURCE: Onco-Innovations Limited
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