Onco-Innovations Advances Progress Towards First-in-Human Trial with Avance Clinical Start-Up Agreement

August 04, 2025 at 16:05 PM EDT

VANCOUVER, BC / ACCESS Newswire / 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
investors@oncoinnovations.com

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: https://medlineplus.gov/genetics/gene/pten

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): https://www.ncbi.nlm.nih.gov/gene/5777

³https://www.avancecro.com/capabilities/our-capabilitie

⁴https://www.avancecro.com/knowledge-center/avance-clinical-north-america-proven-expertise-with-global-solutions-for-us-biotechs

⁵https://www.avancecro.com/therapeutic-areas/rare-disease-orphan-drug

SOURCE: Onco-Innovations Limited

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