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

Rhea-AI Summary

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.

Positive

• None.

Negative

• Additional preclinical work may be required following gap analysis
• Multiple regulatory approvals still needed before human trials can begin

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

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

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

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

SOURCE: Onco-Innovations Limited

View the original press release on ACCESS Newswire

FAQ

What is the purpose of Onco-Innovations' (ONNVF) agreement with Avance Clinical?

The agreement aims to prepare essential regulatory and clinical documentation needed for human trial approvals of their PNKP inhibitor therapy, including development of an Investigator's Brochure and clinical trial protocols.

What type of cancer treatment is Onco-Innovations (ONNVF) developing?

Onco-Innovations is developing a first-in-class, polymer-encapsulated PNKP inhibitor therapy targeting advanced-stage cancers with PTEN1 or SHP-12 deficiency.

What are the next regulatory steps for Onco-Innovations' (ONNVF) cancer therapy?

The company is preparing for a pre-IND meeting with the FDA and conducting a nonclinical gap analysis to identify any additional preclinical work needed for the IND application.

When will Onco-Innovations (ONNVF) begin human clinical trials?

The exact timeline is not specified, as the company is currently in the preparatory phase, developing required documentation and seeking necessary regulatory approvals for human testing.

What deliverables will Avance Clinical provide to Onco-Innovations (ONNVF)?

Avance will provide an Investigator's Brochure, clinical trial protocol, independent medical and statistical review for Phase I study, and nonclinical gap analysis.