Onco-Innovations Enters Agreement with Nucro-Technics for IND-Enabling Studies, Taking a Key Step Toward Human Trials
Onco-Innovations (OTCQB:ONNVF) has signed a crucial agreement with Nucro-Technics to conduct IND-enabling preclinical studies for its lead drug candidate. The studies will focus on the company's PNKP inhibitor (NP/A83), which targets advanced-stage, PTEN- or SHP-1-deficient cancers.
The comprehensive testing program includes drug metabolism testing (ADME studies) and GLP-compliant safety studies required for regulatory approval. Nucro-Technics, a Toronto-based CRO with 55 years of experience, will evaluate the drug's bioavailability, biodistribution, pharmacokinetics, and safety profile to support future IND applications with both FDA and Health Canada.
The agreement represents a significant milestone toward initiating Phase I/II clinical trials, including validation of analytical methods and safety assessment of the novel polymer delivery system (mPEO-bPBCL).
Onco-Innovations (OTCQB:ONNVF) ha firmato un accordo fondamentale con Nucro-Technics per condurre studi preclinici abilitanti IND sul suo principale candidato farmaco. Gli studi si concentreranno sull'inibitore PNKP (NP/A83) dell'azienda, mirato ai tumori in stadio avanzato con carenza di PTEN o SHP-1.
Il programma di test completo include studi sul metabolismo del farmaco (studi ADME) e studi di sicurezza conformi alle normative GLP necessari per l'approvazione regolatoria. Nucro-Technics, una CRO con sede a Toronto e 55 anni di esperienza, valuter脿 la biodisponibilit脿, la biodistribuzione, la farmacocinetica e il profilo di sicurezza del farmaco per supportare future domande IND sia con la FDA che con Health Canada.
L'accordo rappresenta una tappa importante per l'avvio delle prove cliniche di Fase I/II, inclusa la validazione dei metodi analitici e la valutazione della sicurezza del nuovo sistema di somministrazione polimerico (mPEO-bPBCL).
Onco-Innovations (OTCQB:ONNVF) ha firmado un acuerdo crucial con Nucro-Technics para realizar estudios precl铆nicos que permitan la presentaci贸n de IND para su principal candidato a medicamento. Los estudios se centrar谩n en el inhibidor PNKP (NP/A83) de la compa帽铆a, dirigido a c谩nceres en etapa avanzada con deficiencia de PTEN o SHP-1.
El programa integral de pruebas incluye estudios de metabolismo del f谩rmaco (estudios ADME) y estudios de seguridad conformes a GLP requeridos para la aprobaci贸n regulatoria. Nucro-Technics, una CRO con sede en Toronto y 55 a帽os de experiencia, evaluar谩 la biodisponibilidad, biodistribuci贸n, farmacocin茅tica y perfil de seguridad del f谩rmaco para apoyar futuras solicitudes IND ante la FDA y Health Canada.
El acuerdo representa un hito significativo para iniciar ensayos cl铆nicos de Fase I/II, incluyendo la validaci贸n de m茅todos anal铆ticos y la evaluaci贸n de seguridad del novedoso sistema de administraci贸n polim茅rico (mPEO-bPBCL).
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Onco-Innovations (OTCQB:ONNVF) a sign茅 un accord crucial avec Nucro-Technics pour mener des 茅tudes pr茅cliniques habilitantes IND sur son principal candidat m茅dicament. Les 茅tudes porteront sur l'inhibiteur PNKP (NP/A83) de la soci茅t茅, ciblant les cancers en phase avanc茅e d茅ficients en PTEN ou SHP-1.
Le programme complet de tests inclut des 茅tudes du m茅tabolisme du m茅dicament (茅tudes ADME) et des 茅tudes de s茅curit茅 conformes aux normes GLP n茅cessaires 脿 l'approbation r茅glementaire. Nucro-Technics, une CRO bas茅e 脿 Toronto avec 55 ans d'exp茅rience, 茅valuera la biodisponibilit茅, la biodistribution, la pharmacocin茅tique et le profil de s茅curit茅 du m茅dicament afin de soutenir les futures demandes IND aupr猫s de la FDA et de Sant茅 Canada.
L'accord repr茅sente une 茅tape importante vers le lancement des essais cliniques de phase I/II, incluant la validation des m茅thodes analytiques et l'茅valuation de la s茅curit茅 du nouveau syst猫me de d茅livrance polym猫re (mPEO-bPBCL).
Onco-Innovations (OTCQB:ONNVF) hat eine wichtige Vereinbarung mit Nucro-Technics unterzeichnet, um IND-erforderliche pr盲klinische Studien f眉r seinen f眉hrenden Arzneimittelkandidaten durchzuf眉hren. Die Studien konzentrieren sich auf den PNKP-Inhibitor (NP/A83) des Unternehmens, der auf fortgeschrittene, PTEN- oder SHP-1-defiziente Krebsarten abzielt.
Das umfassende Testprogramm beinhaltet Arzneimittelstoffwechseltests (ADME-Studien) und GLP-konforme Sicherheitsstudien, die f眉r die beh枚rdliche Zulassung erforderlich sind. Nucro-Technics, eine in Toronto ans盲ssige CRO mit 55 Jahren Erfahrung, wird die Bioverf眉gbarkeit, Biodistribution, Pharmakokinetik und das Sicherheitsprofil des Medikaments bewerten, um zuk眉nftige IND-Antr盲ge bei der FDA und Health Canada zu unterst眉tzen.
Die Vereinbarung stellt einen bedeutenden Meilenstein f眉r den Beginn von Phase I/II klinischen Studien dar, einschlie脽lich der Validierung analytischer Methoden und der Sicherheitsbewertung des neuartigen polymeren Abgabesystems (mPEO-bPBCL).
- Partnership with experienced FDA-inspected CRO with 55 years of expertise
- Comprehensive IND-enabling studies covering both drug metabolism and safety testing
- Progress toward Phase I/II clinical trials for novel cancer treatment approach
- Dual regulatory pathway preparation for both FDA and Health Canada submissions
- No clinical data available yet as studies are still in preclinical stage
- Significant testing and regulatory hurdles remain before human trials can begin
VANCOUVER, BC / / July 4, 2025 / Onco-Innovations Limited (CBOE CA:ONCO)(OTCQB:ONNVF)(Frankfurt:W1H,WKN: A3EKSZ) ("Onco" or the "Company") is pleased to announce that it has entered into an agreement with Nucro-Technics Inc. ("Nucro-Technics"), dated July 3, 2025, pursuant to which Nucro-Technics is to conduct a broad range of preclinical studies in support of the Company's lead drug candidate. These specialized lab tests are intended to characterize the drug's behavior in animal and in vitro models, including its bioavailability, biodistribution, pharmacokinetics profile, as well as to assess its safety through regulatory compliant toxicology testing. Together, these studies represent a major step forward in Onco's path toward human clinical trials, enabling key safety evaluations and supporting a series of required animal studies. The work program includes two main components: drug metabolism testing (in vitro ADME studies) and formal safety studies conducted under Good Laboratory Practice (GLP) standards, as required by regulators before first-in-human use. This work will support the development of Onco's exclusively licensed Polynucleotide Kinase Phosphatase (PNKP) inhibitor (the "Technology").
Nucro-Technics is a Toronto-based, Health Canada- and FDA-inspected contract research organization with 55 years of experience supporting GLP and GMP testing for a variety of therapeutic indications. Now part of Frontage Laboratories, Nucro-Technics specializes in GLP-compliant toxicology, pharmacokinetics, in vitro ADME, and analytical services for biotechnology and pharmaceutical clients.
The contract with Nucro-Technics covers the full scope of IND-enabling work for Onco's lead program, NP/A83 (OI-83463), a polymer-encapsulated PNKP inhibitor being developed for patients with advanced-stage, PTEN- or SHP-1-deficient cancers. In addition to drug behaviour and safety testing, the agreement provides for key supporting activities such as validating the analytical methods used to measure the drug in biological samples, evaluating the safety of the novel polymer delivery system (mPEO-bPBCL), and assembling submission-ready data packages for regulatory review. This integrated preclinical program is designed to meet both FDA and Health Canada standards and to generate the data required for an Investigational New Drug (IND) application and the initiation of Phase I/II clinical trials.
This agreement marks a significant step in Onco's regulatory preparation efforts, as the studies conducted are aimed at generating both pharmacokinetic and safety data essential for moving the Technology into clinical testing. The ADME results are intended to reveal key insights into the drug's stability and metabolism in the body, while the GLP-compliant toxicology studies are intended to evaluate the safety of both the compound and its novel delivery system. Together, these data are expected to form the foundation of the Company's IND submission and support the design of its first-in-human clinical trials.
"Our PNKP inhibitor represents a novel approach to targeting DNA repair vulnerabilities in cancer, and a deep understanding of both its behaviour in the body and its safety profile is crucial to unlocking its full therapeutic potential. The studies we have contracted Nucro-Technics to conduct are intended to not only support our IND filing but to also help guide formulation and dosing strategies as we move towards clinical development. This is more than a regulatory compliance exercise; it's an opportunity to build a robust foundation for long-term success," stated Thomas O'Shaughnessy, CEO of Onco-Innovations.
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.
SOURCE: Onco-Innovations Limited
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