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Onco-Innovations' Inka Health Signs New Analytical Work with AstraZeneca Canada to Advance Real-World Evidence in Regulatory Science

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Onco-Innovations (OTCQB:ONNVF) has announced that its subsidiary Inka Health has secured a new analytical work contract with AstraZeneca Canada on March 20, 2025. The contract focuses on advancing real-world evidence (RWE) research in regulatory science.

Under the new agreement, Inka Health will develop a peer-reviewed scientific manuscript examining how international RWE is utilized in submissions to Canada's Drug Agency (CDA). This project expands on previous collaborative work that addressed bias and generalizability challenges in non-local RWE, which has been accepted for presentation at ISPOR 2025 (May 11-15, 2025).

The renewed engagement demonstrates AstraZeneca's confidence in Inka Health's capabilities to support drug evaluation, submission strategies, and evidence planning within Canada's regulatory framework.

Onco-Innovations (OTCQB:ONNVF) ha annunciato che la sua controllata Inka Health ha ottenuto un nuovo contratto di lavoro analitico con AstraZeneca Canada il 20 marzo 2025. Il contratto è incentrato sull'avanzamento della ricerca basata su evidenze del mondo reale (RWE) nella scienza regolatoria.

Secondo il nuovo accordo, Inka Health svilupperà un manoscritto scientifico sottoposto a revisione paritaria che esaminerà come le evidenze RWE internazionali vengano utilizzate nelle sottomissioni all'Agenzia Canadese dei Farmaci (CDA). Questo progetto amplia il lavoro collaborativo precedente che ha affrontato le problematiche di bias e generalizzabilità nelle evidenze RWE non locali, accettato per la presentazione a ISPOR 2025 (11-15 maggio 2025).

Il rinnovo dell'impegno dimostra la fiducia di AstraZeneca nelle capacità di Inka Health di supportare la valutazione dei farmaci, le strategie di sottomissione e la pianificazione delle evidenze all'interno del quadro regolatorio canadese.

Onco-Innovations (OTCQB:ONNVF) ha anunciado que su subsidiaria Inka Health ha asegurado un nuevo contrato de trabajo analítico con AstraZeneca Canadá el 20 de marzo de 2025. El contrato se centra en avanzar la investigación basada en evidencia del mundo real (RWE) en la ciencia regulatoria.

Bajo el nuevo acuerdo, Inka Health desarrollará un manuscrito científico revisado por pares que examinará cómo se utiliza la RWE internacional en las presentaciones ante la Agencia de Medicamentos de Canadá (CDA). Este proyecto amplía el trabajo colaborativo previo que abordó los desafíos de sesgo y generalización en la RWE no local, aceptado para presentación en ISPOR 2025 (11-15 de mayo de 2025).

El renovado compromiso demuestra la confianza de AstraZeneca en las capacidades de Inka Health para apoyar la evaluación de medicamentos, las estrategias de presentación y la planificación de evidencia dentro del marco regulatorio canadiense.

Onco-Innovations (OTCQB:ONNVF)는 자회사 Inka Health가 2025년 3월 20일 AstraZeneca Canada와 새로운 분석 업무 계약을 체결했다고 발표했습니다. 이 계약은 규제 과학 분야에서 실제 세계 증거(RWE) 연구를 발전시키는 데 중점을 두고 있습니다.

새 계약에 따라 Inka Health는 캐나다 의약품청(CDA)에 제출된 국제 RWE 활용 방식을 검토하는 동료 심사 과학 논문을 작성할 예정입니다. 이 프로젝트는 비지역 RWE의 편향 및 일반화 문제를 다룬 이전 협력 연구를 확장한 것으로, ISPOR 2025 (2025년 5월 11-15일)에서 발표가 승인되었습니다.

이번 계약 갱신은 캐나다 규제 체계 내에서 의약품 평가, 제출 전략 및 증거 계획을 지원하는 Inka Health의 역량에 대한 AstraZeneca의 신뢰를 보여줍니다.

Onco-Innovations (OTCQB:ONNVF) a annoncé que sa filiale Inka Health a obtenu un nouveau contrat analytique avec AstraZeneca Canada le 20 mars 2025. Ce contrat vise à faire progresser la recherche sur les preuves du monde réel (RWE) en science réglementaire.

Dans le cadre de ce nouvel accord, Inka Health développera un manuscrit scientifique évalué par des pairs, examinant comment les RWE internationales sont utilisées dans les soumissions à l'Agence canadienne des médicaments (CDA). Ce projet étend les travaux collaboratifs précédents qui ont abordé les défis liés aux biais et à la généralisabilité des RWE non locales, acceptés pour présentation à ISPOR 2025 (du 11 au 15 mai 2025).

Ce renouvellement d'engagement témoigne de la confiance d'AstraZeneca dans les capacités d'Inka Health à soutenir l'évaluation des médicaments, les stratégies de soumission et la planification des preuves dans le cadre réglementaire canadien.

Onco-Innovations (OTCQB:ONNVF) hat bekanntgegeben, dass seine Tochtergesellschaft Inka Health am 20. März 2025 einen neuen analytischen Arbeitsvertrag mit AstraZeneca Canada abgeschlossen hat. Der Vertrag konzentriert sich auf die Weiterentwicklung der Forschung zu Real-World Evidence (RWE) in der regulatorischen Wissenschaft.

Im Rahmen der neuen Vereinbarung wird Inka Health ein begutachtetes wissenschaftliches Manuskript erstellen, das untersucht, wie internationale RWE in Einreichungen bei der kanadischen Arzneimittelbehörde (CDA) genutzt wird. Dieses Projekt baut auf früheren gemeinsamen Arbeiten auf, die sich mit Verzerrungen und Generalisierbarkeitsproblemen bei nicht-lokaler RWE befassten und für eine Präsentation auf der ISPOR 2025 (11.-15. Mai 2025) angenommen wurden.

Die Verlängerung der Zusammenarbeit zeigt das Vertrauen von AstraZeneca in die Fähigkeiten von Inka Health, die Arzneimittelbewertung, Einreichungsstrategien und Evidenzplanung im kanadischen regulatorischen Rahmen zu unterstützen.

Positive
  • Strategic partnership continuation with major pharmaceutical company AstraZeneca
  • Expansion of services in regulatory science and RWE analysis
  • Research findings accepted for presentation at major industry conference ISPOR 2025
Negative
  • None.

VANCOUVER, BC / ACCESS Newswire / April 24, 2025 / Onco-Innovations Limited (CSE:ONCO)(OTCQB:ONNVF)(Frankfurt:W1H,WKN: A3EKSZ) ("Onco" or the "Company") is pleased to announce that its wholly owned subsidiary, Inka Health Corp. ("Inka Health"), signed a new analytical work contract[1] with AstraZeneca Canada ("AstraZeneca") on March 20, 2025 to support the next phase of real-world evidence (RWE) research and scientific dissemination. The Company perceives this renewed engagement as a meaningful signal of confidence in Inka Health's capacity to support drug evaluation, submission strategies, and evidence planning within Canada's regulatory framework.

As part of the new scope of work commissioned by AstraZeneca, Inka Health will lead the development of a peer-reviewed scientific manuscript exploring the evolving role of international RWE in submissions to Canada's Drug Agency (CDA). This project will involve expanded analysis and synthesis of insights to inform how data generated outside Canada is leveraged within the Canadian regulatory environment-a growing area of interest in oncology and broader pharmaceutical development.

"This next phase of work for AstraZeneca gives us a valuable opportunity to examine how international real-world data is being operationalized in regulatory submissions, not just conceptually, but in real-world application. It builds directly on the analytical foundation we've developed through our previous work, and allows us to explore how evidence generated outside of Canada can be responsibly and effectively translated into local regulatory and health technology assessment processes," stated Paul Arora, CEO of Inka Health.

This expanded engagement builds on previously completed analytical work delivered under the AZ Services Agreement, deepening a strategic collaboration that has demonstrated Inka Health's leadership in causal analytics and evidence translation in regulatory and market access contexts. The prior phase of the analytical work focused on methodologies to address bias and generalizability challenges in non-local RWE and included a comprehensive review of RWE use in Canadian regulatory submissions[2]. Findings from this earlier work were accepted for presentation at ISPOR 2025 (from May 11-15, 2025), the leading global conference for health economics and outcomes research (See Company press release April 3, 2025).

About Inka Health
Inka Health is an AI-driven analytics company revolutionizing oncology research and drug development through advanced causal AI. Its proprietary platform, SynoGraph, leverages AI-powered causal inference to identify which cancer patients are most likely to respond to specific treatments, advancing precision medicine. By integrating diverse multimodal medical data-including genomics, transcriptomics, and proteomics-SynoGraph uncovers hidden insights that can optimize treatment decisions and clinical trial design. With this cutting-edge technology, Inka Health helps pharmaceutical companies accelerate drug development, reduce trial failures, and bring life-saving therapies to market faster.

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 prevent and cure cancer through pioneering research and innovative solutions. The company has secured an exclusive worldwide license to patented technology that targets solid tumours, setting new standards in cancer treatment. Onco's commitment to excellence and innovation drives it to develop advanced therapies that improve patient outcomes and offer hope in the fight against cancer.

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

The CSE and Information Service Provider have not reviewed and do not accept responsibility for the accuracy or adequacy of this release.

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 Synograph, as well as the abilities and 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 the Company's technologies, the failure to fulfill contractual requirements, the failure to receive regulatory approval in respect of the technologies, 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] Inka Health entered into the new analytical work contract with AstraZeneca Canada on March 20, 2025, for a prescribed fee. The services under this engagement are scheduled for completion by October 31, 2025.

[2] ISPOR. (2025). A Comprehensive Review of Real-World Evidence (RWE) Use in Submissions to Canada's Drug Agency (CDA). ISPOR 2025 Presentations Database.

SOURCE: Onco-Innovations Limited



View the original press release on ACCESS Newswire

FAQ

What is the significance of Inka Health's new contract with AstraZeneca Canada for ONNVF stock?

The contract strengthens ONNVF's position in regulatory science and demonstrates AstraZeneca's confidence in Inka Health's capabilities, potentially leading to future business opportunities.

What specific work will Inka Health perform under the March 2025 AstraZeneca contract?

Inka Health will develop a peer-reviewed scientific manuscript analyzing how international real-world evidence is used in submissions to Canada's Drug Agency.

How does the new AstraZeneca contract build on Inka Health's previous work?

It expands on prior analysis of bias and generalizability challenges in non-local RWE, which will be presented at ISPOR 2025 conference.

When will Inka Health present their previous research findings at ISPOR 2025?

The findings will be presented at the ISPOR conference scheduled for May 11-15, 2025.
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