{"success":true,"data":{"pressRelease":{"id":"59486","rtpr_id":"nACSphX6Ha","ticker":"ONCO","exchange":"","all_tickers":["ONCO"],"title":"Onco-Innovations Announces Initiation of API Process Development and Intermediate Scale-Up Program for its Proprietary PNKP Inhibitor Technology","author":"ACCESSWIRE","published_at":"2026-06-09T22:00:00.208Z","article_body":"VANCOUVER, BC / ACCESS Newswire (https://www.accessnewswire.com/) / June 9,\n2026 / Onco-Innovations Limited (CBOE CA:ONCO)(OTCQB:ONNVF)(Frankfurt:W1H,\nWKN: A3EKSZ) (\"Onco\" or the \"Company\") is pleased to announce the initiation\nof process development and intermediate[1] scale-up activities for A83B4C63,\nthe Company's active pharmaceutical ingredient (API) in the Company's\nproprietary drug candidate, ONC010 (the \"PNKP Inhibitor Technology\"). This\nmilestone marks an important step in advancing the Company's chemistry,\nmanufacturing, and controls (CMC) strategy as it progresses toward\nIND-enabling studies and planning for First-in-Human clinical evaluation. The\nprogram will focus on optimizing synthetic processes, improving yield and\nreproducibility and scaling production of key intermediates required for\ndownstream manufacturing and formulation.\n\nThe process development effort will be conducted in collaboration with Dalton\nPharma Services, a leading GMP-compliant contract development and\nmanufacturing organization, with additional technical integration support\nacross the Company's broader development ecosystem. The initiative is designed\nto ensure that the API manufacturing process is robust, scalable and aligned\nwith future GMP production requirements. By advancing intermediate scale-up,\nOnco-Innovations aims to establish consistent production of high-purity\nmaterial suitable for continued preclinical development, analytical validation\nand eventual clinical supply. The work will also support refinement of\ncritical quality attributes, including impurity profiles and batch\nreproducibility, which are essential for regulatory readiness.\n\n\"This is an important step in translating our scientific innovation into a\nclinically viable product. Establishing a scalable and reproducible\nmanufacturing process is fundamental to our development strategy. The\ninitiation of the API process development and scale-up strengthens our path\ntoward IND-enabling milestones and reinforces our commitment to disciplined,\nhigh-quality execution,\" said Thomas O'Shaughnessy, Chief Executive Officer of\nOnco-Innovations.\n\nAbout Onco-Innovations Limited\n\nOnco-Innovations is a Canadian-based company dedicated to cancer research and\ntreatment, specializing in oncology. Onco's mission is to pursue the\nprevention and treatment of cancer through pioneering research and innovative\nsolutions. The company has secured an exclusive worldwide license to patented\ntechnology that targets solid tumours.\n\nON BEHALF OF ONCO-INNOVATIONS LIMITED,\n\n\"Thomas O'Shaughnessy\"\nChief Executive Officer\nFor more information, please contact:\nThomas O'Shaughnessy\nChief Executive Officer\nTel: + 1 888 261 8055\ninvestors@oncoinnovations.com\n\nForward-Looking Statements Caution. This news release contains forward-looking\nstatements, including in relation to the Company's research and development\nplans, business and plans generally, and other statements that are not\nhistorical facts. Forward-looking statements are often identified by terms\nsuch as \"will\", \"may\", \"potential\", \"should\", \"anticipate\", \"expects\" and\nsimilar expressions. All statements other than statements of historical fact,\nincluded in this release are forward-looking statements that involve risks and\nuncertainties. There can be no assurance that such statements will prove to be\naccurate and actual results and future events could differ materially from\nthose anticipated in such statements. The reader is cautioned that assumptions\nused in the preparation of any forward-looking information may prove to be\nincorrect. Events or circumstances may cause actual results to differ\nmaterially from those predicted, as a result of numerous known and unknown\nrisks, uncertainties, and other factors, many of which are beyond the control\nof the Company. In particular, the Company may not be able to carry out its\nresearch and development plans for a variety of reasons, including, but not\nlimited to, the failure to receive regulatory approvals, the failure to\nmaintain contractual relations and the failure to obtain financing and retain\nkey personnel. The reader is cautioned not to place undue reliance on any\nforward-looking information. Such information, although considered reasonable\nby management at the time of preparation, may prove to be incorrect and actual\nresults may differ materially from those anticipated. Forward-looking\nstatements contained in this news release are expressly qualified by this\ncautionary statement. The forward-looking statements contained in this news\nrelease are made as of the date of this news release and the Company will\nupdate or revise publicly any of the included forward-looking statements as\nexpressly required by applicable law.\n\n[1] A material produced during steps of the processing of an API that\nundergoes further molecular change or purification before it becomes an API.\n(See International Council for Harmonisation, ICH Q7 Guideline, p. 40.)\n\nSOURCE: Onco-Innovations Limited\nView the original press release\n(https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/onco-innovations-announces-initiation-of-api-process-development-and-1174645)\non ACCESS Newswire\n\n\nCopyright 2026 ACCESS Newswire. All Rights Reserved.","article_body_html":"","raw_payload":{"data":{"id":"nACSphX6Ha","title":"Onco-Innovations Announces Initiation of API Process Development and Intermediate Scale-Up Program for its Proprietary PNKP Inhibitor Technology","author":"ACCESSWIRE","ticker":"ONCO","created":"2026-06-09T22:00:00.208Z","tickers":["ONCO"],"exchange":"","article_body":"VANCOUVER, BC / ACCESS Newswire (https://www.accessnewswire.com/) / June 9,\n2026 / Onco-Innovations Limited (CBOE CA:ONCO)(OTCQB:ONNVF)(Frankfurt:W1H,\nWKN: A3EKSZ) (\"Onco\" or the \"Company\") is pleased to announce the initiation\nof process development and intermediate[1] scale-up activities for A83B4C63,\nthe Company's active pharmaceutical ingredient (API) in the Company's\nproprietary drug candidate, ONC010 (the \"PNKP Inhibitor Technology\"). This\nmilestone marks an important step in advancing the Company's chemistry,\nmanufacturing, and controls (CMC) strategy as it progresses toward\nIND-enabling studies and planning for First-in-Human clinical evaluation. The\nprogram will focus on optimizing synthetic processes, improving yield and\nreproducibility and scaling production of key intermediates required for\ndownstream manufacturing and formulation.\n\nThe process development effort will be conducted in collaboration with Dalton\nPharma Services, a leading GMP-compliant contract development and\nmanufacturing organization, with additional technical integration support\nacross the Company's broader development ecosystem. The initiative is designed\nto ensure that the API manufacturing process is robust, scalable and aligned\nwith future GMP production requirements. By advancing intermediate scale-up,\nOnco-Innovations aims to establish consistent production of high-purity\nmaterial suitable for continued preclinical development, analytical validation\nand eventual clinical supply. The work will also support refinement of\ncritical quality attributes, including impurity profiles and batch\nreproducibility, which are essential for regulatory readiness.\n\n\"This is an important step in translating our scientific innovation into a\nclinically viable product. Establishing a scalable and reproducible\nmanufacturing process is fundamental to our development strategy. The\ninitiation of the API process development and scale-up strengthens our path\ntoward IND-enabling milestones and reinforces our commitment to disciplined,\nhigh-quality execution,\" said Thomas O'Shaughnessy, Chief Executive Officer of\nOnco-Innovations.\n\nAbout Onco-Innovations Limited\n\nOnco-Innovations is a Canadian-based company dedicated to cancer research and\ntreatment, specializing in oncology. Onco's mission is to pursue the\nprevention and treatment of cancer through pioneering research and innovative\nsolutions. The company has secured an exclusive worldwide license to patented\ntechnology that targets solid tumours.\n\nON BEHALF OF ONCO-INNOVATIONS LIMITED,\n\n\"Thomas O'Shaughnessy\"\nChief Executive Officer\nFor more information, please contact:\nThomas O'Shaughnessy\nChief Executive Officer\nTel: + 1 888 261 8055\ninvestors@oncoinnovations.com\n\nForward-Looking Statements Caution. This news release contains forward-looking\nstatements, including in relation to the Company's research and development\nplans, business and plans generally, and other statements that are not\nhistorical facts. Forward-looking statements are often identified by terms\nsuch as \"will\", \"may\", \"potential\", \"should\", \"anticipate\", \"expects\" and\nsimilar expressions. All statements other than statements of historical fact,\nincluded in this release are forward-looking statements that involve risks and\nuncertainties. There can be no assurance that such statements will prove to be\naccurate and actual results and future events could differ materially from\nthose anticipated in such statements. The reader is cautioned that assumptions\nused in the preparation of any forward-looking information may prove to be\nincorrect. Events or circumstances may cause actual results to differ\nmaterially from those predicted, as a result of numerous known and unknown\nrisks, uncertainties, and other factors, many of which are beyond the control\nof the Company. In particular, the Company may not be able to carry out its\nresearch and development plans for a variety of reasons, including, but not\nlimited to, the failure to receive regulatory approvals, the failure to\nmaintain contractual relations and the failure to obtain financing and retain\nkey personnel. The reader is cautioned not to place undue reliance on any\nforward-looking information. Such information, although considered reasonable\nby management at the time of preparation, may prove to be incorrect and actual\nresults may differ materially from those anticipated. Forward-looking\nstatements contained in this news release are expressly qualified by this\ncautionary statement. The forward-looking statements contained in this news\nrelease are made as of the date of this news release and the Company will\nupdate or revise publicly any of the included forward-looking statements as\nexpressly required by applicable law.\n\n[1] A material produced during steps of the processing of an API that\nundergoes further molecular change or purification before it becomes an API.\n(See International Council for Harmonisation, ICH Q7 Guideline, p. 40.)\n\nSOURCE: Onco-Innovations Limited\nView the original press release\n(https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/onco-innovations-announces-initiation-of-api-process-development-and-1174645)\non ACCESS Newswire\n\n\nCopyright 2026 ACCESS Newswire. All Rights Reserved."},"type":"article","timestamp":"2026-06-09T22:00:00.24853937Z","server_sent_at_ms":1781042400248},"received_at":"2026-06-09T22:00:00.319Z","source_url":"https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/onco-innovations-announces-initiation-of-api-process-development-and-1174645"},"analysis":{"id":"48910","press_release_id":"59486","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"clinical_trial","narrative":"Onco-Innovations has initiated API process development and intermediate scale-up for its proprietary PNKP inhibitor candidate, ONC010.\n\nThe work is being conducted in collaboration with Dalton Pharma Services to optimize synthetic processes and ensure GMP compliance for future clinical supply.\n\nThis milestone advances the company's CMC strategy toward IND-enabling studies and eventual First-in-Human clinical evaluation.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Routine CMC progress for ONC010; no clinical data or binary event."},"keyFigures":{"drugName":"ONC010","customDimensions":{"api_code":"A83B4C63","development_stage":"Pre-IND / CMC scale-up"}},"quotedText":"This is an important step in translating our scientific innovation into a clinically viable product. Establishing a scalable and reproducible manufacturing process is fundamental to our development strategy.","namedEntities":{"people":[{"name":"Thomas O'Shaughnessy","role":"Chief Executive Officer"}],"products":["ONC010","A83B4C63","PNKP Inhibitor Technology"],"companies":[{"name":"Onco-Innovations Limited","ticker":"ONCO","relationship":"filer"},{"name":"Dalton Pharma Services","relationship":"contract development and manufacturing organization (CDMO)"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"This is a pre-IND CMC (Chemistry, Manufacturing, and Controls) milestone. While necessary for progression to First-in-Human trials, it is a routine operational step in drug development with no binary clinical data or regulatory decision attached."},"tickerRelevance":{"others":[],"primary":"ONCO"},"globalImportance":15,"audienceRelevance":10,"eventTypeSecondary":["partnership"],"importanceComponents":{"tickerTier":"micro-cap","eventGravity":"pre-clinical operational update","sectorWeight":"biotech","marketCapAdjustment":"low"}},"event_type":"clinical_trial","event_type_secondary":["partnership"],"sentiment":"bullish","material_impact_score":2,"narrative":"Onco-Innovations has initiated API process development and intermediate scale-up for its proprietary PNKP inhibitor candidate, ONC010.\n\nThe work is being conducted in collaboration with Dalton Pharma Services to optimize synthetic processes and ensure GMP compliance for future clinical supply.\n\nThis milestone advances the company's CMC strategy toward IND-enabling studies and eventual First-in-Human clinical evaluation.","key_figures":{"drugName":"ONC010","customDimensions":{"api_code":"A83B4C63","development_stage":"Pre-IND / CMC scale-up"}},"named_entities":{"people":[{"name":"Thomas O'Shaughnessy","role":"Chief Executive Officer"}],"products":["ONC010","A83B4C63","PNKP Inhibitor Technology"],"companies":[{"name":"Onco-Innovations Limited","ticker":"ONCO","relationship":"filer"},{"name":"Dalton Pharma Services","relationship":"contract development and manufacturing organization (CDMO)"}],"dollarAmounts":[]},"model_name":"qwen3_6_27b_awq","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-06-09T22:00:56.105Z","global_importance":15,"audience_relevance":10,"importance_components":{"tickerTier":"micro-cap","eventGravity":"pre-clinical operational update","sectorWeight":"biotech","marketCapAdjustment":"low"}},"durationMs":55812,"modelName":"george-droid-qwen-72b"}}