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Onc.AI Announces Presentation of Breakthrough-Designated AI Model Evaluated in Clinical Trial Data at AACR 2025

Onc.AI Announces Presentation of Breakthrough-Designated AI Model Evaluated in Clinical Trial Data at AACR 2025

Business Wire25-04-2025

CHICAGO--(BUSINESS WIRE)--Onc.AI, a digital health company developing advanced AI-driven clinical management solutions for oncology, today announced that findings from a recent collaboration with global biopharma company GSK using Onc.AI's FDA breakthrough-designated Serial CTRS AI model will be presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting. The study externally evaluated Serial CTRS in GSK's GARNET Phase I clinical trial (NCT02715284) Cohort E, that enrolled patients with advanced non-small cell lung cancer (NSCLC) treated with dostarlimab, GSK's anti-PD-1 checkpoint inhibitor.
Results, highlighted in a poster presentation during the Predictive Biomarkers 2 session (poster #21, April 27, 2025, 2-5pm), demonstrated that the Serial CTRS biomarker, leveraging routine CT imaging without manual annotations, improved prediction of overall survival (OS) compared to traditional surrogates including RECIST 1.1 response criteria and tumor volume. The analysis was conducted through an independent and blinded retrospective validation study carried out by GSK. In particular, Serial CTRS showed the ability to distinguish patients with intermediate versus high probabilities of 12-month OS (HR: 2.91, 95% CI: 1.16–7.31), outperforming RECIST 1.1 (HR: 1.34, 95% CI: 0.57–3.13) and tumor volume change assessments (HR: 1.00, 95% CI: 0.43–2.34). This enhanced predictive performance supports Onc.AI's commitment to establishing Serial CTRS as a new standard for automated, AI-based imaging endpoints in the early assessment of treatment response, seamlessly integrating into standard imaging workflows across diverse therapeutic regimens.
Key findings include:
Serial CTRS improved discrimination between intermediate and high probabilities of overall survival compared to RECIST 1.1 and tumor volume changes.
Serial CTRS remained a significant predictor of overall survival after adjusting for known prognostic factors, such as age, baseline tumor volume, and PD-L1 Tumor Proportion Score (TPS).
'This important milestone for Serial CTRS builds on a recent breakthrough-designation from FDA,' said Akshay Nanduri, CEO of Onc.AI. 'The success of this validation study and ongoing continued collaboration with GSK reflects the strength and robustness of model performance. This can only be achieved using advanced Deep Learning combined with methods for harmonizing diverse imaging data and the breadth of our training data. Onc.AI's high-quality data on thousands of patients has been sourced from dozens of healthcare systems representing hundreds of clinics across the United States and other international cancer centers, ensuring unparalleled diversity in training, test and validation.'
'As the past head of multiple Phase I clinics at top cancer centers, I believe that Onc.AI's innovation with Serial CTRS could transform the pharma clinical development process from Phase I to Phase III studies,' said George R. Simon, MD, FACP, FCCP, Vice President of Oncology at OhioHealth.
About Onc.AI
Onc.AI is a digital health company developing AI-driven oncology clinical management solutions using advanced Deep Learning applied to routine diagnostic images. The company's platform is applied at the point of care by medical oncologists and is also leveraged by global pharmaceutical leaders to accelerate oncology drug development. Onc.AI is backed by premier institutional investors, including: Sandbox/Blue Venture Fund, Action Potential Venture Capital, MassMutual Alternative Investments, Accomplice, Digitalis, KdT, and Life Extension Ventures. Onc.AI is also supported by the National Cancer Institute SBIR program (1R44CA291456-01A1).
For more information, please visit: www.onc.ai.

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About CARTITUDE-1CARTITUDE-1 (NCT03548207) is a Phase 1b/2, open-label, multicentre study evaluating the efficacy and safety of cilta-cel in adults with relapsed and/or refractory multiple myeloma (RRMM), 99 percent of whom were refractory to the last line of treatment; 88 percent of whom were triple-class refractory, meaning their cancer did not or no longer responds to an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 antibody.4,5 The primary objective of the Phase 1b portion of the study, involving 29 patients, was to characterise the safety and confirm the dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2).4 Based on the safety profile observed in this portion of the study, outpatient dosing is being evaluated in additional CARTITUDE studies. 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Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Follow us at Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., and Janssen Research & Development, LLC are Johnson & Johnson companies. This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of cilta-cel. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. * Dr Peter M. Vorhees, M.D., Clinical Professor of Hematology and Oncology at Atrium Health, Levine Cancer Institute at Wake Forest University School of Medicine, has provided consulting, advisory, and speaking services to Janssen-Cilag International NV; he has not been paid for any media work. ### 1 Voorhees, P. Long-term (≥5 year) remission and survival after treatment with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 patients (pts) with relapsed/refractory multiple myeloma (RRMM). Oral presentation. American Society of Clinical Oncology (ASCO) Annual Meeting; May 30 – June 3, 2025.2 Sidana, S. Ciltacabtagene autoleucel (cilta-cel) vs standard of care (SOC) in patients (pts) with relapsed/refractory multiple myeloma (MM): CARTITUDE-4 survival subgroup analyses. Oral presentation. American Society of Clinical Oncology (ASCO) Annual Meeting; May 30 – June 3, 2025.3 Voorhees, P. Long-term (≥5 year) remission and survival after treatment with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 patients (pts) with relapsed/refractory multiple myeloma (RRMM). J Clin Oncol. 43, 7507-7505. DOI:10.1200/JCO.2025.43.16_suppl.7507 4 A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma (CARTITUDE-1). Available at: Study Details | A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma | Last accessed: May 2025.5 Lin Y, et al. CARTITUDE-1 final results: Phase 1b/2 study of ciltacabtagene autoleucel in heavily pretreated patients with relapsed/refractory multiple myeloma. Oral presentation. American Society of Clinical Oncology (ASCO) Annual Meeting 2023.6 A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE4). Available at: Last accessed: May 2025.7 European Medicines Agency. CARVYKTI (ciltacabtagene autoleucel) Summary of Product Characteristics. Available at: Last accessed: May 2025.8 Cho, et al. Targeting B Cell Maturation Antigen (BCMA) in Multiple Myeloma: Potential Uses of BCMA-Based Immunotherapy. Front Immunol 2018;10(9):1821. 9 Tai, et al. Targeting B-cell maturation antigen in multiple myeloma. Immunotherapy 2015;7(11):1187-1199. 10 Janssen Enters Worldwide Collaboration and License Agreement with Chinese Company Legend Biotech to Develop Investigational CAR-T Anti-Cancer Therapy. Available at: Last accessed: May 2025.11 Abdi, et al. Drug resistance in multiple myeloma: latest findings on molecular mechanisms. Oncotarget 2013;4(12):2186-2207.12 American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: Last accessed: May 2025. 13 City of Hope. Multiple Myeloma: Causes, Symptoms & Treatments. Available at: Last accessed: May 2025. 14 ECIS. European Cancer Information System. Estimates of cancer incidence and mortality in 2022, by country. Multiple myeloma. Available at: Last accessed: May 2025.15 Bhatt P, Kloock C, Comenzo R. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347.16 Hernández-Rivas JÁ, et al. The changing landscape of relapsed and/or refractory multiple myeloma (MM): fundamentals and controversies. Biomark Res. 2022;10(1):1-23.17 Gavriatopoulou M, et al. Metabolic Disorders in Multiple Myeloma. Int J Mol Sci. 2021;22(21):11430.18 American Cancer Society. What is Multiple Myeloma? Last accessed: May 2025.19 American Cancer Society. Multiple Myeloma Early Detection, Diagnosis, and Staging. Last accessed: May 2025 CONTACT: Media contact: Jenni Mildon jmildon@ +44 7920 418 552 Investor contact: Lauren Johnson investor-relations@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

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