- |||||||||| ProstAtak (aglatimagene besadenovec) / Candel Therap
Advanced analytics identify a differential immune response to CAN-2409+valacyclovir in non-squamous vs squamous NSCLC, linked to improved survival in patients with progressive ICI-refractory NSCLC (Poster Hall (Exhibit Halls AB); Virtual) - Oct 3, 2025 - Abstract #SITC2025SITC_851; P2 (FNIH) by: AbbVie Inc., Amgen Inc., Boehringer-Ingelheim Pharma GmbH & Co. KG., Bristol-Myers Squibb, Celgene Corporation, Genentech Inc, Gilead, GlaxoSmithKline plc, Janssen Pharmaceutical Companies of Johnson & Johnson, Novartis Institutes for Biomedical Research, Pfizer Inc., and Sanofi.Trial Registration NCT04495153 ClinicalTrials.govEthics Approval Patients participating in the study provided an IRB-approved informed consent at their participating institutions.
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CAN-2409 With Continued Immune Checkpoint Inhibitor (ICI) in Patients With Stage III/IV NSCLC With Inadequate Response to ICI (Room 06) - Jul 22, 2025 - Abstract #IASLCWCLC2025IASLC_WCLC_905; KG., Bristol-Myers Squibb, Celgene Corporation, Genentech Inc, Gilead, GlaxoSmithKline plc, Janssen Pharmaceutical Companies of Johnson & Johnson, Novartis Institutes for Biomedical Research, Pfizer Inc., and Sanofi.Trial Registration NCT04495153 ClinicalTrials.govEthics Approval Patients participating in the study provided an IRB-approved informed consent at their participating institutions. Abstract is embargoed at this time.
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Trial completion date, Trial primary completion date: PrTK03: Phase 3 Study of ProstAtak (clinicaltrials.gov) - Jul 11, 2025 P3, N=711, Active, not recruiting, Abstract is embargoed at this time. Trial completion date: Dec 2024 --> Dec 2030 | Trial primary completion date: Dec 2024 --> Aug 2024
- |||||||||| Cytovene (ganciclovir) / Roche, ProstAtak (aglatimagene besadenovec) / Candel Therap, Pexa-Vec (pexastimogene devacirepvec) / SillaJen, Transgene
Clinical, Review, Journal, Gene therapy: Gene therapy for people with hepatocellular carcinoma. (Pubmed Central) - Jun 5, 2024 The impact of gene therapy on adverse events needs to be investigated further. Evidence on the effect of gene therapy on health-related quality of life is lacking.
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Trial completion date, Trial primary completion date, Checkpoint inhibition, IO biomarker: GMCI, Nivolumab, and Radiation Therapy in Treating Patients with Newly Diagnosed High-Grade Gliomas (clinicaltrials.gov) - Feb 1, 2023 P1, N=36, Active, not recruiting, Trial primary completion date: Mar 2023 --> Dec 2024 Trial completion date: Apr 2023 --> Oct 2023 | Trial primary completion date: Dec 2022 --> Apr 2023
- |||||||||| ProstAtak (aglatimagene besadenovec) / Candel Therap
Trial primary completion date: PrTK03: Phase 3 Study of ProstAtak (clinicaltrials.gov) - Jan 20, 2023 P3, N=711, Active, not recruiting, Trial primary completion date: Nov 2022 --> Jul 2022 Trial primary completion date: Jun 2023 --> Dec 2024
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Dynamic analyses of tumor microenvironment modulation by CAN-2409 treatment using Kaede photoconvertible transgenic mice (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_1442; Conclusions CAN-2409 alters the TME such that newly entering CD8 T cells expand and retain key effector functions while the exhausted CD8 compartment is reinvigorated, likely reducing Treg-mediated suppression. Collectively, these data suggest at least two temporally distinct pathways underpinning CAN-2409 action that overcome cell exhaustion and decreased immune suppression, supporting the rationale for the use of CAN-2409 either as monotherapy or in combination.
- |||||||||| ProstAtak (aglatimagene besadenovec) / Candel Therap
Trial completion date, Trial primary completion date, Checkpoint inhibition, IO biomarker: LuTK02: CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC (clinicaltrials.gov) - Sep 29, 2022 P2, N=86, Recruiting, Collectively, these data suggest at least two temporally distinct pathways underpinning CAN-2409 action that overcome cell exhaustion and decreased immune suppression, supporting the rationale for the use of CAN-2409 either as monotherapy or in combination. Trial completion date: Jun 2024 --> Mar 2025 | Trial primary completion date: Jun 2022 --> Mar 2023
- |||||||||| Cytovene (ganciclovir) / Roche, ceralasertib (AZD6738) / AstraZeneca, ProstAtak (aglatimagene besadenovec) / Candel Therap
Journal, Oncolytic virus, PD(L)-1 Biomarker, IO biomarker: Perturbing DDR signaling enhances cytotoxic effects of local oncolytic virotherapy and modulates the immune environment in glioma. (Pubmed Central) - Aug 30, 2022 The expression of tk in transduced cancer cells results in conversion of the pro-drug ganciclovir into a toxic metabolite causing DNA damage, inducing immunogenic cell death and immune activation...We investigated the effects of ATR inhibitor AZD6738 in combination with CAN-2409 in vitro using cytotoxicity, cytokine, and fluorescence-activated cell sorting (FACS) assays in glioma cell lines and in vivo with an orthotopic syngeneic murine glioma model...In a tumor re-challenge, long-term immunity after combination treatment was not improved. Our results suggest that ATR inhibition could amplify CAN-2409's efficacy in glioblastoma through increased DNA damage while having complex immunological ramifications, warranting further studies to determine the ideal conditions for maximized therapeutic benefit.
- |||||||||| ProstAtak (aglatimagene besadenovec) / Candel Therap
Trial completion date, Trial primary completion date, Checkpoint inhibition, IO biomarker: GMCI, Nivolumab, and Radiation Therapy in Treating Patients with Newly Diagnosed High-Grade Gliomas (clinicaltrials.gov) - Aug 8, 2022 P1, N=36, Active, not recruiting, Our results suggest that ATR inhibition could amplify CAN-2409's efficacy in glioblastoma through increased DNA damage while having complex immunological ramifications, warranting further studies to determine the ideal conditions for maximized therapeutic benefit. Trial completion date: Oct 2022 --> Apr 2023 | Trial primary completion date: Jun 2022 --> Dec 2022
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