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    DRUG:

    ProstAtak (aglatimagene besadenovec)

    i
    Other names: AdV-tk therapy, gene mediated cytotoxic immunotherapy, TKR therapy, adeno-HSV-tk, Ad HSV-tk, adenovirus-mediated herpes simplex virus thymidine kinase gene therapy, CAN-2409, CAN 2409, CAN2409
    Company:
    Candel Therap
    Drug class:
    Gene transference, Thymidine kinase stimulant
    Related drugs:
    5ms
    PrTK03: Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer (clinicaltrials.gov)
    P3, N=711, Active, not recruiting, Candel Therapeutics, Inc. | Trial completion date: Dec 2024 --> Dec 2030 | Trial primary completion date: Dec 2024 --> Aug 2024
    Trial completion date • Trial primary completion date
    |
    ProstAtak (aglatimagene besadenovec)
    5ms
    Intratumoral Gene Mediated Cytotoxic Immunotherapy in Patients With Resectable Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=12, Completed, Candel Therapeutics, Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    ProstAtak (aglatimagene besadenovec)
    5ms
    Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES) (clinicaltrials.gov)
    P2, N=187, Active, not recruiting, Candel Therapeutics, Inc.
    Trial completion date
    |
    ProstAtak (aglatimagene besadenovec)
    10ms
    GMCI, Nivolumab, and Radiation Therapy in Treating Patients with Newly Diagnosed High-Grade Gliomas (clinicaltrials.gov)
    P1, N=41, Completed, Candel Therapeutics, Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    Opdivo (nivolumab) • temozolomide • ProstAtak (aglatimagene besadenovec)
    10ms
    Dynamic tracking of tumor microenvironment modulation using Kaede photoconvertible transgenic mice unveils new biological properties of viral immunotherapy. (PubMed, Cancer Res Commun)
    Collectively, these data defined at least two temporally distinct pathways underpinning the mechanism of action of CAN-2409 action that overcome cell exhaustion and decreases immune suppression. The results also support the rationale for future clinical trials of CAN-2409 treatment combined with anti-CTLA-4 antibody therapy.
    Preclinical • Journal
    |
    CD8 (cluster of differentiation 8)
    |
    ProstAtak (aglatimagene besadenovec)
    1year
    HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM (clinicaltrials.gov)
    P1/2, N=62, Recruiting, The Methodist Hospital Research Institute | Trial primary completion date: Dec 2023 --> Dec 2025
    Trial primary completion date • Gene therapy
    |
    ProstAtak (aglatimagene besadenovec)
    almost2years
    STOMP: SBRT and Oncolytic Virus Therapy Before Pembrolizumab for Metastatic TNBC and NSCLC (clinicaltrials.gov)
    P2, N=57, Completed, The Methodist Hospital Research Institute | Active, not recruiting --> Completed
    Trial completion • Oncolytic virus • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation
    |
    Keytruda (pembrolizumab) • ProstAtak (aglatimagene besadenovec)
    almost2years
    CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC (clinicaltrials.gov)
    P2, N=90, Active, not recruiting, Candel Therapeutics, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Checkpoint inhibition
    |
    ProstAtak (aglatimagene besadenovec)
    2years
    Phase 2a Study of CAN-2409 With Standard Radiation Therapy for Malignant Glioma (clinicaltrials.gov)
    P2, N=52, Completed, Candel Therapeutics, Inc. | Phase classification: P2a --> P2
    Phase classification • Combination therapy • Gene therapy
    |
    temozolomide • ProstAtak (aglatimagene besadenovec)
    2years
    Oncolytic virotherapies for pediatric tumors. (PubMed, Expert Opin Biol Ther)
    We reviewed seven virus types that have been investigated in past or ongoing pediatric tumor clinical trials: adenovirus (AdV-tk, Celyvir, DNX-2401, VCN-01, Ad-TD-nsIL-12), herpes simplex virus (G207, HSV-1716), vaccinia (JX-594), reovirus (pelareorep), poliovirus (PVSRIPO), measles virus (MV-NIS), and Senecavirus A (SVV-001). However, the antitumor effects of OVT remain variable depending on tumor type and viral agent used. Although the widespread adoption of OVT faces many challenges, we are optimistic that OVT will play an important role alongside standard chemotherapy and radiotherapy for the treatment of malignant pediatric solid tumors in the future.
    Review • Journal • Oncolytic virus
    |
    ProstAtak (aglatimagene besadenovec) • Reolysin (pelareorep) • tasadenoturev (DNX-2401) • HSV G207 • MV-NIS • Pexa-Vec (pexastimogene devacirepvec) • SVV-001 • Seprehvir (HSV1716) • zabilugene almadenorepvec (VCN-01)
    over2years
    A Phase 2 study of In Situ Oncolytic Virus Therapy and Stereotactic Body Radiation Therapy Followed by Pembrolizumab in Metastatic Non-Small Cell Lung Cancer. (PubMed, Int J Radiat Oncol Biol Phys)
    Dual approach of in situ ADV/HSV-tk plus valacyclovir gene therapy and SBRT as a chemotherapy sparing strategy to enhance anti-tumor effect of pembrolizumab is a well-tolerated encouraging treatment in patients with mNSCLC.
    P2 data • Journal • Oncolytic virus • Metastases
    |
    Keytruda (pembrolizumab) • ProstAtak (aglatimagene besadenovec)
    over2years
    GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas (clinicaltrials.gov)
    P1, N=36, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: Apr 2023 --> Oct 2023
    Trial primary completion date • Checkpoint inhibition • IO biomarker
    |
    Opdivo (nivolumab) • temozolomide • ProstAtak (aglatimagene besadenovec)