GEN-1013 / GenVivo - LARVOL DELTA

Safety and efficacy evaluation of retroviral vectors GEN-1018 and GEN-1013 toward clinical translation for in vivo immuno-gene therapy and combined suicide gene therapy (ASGCT 2025) - "Our previous preclinical studies supported initiation of clinical trials for in vivo cancer gene therapy with GEN2, a retroviral vector for combined delivery of granulocyte-macrophage colony stimulating factor (GM-CSF) and an enhanced gain-of-function variant of the herpes simplex virus thymidine kinase suicide gene (HSV-eTK)...Preliminary evaluation of therapeutic efficacy was performed by intratumoral (IT) or systemic (IV) administration of mGEN-1018 and mGEN-1013 to subcutaneous CT26 murine colorectal cancer models in syngeneic BALB/c mice, with mGEN-1013 experimental arms also treated with ganciclovir (GCV) prodrug...Based on these results, GEN-1013 is currently being further evaluated in definitive preclinical studies to support clinical translation and Investigational New Drug (IND) application. Disease Focus of Abstract:Cancer Solid Tumors"

Gene therapy • Preclinical • Viral vector • Colorectal Cancer • Gene Therapies • Herpes Simplex • Melanoma • Oncology • Solid Tumor • CSF2 • GZMB • IFNG • IL12A

GenVivo Highlights...GEN-1013 Preclinical Data at the 2025 American Society of Gene + Cell Therapy (ASGCT) Annual Meeting (GlobeNewswire) - "GEN-1013, a non-replicating mRNA vector, delivers a dual payload comprised of an enhanced prodrug-activating enzyme (HSV-eTK) and the immunostimulatory cytokine IL-12 to enhance cytolytic activity and tumor infiltration by NK cells and cytotoxic T lymphocytes (CTLs) without the systemic toxicities associated with past IL-12 therapies. The results highlight GEN-1013’s potential as a transformative therapy for solid tumors, leveraging localized IL-12 expression to stimulate potent immune responses while minimizing toxicity. GenVivo is further developing GEN-1013 with a planned IND-filing mid-2026....89% of mGEN-1013 IV-treated CT26 implanted tumor animals (in the absence of GCV) reached the predetermined study endpoint compared to 11% of the vehicle control animals. (As human IL-12 is inactive in wild type mice, a mouse surrogate vector encoding for mouse IL-12 (mIL-12) is used)."

IND • Preclinical • Solid Tumor

GenVivo Highlights GEN-1013: A Novel Delivery of an IL-12 Immunotherapy at the 2025 American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "GEN-1013 was studied in an aggressive CT26 murine cancer model using both IT and IV administration; Significant tumor reduction was observed in both administration routes; Both IT and IV were well-tolerated and demonstrated enhanced IFN-γ expression in tumor-infiltrating NK and CD8+ T cells."

Preclinical • Oncology