GenVivo Highlights GEN-1013: A Novel Delivery of an IL-12 Immunotherapy at the 2025 American Association for Cancer Research (AACR) Annual Meeting

• 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.

PASADENA, Calif., April 26, 2025 (GLOBE NEWSWIRE) — GenVivo, Inc., a clinical-stage biopharmaceutical company pioneering a patented, off-the-shelf vector platform that fights cancer by activating the patient’s immune system against the breadth of the patient’s own tumor antigens, is presenting compelling preclinical data on GEN-1013, an Interleukin-12 (IL-12) immunotherapy, at the 2025 American Association for Cancer Research (AACR) Annual Meeting, April 25^th – 30^th, in Chicago, IL.

GEN-1013, a non-replicating mRNA vector, delivers a dual payload – an enhanced prodrug-activated enzyme (HSV-eTK) and the immunostimulatory cytokine IL-12 – to achieve potent anti-tumor effects without systemic toxicities associated with past IL-12 therapies.  In preclinical studies using an aggressive CT26 murine cancer model, GEN-1013 demonstrated the following:

• Significant tumor reduction in both the intravenous (IV) and intratumoral (IT) administration arms
• Potent immune responses including increased Interferon-gamma (IFN-γ) expression in tumor-infiltrating Natural Killer (NK) and CD8+ T cells
• Well-tolerated delivery with IL-12 serum levels safely below the maximum tolerated levels

These 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.  

• Abstract Title: “IL-12 immunotherapy using a novel gene delivery platform for RNA payloads achieves effective anti-tumor responses without systemic toxicity in an aggressive CT26 murine cancer model”
• Session Title: Gene and Vector-Based Therapy
• Session Date and Time for Poster Presentation: Sunday, April 27, 2025, from 2:00 PM to 5:00 PM CDT, Section 21
• Abstract Number: 474
• Presenter: Laura Strauss, Ph.D., Senior Principal Scientist, GenVivo, Inc.
• IL-12 exhibits potent anti-tumor properties by enhancing the cytolytic activity and tumor infiltration by NK cells and cytotoxic T lymphocytes (CTLs) and activating Th-1-type immune responses. However, systemic administration of recombinant IL-12 protein is still a challenge due to serious, and sometimes fatal, toxicity resulting from IFN-γ overproduction.
• Realizing the potential benefits of IL-12-based therapies for solid malignancies requires IL-12 expression with only limited systemic exposure to mitigate the associated toxicity.
• As human IL-12 is inactive in wild-type mice, a surrogate vector (mGEN-1013) encoding for murine IL-12 is used in immune-competent BALB/c mice.
• Administration of mGEN-1013 was well-tolerated with final post-administration serum IL-12 levels below maximum tolerated level in humans for both administration routes.
• Reduced tumor volumes compared to control animals were observed after both intravenous (IV) and intratumoral (IT) administration of mGEN-1013.
• In the case of IT administration of mGEN-1013, prodrug treatment was associated with reduced tumor volume when compared to no prodrug treatment; in the IV arm tumor volume reduction did not correlate with prodrug administration.
• Both routes of administration resulted in enhanced IFN-γ expression in tumor-infiltrating NK and CD8+ T cells.

About GenVivo

GenVivo (GVO) is a private, vertically integrated, clinical stage biotechnology company founded to develop innovative gene delivery and immune stimulation therapies, which activate the patient’s immune system to treat cancers. GenVivo is committed to developing and manufacturing products that are rapidly deployed, and easily administered, personalizing, and yet off-the-shelf, with the goal of increasing cancer patient survival and improving quality of life. GEN2, GVO’s first clinical candidate, is currently in a Phase 1 clinical trial in the US (NCT06391918). GenVivo’s pre-clinical pipeline includes GEN-1013, an IL-12 encoding therapy, and an in vivo CAR-T program.

For more information, visit https://genvivoinc.com/

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BD@genvivoinc.com
626-768-5162