- GEN2 is well tolerated with minimal toxicity and signs of pharmacodynamic activity in an ongoing Phase 1 dose escalation and expansion trial.
- GEN-1013 was studied in aggressive murine cancer models using both IV and IT administration; prolonged survival, potent immune responses, and safe IL-12 serum levels were observed.
SAN MARINO, Calif., May 13, 2025 (GLOBE NEWSWIRE) — GenVivo, Inc., a clinical-stage biopharmaceutical company pioneering a patented, off-the-shelf vector platform to combat cancer by activating the patient’s immune system against the breadth of the patient’s own tumor antigens, is presenting updated Phase 1 clinical data on GEN2 and preclinical data on GEN-1013 at the 2025 American Society of Gene + Cell Therapy (ASGCT) Annual Meeting, May 13th – 17th, in New Orleans, LA.
GEN2, a non-replicating mRNA vector, delivers a dual payload comprised of an enhanced prodrug-activating enzyme (HSV-eTK) and the cytokine GM-CSF for stimulation of the immune system against patient-specific tumor antigens, thereby creating a personalizing anti-tumor effect. Early Phase 1 clinical data (NCT06391918) demonstrates that GEN2 is well tolerated and shows signs of pharmacodynamic activity.
Abstract Title: “Phase 1 Study of GEN2, A Personalizing Gene Therapy Vector, in Adult Patients with Locally Advanced or Metastatic Solid Tumor Malignancies”
Session Date and Time for Poster Presentation: Thursday, May 15 – 5:30 – 7:00 PM CT
Abstract Number: 1845
- GEN2 has minimal toxicity and no Dose Limiting Toxicities (DLTs) over the IV dose ranges (3.4E6 TU/kg to 2E8 TU/kg) to date.
- Signs of pharmacodynamic activity including GM-CSF levels and vector persistence in peripheral blood mononuclear cells (PBMCs), are observed during the dosing cycle. Once the Recommended Phase 2 Dose (RP2D) is established, the protocol will open three expansion arms: hepatocellular carcinoma (HCC), hormone positive breast cancer, and cutaneous malignancies. Assessment of paired biopsies is underway.
- Additional cohorts will be initiated with GEN2 in combination with a checkpoint inhibitor (CPI-refractory melanoma, HCC).
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.
Abstract Title: “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”
Session Title: Cancer: F1 – Immunotherapy and Cancer Vaccines
Session Date and Time for Poster Presentation: Tuesday, May 13 – 6:00 – 7:30pm CT
Abstract Number: 709
- 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).
- Notably, immune activation in peripheral blood immune cells was observed with both IV and IT administration, correlating with the presence of intratumoral GEN-1013-transduced T cells.
- GEN-1013 administration resulted in production of IL-12 to stimulate anti-tumor immune responses without approaching any level of serum IL-12 toxicity.
- mGEN-1013 administration is safe and well-tolerated in BALB/c mice at an efficacious dose level within these studies. Comprehensive pharmacology and toxicology assessments to optimize GEN-1013 dose and schedule are in progress.
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 cancer. 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/
Forward-Looking Statements
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Contact
Victor Constantinescu
Head of Business Development
BD@genvivoinc.com
626-768-5162
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