GenVivo Announces Initiation of Patient Dosing in a US Phase I/Ib Clinical Trial Evaluating GEN2, a Personalizing, Gene Vector Immunotherapy, in Patients with Advanced Solid Tumors

• GEN2’s dose-escalation trial, GVO-1102, will establish the Recommended Phase 2 Dose (RP2D), followed immediately by an expansion phase into 3 solid tumor types.
• GEN2 has a dual mechanism: 1) initial suicide gene killing, independent of the tumor’s antigens, and 2) the release of patient-specific tumor antigens which in the presence of the payload-encoded cytokine results in the generation and activation of immune effector cells. Each cycle of GEN2 maintains and continually amplifies therapeutic immune cytolytic responses as more tumor cells are killed and release antigen (including mutating neoantigens).
• GEN2 is an off-the-shelf, non-replicating immunotherapy vector administered by intravenous infusion; it enables immediate treatment without the time delays and expense associated with tumor biopsies and genomic sequencing.

PASADENA, Calif., June 27, 2024 (GLOBE NEWSWIRE) —  GenVivo, Inc., a private, clinical-stage biopharmaceutical company with breakthrough off-the-shelf platforms for cancer gene medicine immunotherapies, announced that it has dosed the first US patient in a Phase I/Ib, open-label, dose-escalation and expansion clinical trial of GEN2. GEN2, GenVivo’s first product candidate to enter clinical development, is a non-replicating mRNA gene therapy vector being developed as a cancer immunotherapy to both kill tumors and activate a patient’s immune system against their individual cancer antigens (neoantigens). GEN2 is an off-the-shelf medicine, providing the advantages of a personalizing therapy without the time delays and expense associated with autologous products or tumor genome sequencing.

This GEN2 Phase I/Ib, dose-escalation clinical trial (NCT06391918) is currently enrolling US patients with advanced solid tumors who have progressed or were non-responsive to prior therapies. The clinical trial is primarily designed to assess the safety and tolerability of GEN2 and to establish the recommended Phase II dose (RP2D). Following the initial dose-escalation phase, the expansion phase will explore the RP2D in 3 arms with defined solid tumor types, to further demonstrate safety, tolerability, and signs of clinical activity. Pharmacokinetic and exploratory biomarker endpoints will be assessed. Additional data relevant to efficacy will be obtained from paired-tumor biopsies, measuring payload expression, immune cell infiltration and activation, and tumor killing.

“The initiation of this US trial represents an important milestone in our efforts to systemically administer our off-the-shelf personalizing gene medicine platform to activate a cancer patient’s immune system against the full breadth of their unique tumor antigens,” said Robert G. Johnson, M.D., Ph.D., Chief Operating Officer of GenVivo, Inc. “We are encouraged by the potential of GEN2 (demonstrated in a prior phase 1 trial, NCT04313868) and look forward to advancing to the expansion phase once the appropriate dose is identified.”

Daneng Li, M.D., Associate Professor, Department of Medical Oncology & Therapeutics Research, Hepatobiliary Lead and Co-Director, Neuroendocrine Tumor Program, City of Hope, Duarte, CA added “We are excited to be working with the GenVivo team on GEN2, an innovative dual-payload targeted vector, with the goal to improve therapies for our patients with refractory disease.”

About GEN2
GenVivo’s product candidate, GEN2, is designed to kill the tumor and trigger direct tumor release of patient specific neoantigens in the presence of a locally produced cytokine. The vector mRNA payload encodes an optimized prodrug-activated enzyme (enhanced viral thymidine kinase (HSV-eTK)) and an immunostimulatory cytokine (GM-CSF). The orally administered prodrug, modified by the HSV-eTK, directly kills tumor cells, releasing the patient’s full complement of unique tumor antigens in the presence of the immunostimulatory cytokine, to then directly stimulate tumor-specific killer cells. These tumor-lytic immune cells amplify and maintain ongoing tumor cell killing, including subsequently arising tumor mutations (neoantigens) and tumors at metastatic sites. Data from 59 patients in a Phase 1 trial in Asia, demonstrated safety and tolerability with signs of clinical benefit (NCT04313868). GVO-1102 (NCT06391918) will complete the intravenous dose escalation started in the Phase 1 trial in Asia.

About GenVivo
GenVivo is a private, vertically-integrated biotechnology company with cGMP manufacturing capabilities, founded to develop the latest novel gene delivery and immune stimulation therapies, which activate the patient’s immune system to treat cancers and prevent infectious diseases. GenVivo is committed to developing and manufacturing products that are rapidly deployed, and easily administered, with the goal of increasing patient survival and improving quality of life.

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

Forward-Looking Statements
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Contact                               
Victor Constantinescu, M.Eng                                                               
Head of Business Development
BD@genvivoinc.com
626-768-5162