Valganciclovir Hydrochloride

GEN2 was evaluated in adult patients with advanced solid tumors in an intravenous dose escalation Phase 1 study GEN2 is well-tolerated, with no Dose Limiting Toxicity or treatment-related discontinuations Dose dependent increases in immunocytokines and vector persistence in peripheral blood mononuclear cells at the two highest dose levels support GEN2 transgene expression and mechanism of action SAN MARINO, Calif., Nov. 07, 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 entire repertoire of their own tumor antigens, announces the presentation of GEN2 Phase 1 clinical trial results in adult patients with advanced solid tumors (NCT06391918), at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting, November 7-9, in National Harbor, MD. Poster Abstract Title: “Phase 1 Study of GEN2, A Personalizing Systemic Cancer Immunotherapy, in Adult Patients with Advanced Solid Tumor Malignancies”Session Date and Time for Poster Presentation: Friday, Nov. 7, 2025Abstract Number: 573Presenter: Anthony El-Khoueiry, MD GEN2, an off-the-shelf non-replicating mRNA vector, delivers two payload genes that provide dual-mechanisms of action: an enhanced prodrug-activator enzyme (HSV-eTK) and an immunostimulatory cytokine (GM-CSF). After valganciclovir (VGCV) prodrug administration, GEN2 triggers the local release of tumor-specific antigens (including neoantigens) to stimulate an immune response. This novel therapy enables faster treatment, as it does not require tumor biopsies or tumor-specific genomic sequencing to identify patient-specific neoantigens and create an individualized therapy prior to commencing treatment. GEN2 was dosed intravenously (IV) across five dose levels (3.4 × 10⁶ to 2 × 10⁸ TU/kg) in combination with VGCV in 23 patients in this Phase 1 dose-escalation trial. GEN2 was administered on Days 1, 3, and 8, followed by VGCV on days 12 to 21 during the four-week cycle. GEN2 demonstrated tolerability and minimal toxicity, with no Dose Limiting Toxicity (DLT) observed and no treatment-related discontinuations. Treatment-related adverse events included diarrhea (22%), nausea (17%), vomiting and fatigue (13% each), all Grade 1–2. Stable disease >24 weeks was observed. GEN2’s mechanism of action was supported through pharmacodynamic and biomarker data (including cytokines and other plasma proteins). Dose-dependent increases in GM-CSF were observed with intravenous GEN2 administration. Levels of IL-2, IFNγ, CCL4 and CCL3 also showed increasing trends, further indicating GEN2 induced biological activity. Vector persistence in peripheral blood mononuclear cells (PBMCs) confirmed GEN2’s transgene expression; elimination of the signal after VGCV administration demonstrated the effectiveness of the pro-drug activated enzyme, HSV-eTK. Cycle 2 Day 1 data showed a lower exposure than for Cycle 1 at the higher dose levels. This was coincident with the development of neutralizing antibodies; alternate dosing schedules, and premedication strategies to mitigate neutralizing antibody generation are under evaluation. A parallel intratumoral (IT) cohort continues in cutaneous malignancies. “GEN2 represents a unique systemic treatment modality employing an ‘off-the-shelf’ gene delivery vector that exerts immunotherapeutic effects through multiple mechanisms of action,” said Dr. Anthony El-Khoueiry, Chief of the Section of Developmental Therapeutics and Verna R. Richter Chair in Cancer Research at the University of Southern California (USC) Norris Comprehensive Cancer Center in Los Angeles, CA. “These data verified GEN2's gene transduction, consistent with its putative mechanism of action, resulting in increased cytokine and immunomodulatory protein biomarkers, and creating the potential to promote an anti-tumor immune response.” “The GEN2’s pharmacokinetic, pharmacodynamic, and safety data together with the demonstration of the effectiveness of the ‘off’-switch provide clinical validation of GenVivo’s G-VolveTM vector platform, the basis for GEN2,” said Dr. Robert G. Johnson, Chief Operating Officer of GenVivo, Inc. “The GEN2 data provide a solid foundation for advancing our G-VolveTM platform, including IL-12 and in vivo CAR-T vector programs.” GEN2’s IV administration represents a major advancement over alternative therapies limited by IT or Intralesional (IL) approaches, as local administration is usually restricted to readily accessible tumors. While clinical trials of oncolytic viruses or replication-deficient vectors have demonstrated encouraging results in skin, bladder, prostate, pancreatic, and lung cancers (sometimes showing abscopal effects in both injected and non-injected tumors), there are practical limitations to IT or IL administration. By contrast, GEN2’s IV administration enables treatment of advanced disease with distant metastases. About GenVivoGenVivo (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 and autoimmune disease. 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 for them and patients with autoimmune disease. 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 vector program. For more information, visit https://genvivoinc.com/ Forward-Looking StatementsThis press release contains forward-looking statements of GenVivo, Inc. (“GenVivo”) that involve substantial risks and uncertainties. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are based on current scientifically based mechanisms, understandings, and expectations and are not guarantees of future performance. GenVivo may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. In addition, the forward-looking statements included in this press release represent GenVivo’s views as of the date of this press release. GenVivo anticipates that subsequent events and developments will cause its views to change. However, while GenVivo may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. “GenVivo,” the GenVivo logo and other trademarks, trade names or service marks of GenVivo appearing in this press release are the property of GenVivo. All other trademarks, trade names and service marks appearing in this press release are the property of their respective owners and are used for reference purposes only. Such use should not be construed as an endorsement of such products or companies. Contact Brian Korb Managing Director Brian.korb@partners.com Victor Constantinescu Head of Business Development BD@genvivoinc.com 626-768-5162

On June 23, 2025, Merck announced that its novel non-nucleoside cytomegalovirus (CMV) inhibitor, Letermovir, in both tablet and injectable forms, has been approved by the National Medical Products Administration (NMPA) for use in children aged 6 months and above, weighing ≥6kg. The newly approved indication covers the prevention of CMV infection and disease in allogeneic hematopoietic stem cell transplant (HSCT) recipients who are CMV-seropositive (R+), including adults and children. According to Merck, Letermovir is the first and only CMV prevention therapy in China available for both pediatric and adult HSCT patients. CMV, a prevalent herpes virus, poses a severe threat to transplant recipients, significantly increasing transplant-related mortality rates. In China, CMV infection is widespread, with 60%-80% of infants testing positive for antibodies. Children, who lack fully developed immune systems, face an increased risk of CMV reactivation after transplantation. Data shows that in 2022 and 2023, there were 39,918 HSCT recipients in China, of which 9,860 were children—accounting for 1 in every 4 transplant patients. The approval of Letermovir addresses a critical unmet need in CMV prevention for this vulnerable group. Previously approved CMV inhibitors in China include Roche’s ganciclovir and valganciclovir, while domestic companies such as Zhejiang Asia-Pacific Pharmaceutical and Shanghai Pharma have also entered the market with generic versions. However, Letermovir offers a novel mechanism of action, making it a game-changing option for CMV prevention in HSCT patients, particularly children.