主要研究目的：研究空腹/餐后状态下单次口服受试制剂盐酸缬更昔洛韦片【规格：0.45g（以缬更昔洛韦计），武汉人福利康药业有限公司生产】与参比制剂盐酸缬更昔洛韦片【商品名：万赛维/Valcyte，规格：450mg（以缬更昔洛韦计）；Roche Pharma (Schweiz)Ltd.持证】在健康受试者体内的药代动力学，评价空腹/餐后状态口服两种制剂的生物等效性。次要研究目的：评价受试制剂盐酸缬更昔洛韦片0.45g和参比制剂盐酸缬更昔洛韦片（商品名：万赛维/Valcyte）450mg在健康受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of a single oral administration of the test preparation valganciclovir hydrochloride tablets [Specification: 0.45g (in terms of valganciclovir), produced by Wuhan Renfu Likang Pharmaceutical Co., Ltd.] and the reference preparation valganciclovir hydrochloride tablets [trade name: Valcyte, specification: 450mg (in terms of valganciclovir); Roche Pharma (Schweiz) Ltd. licensed] in healthy subjects in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary purpose of the study: to evaluate the safety of the test preparation valganciclovir hydrochloride tablets 0.45g and the reference preparation valganciclovir hydrochloride tablets (trade name: Valcyte) 450mg in healthy subjects.

Start Date11 Oct 2024

Sponsor / Collaborator

Yichang Humanwell Pharmaceuticals Co., Ltd.

NCT06102525

/ RecruitingPhase 1/2

A Phase 1/2a, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, and Efficacy of RZ-001 in Combination with Valganciclovir in Subjects with Glioblastoma

This is a Phase 1/2a, open-label study to evaluate the safety, tolerability, immunogenicity, and preliminary clinical activity of RZ-001 administered in combination with VGCV in subjects with hTERT-positive GBM.

Start Date08 Oct 2024

Sponsor / Collaborator

Rznomics Co., Ltd.

NCT05708755

/ RecruitingPhase 2IIT

Cytomegalovirus T Cell Immunity and Antiviral Prophylaxis Minimization in Lung Transplant Recipients

The purpose of this study is to determine the safety and feasibility of using a laboratory test to guide duration of antiviral prophylaxis with valganciclovir (medication used to prevent viral infections) after lung transplant. The laboratory test, inSIGHT™ CMV T Cell Immunity Panel, measures patients' immune response to a common viral infection known as cytomegalovirus (CMV). The goal of this study will be to safely decrease how long patients need to take valganciclovir based on the results of the CMV T Cell Immunity Panel.

Start Date13 Sep 2024

Sponsor / Collaborator

NYU Langone Health

[+1]

100 Clinical Results associated with Valganciclovir Hydrochloride

100 Translational Medicine associated with Valganciclovir Hydrochloride

100 Patents (Medical) associated with Valganciclovir Hydrochloride

1,285

Literatures (Medical) associated with Valganciclovir Hydrochloride

01 Jan 2025·ANNALS OF PHARMACOTHERAPY

Article

Author: Arnouk, Serena ; Dubrovskaya, Yanina ; Patolia, Roshani ; Pluckrose, Dawn M. ; Jonchhe, Srijana ; Li, Yihan ; Papadopoulos, John

Background::

Low-dose valganciclovir (VGC) for cytomegalovirus (CMV) prophylaxis post-transplant has been employed due to cost and safety. The incidence of CMV disease in CMV intermediate-risk liver recipients at 1-year after standard-dose prophylaxis is approximately 5%. However, there are limited data on outcomes after using a “true” low-dose VGC prophylaxis regimen in liver and dual-abdominal transplant recipients as VGC was not dose-adjusted in all patients with impaired renal function in prior studies.

Objective::

The objective was to assess the incidence of CMV associated with low-dose VGC prophylaxis in CMV intermediate-risk liver, simultaneous pancreas-kidney (SPK), and simultaneous liver-kidney (SLK) recipients with creatinine clearance (CrCl) >60 mL/min.

Methods::

This was a retrospective review of CMV intermediate-risk liver, SPK, and SLK recipients with CrCl >60 mL/min transplanted January 2018 to June 2022 who received VGC 450 mg daily for prophylaxis. The primary outcome was incidence of CMV infection 6-months post-transplant.

Results::

Ninety-nine transplant recipients were included (79 liver, 11 SPK, 9 SLK). The primary outcome occurred in 13% of patients (liver 10%, SPK 36%, SLK 10%), including 1 case of CMV disease and 3 breakthrough infections. In addition, 6 patients experienced CMV infection between 6-months and 1-year. Recurrence occurred in 3 patients. There was no evidence of CMV resistance. Thirty patients experienced neutropenia within 1-year, 32 were prescribed granulocyte-colony stimulating factors, and 5 experienced thrombocytopenia. Two patients died due to graft-vs-host disease.

Conclusion and Relevance::

Low-dose VGC prophylaxis led to comparable CMV infection rates at 6-months in CMV intermediate-risk liver and SLK recipients. However, as SPK recipients displayed higher rates of CMV infection, low-dose VGC should be avoided in this population.

01 Jan 2025·BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY

Review

Author: Heath, P. T. ; Soe, A. ; Soe, A ; Ville, Y. G. ; Jones, C E ; Khalil, A ; Jones, C. E. ; Ville, Y G ; Heath, P T ; Khalil, A.

Plain language summary:

Cytomegalovirus (CMV) is the most common cause of viral infection in newborn babies, and affects 1 in 200 of all live born infants in high‐income countries; and 1 in 71 in low‐ and middle‐income countries. It is a major cause of hearing loss and brain damage.Women may get CMV infection for the first time during pregnancy (primary infection) or may experience ‘non‐primary’ infection, either by reactivation of previous CMV infection or by a new infection with a different strain of the virus. The most common source of infection to pregnant women is the saliva and urine of young children. Therefore, all pregnant women, especially those in regular contact with young children, should be informed about hygiene‐based measures to reduce the risks, e.g. handwashing.The UK National Screening Committee recommends against universal antenatal or newborn screening for CMV. Testing for CMV is usually offered only to women who develop symptoms of influenza, glandular fever or hepatitis (liver inflammation) during pregnancy, or for those whom a routine ultrasound scan detects fetal anomalies that suggests possible CMV infection.The risk of harm to the fetus is greatest following primary CMV infection of the woman in early pregnancy, and appears to be very low following infection after 12 weeks of pregnancy. Babies with CMV infection at birth may have jaundice, a rash, enlarged liver or spleen, a small brain, or be small for their gestational age. Around 1 in 8 babies born with CMV infection will have clinically detectable signs at birth. The rest will not have any features detectable by clinical examination alone. Therefore, all infants with CMV infection at birth should be followed up at a minimum of up to 2 years of age or later, depending upon the disease status, to check hearing and brain development.Following primary CMV infection in the first 12 weeks of pregnancy, if the woman starts taking the antiviral medicine valaciclovir (valacyclovir) it reduces the risk of the baby becoming infected.Where CMV infection of the fetus in the womb has been confirmed (by amniocentesis, for example), regular ultrasound scans should be offered every 2–3 weeks until birth. Detailed assessment of the fetal brain is an essential part of these scans. Where maternal CMV infection occurs, but fetal infection is not confirmed, repeated ultrasound scans of the fetus should be offered every 2–3 weeks until birth.In infected fetuses, as well as ultrasound scans, an MRI scan of the brain should be offered at 28–32 weeks of gestation (and sometimes repeated 3–4 weeks later) to assess for any signs of harm to the fetal brain.All babies born to women with confirmed or suspected CMV infection should be tested for CMV with a urine or saliva sample within the first 21 days of life.In newborns with symptomatic CMV infection at birth, treatment with antiviral medicine (valganciclovir or ganciclovir) can reduce hearing loss in 5 out of 6 babies, and improve long‐term brain development outcomes in some. There is no licensed vaccine for CMV.

01 Jan 2025·AMERICAN JOURNAL OF OPHTHALMOLOGY

Multiple Anterior Chamber Paracenteses May Be Needed to Identify Cytomegalovirus Anterior Uveitis

Article

Author: Qian, Ying ; Doan, Thuy ; Shantha, Jessica ; Gonzales, John A ; Lee, Jennifer ; Gonzales, John A. ; Benador-Shen, Christine

PURPOSE:

To demonstrate cases of anterior uveitis requiring more than one anterior chamber paracenesis to elucidate CMV as the causative etiology.

DESIGN:

Retrospective chart review.

METHODS:

Patients were seen at the Francis I. Proctor Foundation at the University of California, San Francisco between 2013 and 2024. Patients who required more than one anterior chamber paracentesis to detect CMV as the etiologic agent of their anterior uveitis were included. Number of anterior chamber paracenteses required to detect CMV, demographic and clinical features, viral load at time of positive anterior chamber paracentesis and association between topical corticosteroid use and viral load at time of positive anterior chamber paracentesis.

RESULTS:

Fourteen patients required a median of 2 (range 2-4) anterior chamber paracenteses to detect CMV. Mean age was 48.2 years, and 57.1% were male. Most patients (64.3%) were born in East and Southeast Asia. All affected eyes featured ocular hypertension. Five patients (35.7%) were initially treated with systemic immunosuppression before CMV was detected. Increasing frequency of topical corticosteroid use was significantly associated with higher CMV viral loads (P < .001). Five patients (35.7%) required glaucoma surgery. In 13 patients with available data, uveitis was present for an average of 2776 days (range 23-7889 days) prior to CMV detection. Once diagnosed, most patients were treated with oral valganciclovir, with one patient transitioning to letermovir due to side effects.

CONCLUSIONS:

CMV anterior uveitis may be more prevalent than previously recognized and often requires multiple anterior chamber paracenteses for diagnosis. Reliance on a signle negative test may lead to misdiagnosis and inappropriate treatment. Clinicians should maintain a high index of suspicion for CMV in cases of recurrent anterior uveitis, particularly in patients of East and Southeast Asian descent. This study highlights the importance of repeated testing and appropriate antiviral treatment to prevent complications such as glaucoma.

News (Medical) associated with Valganciclovir Hydrochloride

13 Nov 2024

·www.globenewswire.com

Viracta Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update

- Reprioritized resources to reduce costs and enhance focus on Nana-val’s development program in relapsed or refractory EBV-positive peripheral T-cell lymphoma (PTCL) - - On track to report data from expansion phase of the Phase 2 NAVAL-1 clinical trial of Nana-val in the first half of 2025 - - Determined recommended Phase 2 dose of Nana-val in patients with advanced EBV-positive solid tumors - SAN DIEGO, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today reported financial results for the third quarter of 2024 and provided a business update. “Last quarter, based on productive feedback from FDA, we announced a sharpened focus on the second-line EBV-positive PTCL subpopulation in the NAVAL-1 trial’s expansion phase, which is ongoing,” said Mark Rothera, President and Chief Executive Officer of Viracta. “To optimally support both the NAVAL-1 trial as well as a randomized controlled trial that we are planning for the second half of next year and reduce cash burn, we recently announced a reprioritization of resources intended to right-size our organization and further reduce our operating expenses. With a clearly defined regulatory path forward for Nana-val, we believe this will allow us to be efficient while we work toward the possible submission of a New Drug Application in 2026 and seek to introduce the first EBV-targeted therapy for lymphoma patients, subject to obtaining requisite funding.” “We are pleased to have determined a recommended Phase 2 dose for Nana-val in patients with advanced EBV-positive solid tumors,” said Darrel P. Cohen, M.D., Ph.D., Chief Medical Officer of Viracta. “Although the EBV-positive solid tumor program has been paused, clinical development in this patient population is ready for Phase 2, with additional financing or with a partner, using nanatinostat and valganciclovir doses that were well tolerated with evidence of antitumor activity.” Clinical Trial Updates and Anticipated Milestones Phase 1b/2 trial of Nana-val (nanatinostat in combination with valganciclovir) in patients with recurrent/metastatic (R/M) Epstein-Barr virus-positive (EBV+) nasopharyngeal carcinoma (NPC) and other advanced EBV+ solid tumors (Study 301) Clinical Trial Update: In October, determined the recommended Phase 2 dose in patients with advanced EBV+ solid tumors. Phase 2 NAVAL-1 trial of Nana-val (nanatinostat in combination with valganciclovir) in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma Clinical Trial Updates: In August, announced positive combined Stage 1 and Stage 2 data (n=21) in the R/R EBV+ PTCL cohort of patients treated with nanatinostat (20 mg orally once daily, 4 days/week) in combination with valganciclovir (900 mg orally once daily, 7 days/week) across the first two stages of the study. Combined data from Stages 1 and 2 demonstrated Nana-val’s substantial antitumor activity and generally well-tolerated safety profile with a median duration of response (DOR) that has not yet been reached. In August, announced that a productive FDA meeting was held to align on a potential regulatory path forward for Nana-val in patients with R/R EBV+ PTCL. Based on feedback from the FDA and the particularly robust response rates observed in the second-line treatment setting, and to target its resources, Viracta will focus the primary analysis on the second-line EBV+ PTCL subpopulation in the ongoing NAVAL-1 trial’s expansion phase.The Company plans to begin a randomized controlled trial (RCT) of Nana-val in the second-line treatment of EBV+ PTCL patients in the second half of 2025, subject to obtaining financing. Anticipated Milestones Viracta plans to deliver on the following milestones, subject to obtaining financing: Meet with the FDA to finalize the proposed RCT design in the second-line treatment of patients with EBV+ PTCL in the first half of 2025. Initiate the RCT in the second half of 2025. Report preliminary data from the expansion phase of the NAVAL-1 trial in second-line EBV+ PTCL patients in the first half of 2025.Report Stage 1 data from patients with R/R EBV+ diffuse large B-cell lymphoma (DLBCL) in the first half of 2025.Present interim analysis outcomes from the NAVAL-1 trial’s expansion phase in second-line EBV+ PTCL patients in 2026.File NDA for accelerated approval in 2026 based on interim analysis of the NAVAL-1 trial’s expansion cohort. Business Updates Announced on November 6th a reprioritization of resources intended to enhance focus on the Company’s lead program, reduce cash burn, and drive shareholder value: Included a reduction in force affecting approximately 42% of the Company’s employees.Also reduced the size of its Board of Directors from 10 to 6 seats following voluntary resignations from 4 directors. Third Quarter 2024 Financial Results Cash position – Cash, cash equivalents, and short-term investments totaled approximately $21.1 million as of September 30, 2024, which Viracta expects will be sufficient to fund operations late into the first quarter of 2025.Research and development expenses – Research and development expenses were approximately $7.2 million and $23.7 million for the three and nine months ended September 30, 2024, respectively, compared to approximately $8.2 million and $24.0 million for the same periods in 2023. The decrease in research and development expenses for the three months ended September 30, 2024 compared to the same period in 2023, was driven by decreases in costs incurred to support the advancement and expansion of our clinical development programs, including incremental costs to support NAVAL-1, our Phase 2 trial of Nana-val in patients with R/R EBV+ lymphomas and personnel-related costs. The decrease in research and development expenses for the nine months ended September 30, 2024 compared to the same period in 2023, was largely due to decreases in costs incurred related to our clinical development programs and personnel-related costs, partially offset by a non-cash adjustment for insurance costs related to the February 2021 reverse merger with Sunesis Pharmaceuticals of $1.8 million.General and administrative expenses – General and administrative expenses were approximately $3.0 million and $10.0 million for the three and nine months ended September 30, 2024, respectively, compared to $4.3 million and $13.2 million for the same periods in 2023. The decrease in general and administrative expenses was largely due to decreases in personnel-related costs, corporate liability insurance premiums and consulting and legal costs.Net loss – Net loss was approximately $10.6 million, or $0.27 per share (basic and diluted), for the quarter ended September 30, 2024, compared to a net loss of $12.6 million, or $0.33 per share (basic and diluted), for the same period in 2023. This change was primarily the result of decreases in research and development expenses and personnel-related costs. Net loss was approximately $29.5 million, or $0.75 per share, (basic and diluted) for the nine months ended September 30, 2024, compared to a net loss of $37.3 million, or $0.97 per share, (basic and diluted) for the same period in 2023. This change was primarily the result of $5.0 million of other income received related to the monetization of a pre-commercialization, event-based milestone from Day One Biopharmaceuticals, Inc. in March 2024, and decreases in costs related to our clinical development programs and personnel-related costs, partially offset by the non-cash adjustment for insurance costs related to the February 2021 merger of $1.8 million. About the NAVAL-1 TrialNAVAL-1 (NCT05011058) is a global, multicenter, clinical trial of Nana-val in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma. This trial employs a Simon two-stage design where, in Stage 1, participants are enrolled into one of three indication cohorts based on EBV+ lymphoma subtype. If two objective responses are achieved within a lymphoma subtype in Stage 1 (n=10), then additional patients will be enrolled in Stage 2 for a total of 21 patients. EBV+ lymphoma subtypes demonstrating promising antitumor activity in Stage 2 may be further expanded following discussion with regulators to potentially support registration. About Nana-val (Nanatinostat and Valganciclovir)Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which are key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a potentially registrational, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed or refractory (R/R) EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 clinical trial in patients with recurrent or metastatic (R/M) EBV+ NPC and other advanced EBV+ solid tumors. About Peripheral T-Cell LymphomaT-cell lymphomas comprise a heterogeneous group of rare and aggressive malignancies, including peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) and angioimmunoblastic T-cell lymphoma (AITL). There are approximately 5,600 newly diagnosed T-cell lymphoma patients and approximately 2,600 newly diagnosed PTCL-NOS and AITL patients in the U.S. annually. Approximately 70% of these patients are either refractory to first-line therapy, or eventually experience relapse of their disease. Clinical trials are currently recommended for all lines of PTCL therapy, and most patients with R/R PTCL have poor outcomes, with median progression-free survival and median overall survival times reported to be 3.7 and 6.5 months, respectively. Approximately 40% to 65% of PTCL is associated with EBV, the incidence of EBV+ PTCL varies by geography, and reported outcomes for patients with EBV+ PTCL are inferior to those whose disease is EBV-negative. There is no approved targeted treatment specific for EBV+ PTCL, and therefore this represents a high unmet medical need. About EBV-Associated CancersApproximately 90% of the world's adult population is infected with EBV. Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of cells for the duration of the patient's life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV-positive (EBV+) lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden including lymphoma, nasopharyngeal carcinoma (NPC), and gastric cancer. About Viracta Therapeutics, Inc.Viracta is a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide. Viracta’s lead product candidate is an all-oral combination therapy of its proprietary investigational drug, nanatinostat, and the antiviral agent valganciclovir (collectively referred to as Nana-val). Nana-val is currently being evaluated in multiple ongoing clinical trials, including a potentially registrational, global, multicenter, open-label Phase 2 basket trial for the treatment of multiple subtypes of relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma (NAVAL-1), as well as a multinational, open-label Phase 1b/2 clinical trial for the treatment of patients with recurrent or metastatic (R/M) EBV+ nasopharyngeal carcinoma (NPC) and other advanced EBV+ solid tumors. Viracta is also pursuing the application of its “Kick and Kill” approach in other virus-related cancers. For additional information, please visit www.viracta.com. Forward-Looking StatementsThis communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the details, timeline and expected progress for Viracta's ongoing and anticipated clinical trials and updates regarding the same, Viracta’s clinical focus and strategy, the Company’s expectations related to the FDA submission process and timelines, expectations regarding the Company’s target patient populations, and expectations regarding the Company’s cash runway and ability to fund continued operations and development. Risks and uncertainties related to Viracta that may cause actual results to differ materially from those expressed or implied in any forward-looking statement include, but are not limited to: Viracta’s ability to continue as a going concern; Viracta's ability to successfully enroll patients in and complete its ongoing and planned clinical trials; Viracta's plans to develop and commercialize its product candidates, including all oral combinations of nanatinostat and valganciclovir; the timing of initiation of Viracta's planned clinical trials; the timing of the availability of data from Viracta's clinical trials; previous preclinical and clinical results may not be predictive of future clinical results; the timing of any planned investigational new drug application or new drug application; Viracta's plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits, and market acceptance of Viracta's product candidates; Viracta's ability to manufacture or supply nanatinostat, valganciclovir, and pembrolizumab for clinical testing; and Viracta's estimates regarding its ability to fund ongoing operations into 2025, future expenses, capital requirements, and need for additional financing in the future. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" and elsewhere in Viracta's reports and other documents that Viracta has filed, or will file, with the SEC from time to time and available at www.sec.gov. The forward-looking statements included in this communication are made only as of the date hereof. Viracta assumes no obligation and does not intend to update these forward-looking statements, except as required by law or applicable regulation. Investor Relations Contact:Michael FaermChief Financial OfficerViracta Therapeutics, Inc.ir@viracta.com SOURCE Viracta Therapeutics, Inc. -- Financial tables attached – Viracta Therapeutics, Inc.Selected Balance Sheet Highlights (in thousands) September 30, December 31, 2024 2023 (Unaudited) Cash, cash equivalents and short-term investments$21,132 $53,691 Total assets$21,958 $56,692 Total liabilities$28,575 $38,373 Stockholders' equity (deficit)$(6,617) $18,319 Viracta Therapeutics, Inc.Condensed Consolidated Statement of Operations and Comprehensive Loss(in thousands except share and per share data)(Unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Operating expenses: Research and development$7,181 $8,158 $23,685 $23,962 General and administrative 3,004 4,317 9,966 13,170 Total operating expenses 10,185 12,475 33,651 37,132 Loss from operations (10,185) (12,475) (33,651) (37,132) Total other income (expense) (368) (125) 4,127 (161) Net loss (10,553) (12,600) (29,524) (37,293) Unrealized gain on short-term investments 14 50 - 113 Comprehensive loss (10,539) (12,550) (29,524) (37,180) Net loss per share, basic and diluted$(0.27) $(0.33) $(0.75) $(0.97) Weighted-average common shares outstanding, basic and diluted 39,574,070 38,683,858 39,434,846 38,568,515

Phase 2Clinical ResultFinancial StatementAccelerated Approval

08 Nov 2024

·www.globenewswire.com

GenVivo to Present Phase 1 Trial Results for GEN2, A Personalizing Gene Vector Therapy, at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting

GEN2 was studied in patients with hepatocellular carcinoma or advanced solid tumors metastatic to the liver and was well-tolerated at all dose levels administered21% of patients remained on study for >6 months, with half at the highest administered doses and the longest up to 21 monthsA Maximum Tolerated Dose (MTD) was not defined in this studyA second Phase 1 study, in the US, exploring a different dosing schedule is underway; once a recommended dose in this study is defined, 3 expansion cohorts will be initiated PASADENA, Calif., Nov. 08, 2024 (GLOBE NEWSWIRE) -- GenVivo, Inc. (GVO) a private, clinical stage biopharmaceutical company with breakthrough “off-the-shelf” gene vector immunotherapies to treat cancer, announces the presentation of GEN2 Phase 1 clinical trial results in adult patients with hepatocellular carcinoma or tumors metastatic to the liver (NCT04313868), at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting, November 8-10, in Houston, TX. GEN2, a non-replicating mRNA vector, delivers two payload genes that provide dual-mechanisms of action: an enhanced prodrug-activated enzyme (HSV-eTK) and an immunostimulatory cytokine (GM-CSF). After valganciclovir 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 prior to commencing therapy. GEN2 was evaluated intravenously (IV) in combination with valganciclovir (VGCV) in 48 patients in this dose-escalation Phase 1 trial. GEN2 was administered on Days 1, 2, and 3 with VGCV on days 8 to 12 on a three-week cycle. GEN2 demonstrated tolerability and minimal toxicity, with no dose-dependent Treatment Emergent Adverse Events (TEAEs). Linear exposure was observed across the 1000-fold dose range. Twenty-one percent of patients remained on therapy for longer than 6 months with the longest up to 21 months. A toxicity-defined maximum tolerated dose (MTD) has not been identified. A second Phase 1 trial, initiated in the US earlier this year under protocol NCT06391918, will identify the Recommended Phase 2 Dose (RP2D) on a different IV schedule and expand into additional tumor types. This trial includes a variety of exploratory objectives including validation of receptor binding, pre- and post-tumor biopsy analyses, cytokine assessment, immunophenotyping and analysis of presence or absence of neutralizing antibodies to optimize the dosing schedule. Once the RP2D has been defined, expansion cohorts will enroll patients with hepatocellular carcinoma (HCC), hormone receptor positive breast cancer and skin cancers. An additional cohort of patients (also with skin cancers) will investigate intratumoral (IT) dosing, with the goal of obtaining paired biopsies and tissue correlative studies. GEN2’s IV administration represents a major advancement over alternative therapies limited by IT or Intralesional (IL) approaches, as the use of 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 effects in both injected and non-injected tumors), there are practical limitations to IT or IL administration. By contrast, GEN2’s IV administration allows for the treatment of advanced disease with malignancies that have spread widely throughout the body. Poster 1 Abstract Title: “A phase 1 clinical trial of GEN2, a personalizing immunotherapy gene vector product, in combination with valganciclovir in adult patients with hepatocellular carcinoma or tumors metastatic to liver”Session Date and Time for Poster Presentation: Friday, November 8, 2024, from 9:00 AM to 7:00 PM CT, Poster HallAbstract Number: 609Presenter: Alison L. Hannah, M.D. Chief Medical Officer, GenVivo, Inc. About GenVivo GenVivo (GVO) is a private, vertically integrated biotechnology company founded to develop novel 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, 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). For more information about GenVivo, visit https://genvivoinc.com/ Forward-Looking Statements This 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.

Phase 1ImmunotherapyClinical ResultASCO

06 Nov 2024

·www.globenewswire.com

Viracta Therapeutics Announces Reprioritization of Resources to Enhance Focus on Nana-val Development Program in Patients with Relapsed or Refractory EBV-Positive Peripheral T-Cell Lymphoma

Company implementing 42% reduction in force and resizing its Board of Directors to six seats from tenSAN DIEGO, Nov. 06, 2024 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today announced that the company has implemented a reprioritization of resources intended to enhance the company’s focus on its Nana-val development program in patients with relapsed or refractory (R/R) EBV-positive peripheral T-cell lymphoma (PTCL). To further align resources with current pipeline priorities, Viracta is announcing today that it has implemented a further reduction in force that impacts approximately 42% of the company’s employees. Viracta expects to recognize approximately $0.7 million in total expenses for severance and related benefits for employees impacted by the reduction in force. “The initiatives that we are announcing today will enable us to conserve resources as we efficiently advance our Nana-val program towards a potential NDA submission for R/R EBV-positive PTCL, our lead indication,” stated Mark Rothera, President and Chief Executive Officer of Viracta. “While these actions are necessary, they unfortunately impact our team. I would like to express my gratitude to the employees who are affected by this very difficult decision for their unwavering dedication to Viracta and its mission.” Viracta also announced a reduction in the size of its Board of Directors, from ten seats to six following the voluntary resignation of four directors, Jane F. Barlow, M.D., Jane Chung, R.Ph., Sam Murphy, Ph.D. and Stephen Rubino, Ph.D., effective October 31, 2024. The resizing followed discussion among such directors and the remaining members of the Board and is intended to reduce costs, streamline operations, and bring the size of Viracta’s Board more in line with the Boards of other similarly sized companies. Following the downsizing, Viracta’s Board will consist of Roger J. Pomerantz, M.D. (Chairman), Flavia Borellini, Ph.D., Thomas E. Darcy, CPA, Mark Rothera, Ivor Royston, M.D. and Barry J. Simon, M.D. Roger J. Pomerantz, M.D., Chairman of Viracta’s Board, stated, “Viracta has adjusted its organization to further focus on the advancement of Nana-val in EBV-positive cancers while reducing cash burn. In line with these actions, I have worked with my fellow Board members to right-size Board membership, while ensuring strong continued governance and maintaining the appropriate capabilities and experience for our journey ahead. I would like to acknowledge the departing directors – Jane, Stephen, Sam and Jane - and thank them for their invaluable insights and contributions.” About Viracta Therapeutics, Inc.Viracta is a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide. Viracta’s lead product candidate is an all-oral combination therapy of its proprietary investigational drug, nanatinostat, and the antiviral agent valganciclovir (collectively referred to as Nana-val). Nana-val is currently being evaluated in multiple ongoing clinical trials, including a potentially registrational, global, multicenter, open-label Phase 2 basket trial for the treatment of multiple subtypes of relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma (NAVAL-1), as well as a multinational, open-label Phase 1b/2 clinical trial for the treatment of patients with recurrent or metastatic (R/M) EBV+ nasopharyngeal carcinoma (NPC) and other advanced EBV+ solid tumors. Viracta is also pursuing the application of its “Kick and Kill” approach in other virus-related cancers. For additional information, please visit www.viracta.com. Forward-Looking StatementsThis communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the company’s focus on its Nana-val development program, the details, timeline and expected progress for Viracta's ongoing and anticipated clinical trials, Viracta’s clinical focus and strategy, the reduction in force and the expected total expenses related thereto, and expectations regarding the Company’s cash runway, generally and the impact of the reduction in force thereon. Risks and uncertainties related to Viracta that may cause actual results to differ materially from those expressed or implied in any forward-looking statement include, but are not limited to: Viracta's ability to successfully enroll patients in and complete its ongoing and planned clinical trials; Viracta's plans to develop and commercialize its product candidates, including all oral combinations of nanatinostat and valganciclovir; the timing of initiation of Viracta's planned clinical trials; the timing of the availability of data from Viracta's clinical trials; previous preclinical and clinical results may not be predictive of future clinical results; the timing of any planned investigational new drug application or new drug application; Viracta's plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits, and market acceptance of Viracta's product candidates; Viracta's ability to manufacture or supply nanatinostat, valganciclovir, and pembrolizumab for clinical testing; and Viracta's estimates regarding its ability to fund ongoing operations into 2025, future expenses, capital requirements, and need for additional financing in the future. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" and elsewhere in Viracta's reports and other documents that Viracta has filed, or will file, with the SEC from time to time and available at www.sec.gov. The forward-looking statements included in this communication are made only as of the date hereof. Viracta assumes no obligation and does not intend to update these forward-looking statements, except as required by law or applicable regulation. Investor Relations Contact:Michael FaermChief Financial OfficerViracta Therapeutics, Inc.ir@viracta.com

Phase 2Executive Change

100 Deals associated with Valganciclovir Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D03256	Valganciclovir Hydrochloride	J05AB14	DB01610

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Virus Diseases	CN	Roche Pharma (Schweiz) AG	13 Dec 2005
Acquired Immunodeficiency Syndrome	JP	Mitsubishi Tanabe Pharma Corp.	05 Nov 2004
Cytomegalovirus Infections	AU	Pharmaco (NZ) Ltd.	17 Jun 2002
Cytomegalovirus Retinitis	US	CHEPLAPHARM Arzneimittel GmbH	29 Mar 2001

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Indication	Highest Phase	Country/Location	Organization	Date
Peripheral Stem Cell Transplantation	Phase 3	US	Roche Pharma AG	01 Nov 2001
HIV Infections	Phase 3	CA	Hoffmann-La Roche, Inc.	01 Jan 1997
Hearing Loss, Sensorineural	Phase 2	US	Genentech, Inc.	31 Aug 2018
Chronic Lymphocytic Leukemia	Phase 2	US	Roche Pharma AG	01 Sep 2003
Human herpesvirus 8 infection	Phase 2	US	Hoffmann-La Roche, Inc.	01 Dec 2002
Cystic Fibrosis	Phase 1	US	Hoffmann-La Roche, Inc.	01 Dec 2004

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01329185 (Pubmed) Manual	Phase 2	EBV viremia \| Cytomegalovirus viremia	137	Valganciclovir	ekfvnlewqi(esrldkqumy) = apjttgqzsc xgxpbnuqjy (rvzzmsccvf ) View more	Positive	01 Jun 2024
				Valganciclovir	ekfvnlewqi(esrldkqumy) = bkobjgzrel xgxpbnuqjy (rvzzmsccvf ) View more
NCT02927067 (AURORA, Pubmed)	Phase 3	Cytomegalovirus Infections	-	Valganciclovir (dose-adjusted for renal clearance)	koeczchspg(xatiikyncb) = rbfoqzjpjs ysugvwzorw (yoqlepcjgs ) View more	Negative	30 Nov 2023
P11.80.A (EANO2023)	Not Applicable	Glioblastoma Add-on MGMT methylation status \| IDH1 wt	220	Valganciclovir	vfbgumjmfa(hmdlcotxvk) = Five patients showed reversible hematological side effects grade 3-4, always with the initial high dose and concomitant to radiochemotherapy. No patient stopped the study due to side effects. medpmthobz (ygsoqwcfje )	Positive	08 Sep 2023
				Placebo
ERA2023	Not Applicable	Cytomegalovirus Infections	33	Low-dose oral valganciclovir (450 mg twice daily)	shvywwmeaj(tabrrbriem) = vsgktefxyy urwhebuiny (ngyitwpzcx, 311.24–826.25)	-	15 Jun 2023
AACR2023 Manual	Phase 1	Recurrent Prostate Carcinoma	15	Ad5-yCD/mutTKSR39rep-hIL-12+5-fluorocytosine+Valganciclovir	oopbfucjnk(wmjeoathug) = pghuymypfz wygddfeggm (dzkzpxicoj ) View more	Positive	14 Apr 2023
ISN WCN2023	Not Applicable	Cytomegalovirus Infections CMV IgG \| CMV IgM \| CMV DNA	32	Valganciclovir prophylaxis	wtvftttbqi(hchnssfxxu) = aauhkprbzr qjrhynzwae (rcbmctffzn )	Negative	01 Mar 2023
				VALGANCICLOVIR (No prophylaxis)	wtvftttbqi(hchnssfxxu) = yfaomlefle qjrhynzwae (rcbmctffzn )
ACTRN12613000554763 (Pubmed \| J Am Soc Nephrol)	Not Applicable	Renal transplant rejection	140	Valganciclovir prophylaxis	dnorhqwflq(umfojcsika) = hlshxxvriv azltpsjbtl (zubxejxmtk ) View more	-	02 Feb 2023
				Preemptive therapy	dnorhqwflq(umfojcsika) = fcxhxgygsu azltpsjbtl (zubxejxmtk ) View more
NCT03301415 (CTgov)	Phase 2	Cytomegalovirus Infections	7	Valganciclovir	pzgrptcecq(ioqxvklkwl) = apcayenfge erjtlsaefz (ghbceqsuru, aqlqmngxwo - ejyvrsnvtl) View more	-	26 Jan 2023
ASN2022	Not Applicable	Renal transplant rejection	-	Valganciclovir (Neutropenic KTRs)	uaimuuavvo(mmjztkyzzp) = nppjreplex azgzallrgj (vcqpyrpyhs ) View more	-	04 Nov 2022
NCT02871401 (CTgov)	Phase 1	Idiopathic Pulmonary Fibrosis	31	valganciclovir (Valganciclovir)	rhcplsxysb(irolblzwbn) = iuhnaceytd cempomzzmw (yodgvjnsde, giucjqjhmi - nubpssbcov) View more	-	29 Apr 2022
				Placebo (Placebo)	rhcplsxysb(irolblzwbn) = rtioqpphvf cempomzzmw (yodgvjnsde, hnmmowzdkx - qrtqeumdtp) View more

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