Valacyclovir Hydrochloride

Aicuris says a phase 3 trial of pritelivir on immunocompromised patients with refractory HSV infection has achieved its primary endpoint. The study paves the way for an FDA new drug application, the German company said.\n In the mid-1990s, researchers identified the viral helicase–primase enzyme complex as a target for a potential anti-herpes simplex virus (HSV) therapy. Three decades later, the first promising treatment to emerge from this area of study has taken a giant step toward reaching the market.Aicuris has reported the success of a phase 3 trial, which has demonstrated the superiority of oral antiviral pritelivir compared to standard-of-care (SOC) treatments in healing lesions of immunocompromised patients with refractory HSV infections, with or without resistance (R+R).After treatment for up to 28 days, patients on pritelivir saw a statistically significant difference in the healing rate of their lesions compared to patients who received an investigator’s choice of SOC treatments, such as acyclovir, valacyclovir, famciclovir or foscarnet. This demonstrated superiority of pritelivir in the 158-participant study allowed it to achieve its primary endpoint.“We will now rapidly advance our New Drug Application submission to the FDA and we look forward to presenting a comprehensive analysis of these positive results at a medical conference next year,” Aicuris CEO Larry Edwards said in an Oct. 16 release.The trial is important because refractory HSV infections “pose a significant challenge for patients whose immune systems are impaired,” according to Cynthia Wat, M.D., the chief medical officer of Aicuris.Immunocompromised patients are susceptible to more severe, lengthy and refractory HSV infections that do not respond to SOC treatments, Aicuris pointed out. The outbreaks can cause painful lesions and can increase the likelihood of hospitalization and the spread of the infection.“With encouraging safety, convenient oral dosing and the statistically superior efficacy in treating R+R HSV as demonstrated in this pivotal trial, pritelivir could be a paradigm shift for immunocompromised patients globally,” Wat added.An approval of pritelivir—which targets both HSV-1, which is primarily spread through oral contact, and HSV-2, which is primarily spread by genital contact—would bring a new mechanism of action to HSV treatment. Unlike traditional antivirals, pritelivir blocks viral DNA synthesis by inhibiting the helicase-primase complex, the company explained.Since pritelivir does not rely on activation by viral enzymes, it can “overcome HSV infections that are R+R to SOC treatments,” added Aicuris, a 2006 spinout of Bayer based in Wuppertal, Germany.Aicuris’ nearly two-decade history includes the development of Prevymis, which scored an FDA approval in 2017 and is marketed by Merck under a 2012 licensing deal. The antiviral, which prevents cytomegalovirus infection and disease, has generated sales of $436 million in the first half of this year.

NEEDHAM, Mass., Oct. 16, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced the appointment of Bali Pulendran, Ph.D. to Candel’s Research Advisory Board (RAB). Dr. Pulendran, an internationally recognized expert in systems immunology and vaccinology, who has pioneered the use of systems approaches to understand human immune responses, will bring his deep expertise to the RAB, as Candel continues to advance its lead viral immunotherapy candidate CAN-2409 across multiple solid tumor indications and CAN-3110 for recurrent high-grade glioma. “I'm honored to join Candel’s Research Advisory Board during this pivotal stage for the Company,” said Dr. Bali Pulendran. “Candel’s innovative viral immunotherapy platform represents a compelling approach to activating the immune system against cancer. I look forward to contributing my experience in systems immunology and understanding immune responses to help advance these promising therapies that have the potential to benefit patients across multiple cancer types.” Dr. Pulendran is the Violetta L. Horton Professor at Stanford University School of Medicine and Director of the Institute for Immunity, Transplantation and Infection at Stanford University and a Fellow at ChEM-H (Chemistry, Engineering and Medicine for Human Health). He received his Ph.D. from the Walter & Eliza Hall Institute under Sir Gustav Nossal. His groundbreaking research has had a transformative impact on human immunology and vaccinology, including the discovery that dendritic cells consist of multiple functionally distinct subtypes and the mechanisms by which microbial stimuli program dendritic cells to modulate immune responses. His research has been published in leading journals including Nature, Science, Cell, Nature Medicine, and Nature Immunology and is listed on Thomson Reuters’ list of Highly Cited Researchers, recognizing the world’s most influential researchers, demonstrated by the production of multiple, highly cited papers that rank in the top 1% by citations. “We are excited to welcome Dr. Pulendran to our Research Advisory Board,” said Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of Candel. “His pioneering work in systems immunology and his deep understanding of how the immune system responds to various stimuli will provide invaluable insights as we continue to advance CAN-2409 across multiple solid tumors and CAN-3110 in recurrent high-grade glioma, developing potentially vital therapies to those who need them most.” About Candel Therapeutics Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf, multimodal viral immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical-stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform. The Company recently completed successful phase 2a clinical trials of CAN-2409 in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and a pivotal, randomized, placebo-controlled, phase 3 clinical trial of CAN-2409 in localized prostate cancer, conducted under a Special Protocol Assessment (SPA) agreed with the FDA. CAN-2409 plus prodrug (valacyclovir) has been granted Fast Track Designation by the FDA for the treatment of PDAC, stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy and localized primary prostate cancer in combination with radiation therapy. The FDA also granted Regenerative Medicine Advanced Therapy (RMAT) Designation to CAN-2409 for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease and Orphan Drug Designation to CAN-2409 for the treatment of PDAC. CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma. Initial results were published in Nature and CAN-3110 received Fast Track Designation and Orphan Drug Designation from the FDA. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. For more information about Candel, visit: www.candeltx.com Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs; expectations regarding early biological readouts as predictor of clinical response; and expectations regarding the therapeutic benefit of the Company’s programs, including the ability of its programs to treat a broad range of solid tumors and improve patient survival. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC) including the Company’s most recent Quarterly Report on Form 10-Q filed with the SEC and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Investor Contact: Theodore Jenkins VP, Investor Relations and Business Development Candel Therapeutics, Inc. tjenkins@candeltx.com Media Contact: Ben Shannon ICR Healthcare CandelPR@icrhealthcare.com