Enfuvirtide

SAN DIEGO, March 4, 2021 /PRNewswire/ -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, today announced that it has strengthened its leadership team with the appointments of Drs. Stephen Rubino and Barry J. Simon to the Board of Directors, the addition of Cheryl A. Madsen, RAC as Senior Vice President, Regulatory Affairs, and the promotion of several members of the management team. "The wealth of biotech leadership and executive experience Drs. Rubino and Simon bring to the Viracta Board will be invaluable as we continue to execute on our corporate strategy," said Roger Pomerantz, M.D., F.A.C.P., Chairman of the Board of Directors of Viracta. "With the help of their counsel and strategic guidance, we aim to build on the momentum generated by our recent entrance into the public market and concurrent financing." "We are very pleased to be complementing these Board additions by bringing on Cheryl Madsen to lead our regulatory efforts," said Ivor Royston, M.D., President and Chief Executive Officer of Viracta. "Cheryl has a proven record of success facilitating the regulatory processes involved in bringing oncology therapeutics to market, which will be crucial as we advance our novel all-oral combination therapy into a global registrational trial in relapsed/refractory Epstein-Barr virus (EBV)-positive lymphoma and further expand into EBV-positive solid tumors." In addition to the appointments of Ms. Madsen and Drs. Rubino and Simon, Viracta also announced the following management promotions, which are significant in the operations of Viracta as a publicly traded company: Dan Chevallard, formerly Chief Financial Officer, has been promoted to Chief Operating Officer and Chief Financial Officer Shelly Vandertie, formerly Senior Director, Finance & Controller, has been promoted to Vice President, Finance Michael Mueller, formerly Senior Director, Corporate Development & Legal Affairs, has been promoted to Vice President, Legal Affairs and General Counsel Appointee Bios Stephen Rubino, Ph.D., MBA has over 30 years of commercial and strategic development experience in the pharmaceutical and biotechnology industries. He is currently the Chief Business Officer at Celyad Oncology SA and sits on the Board of Sermonix Pharmaceuticals. Previously, he was the Chief Business & Strategy Officer at Omega Therapeutics and Global Head of Business Development and Licensing and New Product Marketing for the Cell and Gene Therapies business unit at Novartis Pharmaceuticals. At Novartis, Dr. Rubino led growth opportunities including evaluation, licensure, strategy and commercial development of products across a wide range of therapeutic areas. He received his Ph.D. in virology from Cornell University and an MBA from Baruch College. Barry J. Simon, M.D., is a healthcare executive with more than 30 years of experience spanning the public and private sectors. He previously served on Viracta's board from July 2017 to November 2020 and is currently the President and Chief Administrative Officer (CAO) of Nantkwest, Inc. Prior to serving as Nantkwest's President and CAO, he was the company's President and Chief Executive Officer. Dr. Simon also serves on the boards of several additional life science companies including Nantkwest, Cue BioPharma and Brink Biologics Inc. He has broad experience in public and private companies, having led private and public equity offerings, product and portfolio divestitures and acquisitions, strategic licensing and joint ventures, as well as commercial product launches, IND and BLA regulatory filings, human-enabling programs, and manufacturing, quality control and life cycle management projects. Previously, he held Vice President, senior level and advisory positions at F. Hoffmann-La Roche, Roche Labs, Connetics Corporation, Immunomedics, Immusol, HealthPro BioVentures, LLC, and NorthSound Capital, LLC. In his prior roles, Dr. Simon worked across several therapeutic areas including oncology, virology, ophthalmology and dermatology on product launches including Xeloda®, Pegasys®, Fortovase®, Tamiflu®, Camptobell®, Boniva®, Fuzeon®, Valcyt®, and Accutane®. Dr. Simon attended corporate training programs by the London School of Business and the Amos Tuck School of Business at Dartmouth College. He received his M.D. from the SUNY Downstate Health Sciences Center in New York and trained clinically in infectious diseases, anesthesiology, and internal medicine at Albert Einstein College of Medicine, The Mount Sinai Medical Center and New York University, respectively. Cheryl A. Madsen, RAC brings over 25 years of regulatory affairs experience in the development of both biologics and small molecules ranging from pre-IND through commercial stage companies. Ms. Madsen joined Viracta Therapeutics from Calithera Biosciences where she served as Vice President of Regulatory Affairs. Previously, Ms. Madsen was the Vice President of Regulatory Affairs at Peloton Therapeutics where she facilitated the successful acquisition of their HIF2-α inhibitor (belzutifan) by Merck. Prior to that, she was a Senior Director at Medivation (acquired by Pfizer), where she played an instrumental role in the initial global regulatory filings, approval and launch of XTANDI® (enzalutamide) for the treatment of metastatic castration-resistant prostate cancer. In addition to her regulatory responsibilities, she served as Project Team Leader for XTANDI from 2015-2016. She started her career at Genentech, where during her 13-year tenure she was responsible for the original filing and approval of AVASTIN® (bevacizumab) for first-line metastatic colorectal cancer. She also played a critical role in the parallel filing and approval of the HERCEPTIN® (trastuzumab) BLA for metastatic breast cancer and the premarket approval of HercepTest™, an in vitro diagnostic for HER2 expression and patient selection. Ms. Madsen received her bachelors degree in Psychology from U.C. Santa Cruz and completed additional post-graduate work in Molecular Biology and Biochemistry at U.C. Berkeley. She also holds U.S. and Global Regulatory Affairs Certifications from the Regulatory Affairs Professional Society. About Viracta Therapeutics, Inc. Viracta is a precision oncology company targeting virus-associated malignancies. Viracta's proprietary investigational drug, nanatinostat, is currently being evaluated in combination with the antiviral agent valganciclovir as an oral combination therapy in a Phase 2 clinical trial for EBV-positive lymphoma. Viracta is pursuing application of this inducible synthetic lethality approach in other EBV-associated malignancies, such as nasopharyngeal carcinoma, gastric carcinoma, and other virus-related cancers. For additional information please visit . Forward-Looking Statements This communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the significance of the Board of Director and management appointments and the expected contribution of the appointees; Viracta's clinical development plans; and other statements that are not historical facts. 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 identify additional products or product candidates with significant commercial potential; developments and projections relating to Viracta's competitors and its industry; the impact of government laws and regulations; Viracta's ability to protect its intellectual property position; and Viracta's estimates regarding future expenses, capital requirements and need for additional financing in the future. These risks and uncertainties may be amplified by the COVID-19 pandemic, which has caused significant economic uncertainty. 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 or will file, with the SEC from time to time and available at . 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. Company Codes: NASDAQ-NMS:VIRX

The human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) pandemic is considered to be one of the most significant health crises of a generation. According to the Joint United Nations Programme on HIV and AIDS (UNAIDS), an estimated 75 million people have been infected with HIV since 1981, and AIDS has claimed the lives of more than 32 million people. In some countries, AIDS is the leading cause of death. HIV infects and causes the death of immune cells, resulting in eventual immunosuppression and depletion of T-helper cells that express cluster of differentiation 4 (CD4), which is a glycoprotein also found on the surface of cells such as macrophages, monocytes, and dendritic cells. The destruction of these cells impairs the immune system and leaves patients vulnerable to opportunistic infections that do not typically affect people who are not immunocompromised. Examples of opportunistic infections include Kaposi’s sarcoma, extrapulmonary cryptococcosis, and cytomegalovirus retinitis. The goal of highly active antiretroviral therapy (HAART) is to prolong life, suppress viral replication, and fortify the immune system, which is responsible not only for protecting the body from pathogenic agents but also for antitumor activity and preservation of structures such as the blood-brain barrier. Currently, the overwhelming majority of treatment options are administered orally. Although this is considered to be convenient for most HIV-infected patients, there are some individuals who are unable to adhere to an oral treatment regimen. For some patients, the first noticeable sign of an infection is the presence of lesions or ulcers in the mouth. These patients may have difficulty swallowing and have suboptimal adherence to a regimen that consists only of oral therapies. The infection is incurable and eventually fatal, so patients must continue to take their medication once treatment is initiated. Poor compliance is a risk factor for a shortened life expectancy and a greater chance of contracting opportunistic infections. As such, drug developers have launched injectable therapies that can be used to suppress viral replication. The marketed injectable antiretroviral drugs, Roche’s Fuzeon (enfuvirtide) and TaiMed’s Trogarzo (ibalizumab), have launched in countries such as the US and Germany. However, no injectable anti-HIV drugs have been approved for use in Japan. This is not the first time that the Japan HAART market has lagged behind other countries with sizeable HIV-infected populations. A similar pattern of delayed approvals can be observed with oral antiretroviral drugs. Gilead Sciences/Bristol-Myers Squibb’s Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) was the first once-daily, single-tablet regimen (STR) to launch in the HIV therapeutics market. It became available in the US in 2006, but has still not launched in Japan. The first STR in the Japan market was Stribild (elvitegravir/cobicistat/ tenofovir disoproxil fumarate/emtricitabine), which launched in 2013. Other STRs such as Merck’s Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) and Mylan’s Symfi (efavirenz/lamivudine/tenofovir disoproxil fumarate) are also not available in Japan. One of the main reasons for these delays is the fact that drug developers seeking marketing authorization for therapeutics in Japan are usually required to run clinical trials in the country, which can be costly and time-consuming. Conversely, drugs can gain approval in Australia based on findings from clinical trials conducted in Europe or the US. Although there is an understandable need to ensure that drugs entering the market are safe, effective, and affordable, HIV-infected patients in Japan could be severely disadvantaged by the persisting lack of injectable treatment options. Since the ongoing coronavirus (Covid-19) pandemic poses a significant threat to immunosuppressed individuals, it may be beneficial for the drug approval process in Japan to be reviewed so that the system can efficiently provide vulnerable patients with the opportunity to live long, uninhibited lives. Related Report HIV Tests (In Vitro Diagnostics) – Global Market Analysis and Forecast Model (COVID-19 market impact) Get the Report Latest report from Browse over 50,000 other reports on our store. Visit GlobalData Store Related Companies OPTEL Supply Chain Track-and-Trace Technologies for the Pharmaceutical Industry Solni Tempelj Medical and Wellness Devices and Solutions Solvias Integrated Analytical Services and Solutions for Safer Pharmaceuticals