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VIENNA, June 21, 2023 /PRNewswire/ -- Virion Therapeutics, LLC, a clinical stage company developing T cell-based immunotherapies for cancer and chronic infectious diseases, today, presented data entitled "Intrahepatic CD8+ T cells correlate with significant declines in HBV viral load and S antigen following a single vaccination with VRON-0200 in an AAV mouse model" at the European Association for the Study of Liver Diseases (EASL) annual Congress . These data were recognized as one of the Top 77 posters (out of 1,700 plus presentations) by the meeting organizers. Chronic HBV infection impairs CD8+ T cell functions resulting in the loss of virus control. VRON-0200 is a therapeutic vaccine being developed for HBV Functional Cure that contains key HBV antigens, coupled to glycoprotein D (gD), a checkpoint modifier of early T cell activation. Top line results, following a single intramuscular injection of VRON-0200, versus the same treatment without the checkpoint modifier, gD, include: Significantly enhanced frequencies of CD8+ T cells in the blood and livers, as well as a doubling of breadth of responses in spleens, in VRON-0200 treated mice Reproducible HBV DNA declines in blood of >3 log10 copies/mL versus <1.5 log10 copies/mL in VRON-0200 and non-gD treated mice, respectively HBV DNA declines in blood were strongly inversely correlated with the frequency of IFN-gamma CD8+ T cells in the liver (r2 = -0.83) "A treatment for chronic HBV infection whereby a patient's own immune system can control the infection, without the need for life-long antiviral therapies has been highly sought after," said Andrew Luber, Pharm.D., President, and Chief Executive Officer of Virion. "These data show a direct correlation between vaccine-induced T cells in the liver, where HBV replicates, and HBV declines in the blood; this, to our knowledge, is the first time that this has been observed for an immune-modulator or a vaccine. We believe this further support the potential role that VRON-0200 can play, for use alone, or in combination regimens, to achieve a functional cure and look forward to evaluating its potential in chronically HBV-infected persons starting this summer." "VRON-0200 is unique in its ability to stimulate broad and sustained HBV-specific CD8+ T cell responses. Due to the gD checkpoint modifier adjuvant, which allows for T cell stimulation to weaker antigens that are normally not triggered by a natural infection, we expect to achieve activation of new HBV-specific T cells rather than recall of already activated and potentially impaired T cells which failed when a patient was first exposed to the virus. That makes VRON-0200 so promising," said Hildegund Ertl, MD, Professor, Vaccine & Immunotherapy Center, at The Wistar Institute in Philadelphia PA and Scientific Founder of Virion Therapeutics. PRESENTATION DETAILS Presentation Title: "Intrahepatic CD8+ T cells correlate with significant declines in HBV viral load and S antigen following a single vaccination with VRON-0200 in an AAV mouse model Abstract: #1285; TOP-107 Presenting Author: Andrew Luber Presentation Date: June 23, 2023 The above presentation is available via the EASL-ILC Meeting Site at: , and on Virion's website at . ABOUT VRON-0200 VRON-0200 is designed with the goal of providing a functional cure for chronic HBV infection. While the virus itself stimulates HBV-specific CD8+ T cells, for those patients that can't clear the initial infection, their T cells soon become exhausted, placing limits on their ability to proliferate and control the virus. Our preclinical data support the hypothesis that VRON-0200 can mitigate this exhaustion through checkpoint modification by lowering the activation threshold and stimulating T cells to regions of the virus that are not normally activated during a chronic HBV infection (known as sub-dominant epitopes), which promotes further CD8+ T cell expansion and viral control. A Phase 1b study in chronically HBV-infected patients is scheduled to begin enrollment in Summer 2023. ABOUT VIRION THERAPEUTICS, LLC Virion Therapeutics, LLC, is a science driven company whose mission is to cure cancer and chronic infectious diseases through the development of novel and accessible CD8+ T cell-based immunotherapies. Our proprietary technologies combine genetically encoded checkpoint modifiers with selected and optimized target-specific antigens that are inserted into viral vectors to promote potent, prolonged, and broad CD8+ T cell responses. Founded in early 2018 to advance technology licensed from The Wistar Institute, an international leader in biomedical research with special expertise in vaccine, cancer and infectious disease research, Virion has built a best-in-class, experienced biotechnology management team, augmented by its advisory board that has extensive domain knowledge in antiviral, vaccine, and oncology therapeutic arenas. Media contact: Dr. Sue Currie, Ph.D. [email protected] Phone: 1-800-841-9303 SOURCE Virion Therapeutics, LLC

PHILADELPHIA, March 6, 2023 /PRNewswire/ -- Virion Therapeutics, LLC, a clinical-stage biotech company focused on the development of novel, adaptable, and accessible CD8+ T cell-based technologies focused on cancers and infectious diseases, presented data today of a genetically encoded checkpoint modifier-based immunotherapy, which enhances CD8+ T cell activation, in a fast-growing preclinical tumor model at the ESMO Target Anticancer Therapies Congress in Paris France. Top line results, following a single intramuscular injection of this novel immunotherapy include: Enhanced immune responses (10- to 15-fold) to oncogenic antigens At study completion, 100% survival (n=30/30), 100% initial tumor clearance (n=30/30), and 93% of animals were tumor free (n=28/30) In contrast, all mice treated with a control vaccine experienced rapid tumor growth and death by Day 30 (n=20) These results were durable and reproducible across multiple treatment groups and studies "Glycoprotein D (gD), when genetically expressed as a fusion protein with antigen(s) of choice, enhances, broadens, and prolongs CD8+ T cell responses. In this preclinical model of fast-growing HPV-16-associated tumors, a gD-based immunotherapy against HPV-16 provided incredibly strong protection against tumor growth and death," said Hildegund Ertl, MD, Professor, Vaccine & Immunotherapy Center, at The Wistar Institute in Philadelphia PA and Scientific Co-Founder of Virion Therapeutics. "Targeting different checkpoints of early T cell activation represents a novel approach to overcoming T cell impairments during tumor progression and these data further support its potential application, alone or in combination with other checkpoint inhibitors, for a wide range of cancers." "These preclinical oncology data demonstrated treatment responses which were profound, durable, and reproducible - and show clear differentiation to any other immunotherapy or vaccine in development. We are excited to be advancing our checkpoint modifier pipeline, not only with IND-enabling activities for our oncology program, but also, VRON-0200, for chronic HBV, which is heading to the clinic this summer," said Andrew Luber, Pharm.D., President, and chief executive officer of Virion. Presentation Details Presentation Title: "Therapeutic vaccination with HPV-16 proteins fused into a checkpoint modifier or early T cell activation protects against HPV-associated tumors in a preclinical model." Poster #36P Abstract Number: 277 Presenting Author: Sue Currie, PhD Presentation Date: March 6, 2023 The above presentation is available via the ESMO TAT meeting website, , and on Virion's website at . About Genetically Encoded Checkpoint Modifiers (gCPM) Virion is developing a series of novel gCPMs which act at different stages of T cell activation. The lead gCPM, glycoprotein D (gD), works by blocking an inhibitory signal of early activation (e.g., BTLA/CD160), thereby allowing a co-stimulatory signal to predominate (e.g., LIGHT) – the resultant CD8+ T cells that are induced to the target antigen(s) are enhanced, broadened and prolonged and they are more resistant to becoming impaired over time. This novel mechanism of early checkpoint modification that acts locally at the onset of the immune response has shown promising therapeutic efficacy in several settings, including animal models of fast and slow growing tumors, with viral or human cancer antigens, in young and older animals, and when inserted into DNA or adenovirus vaccine delivery platforms (both human and chimpanzee). About Virion Therapeutics (Virion) Virion Therapeutics, LLC, is a science driven company whose mission is to cure cancer and chronic infectious diseases through the development of novel and accessible CD8+ T cell-based immunotherapies. Our proprietary technologies combine genetically encoded checkpoint modifiers with selected and optimized target-specific antigens that are inserted into viral vectors to promote potent, prolonged, and broad CD8+ T cell responses. Founded in early 2018 to advance technology licensed from The Wistar Institute, an international leader in biomedical research with special expertise in vaccine, cancer and infectious disease research, Virion has built a best-in-class, experienced biotechnology management team, augmented by its advisory board that has extensive domain knowledge in antiviral, vaccine, and oncology therapeutic arenas. Contact: Virion Therapeutics, LLC. Dr. Sue Currie Chief Operating Officer [email protected] SOURCE Virion Therapeutics, LLC

KING OF PRUSSIA, Pa., Feb. 22, 2023 /PRNewswire/ -- Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization (CDMO) dedicated to addressing critical challenges associated with the commercialization of cell and gene therapies, and Virion Therapeutics (Virion), a clinical-stage biotech company focused on the development of novel, adaptable, and accessible CD8+ T cell-based technologies focused on cancers and infectious diseases, today announced a strategic collaboration agreement wherein CBM will manufacture and partner with Virion on their checkpoint modifier clinical development programs, including the First-in-Human VRON-0200 immunotherapy for patients with chronic Hepatitis B Virus (HBV) infection. "Virion is working to revolutionize the immunotherapy treatment landscape, and we are honored to partner with them on this bold mission as we share a common goal – to create a future free of cancer and chronic infectious diseases," said Audrey Greenberg, Co-Founder and Chief Business Officer of CBM. "We have assembled best-in-field technical teams, supported by industry-leading product and process development, manufacturing, and testing capabilities, all located within a single, world-class manufacturing facility. We look forward to working with Virion to bring their life-saving therapies to the patients who need them most, as quickly as possible." One of the key programs CBM and Virion will be working on together is the VRON-2000, a pan-genotypic, global therapeutic immunotherapy for the treatment of chronic HBV infection, which is estimated to impact over 295 million people around the world. HBV infection impairs CD8+ T cells, resulting in the loss of viral control. Research has shown that VRON-0200 induces a very potent and broad CD8+ T cell response that includes responses to the core and pol regions not normally induced by the infection; as such, a new and highly functional immune response is stimulated to help clear the virus. "Virion is delighted to expand our partnership with CBM through this key strategic collaboration," said Virion's Chief Operating Officer Sue Currie, Ph.D. "As we head to the clinic with our first-in-class, first-in-human program, VRON-0200, for a functional cure for HBV, as well as our other IND-enabling activities for our oncology programs, it is critical to have a manufacturing partner like CBM that has not only the capabilities and breadth of services, but also a highly dedicated and experienced team. We are pleased to have this partnership that is also invested in our corporate goals and values." "CBM is a great partner to support Virion's pipeline and help address high unmet medical needs for persons with cancer and infectious disease worldwide," stated Andrew Luber, Pharm.D., Virion's Chief Executive Officer. "We look forward to our continued collaborations and for their assistance in advancing our programs from early- to later-stage clinical trials." About Virion Therapeutics (Virion) Virion Therapeutics, LLC, is a science driven company whose mission is to cure cancer and chronic infectious diseases through the development of novel and accessible CD8+ T cell based immunotherapies. Our proprietary technologies combine genetically encoded checkpoint modifiers with selected and optimized target-specific antigens that are inserted into viral vectors to promote potent, prolonged, and broad CD8+ T cell responses. Founded in early 2018 to advance technology licensed from The Wistar Institute, an international leader in biomedical research with special expertise in vaccine, cancer and infectious disease research, Virion has built a best-in-class, experienced biotechnology management team, augmented by its advisory board that has extensive domain knowledge in antiviral, vaccine, and oncology therapeutic arenas. About Center for Breakthrough Medicines (CBM) Center for Breakthrough Medicines (CBM) is a cell and gene therapy contract development and manufacturing organization (CDMO) uniquely positioned to enable pharma and biotech companies to develop, test, and manufacture life-saving therapies and treatments on a global scale. Ideally located in the heart of Philadelphia's Cellicon Valley, CBM has assembled the most accomplished cell and gene therapy experts in the world, armed with cutting-edge and innovative technologies, to offer scalable, best-in-class pre-clinical through commercial manufacturing capabilities, including process development, plasmid DNA, vector manufacturing, cell banking, cell processing, and a full suite of complementary and standalone testing and analytical capabilities. Purpose-built and patient-driven, CBM was designed from the ground up to be a more-effective CDMO, providing single-source, end-to-end solutions to deliver true partnership and unprecedented value to its customers through teamwork, transparency, and speed-to-market dedication.