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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

WAYNE, Pa. and ROCKVILLE, Md., Nov. 07, 2022 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), today announced it entered into a purchase agreement to sell its economic rights to future payments for previously out-licensed assets including AVTX-007, AVTX-501, and AVTX-611 to ES Therapeutics, LLC (ES) in exchange for $5.0 million. The sale is expected to close in November. “This transaction will strengthen our balance sheet and further demonstrates the execution of our strategy to utilize business development to fund our core programs,” said Garry A. Neil, MD, Chief Executive Officer and Chairman of the Board of Avalo Therapeutics. “Once completed, we will have raised $20 million of nondilutive funding since August. These transactions meaningfully improve our financial position and support our lead asset, AVTX-002, which remains on track to deliver data from our Phase 2 PEAK trial in non-eosinophilic asthma in the first half of next year.” Pursuant to the purchase agreement, at the closing of the transaction Avalo (i) will sell to ES all of Avalo’s (a) rights to any milestone payments under the Asset Purchase Agreement, dated August 14, 2017, by and between Avalo and Janssen Pharmaceuticals, Inc. (relating to AVTX-501), and (b) any future milestone and royalty payments under the License Agreement, dated July 29, 2022, by and between Apollo AP43 Limited and Avalo (relating to AVTX-007), and (ii) will waive all rights, including all payments due to Avalo from ES, under the Assignment of License Agreement, dated August 8, 2019 (relating to AVTX-406), by and among Avalo, ES and Armistice Capital Master Fund Ltd (Armistice). The purchase agreement contains customary representations and warranties and covenants of the Company and ES. ES is an affiliate of Armistice, which is a significant stockholder of the Company. About AVTX-002 AVTX-002 is a fully human monoclonal antibody, directed against human LIGHT (Lymphotoxin-like, exhibits Inducible expression, and competes with Herpes Virus Glycoprotein D for Herpesvirus Entry Mediator (HVEM), a receptor expressed by T lymphocytes). AVTX-002 is currently in Phase 2 development for non-eosinophilic asthma (PEAK trial) with proof-of-concept data in inflammatory bowel diseases and COVID-19 acute respiratory distress syndrome. About AVTX-002 PEAK Trial The Phase 2 PEAK trial (n=approximately 80) is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of AVTX-002 for the treatment of poorly controlled NEA (NCT05288504). The primary endpoint is the proportion of subjects who experience an asthma-related event. At baseline, subjects will be randomized to receive either AVTX-002 or placebo once monthly. About Avalo Therapeutics Avalo Therapeutics is a clinical stage biotechnology company focused on the treatment of immune dysregulation by developing therapies that target the LIGHT network. LIGHT (Lymphotoxin-like, exhibits Inducible expression, and competes with HSV Glycoprotein D for Herpesvirus Entry Mediator (HVEM), a receptor expressed by T lymphocytes; also referred to as TNFSF14) is an immunoregulatory cytokine. LIGHT and its signaling receptors, HVEM (TNFRSF14), and lymphotoxin β receptor (TNFRSF3), form an immune regulatory network with two co-receptors of herpesvirus entry mediator, checkpoint inhibitor B and T Lymphocyte Attenuator (BTLA), and CD160 (the LIGHT-signaling network). Accumulating evidence points to the dysregulation of the LIGHT network as a disease-driving mechanism in autoimmune and inflammatory reactions in barrier organs. Therefore, we believe reducing LIGHT levels can moderate immune dysregulation in many acute and chronic inflammatory disorders. For more information about Avalo, please visit www.avalotx.com. About ES Therapeutics ES Therapeutics is a privately held global pharmaceutical company focused on the development of therapeutics to treat certain neurological disorders. The company is currently engaged in clinical work in the U.S., Australia, and Canada. Forward-Looking Statements This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond Avalo’s control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Avalo’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “might,” “will,” “could,” “would,” “should,” “continue,” “seeks,” “aims,” “predicts,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” or similar expressions (including their use in the negative), or by discussions of future matters such as: the future financial and operational outlook; the development of product candidates or products; timing and success of trial results and regulatory review; potential attributes and benefits of product candidates; and other statements that are not historical. These statements are based upon the current beliefs and expectations of Avalo’s management but are subject to significant risks and uncertainties, including: Avalo's cash position and the need for it to raise additional capital in the near future; drug development costs, timing and other risks, including reliance on investigators and enrollment of patients in clinical trials, which might be slowed by the COVID-19 pandemic; reliance on key personnel, including as a result of recent management changes; regulatory risks; general economic and market risks and uncertainties, including those caused by the COVID-19 pandemic and the war in Ukraine; and those other risks detailed in Avalo’s filings with the SEC. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Avalo expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Avalo’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. For media and investor inquiriesChristopher Sullivan, CFO Avalo Therapeutics, Inc.ir@avalotx.com410-803-6793orChris BrinzeyICR WestwickeChris.brinzey@westwicke.com339-970-2843