SOUTH SAN FRANCISCO, Calif., Oct. 20, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (OTCQX: VXRT) (“Vaxart”), a clinical-stage biotechnology company developing a range of oral recombinant pill vaccines based on its proprietary delivery platform, today announced that it will present research featuring its second-generation norovirus oral pill vaccine candidate at IDWeek 2025 taking place October 19-22, 2025, at the Georgia World Congress Center in Atlanta. IDWeek Oral Abstract Presentation: Presentation Title: An Op ...

SOUTH SAN FRANCISCO, Calif., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (OTCQX: VXRT) (“Vaxart” or the “Company”), a clinical-stage biotechnology company developing a range of oral recombinant pill vaccines based on its proprietary delivery platform, today announced that it will present research highlighting its advances in its norovirus and COVID-19 programs at the World Vaccine Congress Europe 2025 taking place in Amsterdam on October 13-16, 2025. Vaxart’s mission is to improve global public health by ...

Core Insights - Evaxion A/S is set to present new data for its lead asset EVX-01, a personalized cancer vaccine, at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting [1] - The ongoing phase 2 trial of EVX-01 is investigating its efficacy in combination with Merck's KEYTRUDA® for advanced melanoma patients [3][5] - EVX-01 has shown promising results with overall response rates of 69% and 67% in advanced melanoma patients [6] Presentation Details - New biomarker and immune data from the phase 2 trial will be presented at SITC 2025, with two-year clinical efficacy data to be shared at the ESMO 2025 congress on October 17, 2025 [2][8] - The SITC presentation will include an abstract titled "Immune correlates of clinical response following treatment with the personalized cancer vaccine EVX-01 and Pembrolizumab in advanced melanoma patients" [9] About EVX-01 - EVX-01 is designed using Evaxion's AI-Immunology™ platform, targeting the unique tumor profile and immune characteristics of each patient [5][10] - The vaccine aims to engage the patient's immune system to mount a targeted response against tumors, representing a first-line treatment option for multiple advanced solid cancers [5] Clinical Trial Insights - The phase 2 trial combines EVX-01 with KEYTRUDA®, allowing for a personalized approach to treatment based on individual patient biology [3] - The trial has already provided strong one-year interim data, contributing to a robust data package for EVX-01 [2][8]

Core Insights - Evaxion A/S has out-licensed its vaccine candidate EVX-B3 to MSD, receiving an initial cash payment of $7.5 million and potential future payments totaling up to $592 million [1][2][10] - The EVX-B3 vaccine, currently in preclinical development, targets a pathogen linked to serious medical complications and aims to address a significant global health issue [3][4] - The collaboration with MSD validates Evaxion's AI-Immunology™ platform, which has identified novel vaccine targets for challenging pathogens [4][5] Financial Implications - The cash payment extends Evaxion's cash runway into the first half of 2027, allowing continued investment in its AI-Immunology™ platform and R&D projects [6] - Future milestone payments from MSD for EVX-B3 could reach up to $592 million, along with royalties on net sales [2][10] - Should MSD exercise its option on EVX-B2, Evaxion would receive an additional cash payment of $2.5 million and similar milestone and royalty structures as with EVX-B3 [9][10] Development and Collaboration - The collaboration between Evaxion and MSD began in September 2023 and has now expanded to include EVX-B2, a preclinical vaccine candidate against Gonorrhea [7][8] - The evaluation period for EVX-B2 has been extended, with a decision on potential licensing expected in the first half of 2026 [8][9] - MSD will assume full responsibility for the further development of EVX-B3, allowing Evaxion to focus on its strategic partnerships [2][10]

Core Insights - Vaxart, Inc. reported positive data from its Phase 1 clinical trial for second-generation oral norovirus vaccine constructs, showing significant increases in fecal IgA responses compared to first-generation constructs [1][4][5] Group 1: Vaccine Efficacy - The second-generation vaccine candidates demonstrated a 25-fold increase in GII.4 fecal IgA response and a 10-fold increase in GI.I fecal IgA response at high doses after a single tablet administration [2] - At low doses, the second-generation constructs showed an 8-fold increase in GII.4 fecal IgA response and a 7-fold increase in GI.I fecal IgA response [2] - The fecal IgA increases from second-generation constructs were significantly higher than the first-generation constructs, which showed a 13-fold increase for GII.4 and a 6-fold increase for GI.1 [3] Group 2: Immunological Responses - The data indicates that the second-generation constructs induce more robust immunologic responses, which are critical as they correlate with protection from norovirus infection [4][5] - The first-generation constructs achieved a statistically significant 30% relative reduction in infection compared to placebo, suggesting that the enhanced fecal IgA and blocking antibody responses from the second-generation constructs may lead to improved efficacy [4] Group 3: Market Potential and Future Plans - Norovirus is a leading cause of acute gastroenteritis globally, with approximately 685 million infections annually, including 20 million in the U.S., leading to an estimated economic burden of $60 billion worldwide and $10 billion in the U.S. [7] - Vaxart aims to secure partnerships or funding to conduct a Phase 2 trial for these constructs, with plans for a Phase 2b safety and immunogenicity study potentially starting before the end of 2025 [6] - The company is positioned to develop oral vaccines for various diseases, including norovirus, and has filed broad patent applications for its proprietary technology [9]

Core Viewpoint - Soligenix, Inc. has demonstrated the extended stability of its ebolavirus vaccines using the ThermoVax® platform, maintaining potency after two years at high temperatures, which is crucial for deployment in virus-endemic regions and for pandemic preparedness [1][2]. Group 1: Vaccine Stability and Efficacy - The bivalent and trivalent vaccines, targeting Zaire ebolavirus, Sudan ebolavirus, and Marburg marburgvirus, showed no change in potency after two years of storage at 40°C (104°F) [1]. - The vaccines have exhibited broad immune responses in mice and up to 100% protection in non-human primates [2][3]. - The ThermoVax® platform enhances the stability of vaccines, making them competitive with other technologies that require stringent cold-storage [2][3]. Group 2: Vaccine Development and Manufacturing - The filovirus vaccines are subunit protein vaccines developed in collaboration with Dr. Axel Lehrer, utilizing a robust protein manufacturing process [3][4]. - The vaccines are designed to be heat-stable and can be lyophilized, allowing for easy reconstitution with water prior to use [3]. - The adjuvant used in the vaccines has been tested in Phase 1 and Phase 2 clinical studies, supporting its safety and efficacy [4]. Group 3: Regulatory and Market Position - Soligenix has received Orphan Drug Designation from the FDA for its filovirus vaccines, providing market exclusivity and various financial benefits [5]. - The company is positioned to leverage government grants and regulatory advantages to support clinical trials and potential market entry [5]. Group 4: Public Health Context - Filoviruses, including Ebola and Marburg, have high mortality rates and limited treatment options, highlighting the need for effective vaccines [6][7]. - Recent outbreaks of Sudan and Marburg viruses underscore the importance of developing vaccines that can be stored and distributed easily in affected regions [6][7].

Core Points - Vaxart, Inc. announced the retirement of its Chairman, Michael J. Finney, effective September 30, 2025, after a distinguished tenure [1][2] - The CEO of Vaxart expressed gratitude for Finney's leadership and contributions to the company's growth and mission [2] - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using its proprietary delivery platform [3] Company Overview - Vaxart develops oral recombinant vaccines that can be stored and shipped without refrigeration, eliminating the risk of needle-stick injury [3] - The company is working on pill vaccines for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [3] - Vaxart has filed broad domestic and international patent applications for its oral vaccination technology [3]

Company Update - Vaxart, Inc. will provide a business update and report financial results for the second quarter ended June 30, 2025, after market close on August 13, 2025 [2] - A conference call hosted by Vaxart's senior management team will take place on the same day at 4:30 p.m. ET [2] - Investors can submit written questions in advance of the conference call by August 12, 2025 [2] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [4] - The company's vaccines are designed to be administered in pill form, which can be stored and shipped without refrigeration, eliminating needle-stick injury risks [4] - Current development programs include vaccines for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [4] - Vaxart has filed broad domestic and international patent applications covering its proprietary technology for oral vaccination [4]

Core Viewpoint - Sanofi has announced the acquisition of Vicebio Ltd, enhancing its respiratory vaccines pipeline with a focus on developing combination vaccines for respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) [1][2][5] Group 1: Acquisition Details - The acquisition involves an upfront payment of $1.15 billion, with potential milestone payments of up to $450 million based on development and regulatory achievements [5] - The transaction is expected to close in Q4 2025, pending regulatory approvals [5] Group 2: Technology and Product Pipeline - Vicebio's 'Molecular Clamp' technology stabilizes viral proteins, allowing for quicker development of fully liquid combination vaccines that can be stored at standard refrigeration temperatures (2–8°C) [3][4] - Vicebio's pipeline includes VXB-241, a bivalent vaccine candidate for RSV and hMPV currently in exploratory phase 1 study, and VXB-251, a preclinical trivalent vaccine candidate targeting RSV, hMPV, and parainfluenza virus Type 3 (PIV3) [4] Group 3: Strategic Importance - The acquisition allows Sanofi to expand its offerings in the respiratory vaccines space, providing increased options for physicians and patients by adding a non-mRNA vaccine to its pipeline [2] - Sanofi aims to leverage Vicebio's technology to develop next-generation combination vaccines that could protect older adults against multiple respiratory viruses with a single immunization [4]

Core Viewpoint - Vaxart, Inc. has received approval to trade its common stock on the OTCQX Best Market, enhancing transparency and accessibility for investors, following a delisting notice from Nasdaq [1][2]. Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform, which allows for storage and shipping without refrigeration [4]. - The company is advancing multiple vaccine candidates targeting infectious diseases, including those for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [4]. Stock Listing Situation - After receiving a delisting notice from Nasdaq, Vaxart has requested a hearing to appeal the decision, with its common stock currently suspended pending the outcome [2][3]. - The company is exploring all options regarding its stock listing while prioritizing shareholder interests [3].