Latest news with #immunogenicity
Yahoo
6 days ago
- Health
- Yahoo
Novavax's H5N1 Vaccine Candidate Demonstrates Immunogenicity in Preclinical Study
Peer-reviewed data shows Novavax's H5N1 vaccine candidate demonstrated immunogenicity against currently circulating variants following either single or two-dose administration Potential for single intranasal or intramuscular dose could differentiate Novavax's vaccine as part of pandemic emergency preparedness efforts GAITHERSBURG, Md., July 24, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced preclinical data demonstrating that Novavax's H5N1 avian pandemic influenza vaccine candidate, leveraging Novavax's recombinant, protein-based nanoparticle technology and Matrix-M® adjuvant, induced robust immune responses by either single or two-dose intranasal (IN) or intramuscular (IM) administration in nonhuman primates. Results were published in Nature Communications. "These preclinical results underscore the promise and potential of our pandemic influenza program as well as the strength of our technology platform and our ability to deliver against our corporate growth strategy," said Ruxandra Draghia-Akli, MD, PhD, Executive Vice President and Head of Research and Development, Novavax. "Our R&D pipeline focuses on delivering assets ready for partnership and prioritizing areas of unmet medical need, including vaccines for avian pandemic influenza, where we see clear potential advantages for our technology compared with other vaccines that are licensed or in development." Results showed that a single dose administered by either IN or IM routes induced neutralizing antibody responses (IN: 1:54; IM: 1:1,160), at or above the 1:40 titer generally considered to be a protective antibody response. The data showed even higher levels of immunity after two doses. These data suggest that even a single IN dose has the potential to provide protective immunity in individuals previously exposed to seasonal influenza either by vaccination or infection. Further, data showed Novavax's H5N1 vaccine candidate elicited broad antibody responses, suggesting the potential to protect against forward-drift variants from currently circulating strains of the H5N1 virus. H5N1, a highly pathogenic and dynamic avian pandemic influenza virus, is of concern due to its potential to mutate into a strain adapted for sustained human-to-human transmission. To date, there have been 70 confirmed total reported human cases in the U.S., and one death associated with H5N1 avian pandemic influenza infection.1 As of July 2025, no reported cases in the U.S. have been proven to result from human-to-human transmission. As part of its corporate growth strategy, Novavax is making targeted investments in early-stage development programs to create value. Novavax intends to pursue funding, partnership and licensing opportunities for its H5N1 vaccine candidate. About Novavax Novavax, Inc. (Nasdaq: NVAX) tackles some of the world's most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including protein-based nanoparticles and its Matrix-M adjuvant. The Company's growth strategy seeks to optimize its existing partnerships and expand access to its proven technology platform via research and development (R&D) innovation, organic portfolio expansion in infectious disease and beyond, and forging new partnerships and collaborations with other companies. Please visit and LinkedIn for more information. Forward-Looking Statements Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, and the potential for a single intranasal or intramuscular dose differentiating Novavax's H5N1 vaccine, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges pursuing additional partnership opportunities; challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification, assay validation and stability testing, necessary to satisfy applicable regulatory authorities; challenges or delays in conducting clinical trials or studies for its product candidates; challenges or delays in obtaining regulatory authorization for its product candidates, including for future COVID-19 variant strain changes, its CIC vaccine candidate, its stand-alone influenza vaccine candidate or other product candidates; manufacturing, distribution or export delays or challenges; Novavax's substantial dependence on Serum Institute of India Pvt. Ltd. and Serum Life Sciences Limited for co-formulation and filling Novavax's COVID-19 vaccine and the impact of any delays or disruptions in their operations; difficulty obtaining scarce raw materials and supplies including for its proprietary adjuvant; resource constraints, including human capital and manufacturing capacity; constraints on Novavax's ability to pursue planned regulatory pathways, alone or with partners; challenges in implementing its global restructuring and cost reduction plan; challenges in obtaining commercial adoption and market acceptance of its updated COVID-19 vaccine or any COVID-19 variant strain containing formulation, or for its CIC vaccine candidate and stand-alone influenza vaccine candidate or other product candidates; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities, including requirements to deliver doses that may require Novavax to refund portions of upfront and other payments previously received or result in reduced future payments pursuant to such agreements and challenges in amending or terminating such agreements; challenges related to the seasonality of vaccinations against COVID-19; challenges related to the demand for vaccinations against COVID-19 or influenza; challenges in identifying and successfully pursuing innovation expansion opportunities; Novavax's expectations as to expenses and cash needs may prove not to be correct for reasons such as changes in plans or actual events being different than its assumptions; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at and for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Contacts: Investors Luis Sanay, CFA 240-268-2022 ir@ Media Giovanna Chandler (844) 264-8571 media@ References U.S. Centers for Disease Control and Prevention. H5 Bird Flu: Current Situation. 2025. Available at: View original content to download multimedia: SOURCE Novavax, Inc.
Yahoo
10-07-2025
- Business
- Yahoo
Tonix Pharmaceuticals Announces Presentation of New Data on Mpox and Smallpox Vaccine Candidate TNX-801 at the Vaccine Congress 2025
TNX-801 is up to 100,000-fold less virulent than live smallpox vaccine strains and a single dose provides robust immunogenicity and protection against mpox and rabbitpox (more than one year) in animals Subcutaneous administration of TNX-801 yielded equivalent protection to the traditional percutaneous administration CHATHAM, N.J., July 10, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the presentation of new findings on TNX-801 (recombinant horsepox, live virus vaccine) at the Vaccine Congress 2025 in Vienna on July 10, 2025, by Sina Bavari, PhD, Executive Vice President, Infectious Disease Research and Development. 'The data show that TNX-801 can deliver durable immunity while remaining highly attenuated, a balance that sets it apart from earlier orthopox vaccines,' said Seth Lederman, MD, Chief Executive Officer of Tonix Pharmaceuticals. 'The novel finding that subcutaneous (s.c.) administration of TNX-801 provides equivalent protection to percutaneous administration, is leading us to develop the s.c. product first. Most live-virus vaccines are delivered s.c. and this route of administration has further potential benefits of decreased administration-site bacterial superinfection, scarring, or inadvertent transfer to other body sites by itching. We believe TNX-801 has the potential to become a critical tool for containing mpox and preparedness against the malicious reintroduction of smallpox. We look forward to advancing TNX-801 into the clinic by s.c. delivery.' TNX-801 is a recombinant horsepox-derived vaccine candidate designed to prevent orthopox viruses and provide durable humoral and cellular immunity from a single dose. In primary human dermal cells, the virus replicates twenty-seven to one-hundred-nineteen-fold less than licensed vaccinia strains, and in interferon receptor knockout mice it is up to one-hundred-thousand-fold less virulent than those legacy vaccines. Preclinical studies further showed that a single dose of TNX-801 produced strong binding and neutralizing antibody responses across mice, rabbits, hamsters, and cynomolgus macaques, including immunocompromised animals. All vaccinated macaques survived lethal Clade I mpox challenge without lesions, and rabbit models remained fully protected for fourteen months. 'Our data show that TNX-801 delivers durable immunity without safety concerns of live virus vaccines,' said Dr Bavari. 'TNX-801 dissociates immune protection from some of the side-effects associated with traditional vaccinia-based vaccines and potentially offers a unique risk-benefit profile for mpox and smallpox prevention. We are excited to advance this program toward clinical evaluation in collaboration with public-health partners worldwide.' The World Health Organization and the Centers for Disease Control and Prevention continue to classify mpox as an ongoing public-health concern. A single-dose vaccine with the attenuation and immunogenicity profile demonstrated by TNX-801 could streamline outbreak response by reducing the need for approved multi-visit immunization schedules. Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biotech company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix's development portfolio is focused on central nervous system (CNS) disorders. Tonix's priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix's immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix's infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD's Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. * Tonix's product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners. This press release and further information about Tonix can be found at Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as 'anticipate,' 'believe,' 'forecast,' 'estimate,' 'expect,' and 'intend,' among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the 'SEC') on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. Investor Contact Jessica Morris Tonix Pharmaceuticals (862) 799-8599 Brian Korb astr partners (917) 653-5122 Media Contact Ray Jordan Putnam Insights ray@ Indication and Usage Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine. Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age. Important Safety Information Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack: discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem. Do not use Zembrace or Tosymra if you have: history of heart problems narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease) uncontrolled high blood pressure hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider. had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation severe liver problems taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure. are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure. an allergy to sumatriptan or any of the components of Zembrace or Tosymra Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements. Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert. Zembrace and Tosymra may cause serious side effects including: changes in color or sensation in your fingers and toes sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet increased blood pressure including a sudden severe increase even if you have no history of high blood pressure medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider. serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking. hives (itchy bumps); swelling of your tongue, mouth, or throat seizures even in people who have never had seizures before The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only). Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider. This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit or call 1-888-869-7633. You are encouraged to report adverse effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.
Yahoo
10-07-2025
- Health
- Yahoo
Osivax Publishes Phase 2a Results Supporting Co-Administration of OVX836 with Seasonal Flu Vaccine in Vaccines Journal
Co-administration of OVX836 with seasonal inactivated influenza vaccine (Fluarix® Tetra) was well-tolerated and demonstrated a favorable safety profile Robust complementary immune responses were induced, with no major interference observed Lyon, France – July 10, 2025 – Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses, today announced the publication of positive results from its Phase 2a, OVX836-004, study in the journal Vaccines. The study evaluated the safety and immunogenicity of co-administering OVX836, Osivax' broad-spectrum influenza vaccine candidate, with the hemagglutinin antigen (HA)-based inactivated influenza vaccine Fluarix® Tetra. The full article 'Safety and Immunogenicity of OVX836, a Nucleoprotein-Based Universal Influenza Vaccine, Co-Administered with Fluarix® Tetra, a Seasonal Hemagglutinin-Based Vaccine' is now available online. In the OVX836-004 study (NCT05284799), 180 healthy adults aged 18 to 55 years were randomized to each receive two concomitant intramuscular injections of Fluarix® Tetra and placebo, Fluarix® Tetra and OVX836 (480 µg), or OVX836 and placebo, both administered into the deltoid muscle of the non-dominant arm. Key findings include: Favorable safety and tolerability profile of OVX836 when administered alone or in combination with Fluarix® Tetra; no severe or unsolicited adverse events were reported Comparable local and systemic reactions across all treatment groups Strong HA-specific antibody responses were observed in all groups immunized with Fluarix® Tetra, whether co-administered with OVX836 or as a stand-alone, with similar HAI titers across all four influenza strains Robust NP-specific immune responses, both humoral and cell-mediated, were measured in all groups receiving OVX836, whether co-administered with Fluarix® Tetra or as a stand-alone 'The favorable safety profile and strong immune response observed in this study provide encouraging evidence that OVX836 can be co-administered with a standard seasonal influenza vaccine,' commented Dr. Nicola Groth, MD, CMO of Osivax. 'These findings support the potential of OVX836 to lead to higher efficacy due to synergistic effects of the immune responses when combined with standard seasonal flu vaccine and to further reinforce the versatility of our vaccine candidate, marking an important milestone in our efforts to broaden protection against influenza in years of strain mismatches.' 'The results underscore OVX836's strong potential as a valuable component of combination approaches with seasonal vaccines,' added Alexandre Le Vert, CEO and Co-Founder of Osivax. 'By inducing strong and complementary immune responses, our approach positions us to meaningfully advance influenza prevention on a broader scale. The data collected will support the continued development of OVX836 as we focus on a single-injection formulation that streamlines vaccination delivery and maximizes public health impact.' About OVX836 OVX836 is a first-in-class influenza A vaccine candidate that targets the nucleoprotein (NP), a highly conserved internal antigen. Unlike surface antigens, the NP is much less likely to mutate, providing a broader and more universal immune response. Osivax' oligoDOMTM technology enables the design and production of a recombinant version of the NP, which self-assembles into a nanoparticle, thus triggering powerful T- and B-cell immune responses. OVX836 has been tested in 7 clinical trials with 1,400 participants so far, and has shown promising safety, immunogenicity, and efficacy read-outs. About OVX836-004OVX836-004 is a randomized, double-blind, reference-controlled, single-center Phase 2a clinical trial run in Australia (NCT05284799), to assess the co-administration of NP-based flu vaccine OVX836 at 480μg with a conventional seasonal, HA-based quadrivalent inactivated influenza virus vaccine (QIV), the current standard of care in the flu vaccine market. The clinical study is evaluating the safety and level of immune response generated by each vaccine individually and when co-administered to confirm the absence of immune interference. About Osivax Osivax is a clinical-stage biopharmaceutical company leveraging its novel, self-assembling nanoparticle platform technology, oligoDOMTM, to develop transformative, first-in-class pan-respiratory virus vaccines generating superior T-cell responses in addition to strong and sustained B-cell responses. The company is establishing proof of concept with its broad-spectrum influenza vaccine candidate, OVX836, which is currently in Phase 2 clinical trials with over 1,400 volunteers tested and encouraging efficacy proof of concept data. Osivax' ambition is to develop a pan-respiratory virus vaccine to prevent all strains of influenza and all variants of Covid-19 in one single shot. The company will expand into other infectious disease indications through combinations and collaborations worldwide. For further information: ContactAlexandre LE VERT, CEOcontact@ (0)9 70 30 13 80 For Media InquiriesTrophic CommunicationsDesmond James or Anja Heuerosivax@ +49 (0) 151 678 59086 or +49 (0) 151 106 199 05Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Medscape
12-06-2025
- Health
- Medscape
Novel Lyme Disease Vaccine Effective Across All Ages
An investigational vaccine for Lyme borreliosis, VLA15, was safe, well-tolerated, and immunogenic in people aged between 5 and 65 years, with children and adolescents showing notably stronger responses than adults. METHODOLOGY: Researchers assessed the safety and immunogenicity of the Lyme borreliosis vaccine candidate VLA15, administered using different vaccination schedules, in an ongoing randomized phase 2 trial conducted across multiple sites in Lyme borreliosis-endemic regions of the US. They enrolled 625 participants (median age at screening, 23 years; 51% women), including children (5-11 years), adolescents (12-17 years), and adults (18-65 years). Participants within each age cohort were randomly assigned to receive either VLA15 (180 µg) at months 0, 2, and 6 (three-dose regimen); VLA15 at months 0 and 6 with placebo at month 2 (two-dose regimen); or placebo at months 0, 2, and 6. The primary immunogenicity endpoint was the immunoglobulin G (IgG) response against outer surface protein A (OspA), measured using an enzyme-linked immunosorbent assay, at month 7 post-vaccination (1 month after the final vaccine dose) across all age cohorts. The primary safety endpoint was the frequency of solicited local and systemic adverse events within 7 days after any vaccination. TAKEAWAY: OspA-specific IgG geometric mean titers at month 7 were significantly higher in both VLA15 groups than in the placebo group ( P < .0001), with the three-dose regimen group showing higher titers (333.2-656.0 units/mL) than the two-dose regimen group (197.3-460.3 units/mL). < .0001), with the three-dose regimen group showing higher titers (333.2-656.0 units/mL) than the two-dose regimen group (197.3-460.3 units/mL). Immune responses showed an age-specific pattern, with geometric mean titers from the three-dose regimen being highest in children (706.6-1364.1 units/mL), followed by adolescents (514.6-909.5 units/mL) and adults (201.6-419.3 units/mL). Similar trends were observed with the two-dose regimen. Although antibody levels waned between months 7 and 12 in both VLA15 groups, they remained above baseline, with age-dependent patterns persisting. Solicited local and systemic adverse events were more common in the VLA15 group, though none were of grade 4. No deaths were reported during the 12-month duration of the trial. IN PRACTICE: 'VLA15 represents an important advance in the prevention of Lyme borreliosis. It covers a broad spectrum of serotypes and has a favorable safety profile in both children and adults,' the authors of a commentary wrote. SOURCE: This study was led by Laura Wagner, Valneva Austria, Vienna, Austria. It was published online on April 25, 2025, in The Lancet Infectious Diseases . LIMITATIONS: This trial had limited racial diversity, was conducted exclusively at sites in the US, and excluded individuals older than 65 years. DISCLOSURES: This study was funded by Pfizer and Valneva. Few authors reported being current or former employees or paid consultants of Valneva, with possible stock or stock option holdings. One author reported being a former employment at Pfizer, with possible stock or stock option holdings.
