Dengue

Derek Wallace was in a dengue-focused intensive care unmet in Thailand in 2009 when he first saw the devastating impact of the disease up close, also known as breakbone fever. Facing a shortage of space, children shared beds while parents slept together on mattresses tucked below.Thats been the case for decades in some countries, said Wallace, who was a clinical team leader for Sanofi's dengue vaccine studies at the time and is now president of Takeda Pharmaceuticals global vaccine business unit. But whats really important is that its getting worse. Theres 30 times more dengue than there was 50 years ago, and theres eight times more dengue now than there was 20 years ago.The mosquito-transmitted virus is among the top 10 global health threats designated by the World Health Organization. There were a record 6.43 million cases of dengue and nearly 7,000 deaths worldwide in 2023 the largest outbreak ever recorded. Dengue is also spreading faster in places where it hasnt before thanks to factors like climate change, urbanization and increased global travel, according to the WHO.Dengue is moving, and we are starting to get a ton of locally acquired dengue fever cases in the U.S., specifically in Puerto Rico, Virgin Islands and Florida, said Katelyn Jetelina, an epidemiologist and data scientist known for a popular newsletter. And we expect this to continue increasing over time.Despite the rapid global spread, there is no specific treatment for dengue, and worldwide vaccine availability is spottly.Sanofis Dengvaxia is currently the only dengue vaccine approved by the Food and Drug Administration in the U.S. But the company is discontinuing the shot in the third quarter of 2026 due to low global demand for this product, a Sanofi spokesperson said via email.Derek Wallace, president, global vaccine business unit, TakedaPermission granted by TakedaTakedas two-dose dengue vaccine, Qdenga, is approved in 40 countries outside of the U.S, and Takeda withdrew its U.S. application in 2023. Some additional data was requested that we couldn't provide, Wallace said, but declined to provide details.Although the U.S. IND is still open for Qdenga, there are no specific updates to share at this time about the timing of supplying additional data or resubmission, a Takeda spokesperson said via email.The vaccination challengeContracting most viral diseases for the first time will arm the body with antibodies that fend off subsequent infections. But thats not the case with dengue, thanks to antibody dependent enhancement that stems from dengues four closely related, but distinct, viral serotypes.Its challenging because it's a very unique disease in which secondary infections are more severe than the first infections, said Jetelina.Sanofis vaccine has long controversial for this reason. Receiving Dengvaxia could act as a first dengue infection, resulting in a more severe illness after contracting the virus a second time. As a result, Dengvaxia can only be administered to people whove had dengue before, and people must be screened for a previous infection before getting the shot.But thats not how Dengvaxias initial Philippines rollout went a mass vaccination program didnt take this screening step, leading to more severe disease among some patients and potentially some deaths.The onerous logistics of needing a pre-vaccine screening combined with a three-dose regimen not to mention erodeing public trust in vaccines has curbed demand for Dengvaxia so substantially that Sanofi is pulling it from the market.While we have made consistent efforts to facilitate its access and the implementation of the Screen & Vaccinate approach as recommended by WHO in 2018, uptake and demand has remained low, the Sanofi spokesperson said. Despite an increased prevalence of dengue in different parts of the world, theres only one Dengvaxia immunization program in place due to the complexity of implementing this product.Qdenga doesnt have these limitations. According to Takeda, the two-dose jab is the only vaccine approved for use regardless of previous dengue exposure. The WHO doesnt recommend pre-vaccination screenings for Qdenga administration in settings with high dengue transmission, although local approvals may vary. Qdenga has been shown to be 61% effective against symptomatic disease and 84% effective in preventing hospitalization. Still, its not approved in the U. S.Other vaccines are in development, including the single-dose ButantanDengue vaccine that showed positive Phase 3 study results.Dengues spreadThese vaccination and treatment challenges only make dengues spread more worrisome.Dengue is spreading to areas where it was not prevalent, and its affecting more susceptible populations that have no immunity whatsoever, said Andr Siqueira, head of the Dengue Global Program at the nonprofit Drugs for Neglected Diseases.He points to southern Brazil, where dengues recent and rapid spread has overwhelmed health systems in an area that previously didnt have any infections.What has happened the last few years in Brazil may mirror what can happen in these places where dengue transmission is still picking up, Siqueira said.The U. S. is one of those places. In Puerto Rico, a record-high dengue surge sparked a public health emergency in March, and in the Florida Keys, public health officials issued an alert last summer.Dengue thrives in warm urban areas, and the mosquitoes responsible for its spread can efficiently reproduce even in small pockets of water. Therefore, a warming climate with heavier rainfalls, along with increased urbanization, are all fueling the spread. Moreover, these mosquitoes have evolved resistance to insecticides and are adapting to different conditions, including more temperate climates, Siqueira said.Thats why public health organizations are taking action. DNDi kick-started its Dengue Alliance in 2022; the WHO launched a global strategic plan against dengue earlier this month; and Takeda partnered with the Indian pharma Biological E. Limited earlier this year to accelerate access to the vaccine in endemic areas.But public health officials and local health systems are still racing against the clock, calling for more vaccines, dengue-specific treatments and improved diagnostics.There is a perception that well find one solution for dengue, Siqueira said. What we probably need in the most affected areas is an integrated approach. '

Integral Molecular, a company that develops vaccines and therapeutics, announced a five-year $8 million contract from the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID). The funding will be used to support the company's continuing research into emerging viruses recognized as potential pandemic threats. This marks the fourth similar contract awarded to the company in 15 years. Prior contracts allowed responses to virus outbreaks such as SARS-CoV-2, Zika, Ebola, dengue and chikungunya. Integral Molecular will utilize its mapping platform to pinpoint antibody binding sites (epitopes) on viruses, characterizing immune responses to viral threats. According to the company, this type of information can help scientists design effective vaccines. Additionally, Integral Molecular's Reporter Virus Particles (RVPs) is expected to play a vital role in the research. In a statement, the company said the non-replicative virus particles allow safe and high-throughput neutralization studies of highly pathogenic viruses with the use of standard laboratory facilities, and RVPs empower researchers to quickly develop vaccines and therapeutics. The NIAID contract will allow Integral Molecular to expand its research on potential pandemic threats, including Rift Valley Fever, Crimean-Congo Hemorrhagic Fever and Enterovirus D68 viruses. "We are grateful to NIAID for their continued support and trust in our capabilities," Benjamin Doranz, CEO of Integral Molecular, said in a statement. "Viral threats can emerge quickly and with little warning. This contract enables us to contribute to pandemic preparedness by focusing on understudied viruses identified as potential threats, using our technologies to make virology research more accessible to laboratories around the world." THE LARGER TREND In June, Integral Molecular, received ISO 9001 certification for the quality systems and processes used in their virology offerings. In April, Integral Molecular launched its Virus Neutralization Assay Services, which permitted researchers to rapidly obtain high-quality data to advance their vaccines and therapeutic antibodies. Neutralization Assay Services allow diverse applications including neutralization profiling for antibodies targeting viral proteins. That same month, researchers at the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), developed an artificial intelligence tool that predicts whether a patient will respond to cancer-treatment drugs using individual tumor cells, according to a study published in Nature Cancer. Conventional approaches to drug-patient matching center on bulk sequencing of tumor DNA and RNA. The new AI approach, PERCEPTION, takes advantage of single-cell RNA sequencing, which provides better-resolution data to fine-tune predicted drug responses. In 2022, Ro, a direct-to-patient care company, secured an agreement with the National Institute on Aging (NIA) to develop the Registry for Equal Access to Clinical Trials in Alzheimer's Disease (REACT-AD). Ro will employ its telehealth platform to screen and recruit patients who are at a heightened risk for developing Alzheimer's disease or other related dementia to join REACT-AD for potential participation in NIA-conducted and funded clinical trials. The NIA, part of the NIH, was charged with analyzing the data received and supervising the publication of research findings that emanate from REACT-AD.

Saint-Herblain (France), October 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today that members of its senior leadership team will present datasets on the world’s first and only approved chikungunya vaccine, IXCHIQ ® , at several leading scientific conferences during the fourth quarter of 2024. At the International Society of Vaccines Annual Congress taking place in Seoul, South Korea, Valneva will present on the two-year antibody persistence and safety data of its single-dose chikungunya vaccine in adults aged 18 years and above today at 5:00 pm Korea Standard Time (KST). The Company will also display a poster at the event complementing the presentation. At the American Society of Tropical Medicine and Hygiene (ASTMH) 2024 Annual Meeting in New Orleans, Louisiana, Valneva will hold a presentation on the pivotal Phase 3 six-month safety and immunogenicity data of its single-dose chikungunya vaccine in adolescents in Brazil on November 16, 2024, at 11:15 am Central Daylight Time (CDT). The Company will also display four posters: “Chikungunya: Ongoing Dose-Response, Safety, and Immunogenicity Phase 2 Trial of Single-dose Live-attenuated Vaccine (VLA1553) in Children aged 1 to 11 years”, “Modelling of 5 Year Antibody Persistence after Vaccination with Live Attenuated Chikungunya Vaccine VLA1553 (IXCHIQ ® )”, “The Global Health Burden of Chikungunya from 2011 to 2020: A Model-Driven Analysis on the Impact of an Emerging Vector-Borne Disease” and “Predicting Chikungunya in Miami: Outbreak Impact and Effectiveness of Vaccine Intervention with IXCHIQ ® ”. Finally, during the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) European Congress taking place November 17 - 20, 2024 in Barcelona, Spain, Valneva will present a poster on the cost-effectiveness of IXCHIQ ® vaccination in Puerto Rico. About Chikungunya Chikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years. 1 In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas. 2 Between 2013 and 2023, more than 3.7 million cases were reported in the Americas 3 and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem. 4 About Valneva SE We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions. We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines. Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at . Valneva Investor and Media Contacts Laetitia Bachelot-Fontaine VP Global Communications & European Investor Relations M +33 (0)6 4516 7099 laetitia.bachelot-fontaine@valneva.com Joshua Drumm, Ph.D. VP Global Investor Relations M +001 917 815 4520 joshua.drumm@valneva.com Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates, to regulatory approval of product candidates and review of existing products. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 2 3 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). . Last accessed 01 Aug 2023. 4 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas (who.int) Attachment 2024_10_21_Chik_Q4_2024_Conference_Presentations_PR_EN_Final