Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Adenocarcinoma

Phase 1b study evaluating the efficacy and immune response to a synthetic long peptide mutant KRAS vaccine (SPL mKRASvax) combined with Balstilimab and Botensilimab for unresectable or metastatic mismatch repair-proficient (MMR-p) colorectal cancer (mCRC) or unresectable or metastatic MMR-p pancreatic ductal adenocarcinoma (PDAC) patients with measurable disease following first-line FOLFIRINOX/FOLFOXIRI (FFX).

Start Date04 Nov 2024

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+2]

NCT06015724 / RecruitingPhase 2IIT

A Phase 2 Study Evaluating the Efficacy of Anti-CD38 Antibody in Combination With KRAS Vaccine and Anti-PD-1 Antibody in Subjects With Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung Cancer

The goal of this clinical trial is to test the safety and tolerability of anti-CD38 monoclonal antibody (mAb), daratumumab, in combination with KRAS vaccine (Targovax TG-01/Stimulon QS-21) when given with anti-PD-1 (programmed cell death protein 1) mAb (nivolumab) in patients with advanced non-small cell lung cancer (NSCLC) or pancreatic ductal adenocarcinoma (PDAC). The main questions it aims to answer are:
How well does daratumumab and nivolumab, when given with a vaccine, control or stop these types of cancer?
How well does participants bodies handle these study drugs?
Does this combination of study drugs help participants live longer? Participants will receive daratumumab, nivolumab with KRAS vaccine and have regular tests and procedures to follow how the participants are doing on these study drugs.

Start Date31 Jan 2024

Sponsor / Collaborator

Georgetown University

[+3]

NCT05638698 / Active, not recruitingPhase 2IIT

Phase II Randomized Trial Combining Tg01 Vaccine / Qs-21 Stimulon™ With Or Without Balstilimab As Maintenance Therapy Following Adjuvant Chemotherapy In Patients With Resected Pancreatic Cancer(TESLA)

Researchers want to discover if the new drug "TG01" will work with participants' bodies to help their immune system attack any cancer cells that might still be in the blood stream after surgery for pancreatic cancer.
The researchers will also investigate whether or not "TG01" combined with the other study drug, "Balstilimab", will show even greater efficacy.
TG01 and Balstilimab are both experimental treatments and are not approved by the US Food and Drug Administration (FDA) as treatment in the United States, or elsewhere, for pancreatic cancer or any other type of cancer.
Balstilimab has been studied in other cancers and has shown signs of efficacy. Another drug will be used in this study called "QS-21". It is not intended to treat any disease but is used in this study to improve the action of the study drug TG01.
QS-21 has been approved by the US Food and Drug Administration (FDA) to be mixed with a vaccine used to prevent shingles. It has not been approved to be mixed with the study drug, TG01.
Participants will undergo eligibility screening, weekly visits during treatment when receiving the study drug or study drug combination, two safety follow-up visits, at about 30 and 90 days after the last dose of study treatment, and long term follow up for about 12 months after the last dose of study treatment.

Start Date15 Dec 2022

Sponsor / Collaborator

University of Kansas

[+1]

100 Clinical Results associated with QS-21

100 Translational Medicine associated with QS-21

100 Patents (Medical) associated with QS-21

409

Literatures (Medical) associated with QS-21

31 Dec 2024·Expert Review of Vaccines

Adjuvant system AS01: from mode of action to effective vaccines

Review

Author: Ceregido, Maria Angeles ; Burny, Wivine ; Temmerman, Stéphane T ; Coccia, Margherita ; Roman, François ; Laupèze, Béatrice ; Warter, Lucile

INTRODUCTION:

The use of novel adjuvants in human vaccines continues to expand as their contribution to preventing disease in challenging populations and caused by complex pathogens is increasingly understood. AS01 is a family of liposome-based vaccine Adjuvant Systems containing two immunostimulants: 3-O-desacyl-4'-monophosphoryl lipid A and the saponin QS-21. AS01-containing vaccines have been approved and administered to millions of individuals worldwide.

AREAS COVERED:

Here, we report advances in our understanding of the mode of action of AS01 that contributed to the development of efficacious vaccines preventing disease due to malaria, herpes zoster, and respiratory syncytial virus. AS01 induces early innate immune activation that induces T cell-mediated and antibody-mediated responses with optimized functional characteristics and induction of immune memory. AS01-containing vaccines appear relatively impervious to baseline immune status translating into high efficacy across populations. Currently licensed AS01-containing vaccines have shown acceptable safety profiles in clinical trials and post-marketing settings.

EXPERT OPINION:

Initial expectations that adjuvantation with AS01 could support effective vaccine responses and contribute to disease control have been realized. Investigation of the utility of AS01 in vaccines to prevent other challenging diseases, such as tuberculosis, is ongoing, together with efforts to fully define its mechanisms of action in different vaccine settings.

15 Oct 2024·INFECTION AND IMMUNITY

A cynomolgus monkey E. coli urinary tract infection model confirms efficacy of new FimH vaccine candidates

Article

Author: Hu, Jianfang ; Ponce, Christopher ; Donald, Robert G. K. ; Chorro, Laurent ; Burt, Deborah ; Ramaiah, Lila ; Lypowy, Jacqueline ; Torres, Caresse Lynn ; Corts, Paula ; Silmon de Monerri, Natalie C. ; Ciolino, Tara ; Anderson, Annaliesa S. ; Illenberger, Arthur ; Aglione, JohnPaul ; Volberg, Gretchen L. ; La Porte, Annalena ; McGovern, Kathryn ; Kanevsky, Isis

ABSTRACT:

The increase in urinary tract infections (UTI) caused by antibiotic-resistant Escherichia coli requires the development of new therapeutic agents and prophylactic vaccines. To evaluate the efficacy of new lead candidates, we implemented a cynomolgus macaque UTI challenge model that mimics human uncomplicated cystitis in response to transurethral challenge with a multidrug-resistant (MDR) E. coli serotype O25b ST131 isolate. E. coli fimbrial adhesin FimH and O-antigens are separately under clinical evaluation by others as vaccine candidates to prevent UTI and invasive urosepsis disease, respectively. Accordingly, we assessed the protective efficacy of three 50-µg intramuscular doses of a novel recombinant FimH antigen adjuvanted with liposomal QS21/MPLA compared with saline placebo in groups of nine animals. A third group was vaccinated with this FimH formulation in combination with 1 µg each of a four-valent mixture of serotype O1a, O2, O6, and O25b O-antigen CRM 197 lattice glycoconjugates. Both vaccines elicited high levels of serum FimH IgG and adhesin blocking antibodies at the time of bacterial challenge and, for the combination group, O-antigen-specific antibodies. Following bacterial challenge, both vaccinated groups showed >200- and >700-fold reduction in bacteriuria at day 2 and day 7 post-infection compared with placebo, respectively. In parallel, both vaccines significantly reduced levels of inflammatory biomarkers IL-8 and myeloperoxidase in the urine at day 2 post-infection relative to placebo. Results provide preclinical proof-of-concept for the prevention of an MDR UTI infection by these new vaccine formulations.

01 Oct 2024·BRAIN RESEARCH

Immunotherapeutic approaches for Alzheimer’s disease: Exploring active and passive vaccine progress

Review

Author: Belemkar, Sateesh ; Roul, Krishnashish ; Kumar, Devendra ; Bhadane, Priyanshu

Alzheimer's disease (AD) is the most common neurodegeneration having non-effective treatments. Vaccines or monoclonal antibodies are two typical immunotherapies for AD. Due to Aβ neurotoxicity, most of the treatments target its generation and deposition. However, therapies that specifically target tau protein are also being investigated. UB311 vaccine generates N-terminal anti-Aβ antibodies, that neutralize Aβ toxicity and promote plaque clearance. It is designed to elicit specific B-cell and wide T-cell responses. ACC001 or PF05236806 vaccine has the same Aβ fragment and QS21 as an adjuvant. CAD106 stimulates response against Aβ_1-6. However, Nasopharyngitis and injection site erythema are its side effects. AN1792, the first-generation vaccine was formulated in proinflammatory QS21 adjuvant. However, T-cell epitopes are omitted from the developed epitope AD vaccine with Aβ_1-42B-cell epitopes. The first-generation vaccine immune response was immensely successful in clearing Aβ, but it was also sufficient to provoke meningoencephalitis. Immunotherapies have been at the forefront of these initiatives in recent years. The review covers the recent updates on active and passive immunotherapy for AD.

News (Medical) associated with QS-21

18 Sep 2024

·pipelinereview.com

GSK Announces Positive Topline Data on Co-Administration of AREXVY and SHINGRIX

PHILADELPHIA, PA, USA I September 18, 2024 I GSK plc (LSE/NYSE: GSK) today announced positive topline data from the phase 3 trial in adults 50 years and older evaluating the immunogenicity, reactogenicity and safety of AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) when co-administered with SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted), both AS01-adjuvanted vaccines (NCT05966090). 1,2 The data were presented as a late-breaking abstract at the European Geriatric Medicine Society (EuGMS) Congress in Valencia, Spain (September 18-20th, 2024). 2 SHINGRIX is approved for the prevention of shingles (herpes zoster) in adults aged 50 years and older. AREXVY is approved for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older, as well as individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV. The data showed a non-inferior immune response when the vaccines were co-administered compared to when they were administered at separate visits. 2 Co-administration was also well tolerated, with acceptable reactogenicity and safety profiles. 2 In both groups, the most frequently reported adverse events were pain at the injection site, fatigue, and myalgia. 2 The duration of solicited adverse events was comparable across the two groups. 2 Len Friedland, MD, Vice President of Scientific Affairs and Public Health, GSK, said: “We are excited to share data on the co‑administration of our RSV and shingles vaccines. Adult immunization offers immense individual and societal benefits and yet, vaccination rates for adults are often inadequate. With our co-administration studies, GSK is using its science and technology to help remove barriers to adult immunization, by potentially reducing the number of visits to the healthcare offices and pharmacies and ultimately help to get ahead of RSV and shingles.” Results from this trial will be submitted for peer-reviewed scientific publication and will be used to support regulatory submissions to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulators. Both RSV and shingles pose significant health risks to older adults, and these risks only increase with age as the immune system declines. Immunocompromised individuals and those with certain underlying medical conditions—for example, asthma and COPD—may also be at increased risk for these diseases. 3,4,5 RSV is a common, contagious respiratory virus that can lead to potentially serious respiratory illness. 3 Each year, approximately 177,000 adults 65 years and older are hospitalized in the US due to RSV and an estimated 14,000 of those cases result in death. 6 Shingles is a painful, blistering rash that can last for weeks. Because it is caused by the reactivation of the varicella zoster virus (VZV)—the same virus that causes chickenpox—99% of US adults have the virus that causes shingles inside their body, although not everyone will develop shingles. 7 An estimated one million people develop shingles annually in the US. 8 About AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) AREXVY contains recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant. The vaccine has been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in 50 countries, including Europe, Japan and US. It is also approved in several countries for use in adults aged 50–59 at increased risk for RSV-LRTD, including European Union/European Economic Area and US. Regulatory reviews in multiple countries are ongoing. The proposed trade name remains subject to regulatory approval in other markets. The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc. Indication for AREXVY AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: Important Safety Information for AREXVY Please see full Prescribing Information for AREXVY. About SHINGRIX(Recombinant Zoster Vaccine or RZV) SHINGRIX is a non-live, recombinant subunit vaccine indicated for the prevention of shingles in adults 50 and over. It combines an antigen, glycoprotein E, with an adjuvant system, AS01 B , and may help overcome the natural age-related decline in responses to immunization that contributes to the challenge of protecting adults aged 50 and over from shingles. 9,10 RZV is not indicated to prevent primary varicella infection (chickenpox). In several countries, it is also approved for adults aged 18 years or over at increased risk for shingles. The use of RZV should be in accordance with official recommendations and local product label. Indication for SHINGRIX SHINGRIX is an FDA-approved vaccine for the prevention of shingles (herpes zoster) in: SHINGRIX is not used to prevent chickenpox. Important Safety Information for SHINGRIX Please see full Prescribing Information for SHINGRIX. About the NCT05966090 trial The co-administration study is a phase 3, open-label, multi-country study to assess non-inferiority of immune responses in co-administration of GSK’s RSV and Recombinant Zoster Vaccine (RZV) compared to separate administration in adults aged 50 and over. 2 530 participants were randomized 1:1 to receive either GSK’s Recombinant Zoster Virus vaccine first dose and GSK’s Respiratory Syncytial Virus, Adjuvanted at visit one (Co-ad), or GSK’s Recombinant Zoster Virus vaccine first dose alone at visit one (Control). The Control group received GSK’s RSV vaccine at day 31. 1,2 RZV second dose was administered at day 61 for both groups. 1,2 The primary endpoint was the non-inferiority of the humoral immune responses to GSK’s RSV vaccine and RZV when co-administered compared to when administered at separate visits. 1,2 Key secondary endpoints included reactogenicity and safety following co-administration versus sequential administration of GSK’s RSV vaccine and RZV. 1,2 Anti-gE antibody concentrations and RSV-A and RSV-B neutralization titers increased from pre- to post-vaccination and met the non-inferiority criteria in the primary endpoint for the humoral immune responses to GSK’s RSV and shingles vaccines. 2 In both groups, the duration of solicited adverse events was short and comparable, and the most frequently reported adverse events were pain at the injection site, fatigue, and myalgia. 2 Unsolicited adverse events reporting rates were balanced between the co-administration and control groups. 2 About RSV in Adults RSV is a common, contagious respiratory virus affecting the lungs and breathing passages. 3 Adults can be at increased risk for RSV disease due to certain underlying medical conditions, immune compromised status, or advanced age. 3 RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalization, and death. 3 About Shingles Shingles is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox. 11 By age 50, VZV is present in most adults 12 and may reactivate with advancing age. 13 As people age, the strength of the immune system response to infection wanes, increasing the risk of developing shingles. 11 Shingles typically presents as a rash, with painful blisters across the chest, abdomen, or face. 11 The pain is often described as aching, burning, stabbing or shock-like. 14 Following the rash, a person may experience post-herpetic neuralgia (PHN), a long-lasting nerve pain that can last weeks or months and occasionally persists for several years. 14 PHN is the most common complication of shingles, occurring in 5–30% of all shingles cases from findings in various studies. 15 About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. References 1. Clinicaltrials.gov, “A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults (RSV-OA=ADJ-020)”, NCT05966090 – available at: https://clinicaltrials.gov/study/NCT05966090 – Accessed in September 2024. 2. Dennis P, et al. Co-administration of the adjuvanted respiratory syncytial virus (RSV) prefusion F protein vaccine (RSVPreF3 OA) with the adjuvanted recombinant zoster vaccine (RZV) in adults ≥50 years of age. Abstract presented at European Geriatric Medicine Society (EuGMS); 18–20 September 2024, Valencia, Spain. 3. Centers for Disease Control and Prevention (CDC), RSV in Adults. Available at: https://www-cdc-gov.libproxy1.nus.edu.sg/rsv/older-adults/index.html . Last Accessed: September 2024. 4. Marra F, et al. Risk Factors for Herpes Zoster Infection: A Meta-Analysis. Open Forum Infect Dis 2020;7(1):ofaa005. 5. Chen S-Y, et al. Incidence of herpes zoster in patients with altered immune function. Infection. 2014; 42: 325–334 6. Falsey, AR et al. Respiratory syncytial virus infection in elderly and high-risk adults, in New Engl J Med 2005; 352:1749-59. 7. CDC. About Shingles (Herpes Zoster). Available at https://www-cdc-gov.libproxy1.nus.edu.sg/shingles/about/index.html 8. CDC. Shingles (Herpes Zoster): Clinical Overview. Available at: https://www-cdc-gov.libproxy1.nus.edu.sg/shingles/hcp/clinical-overview/index.html 9. Cunningham, AL, et al. Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older. New England Journal of Medicine. 2016;375(11):1019–32. 10. The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon® adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and liposomes. 11. Harpaz R, et al. Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008;57(RR-5):1–30. 12. Johnson, R.W., et al. Herpes zoster epidemiology, management, and disease and economic burden in Europe: a multidisciplinary perspective. Therapeutic advances in vaccines. 2015;3(4):109–20. 13. Mueller, N.H., et al. Varicella zoster virus infection: clinical features, molecular pathogenesis of disease, and latency. Neurologic clinics. 2008;26(3):675–97. 14. Cheng J, Rosenquist RW. Herpes zoster and postherpetic neuralgia. Fundamentals of Pain Medicine . 2018:221-5. 15. Kawai K, Gebremeskel BG, Acosta CJ. Systematic review of incidence and complications of herpes zoster: towards a global perspective. BMJ Open. 2014;4:e004833. doi: 10.1136/bmjopen-2014-004833. SOURCE: GlaxoSmithKline

Phase 3Clinical ResultVaccineDrug Approval

29 Aug 2024

·www.prnewswire.com

Global Vaccine Adjuvants Market to Show Remarkable Growth at a CAGR of ~13% by 2030 | DelveInsight

The rising demand for vaccine adjuvants is mainly due to the increasing rates of infectious and cancerous diseases. Other significant factors include the heightened need for vaccines for specific illnesses, a greater emphasis on immunization, and the expansion of vaccination programs globally. This trend is projected to persist through the forecast period from 2024 to 2030. LAS VEGAS, Aug. 29, 2024 /PRNewswire/ -- DelveInsight's Vaccine Adjuvants Market Insights report provides the current and forecast market analysis, individual leading vaccine adjuvants companies' market shares, challenges, vaccine adjuvants market drivers, barriers, trends, and key market vaccine adjuvants companies in the market. Key Takeaways from the Vaccine Adjuvants Market Report As per DelveInsight estimates, North America is anticipated to dominate the global vaccine adjuvants market during the forecast period. In the product segment of the vaccine adjuvants market, the oil-in-water emulsion category had a significant revenue share in the vaccine adjuvants Market in 2023. Notable vaccine adjuvants companies such as Dynavax Technologies, GSK plc, Croda International plc, SEPPIC, Novavax, SPI Pharma, Agenus Inc., Aurorium, Merck KGaA, Vaxine Pty Ltd., Hawaii Biotech Inc., CSL, OZ Biosciences, InvivoGen, Allergy Therapeutics, EUBIOLOGICS CO., LTD., Pacific GeneTech Limited, Riboxx GmbH, CaPtivate Pharmaceuticals LLC, Mukta Industries, and several others, are currently operating in the vaccine adjuvants market. In May 2023 Croda International Plc entered into a partnership with Amyris and Botanical Solutions Inc. firstly for biotechnology-derived squalene and secondly with BSI to develop a sustainable QS-21 vaccine adjuvant moving towards plant tissue culture-derived approach rather than the traditional method of extracting QS-21 from soap bark trees. In August 2022, GSK Plc entered into an acquisition with Affinivax, Inc. to develop pneumococcal vaccines. To read more about the latest highlights related to the vaccine adjuvants market, get a snapshot of the key highlights entailed in the Global Vaccine Adjuvants Market Report Vaccine Adjuvants Overview Vaccine adjuvants are substances added to vaccines to enhance the body's immune response to the primary antigen. By stimulating the immune system more effectively, adjuvants can reduce the amount of antigen required and increase the duration of immunity. They play a crucial role in improving the efficacy of vaccines, particularly in cases where the antigen alone might not provoke a strong enough immune reaction. Adjuvants can work through various mechanisms, such as promoting a stronger local immune response at the injection site or facilitating a more robust activation of immune cells. Common types of adjuvants include aluminum salts, which have been used for decades and are known for their safety and effectiveness in boosting antibody responses. More recently, newer adjuvants like oil-in-water emulsions and toll-like receptor agonists have been developed to target specific aspects of the immune system. Research continues to explore and refine adjuvants to enhance vaccine performance, aiming to provide better protection against a range of infectious diseases and improve vaccine responses in different populations, including the elderly and immunocompromised individuals. Vaccine Adjuvants Market Insights In 2023, North America is anticipated to represent the largest share of the vaccine adjuvants market among all regions. This growth is driven by several factors. The region benefits from a well-established healthcare infrastructure and strong research and development capabilities, which stimulate advancements in vaccine adjuvant technologies. Additionally, increasing cases of infectious diseases and the threat of potential pandemics, like influenza or new pathogens, have led to greater investment in vaccine and adjuvant research. Government efforts to expand vaccination programs and enhance public health preparedness are also contributing to market growth. For example, the US Department of Health and Human Services (HHS) launched the HPV VAX NOW campaign in January 2021 to boost HPV vaccination rates among young adults. Similarly, the Government of Canada released updated guidelines on seasonal influenza vaccines for 2022-2023 in August 2022, which is expected to further stimulate market growth. Moreover, market expansion is supported by strategies such as product approvals, launches, and agreements. In November 2022, GSK plc's RSV vaccine candidate for older adults received a priority review from the FDA, indicating significant advancements in treatment or prevention. The combined effect of increased government and nonprofit investment in adjuvant development, alongside various product development activities, is set to drive the North American vaccine adjuvants market throughout the forecast period. To know more about why North America is leading the market growth in the vaccine adjuvants market, get a snapshot of the Vaccine Adjuvants Market Outlook Vaccine Adjuvants Market Dynamics The vaccine adjuvants market is experiencing significant growth driven by i ncreasing vaccine development and the demand for enhanced vaccine efficacy. Adjuvants are critical in improving the immune response to vaccines, which is particularly important as new and more complex pathogens emerge. The surge in research and development efforts, especially following the COVID-19 pandemic, has accelerated the need for innovative adjuvant technologies. Companies are focusing on developing adjuvants that can enhance the effectiveness of vaccines with lower doses, thereby addressing both efficacy and cost concerns. Technological advancements are playing a crucial role in shaping the dynamics of the adjuvants market. The development of novel adjuvants, such as nanoparticle-based and recombinant protein adjuvants, is gaining traction. These new technologies offer improved safety profiles and better control over immune responses. Additionally, the rise of personalized medicine and targeted therapies is driving interest in adjuvants that can be tailored to individual patient needs, further expanding the market potential. The r egulatory landscape and approval processes for vaccine adjuvants are also influencing market dynamics. Stringent regulatory requirements and the need for extensive clinical trials can pose challenges for market entry and innovation. However, successful navigation of these regulatory hurdles can lead to significant rewards, as demonstrated by the successful adjuvants used in COVID-19 vaccines. Companies that can efficiently meet regulatory standards while delivering effective solutions are likely to gain a competitive edge. Moreover, the vaccine adjuvants market is witnessing increased investment and collaboration between pharmaceutical companies, academic institutions, and government agencies. This collaborative approach is essential for advancing research, sharing knowledge, and accelerating the development of new adjuvant technologies. The convergence of resources and expertise from multiple stakeholders is expected to drive innovation and expand the market further. Overall, the vaccine adjuvants market is poised for substantial growth due to technological advancements, rising demand for effective vaccines, and increased investment in research and development. As the global focus on public health and disease prevention continues to intensify, the role of adjuvants in enhancing vaccine efficacy will remain a critical component of the healthcare landscape. Get a sneak peek at the vaccine adjuvants market dynamics @ Vaccine Adjuvants Market Dynamics Analysis Vaccine Adjuvants Market Assessment Vaccine Adjuvants Market Segmentation Vaccine Adjuvants Market Segmentation By Product Type: Oil-In-Water Emulsion, Aluminium Salts, Liposomes, Saponin-Based Adjuvants, and Others Vaccine Adjuvants Market Segmentation By Disease Type: Infectious Diseases, Cancer, and Others Vaccine Adjuvants Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the vaccine adjuvants market are set to emerge as the trendsetter explore @ Vaccine Adjuvants Companies Table of Contents Interested in knowing the vaccine adjuvants market by 2030? Click to get a snapshot of the Vaccine Adjuvants Market Trends Related Reports Vaccines Market Vaccines Market Insight, Competitive Landscape, and Market Forecast – 2030 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key vaccines companies, including GlaxoSmithKline, Bharat Biotech, AstraZeneca, Bavarian Nordic A/S, BioNTech, Sanofi, Merck & Co., Inc, Pfizer Inc, Moderna, Meiji Holdings Co., Ltd., EMERGENT, CSL Limited, Johnson & Johnson, VBI Vaccines Inc., Valneva SE., Novavax, CanSinoBIO, Biokangtai, Dynavax Technologies, Zhi Fei Biological, among others. Respiratory Syncytial Virus Market Respiratory Syncytial Virus Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key RSV companies, including Bavarian Nordic, Pfizer, GlaxoSmithKline, Janssen, Sanofi, AstraZeneca, Moderna, ReViral, among others. Respiratory Syncytial Virus Pipeline Respiratory Syncytial Virus Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key respiratory syncytial virus companies, including GlaxoSmithKline, MedImmune, ReViral, Pfizer, Sanofi, BioComo, IMV, Shionogi, Aridis Pharmaceuticals, ADMA Biologics, Enanta Pharmaceuticals, Merck Sharp & Dohme, Janssen Research & Development, Ark Biosciences, BlueWillow Biologics, Meissa Vaccines, Alios BioPharma, Codagenix, Advance Vaccine Laboratories, Bavarian Nordic, ModernaTX, Inc., Virometix, Airway Therapeutics LLC, AlloVir Inc, Anima Biotech Inc, Aridis Pharmaceuticals Inc, Atea Pharmaceuticals Inc, Atriva Therapeutics, Calder Biosciences Inc, Cidara Therapeutics Inc, Clover Biopharmaceuticals, Curevac AG, Enyo Pharma SA, HanaVax Inc., Icosavax Inc, IDBiologics Inc, Pneumagen Ltd, Riboscience LLC, Signia Therapeutics, among others. Human Papillomavirus Market Human Papillomavirus Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key HPV companies, including Inovio Pharmaceuticals, Inc., ISA Pharmaceuticals, Regeneron Pharmaceuticals, Barinthus Biotherapeutics, pHion Therapeutics, Vir Biotechnology, Inc., Antiva Biosciences, Toragen, Inc., Precigen, Inc, Merck Sharp & Dohme LLC, ViMREX GmbH, among others. About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

VaccineAcquisitionPriority Review

08 Jun 2024

·www.biospace.com

US FDA Approves Expanded Age Indication for GSK’s AREXVY, the First Respiratory Syncytial Virus (RSV) Vaccine for Adults Aged 50-59 at Increased Risk

Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of severe RSV outcomes1 Clinical development program continues to evaluate safety and immunogenicity in adults 18+ with data read-outs expected H2 2024 PHILADELPHIA--(BUSINESS WIRE)-- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved AREXVY (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk. In the US, the vaccine is currently approved for use in adults aged 60 and older and recommended by CDC/ACIP using shared clinical decision-making. This press release features multimedia. View the full release here: (Photo: Business Wire) A systematic review of studies in the US showed that RSV is estimated to cause 42,000 hospitalizations* each year in adults aged 50-64 years old.2 Adults with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes3 are at increased risk for severe consequences from an RSV infection compared to those without these conditions. RSV can exacerbate these conditions and lead to pneumonia, hospitalization or death.4 Tony Wood, Chief Scientific Officer, GSK, said: “Today's approval reflects the importance of broadening the benefits of RSV immunization to adults aged 50-59 who are at increased risk. For those with underlying medical conditions, RSV can have serious consequences, so we are proud to be the first to help protect them from RSV-LRTD.” The regulatory application was supported by positive results from a phase III trial [NCT05590403]5 evaluating the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to certain underlying medical conditions. Professor Ann R. Falsey, University of Rochester School of Medicine, said: “I am thrilled that GSK’s RSV vaccine is now approved for adults aged 50-59 at increased risk of RSV-LRTD. When it comes to the risks associated with RSV, age is just a number, an important number, but not the only factor to consider. Many adults in this age group have underlying health conditions that place them at increased risk for serious illness with RSV infection compared with those without these conditions. Now there is a vaccine approved that can help protect them.” GSK has also filed regulatory submissions to extend the use of its RSV vaccine to adults aged 50-59 at increased risk in Europe, Japan and other geographies with regulatory decisions undergoing review. Trials evaluating the immunogenicity and safety of the vaccine in adults aged 18-49 at increased risk and immunocompromised adults aged 18 and over are expected to read out in H2 2024. About AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) Respiratory Syncytial Virus Vaccine, Adjuvanted, contains recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant. In May 2023, the FDA approved GSK’s RSV vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. The use of this vaccine should be in accordance with official recommendations. As with any vaccine, a protective immune response may not be elicited in all vaccines. The vaccine has also been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in over 40 countries, including Europe, Japan and US. Regulatory reviews in multiple countries are ongoing. The proposed trade name remains subject to regulatory approval in other markets. The GSK proprietary AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary of Agenus. Indication for AREXVY AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: Individuals 60 years of age and older; Individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV. Important Safety Information for AREXVY AREXVY is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of AREXVY Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of AREXVY Syncope (fainting) may occur in association with administration of injectable vaccines, including AREXVY. Procedures should be in place to avoid injury from fainting Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AREXVY In adults 60 years of age and older, the most commonly reported adverse reactions (≥10%) were injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%) In adults 50 through 59 years of age, the most commonly reported adverse reactions (≥10%) were injection site pain (75.8%), fatigue (39.8%), myalgia (35.6%), headache (31.7%), arthralgia (23.4%), erythema (13.2%), and swelling (10.4%) There are no data on the use of AREXVY in pregnant and breastfeeding individuals. AREXVY is not approved for use in persons <50 years of age Vaccination with AREXVY may not result in protection of all vaccine recipients Please see full Prescribing Information. About the NCT05590403 trial NCT05590403 is a phase III, placebo-controlled, observer-blind, randomized, multi-country immunogenicity trial to evaluate the non-inferiority of the immune response and evaluate safety in participants aged 50 to 59, including those at increased risk for RSV-LRTD compared to older adults aged 60 years and above after a single dose of GSK’s RSV vaccine. The study assessed the immune response in participants aged 50 to 59 with pre-defined stable chronic diseases leading to an increased risk for RSV disease (n=570). Immune responses in a broader group of participants aged 50-59 years without these pre-defined chronic diseases (n=570) were also evaluated compared to adults aged 60 and older. The trial’s primary endpoints were RSV-A and RSV-B neutralization titers of both groups at one month after the vaccine administration compared to adults aged 60 and older. There were also safety and immunogenicity secondary and tertiary endpoints. Safety and reactogenicity data were consistent with results from the initial AReSVi-006 data read out. The most common local adverse event was pain. The most common systematic adverse events were myalgia, fatigue and headache, which were largely transient and mild to moderate in intensity. Results from this trial have been presented at the ACIP meeting of October 2023 and at ReSVinet in February 2024, and have been submitted for peer-reviewed publication. The data are being submitted to other regulators to support potential label expansions. About RSV in adults RSV is a common contagious virus affecting the lungs and breathing passages. Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status or advanced age.4 RSV can exacerbate conditions, including COPD, asthma and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalization and death.4 Each year, RSV is estimated to cause approximately 177,000 hospitalizations in adults 65 years and older6 and 42,000 in adults aged 50-64 years old in the US2. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q1 Results for 2024. Registered in England & Wales: No. 3888792 Registered Office: 980 Great West Road Brentford, Middlesex TW8 9GS References * adjusted for under-detection 1 Horn et al, “Disparities in Risk Factors for Severe Respiratory Syncytial Virus Disease among Adults in the United States”, Abstract presented at National Foundation for Infectious Diseases – 27 Annual Conference on Vaccinology Research – NFID 2024; May 8-10, 2024. 2 McLaughlin JM et al, “Rates of Medically Attended RSV Among US Adults: A Systematic Review and Meta-analysis” in Open Forum Infectious Diseases, Volume 9, Issue 7, July 2022. 3 Branche AR et al., “Incidence of Respiratory Syncytial Virus Infection Among Hospitalized Adults, 2017–2020” in Clinical Infectious Diseases, 2022:74:1004–1011 4 Centers for Disease Control and Prevention (CDC), RSV in Older Adults and Adults with Chronic Medical Conditions, 2024. 5 ClinicalTrials.gov, A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above 2023. NCT05590403. 6 Falsey, AR et al. Respiratory Syncytial Virus Infection in Elderly And High-Risk Adults, in New Engl J Med 2005; 352:1749-59. View source version on businesswire.com: Contacts GSK enquiries Media: Tim Foley +44 (0) 20 8047 5502 (London) Simon Moore +44 (0) 20 8047 5502 (London) Kathleen Quinn +1 202 603 5003 (Washington DC) Alison Hunt +1 540 742 3391 (Washington DC) Investor Relations: Nick Stone +44 (0) 7717 618834 (London) James Dodwell +44 (0) 20 8047 2406 (London) Mick Readey +44 (0) 7990 339653 (London) Josh Williams +44 (0) 7385 415719 (London) Camilla Campbell +44 (0) 7803 050238 (London) Steph Mountifield +44 (0) 7796 707505 (London) Jeff McLaughlin +1 215 751 7002 (Philadelphia) Frannie DeFranco +1 215 751 4855 (Philadelphia) Source: GSK plc Smart Multimedia Gallery Photo (Photo: Business Wire) Photo (Graphic: Business Wire) Logo View this news release and multimedia online at:

Phase 3Drug ApprovalVaccineClinical Result

100 Deals associated with QS-21

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Indication	Highest Phase	Country/Location	Organization	Date
Colitis, Ulcerative	Phase 3	BE	Alfasigma SpA	01 Apr 2012
Colitis, Ulcerative	Phase 3	CZ	Alfasigma SpA	01 Apr 2012
Colitis, Ulcerative	Phase 3	IL	Alfasigma SpA	01 Apr 2012
Colitis, Ulcerative	Phase 3	IT	Alfasigma SpA	01 Apr 2012
Colitis, Ulcerative	Phase 3	NL	Alfasigma SpA	01 Apr 2012
Colitis, Ulcerative	Phase 3	RO	Alfasigma SpA	01 Apr 2012
Colitis, Ulcerative	Phase 3	RU	Alfasigma SpA	01 Apr 2012
Colitis, Ulcerative	Phase 3	SK	Alfasigma SpA	01 Apr 2012
Herpes Zoster	Phase 3	-	Agenus, Inc.	-
Malaria	Phase 3	-	Agenus, Inc.	-

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NCT01687595 (CTgov)	Phase 2	Herpes Genitalis	80	Placebo	swlwohqktp(euqezexsey) = wguikuqjmo ynpgcikpzp (miqsivlxvy, ervrnohybw - hjxoobtcdi) View more	-	13 Jul 2021

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