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24 October 2024 Single dose of vaccine elicited robust immune response with acceptable safety profile in adults aged 18-49 at increased risk for RSV-LRTD Two doses of vaccine in immunocompromised adults aged 18 and above elicited immune responses similar to one dose in healthy adults aged 50+ and with an acceptable safety profile In the US alone, adults aged 18-49 with at least one risk factor for RSV disease could exceed 21 million1 GSK plc (LSE/NYSE: GSK) today announced new preliminary data for Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) in adults aged 18-49 at increased risk for RSV-LRTD due to certain underlying medical conditions and in adults who are immunocompromised. These data show the vaccine’s potential to help protect a broader group of adults at risk from the potentially serious consequences of RSV. In the US alone, the number of adults aged 18-49 with at least one risk factor that could put them at risk for RSV disease could exceed 21 million.1 The vaccine is currently approved for use in adults aged 60 and above in over 50 countries, and in adults aged 50-59 at increased risk in a number of countries including the US and Europe*. There are currently no RSV vaccines recommended for adults younger than 60 years of age who are at increased risk for RSV disease, despite the burden of disease in this population. Tony Wood, Chief Scientific Officer, GSK, said: “These promising data add to the evidence supporting GSK’s RSV vaccine and could help expand protection to more adults at risk from RSV disease. They also provide valuable insights into the potential impact of a second dose for certain populations. We’re committed to working with health authorities and regulators to help adults at increased risk of RSV disease benefit from vaccination.” In the phase IIIb trial (NCT063894872) a single dose of the vaccine elicited robust immune responses in adults aged 18-49 at increased risk for RSV-LRTD due to certain underlying medical conditions (n=395). The immune response was non-inferior to that observed in adults aged 60 and above (n=417), meeting the trial’s co-primary endpoints. In the phase IIb trial (NCT059219033) a single dose of the vaccine showed a robust immune response in adults aged 18 and above who are immunocompromised due to kidney or lung transplant (n=131), with a second dose (n=130) eliciting responses similar to those of healthy adults aged 50 and older who received one dose (n=125). These immune responses were consistent for RSV-A and RSV-B subtypes in all groups (those who received 1 or 2 doses). These data will be presented today at the meeting of the CDC’s Advisory Committee on Immunization Practices. In both studies, the safety and reactogenicity data were consistent with results from the phase III programme that have supported the initial approval of the vaccine. The most common local adverse event was pain, and most common systematic adverse events were fatigue, myalgia, arthralgia and headache, most of which were transient and mild in intensity. RSV is a common, contagious virus that can cause severe respiratory illness and impacts an estimated 64 million people of all ages globally every year.4 Immunocompromised people and those with certain underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk for severe consequences from an RSV infection compared to those without these conditions,5,6 including having a higher risk of mortality.7 Final results from these trials will be presented at upcoming medical conferences and submitted for peer-reviewed publication. The final data will also be submitted to the US Food and Drug Administration (FDA) and other regulators to support potential label updates. About the trial designs NCT06389487 is a phase IIIb open-label study to evaluate the non-inferiority of the immune response and to evaluate the safety of the GSK’s RSV vaccine in adults aged 18-49 at increased risk for RSV disease (n=395) compared to adults aged 60 and older (n=417). 1,457 participants were enrolled across 52 locations in 6 countries. The trial’s co-primary endpoints were RSV-A and RSV-B neutralisation titers expressed as mean geometric titer ratio (relative to older adults over adults at increased risk) and sero-response in RSV-A and RSV-B neutralising titers one month post vaccine administration. There were also safety and immunogenicity secondary endpoints. An additional cohort of 601 participants aged 18-49 were followed up for adverse events separate to safety follow up of the initial cohort. The study is ongoing to collect further safety and immunogenicity data up to 6 months post vaccination and is expected to finish in 2025. NCT05921903 is a phase IIb, randomized, controlled, open-label, multi-country study to evaluate the immune response and safety of GSK’s RSV vaccine in adults (≥18 years of age) who are immunocompromised due to lung and renal transplant, comparing 1 versus 2 doses (1 dose, n=131, 2 doses, n=130) one month (30-42 days) after the second vaccine administration compared to a control group of non-immunocompromised adults aged 50 and above receiving a single dose of GSK’s RSV vaccine (n=125 non-immunocompromised adults aged 50 and above). 386 participants were enrolled across 48 locations in 8 countries. The trial’s co-primary endpoints were RSV-A and RSV-B neutralisation titers following a first and a second dose of GSK’s RSV vaccine expressed as mean geometric increase post dose 2 relative to post dose 1 at approximatively one month. There were also safety and immunogenicity secondary endpoints. The study is ongoing to collect further safety and immunogenicity data up to 12 months post last dose and is expected to finish in 2025. About GSK’s RSV vaccine Respiratory Syncytial Virus Vaccine, Adjuvanted, contains recombinant RSV glycoprotein F stabilised in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant. 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 vaccinees. The vaccine has been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in more than 50 countries, including Europe, Japan and US. In addition, it is approved in the US and EU/EEA countries for use in individuals aged 50-59 who are at increased risk due to certain underlying medical conditions. Regulatory reviews for this extended indication are also undergoing review in other countries – including Japan. 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. 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 Q2 Results for 2024. References You might also like

PHILADELPHIA, PA, USA I October 08, 2024 I GSK plc (LSE/NYSE: GSK) today announced new data from the AReSVi-006 ( A dult R espiratory S yncytial V irus) phase III trial evaluating the efficacy and safety of a single dose of AREXVY(Respiratory Syncytial Virus Vaccine, Adjuvanted) against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 60 years and older, including those at increased risk, over three full RSV seasons (NCT04886596). 1 These data will be presented today at the CHEST 2024 Annual Meeting, organized by the American College of Chest Physicians. AREXVY is the world’s first RSV vaccine and was approved based on exceptional efficacy in adults aged 60 and older including those who are at increased risk due to certain underlying medical conditions. Today’s results indicate that after a single dose of GSK’s RSV vaccine, cumulative efficacy over three full RSV seasons was clinically meaningful at 62.9% against RSV-LRTD (97.5% CI, 46.7-74.8, 48 of 12,468 vs 215 of 12,498) and 67.4% against severe RSV-LRTD (95% CI, 42.4-82.7, 15 of 12,468 vs 75 of 12,498) compared to placebo. In the third season, the vaccine’s efficacy was 48.0% against RSV-LRTD (95% CI, 8.7-72.0, 16 of 4,988 vs 61 of 10,031). Safety and reactogenicity data were consistent with previous results from the phase III program. In season one, the vaccine was generally well tolerated. The most frequently observed adverse events were pain at the injection site, fatigue, myalgia, headache, and arthralgia within four days of vaccination. These results include efficacy against different RSV subtypes, in adults with advancing age (70-79 years of age), and those with certain underlying medical conditions. Since RSV can exacerbate medical conditions and potentially lead to hospitalizations, cumulative efficacy over three RSV seasons has the potential for significant health impact. It has the potential to offer health care professionals flexibility to administer the vaccine year-round. Over time, revaccination is expected to be required to maintain an optimal level of protection. GSK will continue to share efficacy and immune response data, including on revaccination, with recommending bodies to inform decisions on immunization schedules and future revaccination. RSV is a common, contagious virus affecting the lungs and breathing passages and impacts an estimated 64 million people of all ages globally every year. 2 Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status, or advanced age.RSV can exacerbate multiple conditions, including COPD, asthma, and chronic heart failure, and can lead to severe outcomes, such as pneumonia, hospitalization, and death. 3 Each year in the US, approximately 177,000 adults 65 years and older are hospitalized due to RSV and an estimated 14,000 of those cases result in death. 4 Tony Wood, Chief Scientific Officer, GSK, said: “We are excited by these new data which show that a single dose of AREXVYcould help protect millions of older adults at risk of RSV disease over three seasons to benefit public health. This is the only RSV vaccine with efficacy and safety data available through three full seasons. We will continue to provide data on longer term follow-up to help recommending bodies determine future revaccination schedules.” In addition to the presentation at CHEST, the data will be submitted for scientific peer-reviewed publication and to regulators for review. ​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. In May 2023, AREXVY was first approved by the US FDA for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. Since then, the vaccine has also been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in 50 countries, including Europe and Japan. In addition, it is approved in the US and EU for use in individuals aged 50-59 who are at increased risk due to certain underlying medical conditions. Regulatory reviews for this extended indication are also undergoing review in other countries – including Japan. The proposed trade name remains subject to regulatory approval in other markets. 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 vaccinees. 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 AReSVi-006 This is a randomized, placebo-controlled, double-blind, multi-country phase III trial to demonstrate the efficacy of a single dose of GSK’s adjuvanted RSV older adult vaccine over three years and following an annual revaccination schedule in adults aged 60 years and above compared to a placebo arm. About 25,000 participants have been enrolled from 17 countries. The trial’s primary endpoint was vaccine efficacy against RSV-LRTD after one RSV season. Results were published in the New England Journal of Medicine in February 2023. 5 After the first season, 12,469 participants in the vaccine arm were re-randomized to receive either the RSV vaccine or placebo and were followed up for occurrence of RSV-LRTD. Vaccine efficacy of a single dose against RSV-LRTD after two and three RSV seasons compared to placebo and vaccine efficacy after annual revaccination compared to placebo were confirmatory secondary endpoints. 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 SOURCE: GlaxoSmithKline

NEW YORK, Oct. 8, 2024 /PRNewswire/ -- Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Agenus Inc. (NASDAQ: AGEN) between January 23, 2023 and July 17, 2024, both dates inclusive (the "Class Period"), of the important November 5, 2024 lead plaintiff deadline. So what: If you purchased Agenus securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement. What to do next: To join the Agenus class action, go to call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than November 5, 2024. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Details of the case: According to the lawsuit, throughout the Class Period, defendants made false and/or misleading statements and/or failed to disclose that: (1) the combination therapy of botensilimab, an antigen 4 blocking antibody that is in a Phase 2 clinical trial for the treatment of pancreatic cancer and melanoma, and balstilimab, an anti-PD-1 antagonist that has completed a Phase 2 clinical trial to treat second line cervical cancer, was less effective than defendants had led investors to believe; (2) accordingly, botensilimab and balstilimab's clinical results, as well as their regulatory and commercial prospects, were overstated; and (3) as a result, Agenus' public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages. To join the Agenus class action, go to or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action. No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff. Follow us for updates on LinkedIn: , on Twitter: or on Facebook: . Attorney Advertising. Prior results do not guarantee a similar outcome. Contact Information: Laurence Rosen, Esq. Phillip Kim, Esq. The Rosen Law Firm, P.A. 275 Madison Avenue, 40th Floor New York, NY 10016 Tel: (212) 686-1060 Toll Free: (866) 767-3653 Fax: (212) 202-3827 [email protected] SOURCE THE ROSEN LAW FIRM, P. A. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED