A Phase IIb, Randomized, Observer-Blind Study to Describe the Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents

The purpose of this study is to assess the safety, tolerability, and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY) vaccine (GSK3536819A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups.

Start Date29 Dec 2021

Sponsor / Collaborator

GSK Plc

NCT05082285

/ Active, not recruitingPhase 2

A Phase II, Randomized, Partially Blinded Study to Assess the Safety, Tolerability and Immunogenicity of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Infants

The purpose of this study is to assess the safety, tolerability and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY-2Gen) vaccine intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups, in healthy infants 2 months of age (MoA) at enrolment.

Start Date29 Nov 2021

Sponsor / Collaborator

GSK Plc

NCT04707391

/ CompletedPhase 3

A Phase IIIB, Randomized, Controlled, Observer-blind Study to Evaluate Safety and Immunogenicity of GSK's Meningococcal ABCWY Vaccine When Administered in Healthy Adolescents and Adults, Previously Primed With Meningococcal ACWY Vaccine

The purpose of this study was to assess immunogenicity and safety of MenABCWY vaccine in healthy adolescents and adults aged 15 to 25 years previously vaccinated with MenACWY vaccine.

Start Date25 Jan 2021

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with MenABCWY vaccine (GSK)

100 Translational Medicine associated with MenABCWY vaccine (GSK)

100 Patents (Medical) associated with MenABCWY vaccine (GSK)

Literatures (Medical) associated with MenABCWY vaccine (GSK)

01 Dec 2024·Infectious Diseases and Therapy

Global Epidemiology of Meningococcal Disease-Causing Serogroups Before and After the COVID-19 Pandemic: A Narrative Review

Review

Author: Findlow, Jamie ; Shen, Steven ; Peyrani, Paula

Invasive meningococcal disease (IMD) is associated with high morbidity and mortality and predominantly caused by five Neisseria meningitidis serogroups (A/B/C/W/Y). Polysaccharide conjugate vaccines induce T-cell-dependent immune responses, are immunogenic in infants and adults, and reduce carriage, and vaccination of age groups associated with high-carriage can provide indirect protection in the unvaccinated (herd immunity). Successful vaccination programs must be tailored to local epidemiology, which varies geographically, temporally, and by age and serogroup. Serogroup A IMD once predominated globally, but has largely disappeared following mass vaccination programs. Serogroup B was a predominant cause of IMD in many global regions from 2010 to 2018, typically affecting younger age groups. Spread of serogroup C clonal complex-11 IMD in the 1990s prompted implementation of MenC vaccine programs in many countries, resulting in declines in prevalence. Serogroup C still caused > 20% of global IMD through the mid-2010s. Serogroup W became a significant contributor to global IMD after Hajj pilgrimage outbreaks in 2000; subsequent increases of endemic disease and outbreaks were reported pre-pandemic in many regions. Serogroup Y emerged in the 1990s as a significant cause of IMD throughout various regions and prevalence had increased or stabilized from 2010 to 2018. Serogroup X is uncommon outside the African meningitis belt, and its prevalence has declined since before the COVID-19 pandemic. Global IMD declines during the pandemic were followed by resurgences generally caused by serogroups that were prevalent pre-pandemic and affecting mainly unvaccinated age groups (particularly adolescents/young adults). Recent IMD epidemiology underscores the importance of vaccinating at-risk age groups against regionally prevalent serogroups; for example, the anti-serogroup X component of the recently prequalified MenACWXY vaccine is likely to provide limited protection outside the African meningitis belt. In other regions, comprehensive vaccination against MenB and MenACWY, which could be streamlined by the recently approved MenABCWY vaccine, seems more appropriate.

01 Dec 2024·The Lancet Infectious Diseases

Breadth of immune response, immunogenicity, reactogenicity, and safety for a pentavalent meningococcal ABCWY vaccine in healthy adolescents and young adults: results from a phase 3, randomised, controlled observer-blinded trial

Article

Author: Langley, Joanne M ; Langley, Joanne ; Kiiroja, Kaia ; Grubb, Paul ; Raulier, Stefanie ; Schear, Martin ; Pelayo, Enrique ; Meisalu, Sandra ; Lechevin, Isabelle ; Chakerian, Maia ; Toneatto, Daniela ; Richmond, Peter C ; Dinleyici, Ener Cagri ; Cetin, Benhur ; Morelle, Danielle ; Koski, Susanna ; Gottfredson, Ryan ; Ukkonen, Benita ; Vachon, Marie-Louise ; Byars, William ; Scott, John ; Farjo, Rand ; Osowa, Alexander ; Jones, Jake ; Freeman, George ; Staben, Jonathan ; Bloch, Mark ; Sadarangani, Manish ; Surber, Joseph ; Zemanek, Josef ; Bhusal, Chiranjiwi ; Beran, Jiří ; Athan, Eugene ; Gupta, Anil ; Sanchez, Yamirka ; Dzongowski, Peter ; Ackerman, Ronald ; Dalebout, Marije ; Bernard, David ; Dionne, Marc ; Rok, Walter ; Adamovska, Renata ; Spaziererova, Martina ; Carter, Robert ; Jeanfreau, Robert ; Ulukol, Betul ; Rämet, Mika ; Richmond, Peter ; Finn, Daniel ; Silas, Peter ; Vale, Noah ; Rouhbakhsh, Rambod ; Simon, William ; de Looze, Ferdinandus ; Kokko, Satu ; Laajalahti, Outi ; Tiong, Florence ; Pavlasek, Miroslav ; Ayesu, Kwabena ; Trapani, Mauro ; Patel, Minesh ; Tapiero, Bruce ; Kellner, James ; Willemsen, Arnold ; Seppä, Ilkka ; Lattanzi, Maria ; Mehta, Hemalini ; Dražan, Daniel ; Tipton, Mary ; Paavola, Pauliina ; Ince, Tolga ; Wauters, Dominique ; Nolan, Terry ; Cetin, Benhur Sirvan

BACKGROUNDA multicomponent meningococcal serogroups ABCWY vaccine (MenABCWY) could provide broad protection against disease-causing meningococcal strains and simplify the immunisation schedule. The aim of this trial was to confirm the effect of the licensed meningococcal serogroup B (MenB) vaccine, 4CMenB, against diverse MenB strains, and to assess the breadth of immune response against a panel of 110 MenB strains for MenABCWY containing the antigenic components of 4CMenB and licensed serogroups ACWY vaccine, MenACWY-CRM, the non-inferiority of the immune response with MenABCWY versus 4CMenB and MenACWY-CRM, safety, and MenABCWY lot-to-lot consistency.METHODSWe conducted a phase 3 randomised, controlled, observer-blinded trial of healthy adolescents and young adults (age 10-25 years) across 114 centres in Australia, Canada, Czechia, Estonia, Finland, Türkiye, and the USA. Exclusion criteria included previous vaccination with a MenB vaccine or (within the last 4 years) MenACWY vaccine. Participants were randomly allocated (5:5:3:3:3:1 ratio) via a central randomisation system using a minimisation procedure to receive 4CMenB at months 0, 2, and 6 (referred to as 4CMenB 0-2-6 hereafter); or 4CMenB at months 0 and 6 (referred to as 4CMenB 0-6 hereafter); or MenABCWY (three groups, each receiving one production lot of the MenACWY-CRM component) at months 0 and 6; or MenACWY-CRM at month 0. Demonstration in the per-protocol set of the consistency of three MenACWY-CRM component lots of the MenABCWY vaccine was a primary objective (demonstrated with two-sided 95% CIs for the ratio of human serum bactericidal antibody [hSBA] geometric mean titres against each serogroup within predefined criteria [0·5-2·0]). The primary endpoints (breadth of immune response) for the MenB component of MenABCWY and 4CMenB were measured using the endogenous complement hSBA (enc-hSBA) assay against a panel of 110 diverse MenB invasive disease strains. For each serum sample, 35 strains from the 110 MenB strain panel were randomly selected for testing. The 4CMenB breadth of immune response data have been published separately. For MenABCWY, breadth of immune response was assessed in two analyses: a test-based analysis of the percentage of samples (tests) without bactericidal serum activity against MenB strains 1 month after two MenABCWY doses versus the percentage after one MenACWY-CRM dose in the per-protocol set, and a responder-based analysis of the percentage of participants (responders) whose sera killed 70% or more strains at 1 month after two MenABCWY doses in the full analysis set. A lower limit of two-sided 95% CI above 65% would demonstrate breadth of immune response. Other primary outcomes included non-inferiority (5% margin) of two MenABCWY doses versus two 4CMenB doses by enc-hSBA assay in the per-protocol set, non-inferiority (10% margin) of two MenABCWY doses versus one MenACWY-CRM dose in MenACWY vaccine-naive participants by traditional hSBA assay in the per-protocol set, and safety in all vaccinated participants. This trial is registered with ClinicalTrials.gov, NCT04502693, and is complete.FINDINGSBetween Aug 14, 2020, and Sept 3, 2021, 3651 participants were enrolled and randomly allocated (900 in the 4CMenB 0-2-6 group and 908 in the 4CMenB 0-6 group, 1666 in the three MenABCWY groups combined, and 177 in the MenACWY-CRM group). All primary objectives for MenABCWY were met. Consistency of immune responses against the three production lots of the MenACWY component of MenABCWY was demonstrated since two-sided 95% CIs for the ratios of hSBA geometric mean titres against serogroups A, C, W, and Y for each pair of lots were within the predefined equivalence criteria. The lot data were pooled for the remainder of MenABCWY endpoints. By enc-hSBA assay, breadth of immune response against the MenB strain panel was 77·9% (95% CI 76·6 to 79·2) in the test-based analysis and 84·1% (81·4 to 86·5; 687 of 817 participants) in the responder-based analysis. Non-inferiority of MenABCWY to 4CMenB was demonstrated by enc-hSBA assay: the difference in percentage of samples with bactericidal serum activity between the MenABCWY group (82·5% [95% CI 82·1 to 83·0]; 21 222 of 25 715) and 4CMenB 0-2 group (83·1% [82·7 to 83·6]; 22 921 of 27 569) was -0·61% (-1·25 to 0·03). Non-inferiority of two-dose MenABCWY to one-dose MenACWY-CRM was demonstrated by traditional hSBA assay, with differences between the MenABCWY group and MenACWY group in percentages of participants with a four-fold rise in hSBA titres of 11·3% (5·9 to 19·0) for serogroup A, 47·2% (38·1 to 56·3) for serogroup C, 35·3% (26·9 to 44·5) for serogroup W, and 27·0% (19·4 to 35·8) for serogroup Y. MenABCWY reactogenicity was mostly of mild or moderate severity and transient, with similar frequencies of adverse events in the MenABCWY and 4CMenB groups and no safety concerns were identified.INTERPRETATIONThis study demonstrates breadth of immune response against a panel of 110 MenB strains for the MenB component of the investigational MenABCWY vaccine, when administered as a 0-6 months schedule to the target population of adolescents and young adults, with predefined criteria for success met for both breadth of immune response endpoints and for non-inferiority versus 4CMenB. This investigational vaccine could provide broad meningococcal serogroup coverage in a simplified immunisation schedule, thus aiding the public health attempt in preventing invasive meningococcal disease due to five Neisseria meningitidis serogroups in adolescents and young adults.FUNDINGGSK.

30 Oct 2024·Open Forum Infectious Diseases

4CMenB Breadth of Immune Response, Immunogenicity, and Safety: Results From a Phase 3 Randomized, Controlled, Observer Blind Study in Adolescents and Young Adults

Article

Author: Langley, Joanne ; Wauters, Dominique ; Carter, Robert ; Dionne, Marc ; Finn, Daniel ; Rok, Walter ; Staben, Jonathan ; Langley, Joanne M ; Schear, Martin ; Cetin, Benhur ; Tipton, Mary ; Jeanfreau, Robert ; Nolan, Terry ; Ackerman, Ronald ; Ukkonen, Benita ; Toneatto, Daniela ; Pelayo, Enrique ; Spaziererova, Martina ; Surber, Joseph ; Morelle, Danielle ; Richmond, Peter C ; Osowa, Alexander ; Patel, Minesh ; de Looze, Ferdinandus ; Bloch, Mark ; Cetin, Benhur S ; Willemsen, Arnold ; Farjo, Rand ; Vale, Noah ; Tapiero, Bruce ; Rouhbakhsh, Rambod ; Bhusal, Chiranjiwi ; Zemanek, Josef ; Gupta, Anil ; Dzongowski, Peter ; Adamovska, Renata ; Silas, Peter ; Ulukol, Betul ; Gottfredson, Ryan ; Rämet, Mika ; Sadarangani, Manish ; Beran, Jiří ; Kiiroja, Kaia ; Laajalahti, Outi ; Lattanzi, Maria ; Paavola, Pauliina ; Pavlasek, Miroslav ; Bernard, David ; Simon, William ; Raulier, Stefanie ; Chakerian, Maia ; Freeman, George ; Athan, Eugene ; Vachon, Marie-Louise ; Jones, Jake ; Scott, John ; Dinleyici, Ener Cagri ; Grubb, Paul ; Dražan, Daniel ; Ince, Tolga ; Mehta, Hemalini ; Dalebout, Marije ; Seppä, Ilkka ; Meisalu, Sandra ; Byars, William ; Tiong, Florence ; Dinleyici, Ener C ; Sanchez, Yamirka ; Trapani, Mauro ; Kokko, Satu ; Ayesu, Kwabena ; Kellner, James ; Koski, Susanna ; Lechevin, Isabelle ; Richmond, Peter

AbstractBackgroundMeningococcal serogroup B (MenB) strains are highly diverse. Breadth of immune response for the MenB vaccine, 4CMenB, administered at 0–2, 0–6, or 0–2–6 months, was demonstrated by endogenous complement-human serum bactericidal antibody (enc-hSBA) assay against an epidemiologically relevant panel of 110 MenB strains.MethodsIn a phase 3 trial, 3651 healthy 10- to 25-year-old participants were randomized 5:5:9:1 to receive 4CMenB (0–6 schedule), 4CMenB (0–2–6 schedule), investigational MenABCWY vaccine, or control MenACWY-CRM vaccine. The primary objectives were to evaluate safety and demonstrate breadth of immune response by enc-hSBA assay against the MenB strain panel using test-based (percentage of samples without bactericidal activity against strains after 4CMenB vs control vaccination) and responder-based (percentage of participants whose postvaccination sera kill ≥70% strains) approaches. Success was demonstrated with 2-sided 97.5% confidence interval (CI) lower limit >65%. Immunogenicity was assessed by traditional hSBA assay against four indicator strains.ResultsBreadth of immune response (test-based) was 78.7% (97.5% CI, 77.2–80.1), 81.8% (80.4–83.1), 83.2% (81.9–84.4) for the 0–2, 0–6, and 0–2–6 schedules, respectively, and (responder-based) 84.8% (81.8–87.5), 89.8% (87.2–92.0), and 93.4% (91.2–95.2), respectively. No clinically relevant differences in immunogenicity were observed across schedules. 4CMenB was well tolerated.ConclusionsThe 2-dose (0–2, 0–6) 4CMenB schedules met predefined criteria for success for both breadth of immune response endpoints against a diverse MenB strain panel, had comparable immunogenicity, and safety in line with the established 4CMenB safety profile. The 3-dose schedule provided no additional immunological benefit, supporting use of the 4CMenB 0–2 schedule.

News (Medical) associated with MenABCWY vaccine (GSK)

08 Jan 2025

·www.prnewswire.com

Clarivate Identifies Eleven Potential Blockbuster and Transformative Drugs in Annual Drugs to Watch Report

Anticipated advancements in obesity, oncology, gene therapy and other areas poised to revolutionize patient care LONDON, Jan. 8, 2025 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT) a leading global provider of transformative intelligence, today announced the release of the twelfth annual Drugs to Watch™ report, a trusted guide to the therapies poised to redefine the future of healthcare. This year, the highly anticipated resource highlights 11 drugs projected to achieve blockbuster status or revolutionize treatment paradigms within five years. Since its inception, Drugs to Watch has identified over 98 transformative therapies, cementing its role as an essential resource for navigating the ever-evolving pharmaceutical landscape. This year's report, powered by insights from the Clarivate Cortellis intelligence suite of products, highlights 11 therapies that have recently launched or are set to debut in 2025. These innovations, addressing critical challenges in areas such as obesity, oncology, and gene therapy, are forecast to achieve blockbuster sales by 2030 or dramatically improve patient outcomes on a global scale. The report also explores pivotal trends shaping the industry, including the surging demand for obesity treatments, the transformative potential of gene editing, and the growing impact of regulatory innovation. The report offers an in-depth analysis of the chronic disease market in Mainland China, spotlighting five therapies expected to exceed $1 billion in annual sales over the next five years or deliver transformative outcomes for patients. It also explores critical topics shaping global healthcare, including regulatory advancements, the role of radiopharmaceutical theranostics in oncology, and the growing use of real-world data (RWD) and patient-reported outcomes (PROs) to drive health equity and enhance regulatory submissions. Henry Levy, President, Life Sciences & Healthcare, Clarivate, remarked: "Innovation in the life sciences is reaching unprecedented heights, and this year's Drugs to Watch™ report once again demonstrates the industry's ability to deliver therapies that address unmet medical needs and challenge existing paradigms of care. At Clarivate, we take pride in the precision and reliability of our predictions—last year, we identified 13 molecules as Drugs to Watch, with 12 already approved and launched and one poised for launch. This track record reflects the strength of our comprehensive data and deep expertise. By continuing to provide actionable insights, we empower the sector to navigate opportunities, overcome challenges and drive progress in advancing global health." Mike Ward, Global Head of Thought Leadership, Life Sciences & Healthcare, Clarivate, stated: "2025 represents a turning point for the life sciences sector as it embraces cutting-edge technologies such as AI and machine learning to enhance drug discovery and development. This year's report captures the dynamic forces at play, including groundbreaking progress in precision oncology, the rise of radiopharmaceuticals, and the growing focus on addressing global health disparities." The 2025 Drugs to Watch™ report highlights key trends reshaping the life sciences landscape, emphasizing the transformative impact of emerging technologies and therapeutic breakthroughs. Advances in AI and machine learning are streamlining drug discovery, clinical trials, and real-world data integration, enabling precision medicine approaches. The obesity market is undergoing a revolution driven by next-generation GLP-1 therapies, while radiopharmaceutical theranostics are redefining cancer treatment with a "see it and treat it" paradigm. Gene editing technologies are unlocking new opportunities in personalized medicine, and evolving regulatory frameworks are fostering greater emphasis on patient-reported outcomes and health equity. Together, these trends showcase the sector's resilience and its ability to navigate challenges while driving innovation to improve patient care worldwide. This year's drugs to watch exemplify the fusion of innovation and dedication to advancing patient care in an increasingly complex healthcare ecosystem. The Drugs to Watch™ 2025 list include: AWIQLI® (LAI 287; insulin icodec) developed by Novo Nordisk | Type 1 and type 2 diabetes mellitus AWIQLI®, the first once-weekly, subcutaneous insulin, has launched in Australia, Canada, the EU, Mainland China, and Japan. Its weekly dosing offers a significant advantage over daily basal insulin, potentially reducing the treatment burden for patients with type 1 or type 2 diabetes (T1DM and T2DM). CagriSema (cagrilintide + semaglutide) developed by Novo Nordisk | Obesity and type 2 diabetes mellitus CagriSema, combining cagrilintide, a long-acting amylin analog, with semaglutide, promises superior efficacy over semaglutide (OZEMPIC/WEGOVY®) and tirzepatide (MOUNJARO/ZEPBOUND®) in treating obesity and type 2 diabetes. This next-generation GLP-1 therapy leverages the benefits of GLP-1s, such as enhanced insulin secretion and appetite reduction, while incorporating amylin's effects, including slowed glucose absorption and release. If approved, CagriSema will be the first fixed-dose combination of amylin and GLP-1 receptor agonists in the obesity and T2DM markets. COBENFY™ (KarXT; xanomeline-trospium) developed by Bristol Myers Squibb | Schizophrenia and psychosis related to Alzheimer's disease Amid setbacks for emerging schizophrenia treatments, the approval of COBENFY marks a transformative milestone as the first drug in over 30 years with a novel mechanism of action for treating schizophrenia. Combining xanomeline and trospium, COBENFY selectively targets M1 and M4 receptors, rather than traditional dopamine pathways, while minimizing cholinergic side effects. While further data is needed to assess its effectiveness in Alzheimer's disease-related psychosis, COBENFY shows strong commercial potential if proven effective in treating AD-related hallucinations and delusions. EBGLYSS™ (lebrikizumab) developed by Eli Lilly and Co and Almirall | Atopic dermatitis EBGLYSS™, the third biologic targeting IL-13 for atopic dermatitis, follows DUPIXENT® (dupilumab) and ADBRY®/ADTRALZA® (tralokinumab) to market. Its less frequent dosing, more selective IL-13 inhibition, and strong efficacy and safety data position it as a likely first-line treatment for moderate-to-severe atopic dermatitis when topical corticosteroids are inadequate. Fitusiran developed by Alnylam® Pharmaceuticals Inc and Sanofi | Hemophilia A and B Fitusiran, shown to be effective in phase 3 trials for both hemophilia A and B, regardless of inhibitor status, has the potential to offer a new approach to hemophilia treatment. This small interfering RNA (siRNA) therapy works by inhibiting SerpinPC1 mRNA, reducing antithrombin levels, promoting thrombin generation, and helping to rebalance hemostasis to prevent bleeds. Leveraging Alnylam® Pharmaceuticals' ESC-GalNAc conjugate technology, fitusiran could become the first antithrombin-lowering therapy based on a double-stranded RNA molecule, pending approval. GSK-3536819 (MenABCWY) developed by GSK plc | Meningococcus GSK plc's GSK-3536819 vaccine candidate, a 5-in-1, first-generation formulation, targets the five groups of Neisseria meningitidis (A, B, C, W, and Y) responsible for most invasive meningococcal disease (IMD) cases worldwide. It combines the antigenic components of GSK's licensed meningococcal vaccines, BEXSERO (MenB) and MENVEO (MenACWY), both of which have established efficacy and safety profiles. IMDELLTRA™ (tarlatamab-dlle) developed by Amgen | Small-cell lung cancer (SCLC) IMDELLTRA™ is a first-in-class immunotherapy for extensive-stage small cell lung cancer (ES-SCLC). Using Amgen's bispecific T cell engager (BiTE®) molecules, it targets CD3 on T cells and DLL3 on tumor cells, enabling T cells to attack and lyse the tumor. DLL3 is expressed on the surface of SCLC cells in more than 85% of patients but is minimally expressed on healthy cells making it an attractive target. This mechanism positions IMDELLTRA as a potential standard of care for previously treated ES-SCLC. mRESVIA (mRNA-1345) developed by Moderna Inc | RSV With its U.S. FDA approval in May 2024, mRESVIA® joined AREXVY and ABRYSVO, both featured in Drugs to Watch 2024, as respiratory syncytial virus (RSV) vaccines currently available for adults ages 60 years and older, helping further support the public health initiative to reduce the RSV-related disease burden. Even with available vaccines, RSV infections continue to be a public health concern, particularly for infants and older adults (65 years and older). SEL-212 developed by Sobi® and Cartesian Therapeutics Inc/Selecta Biosciences Inc | Gout SEL-212 is a novel, once-monthly treatment combining pegylated uricase (pegadricase; SEL-037) with ImmTOR™, an immune tolerance technology designed to inhibit the formation of anti-drug antibodies (ADAs). For this application, ImmTOR consists of SEL-110.36, an inhibitor of uricase-specific ADA. This approach may help overcome the limitations of reduced efficacy and tolerability seen with other biologic treatments, such as KRYSTEXXA® (pegloticase), in patients with chronic gout. Vepdegestrant (ARV-471) developed by Arvinas Inc and Pfizer Inc | Breast cancer A global collaboration between Arvinas Inc and Pfizer Inc, vepdegestrant may become the first PROteolysis Targeting Chimera (PROTAC®) protein degrader on the market. Designed to target and degrade the estrogen receptor (ER) protein, early studies suggest PROTAC-induced degradation is more complete than with oral selective estrogen receptor degraders (SERDs). This offers potential for overcoming endocrine resistance in breast cancer. Label expansions, including combination with IBRANCE® (palbociclib), are being explored. Zanzalintinib (XL092) developed by Exelixis Inc | Colorectal cancer, renal cell carcinoma and squamous cell carcinoma of head and neck Zanzalintinib is a third-generation oral tyrosine kinase inhibitor targeting VEGF receptors, MET, and TAM kinases involved in tumor growth and immunosuppression. Currently in phase 3 trials for non-clear-cell renal cell carcinoma (nccRCC), colorectal cancer (CRC) and squamous cell carcinoma of the head and neck (SCCHN), the company anticipates one potential zanzalintinib launch per year starting as early as 2026. Compared to CABOMETYX® (cabozantinib), zanzalintinib may offer benefits, including approval for nccRCC histology and a broader patient population. Access the Drugs to Watch 2025 report from Clarivate, here. For more Drugs to Watch updates and analyses throughout the year, visit the Drugs to Watch web page and follow Clarivate for Life Sciences & Healthcare on LinkedIn and X. Join the conversation, using #DrugstoWatch. To learn more about how Clarivate can help healthcare companies inform and shape the drug discovery, development and delivery process, visit here. Methodology for the Clarivate Drugs to Watch 2025 Report To identify this year's Drugs to Watch, Clarivate drew from the expertise of over 160 analysts covering hundreds of diseases, drugs and markets, along with 11 integrated data sets that span the R&D and commercialization lifecycle, including: Cortellis Competitive Intelligence™, Disease Landscape & Forecast, Epidemiology Intelligence, BioWorld™, Cortellis Regulatory Intelligence™, Drug Timeline & Success Rates, Cortellis Clinical Trials Intelligence™, Cortellis Deals Intelligence™, Access & Reimbursement payer studies, Clarivate Real-World Data and Analytics, Web of Science™, Derwent Innovation™, and other industry sources including biopharma company press releases, filings and peer-reviewed publications. Candidate drugs in phase 2 or phase 3 trials, at pre-registration or registration stage, or already launched in 2024 were selected for analysis, including both novel treatments and already-marketed drugs pursuing new indications that could be particularly impactful. Drugs launched prior to 2024 were excluded. The dataset was filtered for drugs that had total forecast sales of $1 billion or more by 2030. Clarivate experts and analysts evaluated each drug in its individual context, based on factors such as expected approval or launch dates, competitive landscape, regulatory status, trial results, market dynamics and other key factors, and added novel drugs that, while likely to fall short of blockbuster status, are poised to be therapeutic game-changers. Please note that Clarivate analysts generated the data shown in this report prior to December 31, 2024. The Drugs to Watch 2025 Report and the treatments referenced in this release are based on Clarivate's current expectations per existing data, but actual results derived from the drugs named in the report and here may differ significantly. Clarivate is committed to comprehensively supporting customers across the entire drug, device and medical technology lifecycles to advance human health. By combining patient journey data, therapeutic area expertise, artificial intelligence and analytics in ways that unlock hidden insights, data-driven decisions and accelerating innovation, Clarivate's end-to-end research intelligence is designed to enable customers to make informed evidence-based decisions. About Clarivate Clarivate™ is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. For more information, please visit . Media Contact: Catherine Daniel Director, External Communications, Life Sciences & Healthcare [email protected] SOURCE Clarivate Plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

VaccinePhase 3Immunotherapy

20 Oct 2023

·www.fiercepharma.com

Pfizer beats out GSK with FDA nod for first 5-in-1 meningitis shot

While Pfizer’s approval has won Penbraya some time to its own on the market, GSK is close behind with its own pentavalent competitor. In the race to secure U.S. approval for the first five-pronged meningitis vaccine, Pfizer has eked out a regulatory win well ahead of its immunization rival GSK. Friday, the U.S. FDA gave a thumbs-up to Penbraya, the commercial moniker for Pfizer’s pentavalent vaccine defending against the most common serogroups behind meningococcal disease. The shot is approved for adolescents and adults between the ages of 10 and 25. Penbraya mixes components from two of the company’s other meningococcal vaccines—Trumenba and Nimenrix—which together tackle serogroups A, B, C, W and Y. Those serogroups account for nearly all invasive meningococcal disease. Prior to Pfizer’s Penbraya approval, protection from all five groups required four injections from two separate vaccines. Chief to Pfizer’s marketing pitch for Penbraya is that the shot needs only be administered twice. The company figures this feature will streamline standard of care and potentially boost the number of people who get vaccinated. The FDA handed Pfizer its regulatory win based on results from the company’s phase 2 and phase 3 trials, which included a late-stage study pitting Pfizer’s pentavalent shot against other meningitis vaccines currently approved in the U.S. Besides Pfizer, GSK’s Bexsero has competed with Trumenba for the meningococcal B vaccine market. GSK also makes Menveo, a vaccine against meningococcal groups A, C, W-135 and Y. Sanofi separately markets its own MenACWY vaccines called Menactra and MenQuadfi. Now, though, Pfizer is poised to disrupt the market with a shot that protects against the serogroups A, B, C, W and Y. Beyond the shot’s approval, the Centers for Disease Control and Prevention’s advisory committee on immunization practices is set to weigh in on how Pfizer’s vaccine should be used on Oct. 25. While Pfizer’s approval has won Penbraya some time to its own on the market, GSK is close behind with its own pentavalent competitor, coded MenABCWY. In May, GSK unveiled study results pitting the investigational MenABCWY vaccine against a combination of Bexsero and Menveo. GSK found its vaccine candidate was noninferior to the Bexsero-Menveo combination in people aged 10 to 25 years across all five of the targeted serotypes.

Drug ApprovalClinical ResultVaccinePhase 2Phase 3

15 May 2023

·www.pmlive.com

GSK’s five-in-one meningococcal vaccine candidate shows promise in phase 3 trial

GSK’s five-in-one meningococcal vaccine candidate has shown promising results in a phase 3 trial involving healthy individuals aged ten to 25 years. Preliminary results for the MenABCWY candidate were presented by the company at the European Society for Paediatric Infectious Diseases congress in Lisbon, Portugal. Invasive meningococcal disease (IMD) is an uncommon but serious illness that can cause life-threatening complications or even death, with the highest incidence occurring in children and adolescents. Five Neisseria meningitides serogroups – A, B, C, W, and Y – account for nearly all IMD cases, but there are currently no approved vaccines that offer simultaneous protection against all of them. In the US, two separate vaccines needing four injections are required to protect against all five serogroups. This regimen, together with low awareness of the disease, can lead to poor immunisation rates. It is hoped that GSK’s MenABCWY, which combines the antigenic components of its approved Bexsero (MenB) and Menveo (MenACWY) meningococcal vaccines, would provide the widest possible protection against the disease and lead to higher vaccine uptake. The phase 3 study evaluating the candidate met all of its primary endpoints, including a non-inferior immune response against all five serogroups in individuals receiving two doses of the MenABCWY vaccine candidate six months apart, compared to those receiving the Bexsero and Menveo regimen. In a separate confirmatory arm of the trial, the candidate showed immunological effectiveness against a panel of 110 diverse MenB invasive strains, which account for 95% of strains circulating in the US. GSK’s chief scientific officer, Tony Wood, said: “This preliminary data further unlocks the potential of our MenABCWY vaccine candidate in providing protection against invasive meningococcal disease caused by serogroups A, B, C, W and Y. "It’s particularly encouraging to see the breadth of coverage against the broadest panel of circulating MenB strains to date, as we know MenB is the most common cause of meningococcal disease in the US with the lowest immunisation rate.” The company said it is now “working closely” with regulatory agencies to review the full phase 3 results and prepare filings. This includes a supplemental application for Bexsero, which has not yet received traditional approval in the US.

Phase 3VaccineClinical Result

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Indication	Highest Phase	Country/Location	Organization	Date
Meningitis, Meningococcal	Phase 3	US	GSK Plc	25 Jan 2021
Meningitis, Meningococcal	Phase 3	AU	GSK Plc	25 Jan 2021
Meningitis, Meningococcal	Phase 3	CA	GSK Plc	25 Jan 2021
Meningitis, Meningococcal	Phase 3	AR	GSK Plc	25 Jan 2021
Meningococcal Infections	Phase 1	PL	GSK Plc	21 Aug 2014
Meningococcal Infections	Phase 1	FI	GSK Plc	21 Aug 2014

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04707391 (CTgov)	Phase 3	Meningitis, Meningococcal	1,250	Placebo+MenABCWY vaccine (ABCWY Group)	xafoejrfri(qxeafseipk) = bzmvvviokd hqjjmeycmc (rtfkazxbhs, shbaxnypwe - seyvfximgv) View more	-	03 Jul 2024
				MenB vaccine+MenACWY vaccine (ACWY Group)	xafoejrfri(qxeafseipk) = ninrmoilkl hqjjmeycmc (rtfkazxbhs, vbeloalewr - igmjiwgjix) View more
NCT04502693 (CTgov)	Phase 3	Meningococcal Infections	3,657	rMenB+OMV NZ vaccine+Y Conjugate Vaccine (MenACWY) (MenB_0_2_6 Group)	vxfizobvmt(fukedhbppu) = nyfmpxywlf hucjmanubg (hbmkibfona, xeepdeaspu - uarcukxfkb) View more	-	05 Mar 2024
				Placebo+rMenB+OMV NZ vaccine+Y Conjugate Vaccine (MenACWY) (MenB_0_6 Group)	vxfizobvmt(fukedhbppu) = ltcpcsppnn hucjmanubg (hbmkibfona, utmzrlsfoz - xyfpuvptsb) View more
NCT02451514 (CTgov)	Phase 2	Meningococcal Infections	129	MenABCWY+OMV vaccine (MenABCWY+OMV Group)	evtuxvpbbi(goiyodsmnv) = mpnlqmhqoz serotigxcb (eejumxmppd, zuurhezapw - qswondwpbd) View more	-	09 Jul 2020
				MenABCWY+OMV vaccine (MenACWY Group)	evtuxvpbbi(goiyodsmnv) = prcvjfgoob serotigxcb (eejumxmppd, pnmpxdhhzs - bbdepldiwq) View more
NCT02946385 (CTgov)	Phase 2	Meningococcal Infections	604	MenABCWY (ABCWY_0_2)	ebazyihnwv(alinwaonas) = xgshasvias kccgbazcwp (fyaayoezwi, ahqjmwerje - bxfnkanegt) View more	-	20 Aug 2019
				MenABCWY (ABCWY_0_2_6)	ebazyihnwv(alinwaonas) = jbswvmqohw kccgbazcwp (fyaayoezwi, cvddfdlwig - gbqorhsiod) View more
NCT02140762 (CTgov)	Phase 2	Meningococcal Infections	305	MenABCWY (MenABCWY)	oglgdldjis(rsddrcqqrx) = egnefulpbl zmluvghdpo (uafoqcrtqt, ymptjrgtjj - trudkzowge) View more	-	26 Jun 2018
				Placebo+MenACWY (Placebo/MenACWY)	oglgdldjis(rsddrcqqrx) = jrxhssjehz zmluvghdpo (uafoqcrtqt, sinrqyptel - sebwrltafh) View more
NCT02285777 (CTgov)	Phase 2	Meningococcal Infections	189	Meningococcal ABCWY (MenABCWY Group)	hsmphxfspp(cyjmhubzoo) = sjnzqyoedm xkteisigch (oykrjaroml, bdasuxvqdr - pcjodfbszr) View more	-	06 Dec 2017
				Placebo (MenACWY Group)	hsmphxfspp(cyjmhubzoo) = ozkmnlnkqn xkteisigch (oykrjaroml, ulnaqviwad - lypgirkxny) View more
NCT02212457 (CTgov)	Phase 2	Meningococcal Infections	1,063	Saline Placebo+MenABCWY+Havrix (ABCWY_ 0_2 Group)	knjvctiznl(sofgjqbnds) = mvayatzofo jrjfjzdeqn (dymvelmpfb, ohynjlhckn - yrrzvmfblx) View more	-	21 Jul 2017
				Bexsero+Saline Placebo+Havrix (rMenB_0_2 Group)	knjvctiznl(sofgjqbnds) = pjpjnpmlsc jrjfjzdeqn (dymvelmpfb, ugdfrwfdhq - mnuycmsann) View more

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