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Last update 20 Nov 2025

Human papillomavirus vaccine [types 16, 18](GlaxoSmithKline Plc)

Last update 20 Nov 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Virus-like particle vaccine, Prophylactic vaccine, Multivalent vaccine

+ [1]

Synonyms

HPV-16/18 L1 VLP/AS04 ワクチン, Human Papillomavirus (Types 16,18) Vaccine, Adsorbed, Human Papillomavirus Bivalent [Types 16 and 18] Vaccine, Recombinant

+ [11]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsInfectious DiseasesDigestive System Disorders+ [1]

Active Indication

Uterine Cervical DysplasiaUterine Cervical CancerAnus Neoplasms+ [2]

Inactive Indication

Adenocarcinoma in SituCarcinoma in situ of uterine cervixCervical Adenocarcinoma In Situ+ [7]

Originator Organization

GSK Plc

Active Organization

GlaxoSmithKline Biologicals SAGlaxoSmithKline Australia Pty Ltd.

GSK Plc

+ [1]

Inactive Organization

GlaxoSmithKline (China) Investment Co., Ltd.GlaxoSmithKline LLC

License Organization

GSK Plc

SK bioscience Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

Australia (18 May 2007),

Human Papillomavirus InfectionHuman Papillomavirus-Related Cervical Carcinoma

Regulation-

Clinical Trials associated with Human papillomavirus vaccine [types 16, 18](GlaxoSmithKline Plc)

NCT05237947

/ Active, not recruitingPhase 4IIT

Single-Dose HPV Vaccination Among Young Adult Women in Costa Rica: the PRISMA-ESCUDDO Trial (PRevencIón Del Cáncer Cervical Con Una Sola Dosis de Vacuna Contra VPH en Mujeres Adultas Jóvenes)

This phase IV trial tests whether a single dose of the human papillomavirus (HPV) vaccine works in preventing cervical cancer in young women in Costa Rica. Human papilloma viruses, called HPV, are a group of viruses that very frequently cause infection in both men and women, mainly in the genital organs. There are many types of HPV, and some can cause cancer. The World Health Organization recommends a two-dose schedule for adolescents 9-14 and three doses for individuals 15 years old or older. This study examines whether a single dose of HPV vaccine can reduce the frequency with which women between ages 18-30 become infected with HPV.

Start Date01 Mar 2022

Sponsor / Collaborator

National Cancer Institute

NCT04301154

/ CompletedPhase 1IIT

Phase I, Proof of Concept, Open-Label, Randomized Clinical Trial to Evaluate the Safety and Effects of Using Prime-boost HIVIS DNA and MVA-CMDR Vaccine Regimens With or Without Toll-like Receptor 4 Agonist on HIV Reservoirs in Perinatally HIV Infected Children and Youth

Phase I, Proof of Concept, Open-Label, Randomized Clinical Trial to Evaluate the Safety and Effects of Using Prime-boost HIVIS DNA and MVA-CMDR Vaccine Regimens with or without Toll-like Receptor 4 Agonist on HIV Reservoirs in Perinatally HIV Infected Children and Youth

Start Date18 Feb 2022

Sponsor / Collaborator

The Henry M. Jackson Foundation

[+11]

CTR20210535

/ CompletedPhase 4

一项监测葛兰素史克生物制品公司(GSK)希瑞适疫苗上市前后根据当地处方信息(PI)接种希瑞适疫苗的9至45岁中国女性宫颈癌相关终点的观察性数据库研究。

[Translation] An observational database study monitoring cervical cancer-related endpoints in Chinese women aged 9 to 45 years who received GlaxoSmithKline Biologicals (GSK) Cervarix vaccine according to local prescribing information (PI) before and after its launch.

第一步：评估数据库监测宫颈癌相关终点能力（次要目的）第二步：基线分析（次要目的）第三步：主要分析（主要目的）描述上市前后9-70岁女性宫颈癌相关终点(有/无HPV分型)患病率，按总体、疫苗接种状态、年龄组、每日历年描述。描述上市前后参与当地宫颈筛查实践9-70岁女性宫颈癌相关终点(有/无HPV分型)患病率，按总体、疫苗接种状态、年龄组、每日历年描述。第四步：条件分析（次要目的）

[Translation]

Step 1: Evaluate the database's ability to monitor cervical cancer-related endpoints (secondary objective) Step 2: Baseline analysis (secondary objective) Step 3: Primary analysis (primary objective) Describe the prevalence of cervical cancer-related endpoints (with/without HPV typing) in women aged 9-70 years before and after marketing, by overall, vaccination status, age group, and calendar year. Describe the prevalence of cervical cancer-related endpoints (with/without HPV typing) in women aged 9-70 years who participated in local cervical screening practices before and after marketing, by overall, vaccination status, age group, and calendar year. Step 4: Conditional analysis (secondary objective)

Start Date10 Sep 2021

Sponsor / Collaborator

GlaxoSmithKline (China) Investment Co., Ltd.

[+1]

100 Clinical Results associated with Human papillomavirus vaccine [types 16, 18](GlaxoSmithKline Plc)

100 Translational Medicine associated with Human papillomavirus vaccine [types 16, 18](GlaxoSmithKline Plc)

100 Patents (Medical) associated with Human papillomavirus vaccine [types 16, 18](GlaxoSmithKline Plc)

345

Literatures (Medical) associated with Human papillomavirus vaccine [types 16, 18](GlaxoSmithKline Plc)

31 Dec 2025·Human Vaccines & Immunotherapeutics

Real-world safety of HPV vaccines over 18 y: A comprehensive analysis of U.S. VAERS reports

Article

Author: Wei, Jinbao ; Huang, Yirong ; Fu, Honghong ; Zhou, Yanyan ; Wang, Xinjin ; Su, Yonglong ; Wu, Xiaohong

Human papillomavirus (HPV) vaccination is central to preventing cervical and other HPV-associated cancers. Although clinical trials have established favorable safety profiles, long-term, brand-specific real-world data remain limited. We evaluated adverse events (AEs) reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) for Cervarix® (bivalent), Gardasil® (quadrivalent), and Gardasil-9® (9-valent) between January 2006 and December 2024. Domestic VAERS reports listing ≥1 HPV vaccine were extracted, deduplicated, and classified by brand. Disproportionality analyses were performed using reporting odds ratios (RORs) and 95% confidence intervals (CIs), adjusting for multiplicity with a 5% Benjamini - Hochberg false discovery rate (FDR). Time-to-onset was assessed with Kaplan-Meier analysis. This analysis of 76,575 HPV vaccine adverse event reports shows improving safety profiles across vaccine generations. Serious adverse events decreased significantly from Cervarix® (33.4%) to Gardasil® (16.2%) to Gardasil-9® (7.8%). The most common signals were presyncope for Cervarix® (ROR 11.5) and administration errors for Gardasil® and Gardasil-9®, including inappropriate scheduling (ROR 19.5) and incorrect storage (ROR 12.1). Most adverse events (82.9%) occurred within 7 d post-vaccination, with 62.5% occurring on the same day. Gardasil-9® exhibited the narrowest IQR for time to onset (0-1 d), compared to other HPV vaccines. HPV vaccines demonstrate a consistent, favorable safety profile in U.S. real-world practice. Most reported AEs were acute vasovagal reactions, and strongest signals reflected preventable errors. Strengthening provider education in cold-chain management and schedule adherence may further enhance vaccine safety. Continued active surveillance is recommended.

01 Jul 2025·LANCET INFECTIOUS DISEASES

Human papillomavirus (HPV) type 16 and type 18 antibody concentrations after a single dose of bivalent HPV vaccine in girls aged 9–14 years compared with three doses of quadrivalent HPV vaccine in women aged 18–25 years in Costa Rica (PRIMAVERA): a non-randomised, open-label, immunobridging, non-inferiority trial

Article

Author: Schiller, John T ; Pinto, Ligia A ; Porras, Carolina ; Fantin, Romain ; Liu, Danping ; Herrero, Rolando ; Sierra, Monica S ; Hildesheim, Allan ; Cortés, Bernal ; Kemp, Troy J ; Ocampo, Rebeca ; Carvajal, Loretto J ; Kreimer, Aimée R ; Lowy, Douglas R ; Gail, Mitchell H ; Schussler, John ; Sampson, Joshua N

BACKGROUND:

In 2022, WHO recommended single-dose human papillomavirus (HPV) vaccination as an alternative schedule to multidose regimens. To provide evidence to support approval of a single-dose indication for the AS04-adjuvanted bivalent HPV vaccine (Cervarix, GlaxoSmithKline), we investigated whether the immune response to a single dose of the bivalent vaccine in girls aged 9-14 years was non-inferior to the immune response to three doses of the quadrivalent HPV vaccine (Gardasil-4, Merck) in women aged 18-25 years, a dose and population combination with demonstrated efficacy.

METHODS:

This non-randomised, open-label, immunobridging trial enrolled girls aged 9-14 years and women aged 18-25 years in Guanacaste Province, Costa Rica. Healthy girls aged 9-14 years received one dose of bivalent HPV vaccine, whereas healthy women aged 18-25 years received three doses of quadrivalent HPV vaccine at 0, 2, and 6 months. The primary endpoint was geometric mean concentrations (GMCs) of HPV-specific serum antibodies measured by a validated virus-like-particle-based ELISA assay at 36 months. The per-protocol cohort included participants who received the correct number of doses within the predefined vaccination windows, had blood collected at the 36-month study visit for the final analysis, were seronegative at baseline for the specified HPV type, and did not receive additional HPV vaccine doses outside the study. Non-inferiority was declared when the lower bound of the 96% CI for the GMC ratio was greater than or equal to 0·67 for HPV-16 and HPV-18. Seropositivity was a secondary objective. Safety was analysed in the total vaccinated population. This trial is registered with ClinicalTrials.gov, NCT03728881, and is complete.

FINDINGS:

Between April 1 and Aug 16, 2019, 620 girls and 620 women were enrolled and received their first HPV vaccination. After exclusions, 539 girls and 366 women were HPV-16 seronegative at enrolment and were included in the HPV-16 per-protocol cohort; 523 girls and 373 women were HPV-18 seronegative at enrolment and were included in the HPV-18 per-protocol cohort. At 36 months, the HPV-16 GMC was 21·4 international units (IU)/mL (95% CI 19·7-23·3) in girls in the single-dose bivalent vaccine group and 42·9 IU/mL (95% CI 38·9-47·3) in women in the three-dose quadrivalent vaccine group, resulting in a GMC ratio of 0·50 (96% CI 0·44-0·57); the HPV-18 GMC was 8·0 IU/mL (95% CI 7·4-8·8) in girls in the single-dose bivalent vaccine group and 7·2 IU/mL (95% CI 6·4-8·1) in women in the three-dose quadrivalent vaccine group, resulting in a GMC ratio of 1·11 (96% CI 0·95-1·29). At 36 months, 538 (99·8%, 95% CI 99·1-100) of 539 girls in the single-dose bivalent vaccine group were seropositive for HPV-16 compared with 366 (100%, 99·2-100) of 366 women in the three-dose quadrivalent vaccine group (p=1·00). The proportion of participants who were seropositive for HPV-18 was higher in the single-dose bivalent vaccine group (517 [98·9%, 95% CI 97·6-99·5] of 523 girls) than in the three-dose quadrivalent vaccine group (358 [96·0%, 93·6-97·6] of 373 women; p=0·0065). Two serious adverse events were reported in 620 girls and 13 serious adverse events were reported in 620 women; all serious adverse events were deemed to be unrelated to HPV vaccination.

INTERPRETATION:

Non-inferior antibody responses for the single-dose bivalent HPV vaccine were seen for HPV-18 but not HPV-16, which would be insufficient evidence to motivate regulatory change, even though seropositivity approached 100% in the follow-up phase and the observed antibody concentrations were similar to protective levels seen in previous trials. Trials that directly evaluate protection afforded by single-dose HPV vaccination against persistent HPV infection will definitively address the level of protection afforded by single-dose HPV vaccination.

FUNDING:

National Cancer Institute, Cancer Research UK, and the Gates Foundation.

TRANSLATION:

For the Spanish translation of the abstract see Supplementary Materials section.

01 Jul 2025·INDIAN JOURNAL OF DERMATOLOGY

HPV Vaccines – An Overview

Review

Author: Dawn, Ananya ; Ghosh, Aparajita ; Chatterjee, Sambit ; Das, Anupam

Abstract:

Human papilloma viruses (HPVs) are a group of viruses that can infect the stratified epithelium of the skin and mucosa. Based on their oncogenic potential, they can be divided into high risk and low risk types. HPV accounts for 7,30,000 cases of cancers all over the world. In June 2006, the first HPV vaccine – Gardasil – was approved by the FDA. After this in 2007, Cervarix was approved and finally Gardasil 9 in 2014. Currently, there are six prophylactic vaccines against HPV, of which five have been pre-qualified by WHO. The bivalent vaccines offer protection against acquiring HPV 16 and 18, which cause 70% of cervical cancers. The quadrivalent and nonavalent vaccines offer additional protection against low-risk HPV 6 and 11. The currently available vaccines have been found to be safe in both pre- and post-licensure trials. The vaccines offer excellent protection against cervical intra-epithelial neoplasia of grade 2 and 3. The role of HPV vaccines in prevention of other cancers is mostly supported by small retrospective studies. The currently available vaccines are approved for prophylactic use only. There have been attempts to use HPV vaccines therapeutically, and there are conflicting reports regarding their efficacy. This article reviews the currently available vaccines, their indications, adverse effects, contraindications, and epidemiological impact. It also highlights the off label therapeutic uses in various conditions and other potential vaccine candidates.

News (Medical) associated with Human papillomavirus vaccine [types 16, 18](GlaxoSmithKline Plc)

07 Oct 2025

·www.globenewswire.com

Bioxodes appoints industry veteran Philippe Monteyne as chairman as it accelerates late-stage development of breakthrough stroke candidate

Former GSK and Sanofi executive, led Cervarix® development and advanced pioneering therapies for rare diseases, decade of experience as venture capitalistStrengthens Bioxodes leadership following encouraging Phase 2a interim data for lead candidate BIOX-101 in intracerebral hemorrhagePhase 2b trial scheduled to begin in 2027 could be sufficient to submit for conditional marketing authorization in the U.S. and Europe Gosselies, Belgium, 7 October 2025 (08:30 am CET) – Bioxodes SA, a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, today announced the appointment of Philippe Monteyne, MD, PhD, as chairman of its Board of Directors. Dr. Monteyne, a neurologist, has an extensive and successful track record as a life sciences investor and as a pharmaceutical executive, having held a range of senior industry positions and overseen the development and launch of multiple new medicines. “The appointment of Philippe as Chairman is a great win for Bioxodes. His experience and track record in developing new therapies in areas of high unmet medical need will lend invaluable guidance to the company just as new data have confirmed the breakthrough potential of BIOX-101 in treating stroke. I’m looking forward to working with Philippe as we advance this first-in-class drug candidate through clinical trials, with the aim of commercialization, potentially as early as 2030,” said Marc Dechamps, Chief Executive Officer of Bioxodes. “We have benefited enormously from Pierre Detrixhe’s work as chairman of the company over the past years. I thank him for his contributions and I look forward to continue to work with him as a member of the Board of Directors,” he added. Dr. Monteyne will assume his role immediately, as Bioxodes prepares for a potentially registrational global multi-center Phase 2b trial for its lead asset BIOX-101 in patients who suffered intracerebral hemorrhage (ICH). If successful, this trial could be sufficient to submit BIOX-101 for conditional marketing authorizations in the U.S. and Europe. The recombinant peptide will also be developed to treat acute ischemic stroke. Dr. Monteyne is Senior Advisor for Life Sciences at AltamarCAM Partners, which has investments of more than 20.8 billion euros in private markets, and a member of the Investment Committee, former partner of their life science fund Aliath Bioventures in Barcelona, and a previous senior partner of Fund+, a private equity fund in Belgium. In industry, he held senior positions at SmithKline Beecham, GSK and Sanofi. At GSK, he was responsible for the development and launch of the company’s cervical cancer vaccine Cervarix®, and for the research that enabled the development of Strimvelis®, an autologous gene therapy for ADA-SCID, as well as Tegsedi®, an oligonucleotide to treat hATTR, another rare disease. He is a board member of several biotech companies in Belgium, France and Spain, and was a visiting professor of neurology at the Catholic University of Louvain (UCL, Belgium). “Hemorrhagic stroke is an unmet medical need and one of the most pressing unresolved neurological problems science is facing. I’ve been very impressed by the Phase 2a results with BIOX-101, and I believe it could revolutionize treatment of stroke, offering a solution for a disorder that, unfortunately, often leads to crippling disabilities or death. With no approved therapies for hemorrhagic stroke available today, BIOX-101 promises a unique opportunity to help shape an entirely new market by arming physicians with a drug that may significantly reduce mortality and improve outcomes for this lethal disease,” said Philippe Monteyne. In September, Bioxodes announced encouraging second interim results from its BIRCH Phase 2a clinical trial, confirming the breakthrough potential of BIOX-101. All patients treated with the candidate experienced a reduction in hematoma, a finding supported by biomarker measurements, all of which trended in support of the clinical observations. Functional outcomes were also encouraging, with signals of recovery appearing more favorable than those seen in the standard-of-care (SoC) control group, and more patients regaining independence on day 90 after BIOX-101 treatment than in the SoC group.Intracerebral hemorrhage (ICH) is a devastating condition with no approved therapies, accounting for 40% of all stroke-related deaths, despite making up just 15% of cases. Mortality approaches 50 % at 30 days [1], and approximatively half of all ICH-related deaths happen within the first 24 hours [2]. Fewer than 20% of survivors achieve functional independence after six months, often due to secondary damage resulting from the untreatable bleeding and associated inflammation, which causes secondary ischemia, neuroinflammation and neuronal damage, amongst others. BIOX-101 is a proprietary recombinant version of a small protein found in the saliva of the tick (Ixodes ricinus). It is designed to inhibit the harmful secondary effects of hemorrhagic stroke such as secondary ischemia, neuroinflammation and neuronal damage. Unlike currently marketed anticoagulants, BIOX-101 is an investigational anticoagulant that reduces clotting without increasing bleeding. It does this by targeting Factors XIa and XIIa of the intrinsic coagulation pathway. The product also exerts anti-inflammatory effects by inhibiting activation of neutrophils and their release of extracellular DNA filaments (called NETs), which can cause excessive inflammation, exacerbating brain damage and disrupting the blood-brain barrier. Bioxodes has completed a positive Phase 2a clinical proof of concept trial of BIOX-101 to treat ICH and is currently planning a Phase 2b trial in ICH and Phase 2 trials of BIOX-101 to treat acute ischemic stroke and an undisclosed indication. 1. McGurgan, I.J., et al., Acute intracerebral haemorrhage: diagnosis and management. Pract Neurol, 2020. 21(2): p. 128-36.2. Hemphill, J.C., 3rd, et al., The ICH score: a simple, reliable grading scale for intracerebral hemorrhage. Stroke, 2001. 32(4): p. 891-7.Bioxodes SA (www.bioxodes.com) is a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases. The company’s lead asset, BIOX-101, is a first-in-class drug candidate being developed to treat stroke. BIOX-101’s unique mechanism of action is the foundation of an innovative pipeline of drug candidates for treatment and prevention of thromboinflammatory diseases. Worldwide, Bioxodes holds both granted and pending patents associated with BIOX-101. Bioxodes research is supported by the Walloon Region (SPW Recherche), and the company is registered in Belgium under number 825.151.779. HEAD OFFICESBioPark Charleroi-Bruxelles Sud Rue Santos-Dumont, 16041 Gosselies, Belgium+32 496 59 03 54investment@bioxodes.comMEDIA RELATIONS, BELGIUMAlexandra Schiettekatte communication@bioxodes.com+32 476 65 04 38 INVESTOR RELATIONSGiovanni Ca’ ZorziCohesion Bureaugiovanni.cazorzi@cohesionbureau.comMEDIA RELATIONS, INTERNATIONALDouwe MiedemaCohesion Bureaudouwe.miedema@cohesionbureau.com Attachments 20251007 Bioxodes PR Philippe Monteyne (final) Philippe Monteyne October 2025

Phase 2Executive ChangeVaccine

18 Mar 2025

·www.globenewswire.com

Curevo Raises $110 Million to Advance Amezosvatein Shingles Vaccine

-- Amezosvatein has shown excellent immunogenicity and improved tolerability in Phase 2 study -- Medicxi leads round, joined by new investors OrbiMed, HBM Healthcare Investments, and Sanofi Ventures -- Former Chair of GSK’s vaccine business and Chief Scientific Advisor to Operation Warp Speed, Moncef Slaoui, to join Curevo as Board Chair March 17, 2025 -- Curevo Vaccine (Curevo), a privately-held clinical-stage biotechnology company dedicated to developing varicella zoster virus (VZV) vaccines with improved tolerability, today announces the closing of a $110 million Series B round to advance development of amezosvatein, its vaccine for shingles. Leading the round is new investor Medicxi, a European biotech-focused investment firm with significant experience investing in vaccine companies such as Vaxcyte and ViceBio. Joining Medicxi is an international group of investment funds including OrbiMed, HBM Healthcare Investments, and Sanofi Ventures plus existing investors RA Capital Management, Janus Henderson Investors, Adjuvant Capital, and founding investor GC Biopharma. “This Series B round will fund the extension of our successful Phase 2 program into an additional 640 participants, including the key population of adults over age 70, to finalize dose selection ahead of the Phase 3 program,” said Curevo’s CEO, George Simeon, MBA/MPH. “Designed based upon feedback from regulators and other stakeholders, this short extension trial will begin mid-2025 and serve to set the company for clinical, strategic, and regulatory success.” Concurrent with the round, Moncef Slaoui, PhD, will join Curevo as Board Chair. Dr. Slaoui was most recently the Chief Scientific Advisor to Operation Warp Speed during the COVID-19 pandemic, helping deliver vaccines against the SARS-CoV-2 virus. He spent nearly 30 years at GlaxoSmithKline, during which he helped shape its vaccine business by contributing to the creation of numerous new vaccines including Shingrix® (shingles), Cervarix® (HPV-induced cervical cancer), Mosquirix® (malaria), Rotarix® (rotavirus gastroenteritis), and Synflorix® (pneumococcal disease). “I have been collaborating with the Curevo team for several weeks now,” stated Dr. Slaoui. “I’m very excited to work with them to help perfect shingles vaccination, adding good tolerability to the exceptional efficacy achieved by the current vaccine. The data so far show Curevo’s adjuvant technology has the attributes to succeed in this endeavor.” Also joining Curevo’s Board of Directors will be Giovanni Mariggi, PhD, co-founder and Partner at Medicxi, an experienced infectious disease investor and board member. “Patients, doctors, and payors are very clear a new shingles vaccine like amezosvatein would be welcome in the global marketplace. Amezosvatein’s activity and improved tolerability profile could allow it to be a significant product in the shingles vaccines market. We are excited to support Curevo’s plan with a streamlined path to approval,” stated Dr. Mariggi. Tal Zaks, MD/PhD, will be joining Curevo’s Board of Directors on behalf of OrbiMed. Dr. Zaks is the former Chief Medical Officer of Moderna, where he led development of their mRNA vaccine against the SARS-CoV-2 virus. He previously held senior leadership positions in drug development at GSK and Sanofi. “OrbiMed has a long history of investing in biotech companies like Curevo seeking to improve healthcare outcomes while creating long-term shareholder value,” said Dr. Zaks. “The fact amezosvatein contains an optimized version of the TLR4 agonist with a known mechanism of action reduces biological risk while providing the competitive advantage of potentially improved tolerability, which should position it as the first choice for people who want to be protected from shingles.” ‘Amezosvatein’ is the assigned non-proprietary name for CRV-101, a non-mRNA adjuvanted subunit vaccine under investigation by Curevo. Like Shingrix, amezosvatein uses a subunit protein antigen called glycoprotein ‘E’ (gE). Targeting the gE antigen is proven to elicit a long-term, protective immune response to prevent shingles. Amezosvatein’s adjuvant contains an optimized version of the TLR4 agonist proven by Shingrix to be biologically active in shingles vaccination. Amezosvatein was engineered to maintain exceptional efficacy and have a best-in-class tolerability profile. The SLA-SE adjuvant formulation was developed at Seattle-based Access to Advanced Health Institute (AAHI) and amezosvatein was licensed from the Mogam Institute for Biomedical Research, a research institute funded by South Korea’s GC Biopharma. Curevo is a privately held, clinical-stage biotechnology company based near Seattle dedicated to reducing the burden of infectious disease by developing vaccines with improved tolerability and accessibility. Curevo’s lead product is amezosvatein, a non-mRNA adjuvanted sub-unit vaccine to prevent shingles, a serious medical condition involving a painful, blistering skin rash where 10-18% of people also develop serious, long-lasting nerve pain. The current $4+ billion shingles vaccine market is characterized by accessibility issues and vaccine hesitancy/dose avoidance related to vaccine tolerability. For more information visit https://curevovaccine.com/. Medicxi is a healthcare-focused investment firm with the mission to create and invest in companies across the full drug development continuum. Leveraging deep expertise in drug development and company creation spanning over two decades, Medicxi invests in early and late-stage therapeutics with a product vision that can fulfill a clear unmet medical need. For more information, please visit: https://www.medicxi.com. OrbiMed is a leading global healthcare investment firm with approximately $17 billion in assets under management. OrbiMed invests globally across the healthcare industry, from start-ups to large multinational corporations, via private equity funds, public equity funds, and royalty/credit funds. OrbiMed seeks to be a capital provider of choice, providing tailored financing solutions and extensive global team resources to help build world-class healthcare companies. OrbiMed’s team of over 100 professionals is based in New York City, London, San Francisco, Shanghai, Hong Kong, Mumbai, Herzliya, and other key global markets. For more information, please visit www.orbimed.com. Switzerland-based HBM Healthcare Investments focuses on the healthcare sector, holding and managing an international portfolio of promising companies in the human medicine, biotechnology, medical technology, diagnostics, and related areas. Many of these companies have their lead products already available on the market or are at an advanced stage of development. The portfolio companies are closely tracked and actively guided in their strategic direction. This is what makes HBM Healthcare Investments an interesting alternative to investments in big pharma and biotechnology companies. HBM Healthcare Investments has an international shareholder base and is listed on SIX Swiss Exchange (SIX:HBMN). Sanofi Ventures is the corporate venture capital arm of Sanofi, focused on investing in promising early-stage healthcare companies. The firm supports pioneering innovations in biotechnology, digital health, and life sciences aligning with Sanofi’s mission to bring life-changing treatments to patients worldwide. For more information, please visit www.sanofiventures.com. Founded in 2004, RA Capital Management is a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare, life sciences, and planetary health companies. RA Capital creates and funds innovative companies, from private seed rounds to public follow-on financings, allowing management teams to drive value creation from inception through commercialization and beyond. RA Capital's knowledge engine is guided by its TechAtlas internal research division, and Raven, RA Capital's healthcare incubator, offers entrepreneurs and innovators a collaborative and comprehensive platform to explore the novel and the re-imagined. RA Capital has more than 150 employees and over $10 billion in assets under management. Janus Henderson Investors exists to help clients achieve their long-term financial goals. Its active management offers clients the opportunity to outperform passive portfolios over the course of market cycles. With more than 360 investment professionals, Janus Henderson Investors provides access to some of the industry’s most talented and innovative thinkers, spanning equities, fixed income, multi-asset, and alternatives, globally. Its investment teams blend insight, originality, and precision with rigorous analysis, structured processes, and robust risk management. Janus Henderson Investors builds client partnerships on openness and trust, channeling expertise from across the business and communicating the views of its experts in a timely and relevant way. https://www.janushenderson.com/ Headquartered in New York, with offices in Zürich, Adjuvant is a global life science investment fund built to accelerate the development of new technologies for the world's most pressing public health challenges. Backed by prominent healthcare and emerging market investors, Adjuvant draws upon its network of scientists, public health experts, biopharmaceutical industry veterans, and development finance professionals to identify new investment opportunities. Adjuvant invests in companies developing promising new vaccines, therapeutics, diagnostics, and medical devices targeting high-burden infectious diseases, maternal and child health, antimicrobial resistance, and malnutrition, with a commitment to make these interventions accessible globally. For more information, visit http://www.adjuvantcapital.com Founding investor GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company headquartered in Yongin, South Korea. The company has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines and expanded its global presence with the successful USA market entry of ALYGLO™ (intravenous immunoglobulin G) in 2024. In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by leveraging its core R&D capabilities in engineering of proteins, mRNAs, and lipid nanoparticle (LNP) drug delivery platforms to develop therapeutics for the field of rare disease as well as I&I (Immunology & Inflammation). To learn more about the company, visit https://www.gcbiopharma.com/eng/ The content above comes from the network. if any infringement, please contact us to modify.

Vaccine

04 Feb 2025

·ir.arcturusrx.com

Arcturus Therapeutics Announces Appointment of Moncef Slaoui, Ph.D., as Chair Designate

SAN DIEGO --(BUSINESS WIRE)--Feb. 4, 2025-- Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced the appointment of Moncef Slaoui , Ph.D., as Chair Designate. Dr. Slaoui has been serving on the Company’s Board of Directors since June 2024 . “Dr. Moncef Slaoui has a long-proven track record in the pharmaceutical and biotechnology industry, and we are delighted to have him as our Chair Designate,” said Joseph Payne , President & Chief Executive Officer of Arcturus. “We look forward to working with him as we enter a transformative year of advancing our pipeline of therapeutics and vaccines.” “Arcturus has deep expertise in mRNA delivery for therapeutics and a validated commercial stage vaccines platform,” said Dr. Moncef Slaoui . “I am excited to work with the company during this potentially transformational time with multiple key data readouts across its pipeline.” About Dr. Moncef Slaoui Dr. Moncef Slaoui was most recently the Chief Scientific Advisor to Operation Warp Speed. Under his leadership the operation enabled the fastest ever development, manufacturing, and approval of multiple COVID-19 vaccines in less than 11 months after the virus genetic sequence was described. Dr. Slaoui has sat on several biotechnology company boards, including Moderna, Inc. and Lonza Group AG , and he chaired the boards of Galvani, and Vaxcyte, a vaccine development platform company. Dr. Slaoui spent nearly 30 years at GlaxoSmithKline (GSK) holding leadership positions including as member of the Board of Directors of GSK PLC; Chairman of Pharmaceutical R&D; Chairman Global R&D, Vaccines & Oncology; and Chairman, Global Vaccines. As Chairman of Pharmaceutical R&D, Dr. Slaoui led a redesign of GSK’s R&D structure and culture to improve focus on innovation and productivity. As Chairman of Global Vaccines, Dr. Slaoui was directly involved in GSK's vaccine pipeline, leading to the creation of 14 new vaccines, including Shingrix®, to prevent shingles; Cervarix®, to prevent cervical cancer; Mosquirix, to prevent malaria; Rotarix®, to prevent rotavirus gastroenteritis; and Synflorix, to prevent pneumococcal disease. In 2016, Dr. Slaoui was recognized as one of Fortune's 50 Greatest World Leaders for his work in under-researched diseases common in the developing world. He served on the Advisory Committee to the Director of the NIH from 2011 to 2016 and has advised the U.S. President's Council of Advisors on Science and Technology . Dr. Slaoui holds a Ph.D. in Molecular Biology and Immunology from the Université Libre de Bruxelles , completed postdoctoral studies at Harvard Medical School and Tufts University School of Medicine , and was a Professor of Immunology at the University of Mons , Belgium . He received an accelerated Master of Business Administration from IMD, Switzerland in 1998. About Arcturus Founded in 2013 and based in San Diego, California , Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a commercial mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA Technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus developed KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus, and a joint venture in Japan , ARCALIS , focused on the manufacture of mRNA vaccines and therapeutics. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus' technologies are covered by its extensive patent portfolio (over 400 patents and patent applications in the U.S. , Europe , Japan , China , and other countries). For more information, visit www.ArcturusRx.com. In addition, please connect with us on Twitter and LinkedIn. View source version on businesswire.com: https://www.businesswire.com/news/home/20250204663825/en/ Arcturus Therapeutics Public Relations & Investor Relations Neda Safarzadeh VP, Head of IR/PR/Marketing (858) 900-2682 IR@ArcturusRx.com Source: Arcturus Therapeutics Holdings Inc.

VaccineExecutive ChangemRNA

100 Deals associated with Human papillomavirus vaccine [types 16, 18](GlaxoSmithKline Plc)

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Cervical Adenocarcinoma In Situ	United States	GlaxoSmithKline LLC	16 Oct 2009
Uterine Cervical Cancer	United States	GlaxoSmithKline LLC	16 Oct 2009
Uterine Cervical Cancer	Japan	GlaxoSmithKline KK	16 Oct 2009
Uterine Cervical Dysplasia	United States	GlaxoSmithKline LLC	16 Oct 2009
Anus Neoplasms	European Union	GlaxoSmithKline Biologicals SA	20 Sep 2007
Anus Neoplasms	Iceland	GlaxoSmithKline Biologicals SA	20 Sep 2007
Anus Neoplasms	Liechtenstein	GlaxoSmithKline Biologicals SA	20 Sep 2007
Anus Neoplasms	Norway	GlaxoSmithKline Biologicals SA	20 Sep 2007
Human Papillomavirus Infection	Australia	GlaxoSmithKline Australia Pty Ltd.	18 May 2007
Human Papillomavirus-Related Cervical Carcinoma	Australia	GlaxoSmithKline Australia Pty Ltd.	18 May 2007

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Meningococcal Infections	Phase 3	Dominican Republic	GSK Plc	11 Jan 2013
Meningococcal Infections	Phase 3	Estonia	GSK Plc	11 Jan 2013
Meningococcal Infections	Phase 3	Thailand	GSK Plc	11 Jan 2013
Chronic human papillomavirus (HPV) infection	Phase 3	Senegal	GSK Plc	01 Oct 2007
Chronic human papillomavirus (HPV) infection	Phase 3	Tanzania	GSK Plc	01 Oct 2007
Adenocarcinoma in Situ	Phase 3	Costa Rica	GSK Plc	30 Jun 2004
Carcinoma in situ of uterine cervix	Phase 3	Costa Rica	GSK Plc	30 Jun 2004
HPV16 Infection	Phase 3	Costa Rica	GSK Plc	30 Jun 2004
Precancerous Conditions	Phase 3	Costa Rica	GSK Plc	30 Jun 2004
Cervical Intraepithelial Neoplasia	Phase 3	United States	GSK Plc	06 May 2004

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


IRCT20090526001952N9 (Pubmed \| Eur J Cancer Prev)	Phase 3	-	218	04-adjuvanted human papillomavirus vaccine (Papilloguard)	xbbwzlvirl(qezkvqobtb) = The most common AE was discomfort at the injection site, which was well tolerated xytdrwalua (stavenwgnd )	-	29 Mar 2022
				04-adjuvanted human papillomavirus vaccine (Cervarix)
NCT00122681 \| NCT00169494 \| NCT00092534 (NCT00122681, NCT00169494, NCT00092534, Pubmed \| BMJ Open)	Phase 3	HPV-related carcinoma	3,341	Human papillomavirus vaccine (non-HPV-vaccinated cohorts)	qobrevcbxa(vizvxjxjrv) = dhcrinniih mqflxiuali (dkxcxvmaju )	-	30 Dec 2021
NCT00779766 \| NCT00122681 (Pubmed \| Expert Rev Vaccines) Manual	Phase 3	Human Papillomavirus Infection \| Uterine Cervical Diseases	1,324	AS04-HPV-16/18 vaccine (oncogenic HPV types)	tmbzjnynef(cwfmqidiiy) = The risk of progression from 6MPI to CIN2+ was substantially higher for oncogenic versus non-oncogenic HPV types. uwbocgrqqd (okdnhuavqw )	Negative	23 Dec 2021
				AS04-HPV-16/18 vaccine (non-oncogenic HPV types)
NCT00534638 (Pubmed \| Prev Med)	Phase 4	Obstetric Labor, Premature	34,412	bivalent HPV vaccination (HPV-vaccinated women)	iapdaxkygs(ytsfnbfdfn) = jpaookkiqp eutcuihabs (ettudcilrw )	-	24 Feb 2021
				bivalent HPV vaccination (Non-HPV-vaccinated women)	iapdaxkygs(ytsfnbfdfn) = bbzfnymrcd eutcuihabs (ettudcilrw ) View more
NCT03629886 (HPV-092, CTgov)	Phase 4	Cervical Intraepithelial Neoplasia	6,051	HPV (Types 16, 18) Vaccine, Adsorbed (Vacc-092 Group)	kpifbqeinn = zjnrqmmioh bxnzvlapzw (bnajfxrsyi, rpevtnceqq - wwljpcavvz) View more	-	19 Dec 2020
				HPV vaccine (Vacc-039 Group)	krfhvrnhid = hdieewclrl vztycowhrf (vhebjgvyon, bdwnkpohcf - bfwdpsgzfg) View more
NCT00534638 (Pubmed \| Hum Vaccin Immunother)	Phase 4	-	34,412	AS04-HPV-16/18 vaccine	zadpbhysjf(afoyvfvruj) = nkboxdcewg sfijhpumql (iqdjlelcxw ) View more	-	02 Jun 2020
				Hepatitis-B virus vaccine	zadpbhysjf(afoyvfvruj) = onqkzjzxfo sfijhpumql (iqdjlelcxw ) View more
NCT02979535 (CTgov)	Phase 3	Human Papillomavirus Infection \| Severe Dengue	480	CYD Dengue Vaccine+18] Vaccine, Recombinant+Recombinant (CYD Dengue Vaccine + Cervarix (Concomitant Administration))	uakrhnpsmv(xykshijkbg) = pqivewnhqd aupygtuygw (nnhskxjrsn, pirwnniung - kzfknzqjgj) View more	-	09 Mar 2020
				CYD Dengue Vaccine+Human Papillomavirus Bivalent [Types 16 and 18] Vaccine, Recombinant (CYD Dengue Vaccine + Cervarix (Sequential Administration))	uakrhnpsmv(xykshijkbg) = tgknuirmyp aupygtuygw (nnhskxjrsn, bmrtrdojuw - rldottpzyf) View more
NCT00231413 (CTgov)	Phase 2	Human Papillomavirus Infection	383	HPV 16/18 L1 AS04 (HPV-16/18 Group)	skslffoioq = dyisbulagp dlqcjnhgxe (ibvwqtjmdl, rfdvdodudy - lkjtuntpdx) View more	-	12 Dec 2019
				HPV-16/18/31/45 L1 AS04 Formulation 1 (HPV-TETRA A Group)	skslffoioq = syifyfpfvo dlqcjnhgxe (ibvwqtjmdl, rieokbefcd - rwlmeowibp) View more
NCT01031069 (CTgov)	Phase 4	Human Papillomavirus Infection \| HIV Infections	873	GSK Biologicals' HPV vaccine 580299 (HIV+/Cervarix Group)	bzdwokaygw = zzmnbnutqy bywpiuwkvn (rtfdyhewwp, yvutxyecxc - pvmuhhohck) View more	-	24 Jul 2019
				Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16,+Human Papillomavirus Quadrivalent (Types 6, 11,+Merck (HIV+/Gardasil Group)	bzdwokaygw = wfaqxugngm bywpiuwkvn (rtfdyhewwp, rxawihmwpa - inkyqcnaqm) View more
NCT01190189 (CTgov)	Phase 3	Human Papillomavirus Infection	137	GSK580299 (Cervarix)	ivrxbujrup = mtkvhwtgxz pqeukwbqkt (iidvnqbunv, yzpyhawxsf - aupqmzgdvd) View more	-	17 Dec 2018

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