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Last update 16 May 2025

Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)

Last update 16 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

Circumsporozoite protein hepatitis-B surface antigen fusion protein- GlaxoSmithKline, CSP-HBsAg - GlaxoSmithKlineCSP-HBsAg - GlaxoSmithKline, CSP-HBsAg/SBAS2-GlaxoSmithKline

+ [27]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious Diseases

Active Indication

Malaria, Falciparum

Inactive Indication

Hepatitis BHIV InfectionsMeasles+ [2]

Originator Organization

GSK Plc

Active Organization

GSK Plc

Inactive Organization

University of Oxford

License Organization-

Drug Highest PhaseApproved

First Approval Date

Belgium (10 Jan 2015),

Malaria, Falciparum

Regulation-

Structure/Sequence

Sequence Code 126827

Clinical Trials associated with Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)

PACTR202503849420187

/ SuspendedPhase 2

A Phase 2a, open label, randomized, interventional study to assess the safety and immunogenicity of alternative vaccination regimens and reduced antigen doses of RTS,S/AS01E vaccine in healthy children aged 5-60 months in a malaria-endemic area

Start Date02 Jun 2025

Sponsor / Collaborator

GlaxoSmithKline Biologicals SA

PACTR202409856142141

/ SuspendedNot ApplicableIIT

Evaluating antibody responses longitudinally and correlation to clinical malaria in children who received seasonal vaccination with RTS,S/AS01E with and without seasonal malaria chemoprevention in Mali.

Start Date01 Oct 2024

Sponsor / Collaborator-

NCT06424002

/ Not yet recruitingPhase 4IIT

The Impact, Feasibility Acceptability and Cost Effectiveness of the RTS,S/AS01 Malaria Vaccine in School Aged Children

Across sub-Saharan Africa, school-age children bear an under-appreciated burden of malaria. An estimated 200 million school-age children are at risk of malaria and in many areas prevalence of infection exceeds 50%. The high infection rates in this group serves as a source of onward parasite transmission, undermining elimination and control efforts. Furthermore, malaria illness and malaria-induced anemia in this age group lead to school absenteeism, and impaired cognitive function and classroom attention, ultimately resulting in reduced academic achievement. Although universal malaria interventions, such as insecticide treated nets (ITNs) and access to prompt diagnosis and treatment are available to school-age children, this age group is the least likely to benefit from these interventions. Furthermore, efficacy of these approaches may be compromised by increasing anti-malarial drug and insecticide resistance. A malaria vaccine could help to avert the burden of malaria in this age group.
The RTS,S/AS01 malaria vaccine has recently been recommended for vaccination of young children (< 24 months) by the World health organization (WHO) after a Phase 3 trial and an implementation trial showed that the vaccine had moderate but significant efficacy to prevent clinical and severe malaria in young children. Previous randomized trials suggest that the vaccine is safe for older children. However, efficacy of the vaccine has never been assessed in school age children. Kamuzu University of Health Sciences in partnership with the Malawian Ministry of Health seeks to evaluate the efficacy of the newly introduced RTSS/AS01 malaria vaccine in school aged children. The study hypothesizes that vaccination will decrease the morbidity and transmission of malaria, as well as improve school absenteeism and educational outcomes.

Start Date01 Jun 2024

Sponsor / Collaborator

Michigan State University

[+2]

100 Clinical Results associated with Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)

100 Translational Medicine associated with Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)

100 Patents (Medical) associated with Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)

468

Literatures (Medical) associated with Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)

01 May 2025·Lancet Global Health

Incidence rates of malaria, meningitis, and mortality in children younger than 5 years: a prospective cohort study in Ghana and Kenya before the roll-out of the RTS,S/AS01E malaria vaccine from 2016 to 2022

Article

Author: Oguk, Esther ; Awuni, Dennis Azabra ; Harrison, Samuel Bernard Ekow ; Haine, Valérie ; Oyieko, Janet ; Cravcenco, Cristina ; Kaali, Seyram ; Agyapong, Prince Darko ; Sing'oei, Valentine ; Ansah, Nana Akosua ; Kaburise, Michael Bandasua ; Asante, Kwaku Poku ; Otieno, Walter ; Owusu-Agyei, Seth ; Boahen, Owusu ; Kayan, Kingsley ; Roman, François ; Schuerman, Lode ; Otieno, Lucas ; Dosoo, David ; Ansah, Patrick Odum ; Bozonnat, Marie-Cécile ; Adeniji, Elisha ; Tivura, Mathilda ; Savic, Miloje

BACKGROUND:

The RTS,S/AS01_E malaria vaccine was introduced in selected communities of Ghana, Kenya, and Malawi in 2019 under a WHO-coordinated pilot programme. The scarcity of background disease incidence rates might hamper the assessment of vaccine safety and effectiveness. We aimed to determine the incidence rates of malaria, meningitis, and death, and health outcomes leading to hospital admission in children younger than 5 years enrolled before RTS,S/AS01_E implementation. Interim results from EPI-MAL-002 up to Oct 5, 2018, were reported previously. Here, we report results from the final analysis of the pre-vaccine introduction study.

METHODS:

This disease surveillance study combined two approaches: (1) prospective cohort event monitoring (home visits scheduled to mimic a future four-dose RTS,S/AS01_E vaccination schedule [ie, a simulated vaccination schedule], with additional visits after the simulated schedule and continuous disease monitoring of outpatient visits and hospital admission) in children enrolled in two age groups (6-12 weeks [6-12W] and 5-17 months [5-17M]), and (2) hospital-based disease surveillance for children not enrolled in the prospective cohort, in three sites in Ghana and Kenya. Key outcomes were rates of meningitis, malaria, adverse events of special interest, other adverse events leading to hospital admission, all-cause mortality, and malaria-attributable mortality.

FINDINGS:

The final analysis included 23 427 children: 9032 in the 6-12W age group, 9694 in the 5-17M age group, and 4701 in hospital-based disease surveillance. In the 5-17M age group (corresponding to the WHO-recommended age for RTS,S/AS01_E vaccination), the incidence rates of meningitis and cerebral malaria within an at-risk period of 1 year after the simulated vaccination schedule were both equal to 28 (95% CI 9-65) per 100 000 person-years. There were 11 (0·1%) children with an adverse event of special interest during hospital admission. In the 5-17M age group, the all-cause mortality rate was 643 (95% CI 531-771) per 100 000 person-years.

INTERPRETATION:

Observed incidence of meningitis and cerebral malaria were in the previously published range, whereas childhood mortality was lower, suggesting that the recent efforts to reduce mortality in children younger than 5 years have been impactful. Data from this study have public health use and will form the baseline evidence for ongoing evaluation of the benefit-risk of RTS,S/AS01_E.

FUNDING:

GSK and PATH.

01 Apr 2025·Lancet Global Health

Safety of RTS,S/AS01E malaria vaccine up to 1 year after the third dose in Ghana, Kenya, and Malawi (EPI-MAL-003): a phase 4 cohort event monitoring study

Article

Author: Owusu-Agyei, Seth ; Mzanga, Phylis ; Onyango, Irene ; Nyangulu, Wongani ; Okoth, George Odhiambo ; Kaali, Seyram ; Ababio, Lucy Osei ; Sifuna, Peter M ; Cherop, Reuben Yego ; Roman, François ; Jere, Tikhala Makhaza ; Awuni, Denis ; Maleta, Kenneth ; Orsini, Mattea ; Otieno, Walter ; Kaburise, Michael Bandasua ; Adeniji, Elisha ; Haine, Valérie ; Guerra Mendoza, Yolanda ; Amoit, Stellah Kevyne ; Phiri, Vincent Katunga ; Odera-Ojwang, Patricia ; Oneko, Martina ; Oyieko, Janet Nyawira ; Ochieng, Benard Omondi ; Chipatala, Raphael ; Kariuki, Simon ; Orimbo, John ; Debois, Muriel ; Kayan, Kingsley ; Cravcenco, Cristina ; Harrison, Samuel B E ; Asante, Kwaku Poku ; Olewe, Fredrick ; Sing'oei, Valentine ; Agyapong, Prince Darko ; Savic, Miloje ; Ansah, Nana Akosua ; Boahen, Owusu ; Schuerman, Lode ; Mategula, Donnie ; Ogutu, Bernhards ; Achieng Oguk, Esther ; Devadiga, Raghavendra ; Azongo, Daniel K ; French, Neil ; Ansah, Patrick Odum ; Ndeketa, Latif ; Ong'echa, John Michael ; Oduro, Abraham Rexford

BACKGROUND:

RTS,S/AS01_E has been successfully administered to over two million children since 2019 through the Malaria Vaccine Implementation Programme (MVIP). In this Article, we report the safety results of a study evaluating RTS,S/AS01_E safety and effectiveness in real-world settings.

METHODS:

EPI-MAL-003 is an ongoing phase 4 disease surveillance study with prospective cohort event monitoring and hospital-based surveillance, done in the setting of routine health-care practice in Ghana, Kenya, and Malawi and fully embedded in the MVIP. The study design was dependent on the cluster-randomised vaccine implementation. In active surveillance, we enrolled children younger than 18 months from exposed (where RTS,S/AS01_E was offered) and unexposed clusters. The coprimary endpoints were the occurrence of predefined adverse events of special interest and aetiology-confirmed meningitis. We report primary and secondary safety results up to 1 year after the primary vaccine schedule (three doses). The study is registered with ClinicalTrials.gov, NCT03855995.

FINDINGS:

The first participant was enrolled on March 21, 2019. The cutoff date for the current analysis was 1 year after the third RTS,S/AS01_E dose for each participant. In total, 44 912 children (19 993 in Ghana, 11 990 in Kenya, and 12 929 in Malawi) were included in the analysis set for the cluster-randomised comparison: 22 508 from exposed clusters and 22 404 from unexposed clusters. Incidence rates (expressed per 100 000 person-years) for generalised convulsive seizures and intussusception were similar between vaccinated and unvaccinated children. Aetiology-confirmed meningitis was reported in two children: one case of bacterial meningitis due to Streptococcus pneumoniae in an RTS,S/AS01_E-vaccinated child in the exposed clusters, and one case of viral meningitis due to human herpesvirus 6 in an unvaccinated child in the unexposed clusters. Both cases occurred within 12 months after vaccination in children in the cluster-design analysis set, leading to incidence rates of 4·1 (95% CI 0·1-23·0) per 100 000 person-years in RTS,S/AS01_E-vaccinated children and 4·0 (0·1-22·6) per 100 000 person-years in unvaccinated children, and a country-adjusted incidence rate ratio (IRR) of 0·96 (95% CI 0·06-15·34; p=0·98). Cerebral malaria cases were reported for four (<0·1%) of 20 639 RTS,S/AS01_E-vaccinated children in the exposed clusters and two (<0·1%) of 22 137 unvaccinated children in the unexposed clusters. These included three and two cases occurring within 12 months after the primary vaccination, in RTS,S/AS01_E-vaccinated children and unvaccinated children, respectively (IRR 1·43, 95% CI 0·24-8·58, p=0·70). Incidence rates for all-cause mortality were 659·7 (95% CI 561·5-770·3) in vaccinated children versus 724·5 (622·3-838·8) in unvaccinated children, with similar incidence rates for boys and girls.

INTERPRETATION:

We found no evidence of vaccination being associated with an increased risk of meningitis, cerebral malaria, or mortality among vaccinated children, and no new safety risks were identified.

FUNDING:

GSK.

01 Apr 2025·VACCINE

Novel, fully human, anti-PfCSP antibodies with potent antimalarial activity using a phage display based strategy

Article

Author: Gupta, Dinesh ; Kumar, Dhiraj ; Singh, Susheel K ; Mohmmed, Asif ; Khan, Summaiya ; Junaid, Iqbal Taliy ; Arkam, Shaikh Zikra ; Singh, Agam P ; Verma, Sheenam ; Salunke, Dinakar M ; Ahmad, Shahnawaz ; Parveen, Sadaf ; Tabrez, Shams ; Theisen, Michael ; Malhotra, Pawan ; Rath, Pragyan Parimita ; Singh, Pooja

Developing an effective vaccine against malaria remains a prime goal of human health. The circumsporozoite protein (CSP) is a major surface protein of the sporozoites, and is the target of two licensed Plasmodium falciparum malaria vaccines, RTS,S/AS01, named Mosquirix and R21/Matrix-M. However, to improve the standards set by these vaccines we require a second-generation or prophylactic vaccine. Recently, monoclonal antibodies have emerged as essential biopharmaceutical prophylactic vaccines. The present study targeted recombinant Plasmodium falciparum CSP (rPfCSP) with a phage display of human single-fold scFv Tomlinson libraries I+J and picked fourteen scFvs that represented two independent clones after sequencing; CL1 and CL3. These phages were analysed for their binding to rPfCSP. The selected scFvs were cloned in a human IgG1 Fc tag vector, to generate scFv-Fc full-length antibody clones. CL1 bound rPfCSP protein with a K_D of 3.8x10^-6M and CL3 bound rPfCSP protein with a K_D of 5.6 x 10^-5 M. These antibodies detected native PfCSP on the sporozoite surface. Molecular docking simulation revealed that rPfCSP residues interacting with CL1 and CL3 were downstream of the repeat region. These antibodies inhibited the sporozoite infectivity into HepG2 cells, similar to a gold standard monoclonal antibody, 2A10. Low-dose passive transfer of the CL1 and CL3 antibodies conferred high-level protection when challenged with PfCSP-Pb transgenic parasites in the mouse infection model. The high in vitro and in vivo efficacies of the CL1 and CL3 antibodies have applications in malaria immunoprophylaxis in protecting travellers and military servicemen or as a therapeutic vaccine in malaria elimination programmes.

News (Medical) associated with Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)

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

21 Nov 2024

·vicebio.com

Vicebio Advances Clinical Study of RSV/hMPV Bivalent Vaccine…

Vicebio enters the second stage of its Phase 1 Clinical Study of its lead candidate VXB-241 The Clinical Study, an actively controlled Proof of Concept Phase 1 conducted in target population aged 60+, is progressing as planned with initial data expected by mid-2025 Moncef Slaoui, former Chief Scientific Advisor of Operation Warp Speed & former Chair of R&D at GlaxoSmithKline and Khurem Farooq, previously CEO of Aiolos, join Board of Directors London, UK, 21 November 2024: Vicebio Ltd (“Vicebio”), a biopharmaceutical company pioneering next-generation vaccines for life-threatening respiratory viruses, today announces its progress in the ongoing VXB-241 bivalent RSV-hMPV Phase 1 (P1) study as well as the appointment of Moncef Slaoui, PhD, and Khurem Farooq to its Board of Directors. Vicebio is progressing into the second stage of its clinical study of VXB-241 and is now enrolling individuals aged 60 years of age and above to evaluate the candidate vaccine’s safety in this vulnerable population. Early data from the study are expected by mid-2025. Vicebio anticipates these data will represent a significant milestone in the clinical validation of its platform. More information on the P1 study can be found on clinicaltrials.gov (NCT06556147). Moncef Slaoui, PhD, and Khurem Farooq join the Board of Directors, effective immediately. Both bring vast experience in vaccine development and biopharmaceutical leadership. Emmanuel Hanon, Chief Executive Officer of Vicebio, said: “In connection with our significant Series B financing, we are building upon our world-class leadership team with the addition of Moncef and Khurem to the Board. Their expertise not only further supports our innovation but will be essential as we continue to advance the Company’s vision to deliver the next generation of respiratory viral vaccines.” At the heart of Vicebio’s innovation is its proprietary Molecular Clamp technology, designed to stabilise viral antigens and enhance protective immunity across multiple respiratory pathogens. This transformative technology supports the development of multivalent respiratory viral vaccines that are ready-to-use, cost-effective, and capable of addressing critical needs in global respiratory health. Moncef Slaoui, PhD, newly appointed Independent Board Member at Vicebio, commented: “Vicebio’s Molecular Clamp technology marks a transformative advancement in vaccine development. It is fantastic to be joining the Board of a company where the technology and novel approach holds the potential to expedite delivery of highly effective and stable vaccines in ready-to-use prefilled syringes.” Khurem Farooq, newly appointed Independent Board Member at Vicebio, added: “Vicebio is at an exciting phase of growth as it looks to advance its pipeline of multivalent vaccines with the potential to prevent a wide range of diseases in a single vaccine.” Moncef Slaoui, PhD, has extensive experience in drug development and commercialisation. He currently serves as an advisor to Medicxi and is on the Board of Directors of several companies including Arcturus Therapeutics, Altesa, and Zephyr AI. Under his leadership as Chief Scientific Advisor to Operation Warp Speed, he played a critical role in the rapid development and deployment of multiple of COVID-19 vaccines in the US. Prior to this Moncef’s career at GlaxoSmithKline (GSK) spanned nearly three decades, where he held several senior leadership roles, including being a member of the Board of Directors. He spearheaded GSK’s Pharmaceutical R&D restructuring to improve focus on innovation and productivity, and was instrumental in the development of 14 new vaccines, including Shingrix, to prevent shingles; Cervarix, to prevent cervical cancer and Mosquirix, to prevent malaria. Moncef earned a PhD in Molecular Biology and Immunology from the Université Libre de Bruxelles and completed postdoctoral studies at Harvard Medical School and Tufts University. He also holds an accelerated MBA from IMD in Switzerland. Khurem Farooq is an avid biotech entrepreneur with over 20 years of experience in drug development. Khurem was co-founder and CEO of Aiolos Bio, which was acquired by GSK for $1.4bn in February 2024. Prior to this, Khurem served as CEO of Gyroscope, which was acquired by Novartis in 2021 for up to $1.5bn. Khurem was Senior Vice President of the Immunology and Ophthalmology business unit at Genentech, a member of the Roche Group, where he played a key role in the commercialisation and launch strategies of several medicines and contributed to the development of numerous pipeline products. He holds an MBA and a BSc in Biological Sciences, with honours, from Aston University and University of Wolverhampton, respectively. For further information, please contact: Optimum Strategic Communications Mary Clark, Hana Malik, Vareen Outhonesack Tel: +44 (0) 203 922 0889 Email: vicebio@optimumcomms.com Vicebio is backed by a global syndicate of life science investors including Medicxi, UniQuest, TCGX, Goldman Sachs Alternatives, Avoro Ventures and venBio. For more information, please visit: www.vicebio.com About Vicebio Vicebio is focused on developing next-generation respiratory virus vaccines using the Molecular Clamp Technology. The company was founded with investment from Medicxi and acquired the rights to the Molecular Clamp technology through a license from UniQuest, the commercialization arm of The University of Queensland, Australia. This proprietary technology was developed by Prof. Paul Young, Prof. Daniel Watterson, and Prof. Keith Chappell at UQ. For more information, please visit: https://www.vicebio.com About Medicxi 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 fulfil a clear unmet medical need. For more information, please visit: https://www.medicxi.com About UniQuest UniQuest is the commercialisation company of The University of Queensland (UQ). In partnership with UQ researchers, UniQuest creates impact through the commercialisation of UQ intellectual property. Established in 1984, UniQuest’s commercialisation track record positions UQ as the leader of research commercialisation in Australasia. Notable successes include the blockbuster cervical cancer vaccine Gardasil® and start-up companies Spinifex Pharmaceuticals Inc and Inflazome Ltd, which were acquired in two of the largest university start-ups exits in Australian history. UniQuest has also established the Queensland Emory Drug Discovery Initiative (QEDDI), a world-class small molecule drug discovery and development group, dedicated to translating academic biomedical research into drug candidates for partnering. In 2024, UniQuest launched its AUD$32 million UniQuest Extension Fund, an investment fund dedicated to supporting the start-up eco-system at The University of Queensland. For more information, please visit: https://uniquest.com.au/about/ About TCGX TCGX is a healthcare investment firm dedicated to advancing disruptive medicines and supporting companies that can improve the lives of patients. TCGX invests in pioneering healthcare companies led by exceptional entrepreneurs focused on developing better treatment options for patients. TCGX has investment teams in San Francisco, Palo Alto, and New York City. For more information, please visit: www.tcgcrossover.com Goldman Sachs (NYSE: GS) is one of the leading investors in alternatives globally, with over $450 billion in assets and more than 30 years of experience. The business invests in the full spectrum of alternatives including private equity, growth equity, life sciences, private credit, real estate, infrastructure, hedge funds, and sustainability. Clients access these solutions through direct strategies, customized partnerships, and open-architecture programs. The business is driven by a focus on partnership and shared success with its clients, seeking to deliver long-term investment performance drawing on its global network and deep expertise across industries and markets. The alternative investments platform is part of Goldman Sachs Asset Management, which delivers investment and advisory services across public and private markets for the world’s leading institutions, financial advisors, and individuals. Goldman Sachs has over $2.8 trillion in assets under supervision globally as of March 31, 2024. About Avoro Ventures Avoro Ventures is a global life sciences investment firm, and an affiliated company of Avoro Capital Advisors, an SEC-registered investment manager based in New York City, with over $6.5 billion in capital primarily focused on supporting emerging life sciences and biotechnology companies. For more information, please visit: www.avorocapital.com About venBio venBio is a life sciences investment firm that partners with industry leaders to build innovative medicines and technologies, with a focus on novel therapeutics for unmet medical needs. For more information, please visit: www.venbio.com

VaccinePhase 1AcquisitionExecutive Change

100 Deals associated with Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J07X	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Malaria, Falciparum	Belgium	GSK Plc	10 Jan 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Measles	Phase 3	Ghana	GSK Plc	10 May 2017
Rubella	Phase 3	Ghana	GSK Plc	10 May 2017
Yellow Fever	Phase 3	Ghana	GSK Plc	10 May 2017
Hepatitis B	Phase 3	Burkina Faso	GSK Plc	17 Nov 2011
Hepatitis B	Phase 3	Ghana	GSK Plc	17 Nov 2011
HIV Infections	Phase 3	Kenya	GSK Plc	30 Jul 2010
Malaria	Phase 3	Burkina Faso	GSK Plc	27 Mar 2009
Malaria	Phase 3	Gabon	GSK Plc	27 Mar 2009
Malaria	Phase 3	Ghana	GSK Plc	27 Mar 2009
Malaria	Phase 3	Kenya	GSK Plc	27 Mar 2009

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04661579 (CTgov)	Phase 2	Malaria, Falciparum	620	Dihydroartemisinin-piperaquine (DHA/Pip)+Artemether / Lumefantrine+Primaquine+Malaria Vaccine RTS,S/AS01E (Group 1: Positive Parasitemia; Anti-malarial Treatment + RTS,S/AS01E Vaccine)	clqxgqjket = hwzhvlqglq zmgieogyty (bvoiqufprj, hqikpkvwil - jpttabboxq) View more	-	19 Jul 2024
				Abhayrab rabies vaccine+Dihydroartemisinin-piperaquine (DHA/Pip)+Artemether / Lumefantrine+Primaquine (Group 4: Positive Parasitemia; Anti-malarial Treatment + Rabies Vaccine)	clqxgqjket = cblzoybbwz zmgieogyty (bvoiqufprj, waxznzdtzh - oqvhidbble) View more
NCT03276962 (CTgov)	Phase 2	Malaria	1,500	S+RTS,S/AS01E (Full dose) (Fx012-14-mFxD Group)	mcybbvohnj = kvmlvjvdmu srzgmwvrrr (dfxrypgftf, xrjuffxxja - wifgzuvncd) View more	-	21 May 2024
				RTS,S/AS01E (Full dose) (R012-20 Group)	knhfqbucir = cowhrjyhqv notkqfbshv (ktwycmjdwu, fmqhlnvoxl - sbozwodfrf) View more
NCT03162614 (Phase IIa Controlled Human Malaria Infection and Immunogenicity Study of RTS,S/AS01E and RTS,S/AS01B Delayed Fractional Dose Regimens in Malaria-Naive Adults, Pubmed \| J Infect Dis)	Phase 2	Malaria Plasmodium falciparum-infected mosquito challenge	130	RTS,S/AS01B three-dose regimen	pmjjgoxqbh(gjwqwrmipq) = sbvtkcfzhh lbxwveuauj (pxstusawnn, 27 - 72)	Positive	13 Oct 2020
				RTS,S/AS01E three-dose regimen	pmjjgoxqbh(gjwqwrmipq) = zmyicgmjjs lbxwveuauj (pxstusawnn, 48 - 89)
NCT02699099 (CTgov)	Phase 3	Yellow Fever \| Malaria \| Rubella ... View more	699	Vitamin A+Stamaril+MR-Vac+Candidate Plasmodium falciparum malaria vaccine (Coad Group)	bkdiibdevn(jfcyccglal) = vjfasrsjji vxmiaiybkr (pyjqukbvci, sgaergbhdb - xasalwmwgg) View more	-	29 Aug 2019
				Vitamin A+Stamaril+MR-Vac+Candidate Plasmodium falciparum malaria vaccine (RTS,S Group)	bkdiibdevn(jfcyccglal) = yaumebmoyd vxmiaiybkr (pyjqukbvci, bkltkwohdr - ecnregqweg) View more
NCT02207816 (CTgov)	Phase 3	Malaria	3,084	Blood sampling+Polio Sabin Oral Polio Vaccine+Malaria Vaccine 257049 (MALARIA-055 PRI) (GSK257049 Group)	owtquohvca(jknlfwvedm) = xwaajdbxjh bduamvsxwn (rybbsqznvo, btnoasvksw - kpjlezqufx) View more	-	15 Aug 2019
				Blood sampling+Malaria Vaccine 257049 (MALARIA-055 PRI) (GSK257049 Comparator Group)	owtquohvca(jknlfwvedm) = cwpvuyghvo bduamvsxwn (rybbsqznvo, aiujyfihvt - lhbxbmyxlp) View more
NCT02992119 (RTSS, CTgov)	Phase 2	Malaria	193	S+AS01B+RTS (Group 1)	zoexgbsqht = jixdrvmjbt nrduvguiqu (vlhccyfpiw, apupdiswrt - aorzxmizjo) View more	-	29 Jul 2019
				Double RTS,S/AS01E Fractional dose (Group 2)	zoexgbsqht = ekczvoaqjq nrduvguiqu (vlhccyfpiw, zsqwmjrwgp - tfvqzgglcf) View more
NCT03162614 (Phase IIa Controlled Human Malaria Infection and Immunogenicity Study of RTS,S/AS01E and RTS,S/AS01B Delayed Fractional Dose Regimens in Malaria-Naive Adults, CTgov)	Phase 2	Malaria	154	Sporozoite-infected mosquitoes challenge.+RTS,S/AS01B (AduFx Group)	lfczdinjmf = sgovyvfcto pjwvtaprku (qyikpgecmw, modqvlxpzu - mqvioqsugk) View more	-	24 Jul 2019
				Sporozoite-infected mosquitoes challenge.+RTS,S/AS01E (2PedFx Group)	lfczdinjmf = udpmaimqmf pjwvtaprku (qyikpgecmw, dlryfpgltf - uknkjrdtoq) View more
NCT01148459 (CTgov)	Phase 3	Malaria \| HIV Infections	200	GSK257049 vaccine (GSK257049 Group)	zimrfijsjz = repyxzoehn hztcyyclsp (ntemotqbzv, zxbcjycpbk - xmxejqqxpf) View more	-	16 Jan 2019
				Verorab (Verorab Group)	zimrfijsjz = qhfljbyhpj hztcyyclsp (ntemotqbzv, rbckftlxnk - qulapujtml) View more
NCT00380393 (RTS,S/AS01E, CTgov)	Phase 2	Malaria, Falciparum	894	GSK malaria vaccine 257049 Vaccine (GSK257049 Group)	nlelrepfbs = bgpvjjidry ckxekkftpl (pncvermgyt, qvflqcrjyf - inmnpzlrtq) View more	-	03 Jul 2018
				Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine (Rabipur Group)	nlelrepfbs = hkgftsswaq ckxekkftpl (pncvermgyt, wegzylzyyn - cjdvkvsock) View more
NCT00360230 (CTgov)	Phase 2	Malaria	540	GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 (SB257049 F2 0-1 M Group)	qnjdterqmo = osvtndjjcp zvctcnskwg (txxlbcausy, rfpdfugdow - yswjyqicbp) View more	-	19 Feb 2018
				GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 (SB257049 F1 0-1 M Group)	qnjdterqmo = syvoccgbak zvctcnskwg (txxlbcausy, yrliokhooz - qrhttnyuzj) View more

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Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)

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