SumayaVac-1 / Sumaya Biotech - LARVOL DELTA

CHMI-SUM-101: A Challenge Study to Assess the Blood-stage Efficacy of Full-length SUM-101 Malaria Vaccine Candidate (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: European Vaccine Initiative | Initiation date: Oct 2025 ➔ Mar 2026 | Trial primary completion date: Dec 2025 ➔ Jul 2026

Trial initiation date • Trial primary completion date • Infectious Disease • Malaria

Safety and Immunogenicity of SUM-101 Malaria Vaccine in Children and Infants Living in Burkina Faso (clinicaltrials.gov) - P1 | N=69 | Active, not recruiting | Sponsor: European Vaccine Initiative | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Malaria

Full-length merozoite surface protein 1 formulated with GLA-SE adjuvant in malaria pre-exposed adults: a randomised, controlled, double-blind, parallel-group, single-centre Phase Ib trial. (PubMed, EClinicalMedicine) - P1 | "A highly effective blood-stage malaria vaccine targeting the merozoite surface protein 1 (MSP1) of Plasmodium falciparum (Pf) might complement the imperfect protection conferred by the currently available first-generation pre-erythrocytic malaria vaccines RTS,S/AS01E and R21/Matrix-M...SUM-101 elicited robust MSP1-specific IgM and IgG antibody titers, with peak levels observed on day 56 and day 84, respectively...KG by the EU Malaria Fund Berlin GmbH & Co. KG."

Journal • P1 data • Fatigue • Hematological Disorders • Infectious Disease • Malaria • Pain

A randomised, controlled, double-blind, parallel group, single center Phase Ib trial to assess safety, reactogenicity and immunogenicity of a candidate dual-stage malaria vaccine, SumayaVac-1 (MSP-1 with GLA-SE as adjuvant) in healthy malaria . (ASTMH 2025) - "A blood-stage malaria vaccine could enhance protection provided by existing pre-erythrocytic vaccines, such as RTS.S/AS01E and R21/Matrix-M...The vaccine-induced antibodies were maintained during the three months follow up period after the last vaccine inoculation. Together, our findings support the development of SUM-101 as component of a next generation, multi-stage malaria vaccine targeting several parasite life cycle stages."

Clinical • P1 data • Infectious Disease • Malaria

Safety and Immunogenicity of SUM-101 Malaria Vaccine in Children and Infants Living in Burkina Faso (clinicaltrials.gov) - P1 | N=69 | Recruiting | Sponsor: European Vaccine Initiative | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Malaria

CHMI-SUM-101: A Challenge Study to Assess the Blood-stage Efficacy of Full-length SUM-101 Malaria Vaccine Candidate (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: European Vaccine Initiative

New P1 trial • Infectious Disease • Malaria

Safety and Immunogenicity of SUM-101 Malaria Vaccine in Children and Infants Living in Burkina Faso (clinicaltrials.gov) - P1 | N=69 | Not yet recruiting | Sponsor: European Vaccine Initiative | Trial completion date: Oct 2025 ➔ Aug 2026 | Initiation date: Apr 2025 ➔ Sep 2025

Trial completion date • Trial initiation date • Infectious Disease • Malaria

Safety and Immunogenicity of SUM-101 Malaria Vaccine in Children and Infants Living in Burkina Faso (clinicaltrials.gov) - P1 | N=69 | Not yet recruiting | Sponsor: European Vaccine Initiative

New P1 trial • Infectious Disease • Malaria

SUM-101: Assessment of the Malaria Vaccine Candidate SumayaVac-1 in Healthy Adults Aged 18-45 Years Living in a Malaria Endemic Country (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Swiss Tropical & Public Health Institute | Recruiting ➔ Completed | Trial completion date: Jul 2024 ➔ Apr 2024 | Trial primary completion date: Jul 2024 ➔ Apr 2024

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Malaria • CD4 • CD8

IgG Subclass Switch in Volunteers Repeatedly Immunized with the Full-Length Plasmodium falciparum Merozoite Surface Protein 1 (MSP1). (PubMed, Vaccines (Basel)) - "We have recently conducted a first-in-human clinical trial featuring SumayaVac-1, a malaria vaccine based on the recombinant, full-length merozoite surface protein 1 (MSP1FL) formulated with GLA-SE as an adjuvant...These findings underscore the importance of considering the impact of IgG subclass composition on vaccine-induced immunity, particularly concerning Fc-mediated effector functions. This knowledge is pivotal in guiding the design of optimal vaccination strategies against malaria, informing decision making for future endeavors in this critical field."

Journal • Infectious Disease • Malaria

SUM-101: Assessment of the Malaria Vaccine Candidate SumayaVac-1 in Healthy Adults Aged 18-45 Years Living in a Malaria Endemic Country (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Swiss Tropical & Public Health Institute | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Malaria • CD4 • CD8

Multifunctional IgG/IgM antibodies and cellular cytotoxicity are elicited by the full-length MSP1 SumayaVac-1 malaria vaccine. (PubMed, NPJ Vaccines) - "We further present evidence of SumayaVac-1 eliciting a recallable cellular cytotoxicity by IFN-γ producing CD8+ T cells. Our study revitalizes MSP1 as a relevant blood stage vaccine candidate and warrants further evaluation of SumayaVac-1 in a phase II efficacy trial."

Journal • Infectious Disease • Malaria • CD8 • IFNG

SUM-101: Assessment of the Malaria Vaccine Candidate SumayaVac-1 in Healthy Adults Aged 18-45 Years Living in a Malaria Endemic Country (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Swiss Tropical & Public Health Institute | Trial completion date: Oct 2024 ➔ May 2024 | Initiation date: Feb 2023 ➔ Jul 2023 | Trial primary completion date: Oct 2024 ➔ May 2024

Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease • Malaria • CD4 • CD8

SUM-101: Assessment of the Malaria Vaccine Candidate SumayaVac-1 in Healthy Adults Aged 18-45 Years Living in a Malaria Endemic Country (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Swiss Tropical & Public Health Institute

New P1 trial • Infectious Disease • Malaria • CD4 • CD8