Publication of clinical Phase Ib trial data for the adjuvanted RH5.1 blood-stage malaria vaccine
Hørsholm, Denmark, 21 June 2024 – ExpreS2ion Biotech Holding AB’s affiliate ExpreS2ion Biotechnologies ApS (“ExpreS2ion") announces the new publication in The Lancet of a scientific paper titled “Blood-stage malaria vaccine candidate RH5.1/Matrix-M in healthy Tanzanian adults and children; an open-label, non-randomised, first-in-human, single-centre, phase 1b trial”. The article is based on a clinical study conducted by researchers at the University of Oxford.
Chief Scientific Officer Farshad Guirakhoo comments:
“These are the first data on the RH5.1/Matrix-M blood-stage malaria vaccine’s safety and immunogenicity in Tanzania published in the Lancet. These findings indicate the highest levels of functional antibody responses recorded to date in the malaria vaccine target population: young African children. The results are promising and support the ongoing Phase IIb efficacy trial of RH5.1/Matrix-M in Burkina Faso.”
The article can be reached via this link: https://doi.org/10.1016/S1473-3099(24)00312-8.
About University of Oxford’s malaria vaccine programs employing the ExpreS2™ system
Since the first research license agreement in 2012, ExpreS2ion has been supporting the University of Oxford’s malaria vaccine research groups, led by Prof. Simon J. Draper, Professor of Vaccinology and Translational Medicine, Department of Biochemistry, and Associate Professor Sumi Biswas, Transmission-blocking Malaria Group, The Jenner Institute. Four clinical-stage malaria vaccine projects have emerged from these efforts, RH5.1, R78C, RH5.2-VLP, and Pfs48/45, all relying on ExpreS2ion’s unique ExpreS2™ technology for the antigen manufacturing. This technology has been the only system capable of producing sufficient amounts of the active ingredient necessary for on-going development. To date, these four clinical-stage malaria vaccine projects are undergoing a total of seven clinical studies, detailed as follows:
| Trial abbreviation | Phase | Sites | Vaccines in trial | Trial status | Year started |
| VAC089 | Ia | Oxford, UK |
RH5.11 R78C |
Vaccinations on-going | 2023 |
| VAC086 | Ib | MRC unit, The Gambia |
RH5.2-VLP R21-VLP |
Vaccinations on-going | 2023 |
| VAC091 | IIb | IRSS CRUNBurkina Faso |
RH5.1 RH5.2-VLP |
Vaccinations on-going | 2023 |
| BIO-001 | I/IIa | Oxford, UK |
RH5.1 RH5.2-VLP |
Screening &vaccinations on-going | 2023 |
| BIO-002 | I | Sheffield, UK |
RH5.1 |
Vaccinations on-going | 2023 |
| BIO-003 | I | IHI BagamoyoTanzania |
RH5.1 R78C |
In set-up | N/A |
| VAC-085 | I | Oxford, UK |
Pfs48/45 |
Vaccinations on-going | 2023 |
The four malaria vaccine research programs, that ExpreS2ion has a part in by virtue of basing the manufacturing on the Company’s proprietary protein expression system made in Drosophila S2 insect cells, are all in the current clinical study set-up financed by grants applied for and awarded to the University of Oxford and/or its collaborating partners. All the vaccines apply the adjuvant Matrix-M™ from Novavax.
1 Silk et al, Lancet (2024): Blood-stage malaria vaccine candidate RH5.1/Matrix-M in healthy Tanzanian adults and children; an open-label, non-randomised, first-in-human, single-centre, phase 1b trial
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