Publication of clinical Phase Ib trial data for the adjuvanted RH5.1 blood-stage malaria vaccine

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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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For further information about ExpreS2ion, please contact:
Bent U. Frandsen, CEO
Keith Alexander, CFO

Email: investor@expres2ionbio.com

 

About ExpreS2ion

ExpreS2ion is a biotechnology company that develops innovative vaccines for a healthier world. We want to transform healthcare by developing novel vaccines, that are life-saving and improving quality of life across the world. ExpreS2ion has developed the unique human clinical Phase III-validated technology platform, ExpreS2™, for fast and efficient development and production of the active material in vaccines. The platform, under the brand GlycoX-S2™, includes functionally modified glycosylation variants for enhanced immunogenicity and pharmacokinetics. Since 2010, ExpreS2ion has produced more than 500 proteins and virus-like particles (VLPs) in collaboration with leading research institutions and companies. ExpreS2ion develops novel VLP based vaccines in association with AdaptVac ApS, of which ExpreS2ion owns 34%. For additional information, please visit www.expres2ionbio.com.

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