ExpreS2ion has been awarded SEK 2.7 million for continued development of two malaria vaccine candidates

ExpreS2ion Biotech Holding AB (“ExpreS2ion”) announces that the Company has been awarded SEK 2.7 million as part of the Horizon 2020-funded OptiMalVax grant consortium, led by Jenner Institute at the University of Oxford, to establish monoclonal Drosophila S2 cell banks for two new malaria vaccine candidates. One targets blood-stage malaria, potentially in combination with the RH5 vaccine candidate that was successfully tested in a Phase IIa clinical trial, and the other is a transmission-blocking vaccine. The ultimate goal of the project is to create a next generation blood-stage combination vaccine to address the USD 400 million malaria vaccine market.

ExpreS2ion’s role in the clinical development program is to establish monoclonal Drosophila S2 cell banks for the two vaccines using the ExpreS2 platform, which will be used to manufacture cGMP material for the clinical trials. The consortium aims to start production for the blood-stage vaccine in Q1 2020, and a Phase Ia clinical trial will subsequently be initiated.

A next generation combination blood-stage malaria vaccine

OptiMalVax’s blood-stage vaccine development program is using a novel blood-stage antigen, with potential synergy with RH5. The RH5 antigen was for the first time successfully produced using ExpreS2 in 2014, and it was thereafter developed and taken into clinical trials by Jenner Institute in Oxford. It is the first malaria vaccine to demonstrate the ability to reduce parasite multiplication rate in a Phase I/IIa clinical trial. Based on preclinical proof of concept studies, the consortium now aims to ultimately combine the RH5 vaccine with the new blood-stage vaccine in order to create a combination vaccine with optimal protection against blood-stage malaria.

Breakthrough in the development of a transmission-blocking vaccine

The goal for a transmission-blocking vaccine is to prevent the transfer to mosquitos feeding on persons infected with malaria, thus effectively hindering further spread of the disease. Thereby a transmission-blocking vaccine does not give direct protection from the disease, but it stops the disease from spreading and could therefore lead to eradication of malaria. During the last decade, the inability to produce the full-length Pfs48/45 antigen has been a major roadblock for researchers aiming to create a transmission-blocking malaria vaccine. However, this challenge was recently overcome by ExpreS2ion and Jenner Institute, and proof of concept of its vaccine efficacy was published in Nature Communications as announced by ExpreS2ion in October 2018.

Further validation of the ExpreS2 system: Five malaria vaccines in/entering clinical trials

These two vaccines join the two malaria projects in clinical trials, which are already employing ExpreS2 (see press releases from October 31st 2018 and January 10th 2019), as well as the Rh5.2-VLP vaccine funded by Wellcome Trust (see press release from September 23rd 2019), bringing the total number of clinical stage malaria vaccines relying on ExpreS2ion’s ExpreS2 system to five. This clearly validates the broad applicability of the Company’s platform as being uniquely able to solve complex vaccine antigen production challenges in even the most cost sensitive segments.

ExpreS2ion strengthens its collaboration with GenIbet

GenIbet is an experienced vaccine contract development manufacturing organisation (CDMO) based in Portugal. As ExpreS2ion’s preferred cGMP partner, GenIbet has been approved by the OptiMalVax Project Steering Committee as manufacturer and is in negotiations to produce the cGMP material for the two new vaccine candidates. The manufacturing process will be based on the template production and purification approach used for the RH5 vaccine, which will speed up the manufacturing process development and technology transfer significantly.

“The Drosophila ExpreS2 platform enabled us to progress the RH5 protein antigen into clinical trials for the first time. I am delighted that we will now further strengthen our partnership with ExpreS2ion Biotechnologies by working together to manufacture a second component for this promising blood-stage malaria vaccine” says Prof. Simon Draper from Jenner Institute, Oxford University.

“We are proud to contribute to this project and the development of next-generation, high-efficacy malaria vaccines through our unique ExpreS2 protein production platform. It is inspiring that our ExpreS2 system once again enabled the development of an important malaria vaccine antigen, which has been considered almost impossible to produce for a decade“ says ExpreS2ion’s CSO, Dr. Wian de Jongh.

About the OptiMalVax consortium

The objective of the OptiMalVax consortium is to create the best malaria vaccine targeting Plasmodium falciparum, one of the most prominent causes of malaria. The final vaccine is expected to have high efficacy and will target multiple stages of the parasite’s lifecycle through a multi-antigen vaccine approach. The final vaccine must also be deployable and cost-effective to address the unique challenges inherent to malaria vaccines. The project’s clinical program will include trials to assess the pre-erythrocytic, blood-stage and mosquito-stage components of the combination vaccine. Furthermore, state-of-the art immune monitoring, key functional assays of vaccine-induced immunogenicity and parasite challenges will be performed to demonstrate vaccine safety, immunogenicity and efficacy.

The project has received funding from the European Union’s Horizon 2020 Research and Innovation program under grant agreement No.733273.

Malaria facts (WHO)

Malaria is a life-threatening disease caused by parasites transmitted into the human body via infected female Anopheles mosquitoes. Even though the disease is preventable and curable, it is estimated that 219 million people in 87 countries were infected with malaria in 2017, and the number of deaths were estimated to 435,000 in the same year. In a market assessment study conducted by the Boston Consulting Group sponsored by the Malaria Vaccine Initiative, the global market value for malaria vaccines was estimated to up to USD 400 million per year based on estimated malaria vaccine demand.

Certified Adviser

Svensk Kapitalmarknadsgranskning AB

Telephone: +46 70 755 95 51

E-mail: ca@skmg.se

For further information about ExpreS2ion Biotech Holding AB, please contact:

Dr. Steen Klysner, CEO
Telephone: +45 2062 9908
E-mail:
sk@expres2ionbio.com

This press release contains information that ExpreS2ion is obligated to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication through the agency of the contact person set out above on December12, 2019.

About ExpreS2ion

ExpreS2ion Biotechnologies ApS is a fully owned Danish subsidiary of ExpreS2ion Biotech Holding AB with company register number 559033-3729. The subsidiary has developed a unique proprietary platform technology, ExpreS2, for fast and efficient preclinical and clinical development as well as robust production of complex proteins for new vaccines and diagnostics. Since the Company was founded in 2010, it has produced more than 300 proteins and 40 virus-like particles (VLPs) in collaboration with leading research institutions and companies, demonstrating superior efficiency and success rates. In addition, ExpreS2ion develops novel VLP based vaccines through the joint venture AdaptVac ApS, which was founded in 2017. For additional information, please visit www.expres2ionbio.com and www.adaptvac.com.

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About Us

ExpreS2ion Biotechnologies ApS is a fully owned Danish subsidiary of ExpreS2ion Biotech Holding AB with company register number 559033-3729. ExpreS2ion has developed a unique technology platform, ExpreS2, for fast and efficient non-clinical development and production of complex proteins for new vaccines and diagnostics. ExpreS2 is regulatorily validated for clinical supply. The platform includes functionally modified glycosylation variants for enhanced immunogenicity and pharmacokinetics. Since 2010, the Company has produced more than 300 proteins and 40 virus-like particles (VLPs) in collaboration with leading research institutions and companies. Since 2017, ExpreS2ion develops novel VLP based vaccines through its joint venture AdaptVac ApS. For additional information, please visit www.expres2ionbio.com and www.adaptvac.com.

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