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2020-07-08

ExpreS2ion Biotechnologies: ExpreS2ion provides update on negotiations with Bavarian Nordic and progress towards clinical Phase I/IIa trial

The capsid virus-like particle (cVLP) COVID-19 vaccine combines AdaptVac's and ExpreS[2]ion's patented cVLP and ExpreS[2] technology platforms, and was developed by scientists at AdaptVac, ExpreS[2]ion and the University of Copenhagen's Institute for Immunology and Molecular Biology from vaccine design to lead candidate selection in less than two months. Importantly, the on-going negotiations with Bavarian Nordic do not change the previously reported timelines for the development of the vaccine. ExpreS[2]ion, as well as the other scientific partners in the EU sponsored PREVENT-nCoV consortium, still expects the vaccine to enter the first clinical Phase I/IIa safety trial before the end of 2020.

The clinical PhaseI/IIa COVID-19 vaccine trial

The clinical Phase I/IIa trial, which is scheduled to begin in December 2020, will be conducted as planned by the Institut Für Tropenmedizin (ITM) at the University of Tübingen and is expected to enrol 48 healthy volunteers. ITM is the leading German Centre of Excellence for performing clinical trials in infectious diseases, both at the University Hospital of Tübingen and in collaboration with partner sites around the world. The institute's clinical trial platform was developed to conduct Phase I-IV clinical trials according to GCP (Good Clinical Practice) standards. The primary endpoint of the COVID-19 clinical hase I/IIa trial is vaccine safety at various doses. Secondary endpoints include SARS-CoV-2 neutralizing antibody development as a surrogate marker for efficacy.

The clinical Phase I/IIa trial is already fully funded under the EU Horizon 2020 grant announced on March 6, 2020. In preparation of the trial, the GMP manufacturing process transfer to AGC Biologics has been initiated. ExpreS[2]ion expects to be able to announce headline results from the trial towards the end of Q1, 2021. Assuming the study meets its safety endpoints, a large phase II/III trial will be initiated immediately after the conclusion of the trial.

The Bavarian Nordic license agreement

On May 6, 2020 ExpreS[2]ion announced that its joint venture AdaptVac had entered into an exclusive head of terms agreement with Bavarian Nordic to license the COVID-19 vaccine. At that time the parties announced that they would seek to enter into the final license agreement within two months. The negotiations have not resulted in changes to the main commercial parameters described and agreed in the head of terms agreement. The parties still expect the license deal to include an initial upfront payment to AdaptVac in addition to future development and sales milestones and royalties. As previously anticipated, ExpreS[2]ion will retain a portion of the future milestone payments and royalties. The parties have agreed to finalise the license agreement as soon as possible but has decided not to provide a new time estimate.

Bent U. Frandsen, CEO in ExpreS[2]ion and board member of AdaptVac says:

"While we are eagerly anticipating the final agreement with Bavarian Nordic, I think it is important to underline to our shareholders that for now and at least well into the clinical Phase I/IIa trial next year, none of the clinical activities, nor the detailed planning for the later stage clinical development program for the COVID-19 vaccine requires ressources other than those already available to the members of the PREVENT-nCoV consortium. Needless to say, having Bavarian Nordic as a partner will help us further accelerate the program, not least when we get into 2021. Should the negotiations turn out to be unsuccesful -  and I know of no reason why they should be - there are several alternative funding options for the later stage development, including governmental- and quasi governmental funding, as well as other big pharma partners."

About the COVID-19 Coronavirus outbreak

A novel Coronavirus (COVID-19) outbreak was reported in Wuhan, China in late December 2019 and declared a pandemic by WHO on March 11[th], 2020. The COVID-19 Coronavirus is a part of the same family as SARS and MERS, and there have been more than 11.6 million confirmed cases and over 530,000 deaths reported as of July 7, 2020. The latest situation updates are available on the WHO web page: https://www.who.int/emergencies/diseases/novel-coronavirus-2019.

About the cVLP COVID-19 vaccine product

ExpreS[2]ion and its joint venture partner AdaptVac are engaged in the development of a unique capsid virus-like particle (VLP) COVID-19 vaccine, partly sponsored through a Horizon 2020 EU grant award (https://news.cision.com/expres2ion-biotechnologies/r/expres2ion-announces-eu-grant-award-for-the-covid-19-vaccine-development-programme,c3054055) to the PREVENT-nCoV consortium to rapidly advance the vaccine candidate against COVID-19 into the clinic. This vaccine technology has the potential to mimic a virus to the body's immune system, giving the optimal stimulus to generate a fast, long-lasting immune response that offers a highly-efficacious protection. Importantly, the production of the vaccine technology can be readily scaled to commercial quantities and AdaptVac is working with AGC Biologics for the manufacture and scale-up of the vaccine (https://news.cision.com/expres2ion-biotechnologies/r/expres2ion-announces-selection-of-agc-biologics-as-manufacturing-partner-for-the-covid-19-vaccine-an,c3094798). The current plan is to initiate a clinical study before the end of 2020.

About AdaptVac

AdaptVac (http://www.AdaptVac.com.) is a joint venture between ExpreS[2]ion Biotechnologies and NextGen Vaccines, owned by the inventors of the novel proprietary and ground-breaking capsid virus-like particle (cVLP) platform technology spun out from the University of Copenhagen. The Company aims to accelerate the development of highly efficient therapeutic and prophylactic vaccines within high value segments of oncology, infectious diseases and immunological disorders. Granting of the core patent in the U.S. has expanded AdaptVac's patent protection to include the full pipeline of vaccines and immunotherapies in development.

About the PREVENT-nCoV consortium

ExpreS[2]ion Biotechnologies and AdaptVac are members of the PREVENT-nCoV consortium that earlier this year received an EU Horizon 2020 grant to rapidly advance a unique cVLP vaccine candidate against COVID-19 into the clinic. The members of the consortium hold preclinical and clinically validated experience from working with similar Coronaviruses such as MERS and SARS, as well as malaria vaccines, using AdaptVac's capsid VLP technology and ExpreS[2]ion's ExpreS[2] technology. In addition to to ExpreS[2]ion (http://www.expres2ionbio.com) and AdaptVac (http://www.AdaptVac.com), the consortium members are Leiden University Medical Center (LUMC (http://www.lumc.nl/)), Institute for Tropical Medicine (ITM (http://www.medizin.uni-tuebingen.de/en-de/das-klinikum/einrichtungen/kliniken/medizinische-klinik/tropenmedizin)) at University of Tübingen, The Department of Immunology and Microbiology (ISIM (https://isim.ku.dk/)) at University of Copenhagen, and the Laboratory of Virology at Wageningen University (https://www.wur.nl/).

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