BioVersys, TASK and GSK receive 2.7 million Euro from EDCTP for Phase 2a Clinical Trial

24.02.2021 09:53, Guillaume Tinsel

BioVersys and consortium partners TASK Foundation and GSK have been awarded 2.7 million Euro from the European and Developing Countries Trial Partnership (EDCTP) for the further development of BVL-GSK098 with ethionamide in a Phase 2a tuberculosis clinical trial study. We interviewed CEO Marc Gitzinger about his entrepreneurial path and inspiration.

Tuberculosis remains a formidable Global Health challenge particularly considering the fact that about 1.7 billion people, 23% of the world’s population, are estimated to have a latent TB infection, and are thus at risk of developing active TB disease during their lifetime, as currently estimated by World Health Organization (2018).1 1.5 million people died from TB in 2018 and it remains one of the top 10 causes of death worldwide and the leading cause from a single infectious agent (above HIV/AIDS).1 In 2018, there were an estimated 10 million new TB cases worldwide, 5.7 million men, 3.2 million women, 1.1 million children and 860 thousand were people living with HIV.

BioVersys AG, a privately owned, multi-asset Swiss pharmaceutical company focusing on research and development of small molecules for multidrug-resistant bacterial infections with applications in Anti-Microbial Resistance (AMR) and targeted microbiome modulation, announced today that a consortium of BioVersys, the TASK Foundation, and GSK have been awarded 2.7 million Euro funding from the EDCTP to conduct a Phase 2a tuberculosis (TB) clinical trial study with BioVersys’ clinical candidate BVL-GSK098 in combination with ethionamide (Eto).

BVL-GSK098 has been developed from BioVersys’ award-winning Transcriptional Regulatory Inhibitory Compounds (TRIC) platform in a successful collaboration with GSK, the Institut Pasteur de Lille, and the University of Lille. BVL-GSK098 is currently being studied in First in Human (FiH) Phase 1 clinical trials, supported by the IMI2 AMR Accelerator from the EU (TRIC-TB Project), which is anticipated to be completed in 2H 2021. BVL-GSK098 in a fixed combination with Eto has also received Qualified Infectious Disease Product designation from the U.S. FDA in June 2020, for oral use in the treatment of pulmonary tuberculosis, making BVL-GSK098 eligible for FDA priority review, Fast Track designation, and a five-year extension of market exclusivity upon approval.

The World Health Organization (WHO) considers Eto a crucial pillar of TB treatment, especially against MDR (multidrug-resistant) and XDR (extensively drug-resistant) strains. BVL-GSK098 boosts the activity of Eto (bEto), resulting in an increase of Eto efficacy by at least three-fold in vivo, which could allow for lower efficacious doses of Eto in human anti-TB treatments with a reduction in dose-dependent adverse effects in TB patients. Furthermore, preclinical data shows that BVL-GSK098 overcomes pre-existing resistance against Eto, isoniazid (INH), and rifampicin in Mycobacterium tuberculosis, by employing novel bioactivation pathways for Eto. Therefore, a bEto combination has the potential to not only be part of an effective MDR-TB regimen but also the potential to replace INH in first-line TB regimens.

“We are delighted and grateful to receive this grant from the EDCTP, supporting the further development of BVL-GSK098 in combination with Eto. bEto is an innovative combination therapy that is in-line with the global need to conserve our current antimicrobial therapeutic armory, by reinvigorating a WHO’s essential medicine, Eto, a valuable weapon against DS and MDR-TB. We look forward to continuing to work with GSK on this project and warmly welcome the opportunity to work with TASK, a world-leading clinical trials center for TB.” said Dr. Marc Gitzinger, CEO and co-founder of BioVersys.

BioVersys participated in Venture Kick and Venture Leaders Technology in 2008, were among the TOP 100 Swiss Startups in 2011, 2012, and 2013 and were selected for the Venture Leaders China in 2018. We interviewed Marc Gitzinger about his experience along this entrepreneurial journey.

Marc, how will the 2.7M € million-investment from EDCTP help achieve your vision?
This is a crucial step in financing a Tuberculosis project to show its ability to really make a difference in patients. With this funding, we will be able to show that a project coming from academia can hopefully impact patients suffering from the devastating disease, positively. 

You won Venture Kick and Venture Leaders Technology in 2008. How did it help you lay the foundation for your growth and today's achievement?
While the “early stage” prizes are already a while back for BioVersys, we should never forget that without a strong foundation, we would have never been able to get this far. 

You also participated in Venture Leaders China in 2016 and were selected on TOP 100 Swiss Startups Awards from 2011 to 2013. How did it leverage your fundraising strategy? 
Being represented in the Swiss Top 100, for us actually twice in the Top 5 is a great platform to get known by investors. Besides, it is simply an honor to be up there in Switzerland with so many fantastic peers, building the companies of the future. Venture Leaders China was a great experience and we are still working with contacts in China dating back to this trip. 

When, and what, was your inspiration to found Bioversys?
I could paint a very romantic picture now, but truth is, it was quite simple. We had a good idea, there was a market defined by a high unmet medical need and we went for it. The ride ever since is exciting never stops to surprise me and gets us closer to a goal that was at the time still very distant: Impacting with our products the health and wellbeing of patients.

What is your advice for the potential biotech entrepreneurs launching companies in Switzerland today? 
Get into the Venturelab ecosystem and don’t let anyone discourage you. Switzerland needs more entrepreneurs in general and certainly more biotech entrepreneurs.   

Source: Bioversys Press Release 24.02.2021