On July 17, 2024, in collaboration with MSQ Ventures and BioAroundWorld, hosted a pivotal webinar "BioVersys: Impactful Solutions for Antimicrobial Resistance (AMR)." The webinar featured Dr. Marc Gitzinger, CEO and Founder of BioVersys AG, as a guest speaker and was moderated by Echo Hindle-Yang, Founder and CEO of MSQ Ventures. The session provided a comprehensive exploration of BioVersys' innovative approaches to tackling antimicrobial resistance, highlighting their strategic partnerships and pioneering technological advancements. 

Introduction to Marc Gitzinger: 

Dr. Marc Gitzinger shared his journey from arriving in Switzerland for his Ph.D. at the Swiss Federal Institute of Technology in Zurich to founding BioVersys. He credited Switzerland's infrastructure and support programs for high-tech studies with helping to kickstart BioVersys. 

Discussion on BioVersys’ Global Reach: 

Dr. Gitzinger highlighted the importance of the Chinese market for BioVersys’ clinical trials due to the prevalence of drug-resistant infections. BioVersys is preparing for global Phase 3 studies and has initiated interactions with the Chinese NMPA to run preparatory studies in China. 

Technological Innovations and Strategic Collaborations: 

BioVersys emphasizes its focus on addressing antimicrobial resistance through innovative small molecules and partnerships. The company collaborates with institutions such as the Pasteur Institute in Lille, France, and maintains global partnerships, including one with GSK. The strategic approach involves selecting programs that address the highest unmet medical needs. 

Long-term Vision and Challenges: 

The critical threat of antimicrobial resistance and the need for new antibiotics were discussed, outlining BioVersys’ long-term strategy to combat this threat. The focus is on global collaborations and strategic partnerships to ensure the sustainable use and access to new antibiotics.

Presentation Summary: 

Company Overview and Financial Background: 

BioVersys has raised significant equity funding, approximately $90 million USD, and secured non-dilutive funding through various government grants from organizations such as CARB-X in the US and the European Union. Additionally, they have a venture loan facility from the European Investment Bank. The company maintains a partnership with GSK for co-development projects. 

Technological Platforms: 

Marc highlighted the evolution of BioVersys' technology platforms: 

• TRIC Platform: Originating from his PhD thesis, this platform targets bacterial transcription regulators and has progressed to Phase 2 development. 

• Pipeline Programs: These include a follow-on program targeting Staphylococcus aureus with a focus on atopic dermatitis and the development of lead asset BV100, in collaboration with the University of Southern California, aimed at hospital infections. 

Pipeline and Clinical Development: 

BioVersys’ pipeline includes several key assets: 

• BV100: A lead asset targeting hospital infections, particularly ventilator-associated and hospital-acquired pneumonia, and bloodstream infections caused by Acinetobacter baumannii. BV100 is in Phase 2 trials and has received QIDP designation from the FDA, allowing for fast-track approval and extended market exclusivity. 

• Other Assets: These include a tuberculosis program partnered with GSK, a program targeting Staphylococcus aureus in atopic dermatitis, and BV500 for non-tuberculosis mycobacteria in cystic fibrosis and COPD. 

Addressing Critical Pathogens: 

BioVersys focuses on critical pathogens identified by the WHO and national health organizations, which have high resistance levels and few treatment options. Their lead assets target Acinetobacter baumannii and drug-resistant tuberculosis, which are among the most challenging infections to treat. 

Importance of New Antibiotics: 

The crucial need for effective antibiotics, especially for severe infections with high resistance levels, was emphasized. The role of antibiotics in maintaining the infrastructure of modern medicine and the growing challenges in treating infections in immunocompromised patients, such as those undergoing cancer treatment, were highlighted.

Challenges and Solutions in Antibiotic Development: 

BioVersys addresses the commercial challenges in antibiotic development by focusing on high-resistance infections and life-threatening conditions. They support stewardship regulations and are engaged in global efforts to reform antibiotic reimbursement. The G7 countries are working towards delinking reimbursement from sales volume to ensure sustainable use while fairly compensating innovation. 

Lead Asset BV100: 

BV100 targets carbapenem-resistant Acinetobacter baumannii, a pathogen with extremely high mortality rates and resistance levels. BioVersys developed an injectable formulation of rifuging, a molecule with a novel mode of action, showing promising efficacy and safety in clinical trials. The ongoing Phase 2 trial compares BV100 against the best available therapy, showing encouraging early results. 

Key Achievements: 

Dr. Gitzinger highlighted BioVersys' successful Phase 2 trials and the establishment of global clinical trial networks. He reiterated the company’s commitment to advancing its innovative pipeline and securing additional funding to support ongoing projects and future pipeline developments. 

Future Plans: 

BioVersys plans to initiate Phase 3 trials for BV100 in the first half of 2025, including sites in China. They are well-positioned against competitors in the Acinetobacter baumannii space, with strong synergy with existing standard-of-care drugs and a differentiated mode of action. 

Global Health Focus: 

BioVersys also addresses global health issues, particularly tuberculosis, which remains a leading infectious disease killer. Their tuberculosis program, partnered with GSK, focuses on addressing unmet medical needs in this area. 

BioVersys’ commitment to addressing critical infectious diseases through innovative technological platforms and strategic global partnerships, aiming to provide effective solutions for high-resistance and life-threatening infections.