BioVersys AG and Shionogi & Co., Ltd. announced a strategic research collaboration and exclusive license option agreement to jointly develop novel ansamycin leads from BioVersys' BV500 program into clinical candidates for treating non-tuberculous mycobacteria (NTM) infections. The partnership represents a significant advancement in addressing one of infectious disease medicine's most challenging therapeutic areas.
Financial Terms and Structure
Under the agreement terms, BioVersys will receive upfront and near-term research payments totaling CHF 5.0 million. Once clinical candidates are selected, Shionogi may exercise a license option that would make BioVersys eligible for up to CHF 479 million in regulatory and sales milestones, plus tiered royalties on global sales.
The collaboration grants Shionogi access to BioVersys' proprietary ansamycin platform and the BV500 program, with exclusive licensing rights for selected molecules for further clinical development and global commercialization.
Scientific Foundation and Drug Development
The BV500 NTM program derives from BioVersys' proprietary Ansamycin Chemistry platform. Research teams in Lille, France, and Basel, Switzerland, have identified and developed several advanced, highly potent and orally bioavailable lead candidates with broad-spectrum in vitro and in vivo anti-NTM activity that are devoid of cross-resistance with other therapeutic classes.
"BV500 has the potential to become a best in class therapeutic for NTM infections," said Dr. Nawaz Khan, Head of Research at BioVersys. "We are proud that the program attracted such a strong partner. This is a validation of our work and will accelerate the development of the project."
The joint research teams aim to deliver clinical candidates and back-up molecules during the research collaboration period, leveraging complementary expertise from both organizations.
Addressing Critical Medical Need
Non-tuberculous mycobacteria are ubiquitous environmental bacteria whose common clinical manifestation is pulmonary disease, caused most frequently by Mycobacterium avium complex (MAC) and Mycobacterium abscessus subspecies (MAB). NTM pulmonary disease affects approximately 250,000 people per year, predominantly in North America and Asia.
Current treatment challenges include variable intrinsic bacterial susceptibility, acquired resistance to commonly used antimicrobial agents, lengthy therapy duration of at least 12 months, and adverse effects associated with existing treatment options. Macrolide-based triple drug regimens plus aminoglycosides for chronic infections are considered only moderately effective for treating MAC, while no therapy of predictable efficacy exists for MAB treatment—a pathogen associated with up to 50% mortality.
The incidence of NTM infections among people living with cystic fibrosis has increased dramatically from 3.3% to 22.6%, with MAB becoming a more prominent pathogen. Patients with preexisting conditions, including cystic fibrosis, other lung diseases, and immune-compromised individuals are more easily colonized.
Strategic Partnership Benefits
"We are excited to work with our colleagues at Shionogi to advance the development of our NTM asset expeditiously towards patients in need," said Dr. Marc Gitzinger, CEO & Co-founder of BioVersys. "This collaboration reduces research and development risk for BioVersys while preserving financial discipline. It also expands the reach of our pipeline and ensures the expedited development of our drug candidates."
John Keller, Ph.D., Director of the Board and Senior Vice President of R&D Supervisory Unit at Shionogi, emphasized the partnership's alignment with the company's infectious disease focus: "This collaboration reflects our commitment to advancing innovative treatments for infectious diseases with significant unmet medical needs, and Shionogi will be bringing our scientific knowledge and operational capabilities fully to bear to maximize the potential of BioVersys' BV500 program."
Collaborative Research Foundation
The BV500 program originated from a successful collaboration within the SmartLab public-private partnership with the University of Lille, France, serving as an incubator for early-stage idea generation. The program has received funding support and access to key expertise from the CF AMR Syndicate and the EU IHI funded RespiriNTM programme, partnerships that will continue during ongoing research and development.
BioVersys remains on track to initiate the Phase 3 trial for its most advanced asset BV100 later this year, demonstrating the company's broader pipeline advancement alongside this new partnership.
