Partnership Forms to Develop Broad-Spectrum NTM Clinical Candidate

BioVersys and Shionogi are joining forces to progress the development of non-tuberculous mycobacteria clinical candidates with the potential for a selected number of molecules to be licensed for global commercialization.

Mulit-asset, clinical-stage biopharmaceutical company, BioVersys, is partnering with Japanese pharmaceutical company, Shionogi, to develop novel ansamycin leads from BioVersys’ BV500 program into clinical candidates. The research and exclusive license agreement was announced in a July 2, 2025 press release (1).

Derived from BioVersys’ proprietary Ansamycin Chemistry platform, the BV500 non-tuberculous mycobacteria (NTM) program includes several advanced, highly potent, and orally bioavailable lead candidates that have broad-spectrum in vitro and in vivo anti-NTM activity. These candidates are also devoid of cross-resistance with other therapeutic classes.

“BV500 has the potential to become a best in class therapeutic for NTM infections. 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,” said Dr. Nawaz Khan, Head of Research at BioVersys, in the company press release (1). “We look forward to the partnership with our colleagues at Shionogi and to the opportunity to leverage a broad range of complementary expertise.”

The research teams from both BioVersys and Shionogi will focus on delivering clinical candidates and back-up molecules during the research collaboration period of the agreement. After this period, Shionogi will have the exclusive option to license a selected number of molecules for further clinical development and global commercialization.

“We are excited to work with our colleagues at Shionogi to advance the development of our NTM asset expeditiously towards patients in need. 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,” commented Dr. Marc Gitzinger, CEO and Co-founder of BioVersys, in the press release (1). “Shionogi is an ideal partner for this program, given its expertise and commitment in infectious diseases and the company’s global reach. Partnerships like this one strongly benefit patients and other stakeholders. Beyond the BV500 program, BioVersys remains on track to initiate the Phase III trial for our most advanced asset BV100 later this year and we look forward to updating our stakeholders on the progress.”

“We are pleased to announce this partnership with BioVersys,” added John Keller, Ph.D. Director of the Board, Senior Vice President, R&D Supervisory Unit at Shionogi & Co., Ltd., in the press release (1). “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.”

BioVersys will receive an upfront payment and near-term research payments worth a total of CHF 5.0 million, under the terms of the agreement. Additionally, after clinical candidates have been selected and Shionogi exercises its license option, BioVersys would be eligible to receive up to CHF 459 million in regulatory and sales milestones payments, as well as tiered royalties on global sales.

Reference

  1. BioVersys. BioVersys and Shionogi Enter into Global Research Collaboration for Broad-Spectrum Non-Tuberculous Mycobacteria (NTM) Clinical Candidate. Press Release, July 2, 2025.

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