Bionyra Secures $165M to Accelerate Clinical Development of Next-Generation TL1A Antibody, BYN-002
Largest Funding Round in French Biotech History
Bionyra Pharma has officially launched, securing $165 million (approximately €143 million) in a Series A funding round, marking the largest funding round in the history of French biotech companies. This round was co-led by Sofinnova Partners and Jeito Capital, with participation from Sanofi Ventures, among others. Investors' significant investment in the startup is driven by the potential of Bionyra's next-generation Half-Life Extension (HLE) technology. This technology can drastically reduce the frequency of administration, maximizing patient convenience and providing a unique competitive advantage over existing treatments.
Experienced Leadership from Sanofi and a Robust Global Pipeline
Dr. Frédéric Marrache, co-founder and CEO of Bionyra, is a leading expert with nearly a decade of experience leading immunology R&D and clinical development at Sanofi. He chose to leverage the agility of a biotech company to rapidly commercialize promising targets that were previously difficult to develop or deprioritized within a large pharmaceutical company. Bionyra quickly in-licensed three validated early-stage pipeline assets from TrueLab Biopharmaceutical and NovaRock Biotherapeutics. The combination of validated assets and experienced management is driving the company's development, reducing the risk of failure in early-stage biotechs and significantly accelerating global clinical development.
Key Target for Transforming the IBD Treatment Market
Two key candidates, currently in Phase 1 clinical trials, target some of the most promising targets in the Inflammatory Bowel Disease (IBD) market. BYN-002, a monoclonal antibody, targets TL1A, which was recently acquired by Merck and Roche for billions of dollars, and aims to differentiate itself through its proprietary HLE technology. In addition, the bispecific antibody BYN-003, currently in development, has an innovative mechanism of action that simultaneously inhibits TL1A and Interleukin-23 (IL-23p19). This is designed to address the limitations of existing single-target therapies such as Stelara and Skyrizi, and to provide a new treatment option for patients with severe IBD who have high unmet needs.
Next-Generation HLE Drug for Treating Atopic Dermatitis
The third pipeline product, BYN-001, is an antibody that targets Interleukin-25 (IL-25), and targets the global atopic dermatitis and inflammatory disease market, which is worth approximately $20 billion annually. Bionyra plans to develop BYN-001 as a once-quarterly or twice-yearly administration formulation, providing significantly improved convenience compared to competing drugs that require frequent injections. Recently, JAK inhibitor-based therapies have received Black Box Warnings due to safety concerns, increasing the demand for safe biological agents. With this investment, Bionyra's next-generation immune therapy clinical trials are expected to be a major milestone in changing the paradigm of the global autoimmune treatment market.
The $165 million secured through this Series A financing will be used to complete the development of anti-TL1A antibody BYN-002 and TL1A/IL-23p19 bispecific antibody BYN-003, which are in Phase 1 clinical trials, and to support entry into Phase 2 clinical trials. In the global IBD market, valued at approximately $25 billion, Merck and Roche's recent acquisitions of TL1A-targeted pipelines for billions of dollars highlight the value of Bionyra, which possesses next-generation HLE technology. The rapid clinical development led by experienced immunology R&D leadership from Sanofi is a key short-term momentum to capture the niche in the IL-23 market, which is currently dominated by AbbVie's Skyrizi and J&J's Tremfya. In the medium to long term, the IL-25-targeted antibody BYN-001, which incorporates HLE technology, can provide excellent treatment options for patients with atopic dermatitis by overcoming the frequent administration limitations of existing competing drugs. If it can demonstrate superior safety compared to JAK inhibitors, which have safety concerns, it will increase the potential for large-scale out-licensing agreements and M&A with global Big Pharma companies, providing investors with an attractive return scenario.
Source: BioPharma Dive (rss)
https://www.biopharmadive.com/news/bionyra-immune-drug-startup-sofinnova-jeito/823296/