Inflammation Startup Bionyra Launches With $165M and Ex-Sanofi Exec at the Helm – MedCity News

As a Sanofi veteran, Frédéric Marrache is well aware of the innovations shaping immunology. His tenure there came as Dupixent grew into the company’s top-selling product, now spanning nine inflammatory conditions. The next generation of immunology drugs is going after new targets with candidates in the hands of several big pharma companies. Marrache is still in the mix, but as the CEO of Bionyra Pharma. The startup is now asserting its place in the field, launching with in-licensed assets and $165 million to support their clinical development.

The Series A financing announced Monday was co-led by Jeito Capital and Sofinnova Partners.

At Sanofi, Marrache held several senior positions, most recently serving as the company’s global project head, clinical development, immunology and inflammation therapeutic area. But he said he has had entrepreneurial aspirations for a long time and kept in touch with several investment firms. One of them was Sofinnova, which has been investing in the life sciences for more than 50 years. Sofinnova and Marrache co-founded Bionyra last year.

Sofinnova has proprietary technology that maps the landscape of innovation, Marrache said. This global map, which is updated weekly, provided Bionyra with more than 100 opportunities to review. The Paris-based startup focused on assets that address certain validated targets while also offering the potential to bring an advantage over programs in development by other companies. Bionyra in-licensed three assets, two from China-based TrueLab Biopharmaceutical and one from NovaRock Biotherapeutics in New Jersey.

The most advanced Bionyra program is BYN-002, a monoclonal antibody that TrueLab designed to block tumor necrosis factor-like ligand A (TL1A), a signaling protein that drives inflammation. The role that TL1A plays in gastrointestinal inflammation has made it an attractive target for inflammatory bowel disease (IBD) drug research. Partners Teva Pharmaceuticals and Sanofi are developing duvakitug, an antibody currently in Phase 3 testing for ulcerative colitis and Crohn’s disease. Others that have reached pivotal testing with TL1A-targeting antibodies include Merck and its drug tulisokibart and Roche with afimkibart. These drugs are being tested for monthly dosing. AbbVie is catching up with ABBV-701, a TL1A-targeting antibody in early clinical development for IBD.

BYN-002 is designed with half-life extension technology that enables longer dosing intervals. A Phase 1 test in healthy subjects is fully enrolled. Marrache said data will be presented in the future, but the company has already had a peek. These results could support dosing every three months or even every six months, he said. Beyond the longer half-life, Marrache said this drug could also offer more potency than others in its class.

The Bionyra pipeline includes another drug in Phase 1 testing that goes after multiple targets. BYN-003, also from TrueLab, is a bispecific antibody designed to block TL1A and IL-23p19. The latter target is already addressed by the blockbuster antibody drugs Skyrizi from AbbVie and Tremfya from Johnson & Johnson. Marrache said IL-23p19 is “the dream partner, ideal partner,” for combination with TL1A, because it’s highly effective and validated and has a very good safety profile. BYN-003 is based on the same backbone as the monospecific molecule from TrueLab that targets only TL1A. The early results for the monospecific drug suggest it offers low immunogenicity, an immune response that could make a drug less effective or cause unwanted side effects.

“I don’t believe there’s meaningful competition that is already at the clinical stage with this combination,” Marrache said. “We have already data that de-risk the monospecific molecule, and we believe this finding will be translated to the bispecific molecule in terms of immunogenicity profile, [a] favorable immunogenicity profile.”

The third in-licensed asset that Bionyra is disclosing is BYN-001, which the startup describes as a potentially first and best-in-class monoclonal antibody designed to target IL-25, a signaling pathway involved in inflammation. This drug is currently in late-preclinical development for treating atopic dermatitis and type 2 inflammation. BYN-001 was licensed from NovaRock.

Bionyra holds global rights to its in-licensed assets, excluding Greater China. The startup also has additional preclinical molecules from TrueLab, but Marrache said the near-term focus is developing the three most advanced programs. By the end of 2028, he expects the company will have proof of concept data that will provide a good understanding of the efficacy and tolerability profile of these drugs, which should inform future development. That future could include other indications. TL1A is also associated with fibrosis, the development of scar tissue in organs.

“There’s a lot of optionality that is going to materialize, there’s going to be some readouts in multiple indications,” Marrache said. “And I think it will help us better understand the path forward, whether the path forward has to be in the IBD space or whether it has to be in other indications. And also, whether the path forward is as a standalone molecule or in combination.”

Bionyra received seed financing from Sofinnova. Other participants in the Series A round include Arkin Bio, Sanofi Ventures, Sixty Degree Capital, Vives Partners, and Apollo Health Ventures.

Photo by Bionyra Pharma