For Bionyra Pharma co-founder and CEO Frédéric Marrache, M.D., Ph.D., “the planets had to align” to pull him out of his R&D VP role at Sanofi. But after weighing the opportunity to lead immunology and inflammation (I&I) biotech, he decided to take the jump and scratch the entrepreneurial itch he had been feeling for years.
Marrache now leads a company that is emerging from stealth with an oversubscribed Series A round of $165 million co-led by Jeito Capital and Sofinnova Partners, according to a June 22 release. Arkin Bio, Sanofi Ventures, Sixty Degree Capital, Vives Partners and Apollo Health Ventures also participated in the round after the company received seed financing from Sofinnova Partners.
Despite I&I receiving significant attention in the biopharma world, Marrache told Fierce he was drawn away from Big Pharma because of the remaining unmet need in the sector. “If you look at the clinical trials conducted with approved drugs, the response rate is usually less than 50%,” he said. “That speaks to the need to improve things and is one of the drivers behind the creation of Bionyra.”
Bionyra is emerging with three licensed antibodies aimed at diseases with unmet need despite currently available treatments, including atopic dermatitis and inflammatory bowel disease (IBD).
Patients who suffer from I&I conditions often experience daily pain, fatigue and uncertainty, and they live at the mercy of flares that can result in hospital stays.
Bionyra licensed the ex-China rights to BYN-001 from New Jersey-based NovaRock Biotherapeutics. The monoclonal antibody targets the IL-25 pathway, has half-life extension (HLE) technology and is at the IND filing stage for atopic dermatitis, according to the company.
Marrache said he is excited about the drug’s potential to contribute to combination treatments and said the half-life technology could enable the drug to become a best-in-class offering. “Having this half-life extension will help us potentially down the road make this molecule a good partner for antibodies targeting complementary pathways,” he said.
Elsewhere, Bionyra has licensed two TL1A-targeting assets from Chinese biotech TrueLab Biopharmaceutical. “TL1A is a game changer in the immunology and inflammation field, because it has shown great promise to have dual anti-inflammatory, anti-fibrotic effect in inflammatory bowel disease, but also because it has potential to be relevant across multiple indications and to be another drug in [a] pipeline story in the I&I field,” Marrache said.
Other players in the space have echoed Marrache’s feelings about TL1A. Last week, Spyre shared a positive phase 2 readout for its anti-TL1A antibody in patients with ulcerative colitis, and in March, Teva Pharmaceuticals secured $400 million from Blackstone Life Sciences to fuel the development of its Sanofi-partnered anti-TL1A antibody, duvakitug, for patients with IBD.
Bionyra wants its own shot at the TL1A market. BYN-002 is an anti-TL1A monoclonal antibody with HLE technology for patients with IBD and other TL1A-relevant indications. A Phase 1 study in healthy volunteers is already fully enrolled. BYN-003 is a TL1AxIL-23p19 bispecific antibody with HLE technology that began a Phase 1 study for healthy volunteers with IBD in April.
The Series A funds will be used to grow the company and move these assets forward, Marrache said, with the goal of advancing all three assets through Phase 1 by the end of the year, followed by further studies in 2027 and proof-of-concept data in 2028. Bionyra is also progressing additional innovative preclinical assets, including additional candidates from TrueLab.
Marrache, a trained gastroenterologist who earned a Ph.D. and spent time in management consulting before joining Sanofi, has built the experience needed for the ambitious launch.
“It's a broad endeavor to progress three assets in parallel, but I think they all have very exciting potential of their own,” Marrache said. “That's also how we thought about this pipeline: to have multiple opportunities, to address different unmet needs, to have different value propositions, and as a result have a balanced portfolio.”