Windward Bio, a private, clinical-stage, drug development company committed to improving outcomes for people living with advanced immunological diseases, announced its official launch. OrbiMed, Novo Holdings, and Blue Owl Healthcare Opportunities lead the Series A financing of $200M with the co-investment of SR One, Omega Funds, RTW Investments, Qiming Venture Partners, Quan Capital, and Pivotal bioVenture Partners. Windward Bio has entered into an agreement to license WIN378 from Kelun-Biotech and Harbour BioMed for global rights, excepting China and select smaller markets in Asia.

WIN378 is a potential best-in-class, long-acting monoclonal antibody targeting the ligand of thymic stromal lymphopoietin (TSLP) that has the potential to be dosed every 6 months. The company is preparing to begin a phase 2 trial investigating WIN378 in severe asthma with initial clinical readouts expected in 2026. Additional clinical trials are planned in asthma and chronic obstructive pulmonary disease (COPD), aiming to address unmet needs in approximately 5 million advanced, uncontrolled patients in the US, Europe, and Japan.

“Our mission in starting Windward Bio is to discover and develop novel therapeutics for people living with serious immunological conditions,” said Luca Santarelli, MD, founder, CEO, and Chairman of Windward Bio. “Targeting the TSLP ligand is a highly validated approach in multiple immunological conditions, and WIN378 represents a significant advance in TSLP therapy by enhancing the benefits of this class with a dosing regimen of every 6 months, which can reduce the burden of treatment and improve outcomes for people living with severe asthma.”

“By leading the investment in Windward Bio, we see the opportunity to leverage a highly successful team to create a biopharmaceutical company that can bring best-in-class therapeutics to people living with asthma, COPD, and other immunological conditions,” said David Bonita, MD, General Partner at OrbiMed. “We look forward to continuing to build Windward Bio’s immunology pipeline through both internal research and business development activities.”

The founding Windward Bio team, led by Dr. Santarelli, includes an accomplished group of seasoned biopharmaceutical executives with repeated success in bringing compounds from target identification through commercialization. Collectively, they have contributed to 15+ product launches and executed 2 Nasdaq IPOs and 2 sales (Therachon to Pfizer in 2019, for $810M, and VectivBio to Ironwood in 2023, for $1.2B).

The company is also building a discovery pipeline of long-acting bispecifics harnessing validated targets and synergistic biology to achieve best-in-disease efficacy for immunology indications. Series A financing supports the advancement of 2 undisclosed programs through Investigational New Drug (IND)–enabling studies.

Windward Bio’s highly experienced Board will initially include Luca Santarelli, MD; David Bonita, MD (OrbiMed); Naveed Siddiqi, MD (Novo Holdings); Tim Anderson (Blue Owl Healthcare Opportunities); Iqbal Mufti (SR One); and Otello Stampacchia, PhD (Omega Funds).