
Windward Bio’s lead candidate, WIN378, which has been in-licensed from Kelun-Biotech and Harbour BioMed, 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 six 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.
The $200 million oversubscribed Series A launch financing was co-led by OrbiMed, Novo Holdings and Blue Owl Healthcare Opportunities, and joined by SR One, Omega Funds, RTW Investments, Qiming Venture Partners, Quan Capital, and Pivotal bioVenture Partners.
In addition to WIN378, Windward Bio is building a discovery pipeline of long-acting bispecifics, harnessing validated targets and synergistic biology to achieve best-in-disease efficacy for immunology indications. The Series A financing supports the advancement of two undisclosed programs through Investigational New Drug (IND)–enabling studies.
"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 six months, which can reduce the burden of treatment and improve outcomes for people living with severe asthma."
Experienced team
Led by CEO Luca Santarelli, Windward Bio's founding team comprises seasoned biopharmaceutical executives with significant expertise in advancing compounds from target identification through to commercialisation. Collectively, they have contributed to over 15 product launches, executed two Nasdaq IPOs, and completed two strategic exits.
The Board of directors will initially include Luca Santarelli, MD (CEO); 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). Campbell Stewart, MD (Principal, Venture Investments, Novo Holdings), joins as Observer to the Board.
“Addressing the unmet needs of patients with severe, uncontrolled asthma and COPD, particularly through innovative therapies that reduce the burden of care for both individuals and healthcare systems, represents a meaningful advancement in respiratory care. WIN378, with its best-in-class potential to provide effective treatment through a six-month dosing regimen, could transform how these challenging conditions are managed, offering both clinical and practical benefits”, said Naveed Siddiqi, Senior Partner, Novo Holdings.
(Press release/RAN)
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