Windward Bio Secures $165M to Advance Ultra Long-Acting Immunology Therapies for Asthma and COPD
Key Insights
Windward Bio (search) raised $165 million in crossover financing led by OrbiMed (search) to advance its pipeline of long-acting immunology therapies targeting serious respiratory and dermatological diseases.
The funding will accelerate WIN378, a potential first-to-market ultra long-acting anti-TSLP (search) antibody with twice-yearly dosing, into Phase 3 trials for asthma (search) by Q4 2026.
WIN027 (search), a dual-targeting bispecific antibody against TSLP (search) and IL-13 (search), aims to set new efficacy standards in asthma (search), COPD (search), and atopic dermatitis (search) with deeper disease control than existing biologics.
Windward Bio (search) announced a $165 million crossover financing round led by OrbiMed (search) to advance its pipeline of long-acting immunology therapies targeting serious respiratory and dermatological diseases. The financing includes participation from new investors RA Capital Management, Janus Henderson Investors, and Sanofi Ventures (search), alongside existing Series A investors including Novo Holdings (search), Blue Owl Healthcare Opportunities, SR One, Omega Funds, RTW Investments, Qiming Venture Partners, Quan Capital, and Pivotal bioVenture Partners.
The proceeds will significantly extend the company's cash runway and enable multiple clinical readouts in the next 12 months, supporting the advancement of two clinical-stage programs with potential best-in-disease profiles.
WIN378 Targets First-to-Market Position in Anti-TSLP Space
WIN378, the company's lead program, is a next-generation, fully human monoclonal antibody that potently binds to the thymic stromal lymphopoietin (TSLP (search)) ligand. This well-validated cytokine plays a key role in the development and progression of a wide array of immunological diseases. WIN378 has the potential to be the first-to-market, ultra long-acting anti-TSLP antibody with twice-yearly dosing.
The antibody has been engineered to achieve half-life extension and have a silenced effector function. Phase 1 trial results confirmed an extended half-life suitable for twice-yearly dosing, demonstrated a low rate of antidrug antibodies, and showed the treatment was safe and well tolerated up to the highest dose tested. WIN378 is administered subcutaneously.
The financing will accelerate development of WIN378, which is currently being studied in the Phase 2/3 POLARIS program in asthma (search). The Phase 2 dose-ranging component of POLARIS is fully recruited, with initial data expected in the second half of 2026. The first Phase 3 study of WIN378 is expected to begin in the fourth quarter of 2026. Additionally, the Phase 2 SIRIUS study in chronic obstructive pulmonary disease (COPD (search)) is anticipated to start in the second quarter of 2026.
WIN027 Offers Dual-Target Approach
WIN027 (search), the company's second program, is a highly potent, long-acting bispecific antibody targeting both TSLP (search) and interleukin-13 (IL-13 (search)), two well-validated and synergistic drivers of inflammation in severe asthma (search), COPD (search), and atopic dermatitis (search). The bispecific monoclonal antibody has subpicomolar affinity for both targets and has been engineered to achieve an extended half-life and enable less frequent dosing.
Through this dual, long-acting inhibition, WIN027 (search) is designed to set a new standard of efficacy in conditions such as asthma (search), COPD (search), and atopic dermatitis (search), potentially delivering deeper and more durable disease control than existing biologics. WIN027 is currently in a Phase 1 study with data readout expected by the end of 2026. The financing will support multiple proof-of-concept studies across respiratory and dermatology indications starting in Q4 2026.
Rapid Company Progress Since Launch
Since launching in January 2025, Windward Bio (search) has in-licensed two clinical-stage assets, raised $365 million, and rapidly advanced both programs in the clinic. The company licensed global rights for WIN378 (excluding Greater China and several Southeast and West Asian countries) from Kelun-Biotech (search) and Harbour BioMed (search), while WIN027 (search) was licensed from Qyuns Therapeutics (excluding Greater China).
"We are excited to expand our shareholder base of top-tier investors to include RA Capital, Janus Henderson Investors, and Sanofi Ventures (search)," said Luca Santarelli, MD, Founder, Chief Executive Officer, and Board Chair of Windward Bio (search). "This financing further strengthens our balance sheet and allows us to advance our programs of next-generation therapies for patients living with serious respiratory and dermatological diseases."
David Bonita, General Partner at OrbiMed (search), commented: "Windward Bio (search) is uniquely positioned to make an impact in immunology with a differentiated portfolio that could raise the standards of care in respiratory and dermatology. We are impressed with the significant progress the Windward Bio team has made since the company's launch in 2025 and are proud to lead this high-caliber investor syndicate in supporting Windward Bio's mission to discover and develop novel therapeutics for serious immunological conditions."
Naveed Siddiqi, Senior Partner, Venture Investments at Novo Holdings (search), added: "Spearheaded by a highly experienced clinical and commercial leadership consisting of serial entrepreneurs, Windward Bio (search) has made rapid progress since it launched in 2025, including bringing in a second clinical stage asset, WIN027 (search). There is much more to be done towards improving dosing frequency and outcomes for the benefit of patients suffering from serious and chronic immunological conditions, and as a significant shareholder, we are pleased to support Windward Bio as it advances its innovative and developing pipeline into late-stage trials."