Novo Holdings invests in $200M Series A for Windward Bio launch to advance long-acting treatments for asthma and COPD

• High unmet medical need for therapies that can reduce the substantial treatment burden affecting millions of patients globally
• Combined in-licensing and financing for a novel long-acting clinical stage monoclonal antibody targeting TSLP ligand as well as building a discovery pipeline of long-acting bispecifics
• Naveed Siddiqi, Senior Partner, Venture Investments, Novo Holdings, to join the Windward Bio Board of Directors

COPENHAGEN, Denmark, Jan. 10, 2025 /PRNewswire/ -- Novo Holdings, a leading life science investor, today announced that it has invested in a $200M Series A launch financing for Windward Bio. Headquartered in Switzerland, Windward Bio is a clinical-stage drug development company committed to improving outcomes for people living with advanced immunological diseases with an initial focus on severe respiratory conditions.

The 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.

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.

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."

Naveed Siddiqi, Senior Partner, Novo Holdings, said: "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. At Novo Holdings, we are committed to supporting innovative approaches that improve patient outcomes. We are excited to partner once again with the management team of Windward Bio, serial entrepreneurs with a proven track record of success."

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.

About WIN378

WIN378 is a novel, recombinant, fully human monoclonal antibody that potently binds to the TSLP ligand, which is a well-validated cytokine that plays a key role in the development and progression of a wide array of immunological diseases, including asthma and COPD. In both these diseases the inhibition of the TSLP ligand has demonstrated benefit in a myriad of inflammatory phenotypes. WIN378 has been engineered to achieve an extended half-life and effector silencing and is subcutaneously administered.

About Windward Bio AG

Windward Bio is a clinical-stage drug development company committed to improving outcomes for patients living with advanced immunological diseases with an initial focus on severe respiratory conditions. The company is led by a highly experienced team of biopharmaceutical executives with deep discovery, development, and commercialization expertise. The company is advancing a potential best-in-class TSLP monoclonal antibody into phase 2 development and creating novel, long-acting bispecific programs for immunological diseases.

About Novo Holdings A/S

Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people's health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation. Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novonesis A/S (Novozymes A/S) and manages an investment portfolio with a long-term return perspective. In addition to managing a broad portfolio of equities, bonds, real estate, infrastructure and private equity assets, Novo Holdings is a world-leading life sciences investor. Through its Seed, Venture, Growth, Asia, Planetary Health and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development. As of year-end 2023, Novo Holdings had total assets of EUR 149 billion. www.novoholdings.dk

About the Novo Nordisk Foundation

Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people's health and the sustainability of society and the planet. The Foundation's mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society.