Windward Bio Launches With $200 Million Series A Financing to Develop Phase 2-Ready, Long-Acting Anti-TSLP Antibody With Best-in-Class Potential in Asthma and COPD
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).
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 people 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 Kelun-Biotech Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization, and global collaboration of innovative biological drugs and small molecule drugs. The Company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and on establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of the world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 2 projects have been approved for marketing, 2 projects are in the NDA stage, and more than 10 projects are in the clinical stage. The Company has established one of the world’s leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in the NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.
About Harbour BioMed Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners, and select acquisitions.
The proprietary antibody technology platforms Harbour Mice® generates fully human monoclonal antibodies in two heavy and two light chains (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology is capable of delivering tumor-killing effects unachievable by traditional combination therapies. Integrating Harbour Mice®, and HBICE® with a single B cell-cloning platform, our antibody discovery engine is highly unique and efficient for the development of next-generation therapeutic antibodies. For further information, please refer to www.harbourbiomed.com or follow us on LinkedIn.
Contacts: For media, business, or investor inquiries, please contact: media@windwardbio.com
