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Transforming treatment for people living with serious immunological conditions

Windward Bio Continues Momentum for WIN378 With Phase 2 COPD Advancement;
Asthma Phase 3 Development Expected in Q4 2026

Latest news

About Windward Bio

Windward Bio is a clinical-stage biotechnology company with deep discovery, development, and commercialization expertise committed to transforming the treatment of people living with serious immunological conditions. Its lead program is WIN378, a potential best-in-disease, ultra long-acting anti-TSLP monoclonal antibody currently in a Phase 2/3 trial for asthma and in a Phase 2 study for COPD. The pipeline also includes WIN027, a clinical-stage, long-acting anti-TSLPxIL-13 bispecific with broad therapeutic potential across immunological diseases, which is currently in Phase 1. The company is building a discovery pipeline of long-acting bispecific antibodies, targeting validated biology in respiratory and dermatological conditions.

Pipeline

WIN378 antibody
WIN027 antibody

WIN378 is an anti-TSLP antibody with potential best-in-disease dosing frequency

WIN378 is a next-generation, fully human monoclonal antibody that potently inhibits the TSLP ligand. This clinically validated target plays a key role in the development and progression of a wide array of immunological diseases, including asthma and COPD.

WIN378 has been engineered to achieve half-life extension (HLE) and have a silenced effector function. It has been studied in a Phase 1 trial, which confirmed an extended half-life suitable for twice-yearly dosing, demonstrated a low rate of antidrug antibodies, and was safe and well tolerated up to the highest dose tested. WIN378 is administered subcutaneously. Windward Bio licensed the global rights (excluding Greater China and several Southeast and West Asian countries) for WIN378 from Kelun-Biotech (also known as SKB378) and Harbour BioMed (also known as HBM9378).

WIN378 is currently being evaluated in the POLARIS Phase 2/3 asthma study with initial readouts expected in the second half of 2026. WIN378 is also being evaluated in the SIRIUS Phase 2 COPD study. The first Phase 3 study of WIN378 is expected to begin in the fourth quarter of 2026.

Meet the Team

Current Investors

News

Press Release

June 9, 2026

Windward Bio Doses First Patients in Phase 2 SIRIUS COPD Study of Ultra Long-Acting Anti-TSLP Antibody WIN378

Press Release

May 4, 2026

Windward Bio Announces $165M Crossover Financing to Advance Pipeline of Long-Acting Immunology Therapies With Best-in-Disease Potential

Press Release

December 21, 2025

Windward Bio Expands Immunology Pipeline With WIN027, a Long-Acting, Clinical-Stage Bispecific Targeting TSLP and IL-13

Press Release

July 23, 2025

Windward Bio Initiates Global Phase 2 Asthma Trial of WIN378, a Potential Best-in-Disease, Long-Acting, Anti-TSLP Monoclonal Antibody

Press Release

January 10, 2025

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

For general inquiries, please contact: media@windwardbio.com

Luca Santarelli

Luca Santarelli, MD

Founder, Chief Executive Officer, and Board Chair

Dr. Luca Santarelli is the founder, Chief Executive Officer, and Chairman of the Board of Windward Bio.

He has more than 25 years of experience in academic and industrial R&D, having led drug programs in the areas of neuroscience, rare diseases, ophthalmology, metabolic, and GI diseases, spanning the value chain from discovery research to commercialization. Dr. Santarelli is also the Chair of the Board of Directors of Alentis Therapeutics, a clinical-stage biotech company focused on cancer and fibrosis. He previously served as a member of the Board of Directors of Cimeio Therapeutics, an immunotherapy company, until April 2025.

Most recently, Dr. Santarelli served as Chief Executive Officer and cofounder of VectivBio AG, a global clinical-stage biotechnology company focused on transforming the lives of patients with rare conditions, until its acquisition by Ironwood Pharmaceuticals in 2023 for $1.2 billion. Prior to VectivBio, he was the Chief Executive Officer and cofounder of Therachon AG, focused on the discovery and development of therapeutics for rare genetic conditions and was later acquired by Pfizer in 2019 for $810 million.

Prior to Therachon, Dr. Santarelli spent 12 years at Roche, most recently serving as the Senior Vice President and Head of Neuroscience, Ophthalmology, and Rare Diseases, as well as Small Molecules Research. In these roles, he advanced more than 20 NMEs to the clinic and various NMEs to registration studies including ocrelizumab for multiple sclerosis, gantenerumab for Alzheimer’s disease, balovaptan for autism, risdiplam for spinal muscular atrophy, and faricimab for diabetic macular edema and neurovascular age-related macular degeneration.

Dr. Santarelli completed his MD and psychiatry residency at the University of Turin, Italy, and a postdoctoral fellowship at Columbia University, focusing on the molecular mechanisms of psychiatric disorders and adult brain stem cells. His work has been published in high-impact journals, including Nature, Science, Nature Neuroscience, Archives of Neurology, and JAMA Psychiatry.

Claudia D'Augusta


Claudia D’Augusta, PhD
Chief Financial Officer

Dr. Claudia D’Augusta has more than 25 years of experience in the fields of corporate finance, capital markets, and M&A.

She was most recently Chief Financial Officer of VectivBio prior to its acquisition by Ironwood Pharmaceuticals in 2023 and at Therachon prior to its acquisition by Pfizer in 2019. Previously, she served as General Manager at TiGenix after its acquisition by Takeda in 2018. Prior to this appointment, Dr. D’Augusta was Chief Financial Officer of TiGenix, where she led the company’s IPO on Nasdaq in 2016, served as a member of the Executive Committee, and was responsible for the financial, legal, and investor relations areas. She also served as the Chief Financial Officer of Cellerix and led its merger with TiGenix, a company listed on Euronext. Before joining Cellerix in 2004, Dr. D’Augusta was Finance Director of Aquanima (Santander Group). Other previous experiences include Deloitte & Touche in Milan and Apax Partners in Madrid.

Dr. D’Augusta holds a bachelor’s degree in economics and a PhD in business administration from Bocconi University, Italy.

Omar Khwaja


Omar Khwaja, MD, PhD 
Chief Medical Officer 

Dr. Omar Khwaja possesses more than 25 years of experience and notable accomplishments in drug development, medicine, and academia.

Prior to joining Windward Bio, Dr. Khwaja served as Chief Medical Officer of VectivBio, and before that, as Chief Medical Officer and Head of R&D at Voyager Therapeutics. Earlier, he held senior leadership positions at Roche, including Global Head of Rare Diseases and Global Head of Neuroscience Early Development, where he led pioneering initiatives in breakthrough therapies. Preceding Dr. Khwaja’s industry experience in drug development, he practiced medicine and clinical research including as Director of the Clinical Neurogenetics program at Boston Children’s Hospital and as a member of the faculty at Harvard Medical School.

Dr. Khwaja received his MD and a PhD in human molecular genetics from the University of Cambridge. He is a fellow of the Royal College of Physicians and serves as a chair or member of a number of industry and foundation scientific or clinical advisory boards; he is also part of the Advisory Board for Pureos Bioventures.

Kevin Harris

Kevin Harris, MBA

Chief Operating Officer

Kevin Harris has more than 25 years of leadership experience in global product strategy, as well as launch and product management in oncology, immunology, and infectious and rare disease products.

Prior to Windward Bio, Mr. Harris was the Chief Commercial Officer at VectivBio for more than 3 years; during that time he led program management, prelaunch, and commercialization planning for apraglutide prior to the company’s sale to Ironwood Pharmaceuticals. Before that, Mr. Harris was at Incyte for more than 10 years, most recently as Group Vice President of Global Product Strategy and Strategic Planning for oncology and immunology programs. He joined Incyte as Vice President of Commercial and built and led most of the US commercial functions for the launch of Jakafi®. Previously, Mr. Harris held roles of increasing responsibility at Pfizer, across the company’s HIV and oncology portfolios. Before that, he served in commercial development and marketing roles at Bristol-Myers Squibb in HIV and oncology. Mr. Harris began his career in management consulting at PRTM and subsequently joined Parexel in a marketing and strategy role.

Mr. Harris holds an MBA from Kellogg Graduate School of Management at Northwestern University and a BA in biology from Cornell University.

Scott Applebaum


Scott Applebaum 
Chief Legal & Corporate Development Officer 

Scott Applebaum brings almost 30 years of legal, regulatory, and operational experience in the biopharmaceutical industry to Windward Bio.

Most recently, Mr. Applebaum was the Chief Legal and Business Officer of VectivBio, leading the successful sale to Ironwood Pharmaceuticals for $1.2 billion. Previously, he was the Chief Legal & Compliance Officer and Senior Vice President of Regulatory Affairs at Trevena, where he played a key role in gaining FDA approval for their first commercial product️. Before that, Mr. Applebaum served as President of Context Therapeutics and was General Counsel at Vitae Pharmaceuticals, where he was instrumental in their sale to Allergan. Formerly, he was Chief Legal Officer for Medgenics, a rare genetic disease company. Prior to that, Mr. Applebaum spent 10 years at Shire in multiple leadership roles, including leading their global legal group, launching their flagship ADHD product outside the United States, and heading their global regulatory, quality assurance, and compliance groups. Previously, he was Senior Counsel for medicines and medical imaging at Bristol-Myers Squibb.

Prior to his career in the biopharmaceutical industry, Mr. Applebaum was a lawyer at Dechert LLP. He received his JD from Stanford Law School and a BS in economics, finance, and accounting from the Wharton School of the University of Pennsylvania.

Michael Steininger

Michael Steininger, MSc

Head of Human Resources

Michael Steininger is a seasoned HR executive with more than 25 years of experience in pharma & biotech across several professional service companies, Roche and VectivBio. Until June 2024, he served as Head HR at VectivBio and led the integration of the organization into its new mother corporation after its acquisition by Ironwood Pharmaceuticals.

Michael is a high-energy HR executive, who has demonstrated impact across global Life Sciences. From pioneering HR strategies in publicly listed VectivBio to steering organizational transformations at industry giant Roche, he blends business acumen with people-first leadership.

Michael has built, transformed, and led people-related functions across continents—Europe, Asia, and North America—cultivating high-performance cultures in complex, fast-paced environments. His record includes shaping HR and integration strategies at VectivBio (through IPO and acquisition), designing the HR architecture that enabled the development of several blockbuster drugs at Roche, and launching a clinical-stage biotech company, Windward Bio, alongside visionary peers.

Leading with clarity, courage, and authenticity, Michael connects with people while driving tangible results. Whether navigating M&A integrations from both sides, scaling organizations, or nurturing leadership pipelines, he acts as a trusted partner and architect of sustainable success.

Michael holds degrees in business administration and sports medicine from the University of Bayreuth, Germany, with specializations in HR, organizational development, psychology, and health. He also studied at Massey University in New Zealand. Certified both as an Agile Coach and Health & Fitness Coach, Michael champions holistic leadership, team vitality, individual and team performance—grounded in strategic thinking and holistic well-being.

Martine Mazzetti

Martine Mazzetti, PhD

Chief of Staff

Martine Mazzetti is a senior pharma executive with 30+ years of global leadership in drug development, regulatory affairs, and project management across Clintec Salvia, Roche, AstraZeneca, and other biotechnology companies. Until January 2024, she held executive roles at VectivBio, including Project Leader, Non-Clinical Team Leader, and Chief of Staff.

A seasoned pharmaceutical leader, Ms. Mazzetti’s experience involved regulatory affairs, project leadership, and executive strategy. She began her career at Clintec Salvia progressing rapidly to head regulatory and quality functions. At Roche, mainly in Basel, she spent nearly 2 decades in key roles, ultimately as Global Head Project Management for pRED, leading global early development projects and complex organizational change.

At AstraZeneca in Cambridge, UK, Ms. Mazzetti served as VP, Head of Project Management for IMED, transforming team structures and introducing new systems and roles to support over 75 projects globally. Following a sabbatical, she founded her own consultancy, guiding biotech firms through governance, regulatory milestones, and portfolio strategy.

From 2019 to 2024, Ms. Mazzetti worked at VectivBio, where she held several leadership roles including Project Leader, Non-Clinical Team Leader, and ultimately Chief of Staff. She contributed to strategic governance, executive operations, and development of key assets such as Apraglutide.

Ms. Mazzetti holds a PhD degree from the University of Saarbrücken, a DUT in Biology & Biochemistry from Paris-Sud University (Paris XI), and completed the Abibac diploma at the International School of Saarbrücken. Her scientific foundation and leadership experience have made her a trusted figure in advancing complex drug development programs.