Star Therapeutics to Present Complete Data from Phase 1/2 Multidose Study of VGA039 in Von Willebrand Disease at ISTH 2026 Congress
Star Therapeutics, a late clinical-stage biotechnology company focused on the discovery and development of life-changing therapies for diseases with significant unmet need, today announced an upcoming oral presentation of complete safety and efficacy data on all patients from its Phase 1/2 multidose study of VGA039 for von Willebrand disease (VWD), along with additional presentations on the program, at the 34th Congress of the International Society on Thrombosis and Haemostasis (ISTH 2026 Congress), being held July 11-15, 2026, in Paris, France.
VGA039 is an investigational monoclonal antibody therapy designed to modulate Protein S to improve hemostasis and improve the body’s ability to control bleeding. VGA039 is in Phase 3 pivotal development for patients with VWD, the most common inherited bleeding disorder. It has the potential to be the first subcutaneous prophylactic therapy for all types of VWD with a once monthly dosing regimen for patients.
Earlier this month, Incyte (NASDAQ:INCY) announced it had entered into a definitive agreement to acquire Vega Therapeutics, Inc., a wholly owned subsidiary of Star Therapeutics, LLC, for $1.25 billion upfront, subject to customary closing adjustments. Star Therapeutics will be eligible to receive up to $750 million in additional payments upon the achievement of sales milestones, for total potential consideration of up to $2.0 billion. The proposed acquisition would add VGA039 to Incyte’s hematology portfolio.
Presentation details include:
Oral Presentations
- Title: Subcutaneous Four-Week Dosing of the Novel Protein S Antibody VGA039 Demonstrates Safety and Clinically Meaningful Bleed Reduction in Patients with Von Willebrand Disease: Phase 1/2 Multi-Dose Study Results
- Publication Number: OC 32.3
- Oral Session: Novel Therapies for Bleeding Disorders, Including VWD and Rare Bleeding Disorders - 2
- Presentation Date and Time: Monday, July 13, 10:00 – 10:15 a.m. CEST
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Presenter: Allison Wheeler, M.D., MSCI
- Title: Prophylaxis Eligibility in Von Willebrand Disease: Prevalence, Disease Burden, and Post-Diagnosis Care Patterns in a Large U.S. Dataset
- Publication Number: OC 53.2
- Oral Session: Von Willebrand Disease
- Presentation Date and Time: Tuesday, July 14, 9:45 – 10:00 a.m. CEST
- Presenter: Robert F. Sidonio, Jr., M.D., MSc
Poster Presentations
- Title: Pharmacokinetic and Pharmacodynamic Characterization of VGA039, a Protein S-targeting Monoclonal Antibody, Supports Subcutaneous Every-4-Week Dosing for Routine Prophylaxis in Phase 3 VWD Trial
- Publication Number: PB2083
- Poster Session: Poster Networking Session
- Session Date and Time: Monday, July 13, 1:45 – 2:45 p.m. CEST
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Presenter: Christopher DelNagro, Ph.D.
- Title: Qualitative Study Exploring the Lived Experiences of Adolescents and Adults with Von Willebrand Disease Treated with VGA039 and Their Families in the VIVID-3 Phase 1/2 Clinical Study
- Publication Number: PB3420
- Poster Session: Poster Networking Session
- Session Date and Time: Tuesday, July 14, 1:45 – 2:45 p.m. CEST
- Presenter: Shilpa Nataraj, M.D.
About VGA039
VGA039 is an investigational monoclonal antibody therapy with a novel mechanism of action that targets Protein S, with dual actions promoting platelet attachment and enhancing fibrin deposition to restore hemostasis. VGA039 is in development as a potential hemostatic therapy for the treatment of numerous bleeding disorders, starting with all types of von Willebrand disease (VWD). As a subcutaneously self-administered investigational antibody therapy with a once monthly dosing regimen, VGA039 has the potential to improve convenience and quality of life for patients.
VGA039 has received Fast Track, orphan drug, rare pediatric disease and Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA). VGA039 has advanced into a Phase 3 study (NCT07115004), VIVID-6, a global single arm cross-over study designed to investigate the safety and efficacy of subcutaneous administration of VGA039 as prophylaxis for bleeding in patients with every type of VWD.
Star Therapeutics, LLC has entered into a definitive agreement with Incyte pursuant to which Incyte would acquire Vega Therapeutics, Inc., a wholly owned subsidiary of Star Therapeutics, including VGA039.
About von Willebrand Disease
Von Willebrand disease (VWD) is the most common inherited bleeding disorder in which the blood does not clot properly, caused by low or defective von Willebrand factor (VWF). VWD patients may experience excessive bleeding with varying severity and frequency, negatively impacting their daily lives. Current therapies for VWD prophylaxis include factor replacement therapies requiring multiple intravenous (IV) infusions every week. Approximately 135,000 people in the United States have been diagnosed with von Willebrand disease.1
About Star Therapeutics
Star Therapeutics is a biotechnology company focused on the discovery and development of life-changing therapies for diseases with significant unmet need. Star Therapeutics' team has invented four first-in-class antibody therapies, including the first approved drug (Enjaymo®) for cold agglutinin disease, and three other therapies that are each in Phase 3 development. For more information, please visit Star-Therapeutics.com and follow us on LinkedIn and X.
Forward-Looking Statements
This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. These statements relate to, among other things, the presentation of data from the Phase 1/2 multidose study of VGA039; the potential and promise offered by VGA039; the proposed transaction between Incyte and Star Therapeutics; and Star Therapeutics’ aspirations and goals, as set forth under the heading "About Star Therapeutics."
Actual results may differ materially from those indicated in the forward-looking statements as a result of various factors, including the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; unanticipated delays or obstacles that impact the ability of Star Therapeutics and Incyte to close on their proposed transaction; the actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; the efficacy or safety of products or product candidates; the ability to achieve commercial success for products, once approved; the ability to obtain and maintain protection of intellectual property for products and technology; reliance on third parties and partners; the acceptance of products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; and greater than expected expenses, including expenses relating to litigation or strategic activities. Star Therapeutics disclaims any intent or obligation to update these forward-looking statements.
1) Data on File.
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