HMB-001 is currently in Phase 1/2 clinical study for Glanzmann Thrombasthenia—early research supports its potential expansion into Factor VII Deficiency

COPENHAGEN, Denmark and BOSTON, MA, USA I June 15, 2023 I Hemab Therapeutics, a clinical-stage biotechnology company developing the first prophylactic therapeutics for serious, underserved bleeding and thrombotic disorders, announced today it will present data from preclinical research of HMB-001 in Factor VII (FVII) deficiency at the upcoming International Society on Thrombosis and Haemostasis (ISTH) 2023 Congress, June 24 – 28, in Montreal.

FVII deficiency can cause spontaneous or excessive and prolonged bleeding after injury or surgery; heavy or prolonged menstrual bleeding in women; and in very severe cases, life-threatening bleeding inside the skull or digestive tract.i Hemab’s lead candidate, HMB-001, is a bispecific antibody that binds and stabilizes endogenous Factor VIIa (FVIIa) with one antibody arm and TLT-1 on activated platelets with the other arm. This allows for accumulation of FVIIa in the body and recruitment of FVIIa directly to the surface of the activated platelets where it is known to facilitate the formation of protective hemostatic plugs to stop bleeding.

In addition, initial findings from the Glanzmann’s 360 natural history study, Hemab’s research initiative in partnership with UK specialist research consultancy Haemnet, will be presented at ISTH 2023. This first-of-its-kind study was designed to better define the real-life social, economic and clinical burdens experienced by people living with Glanzmann Thrombasthenia (GT), a rare platelet disorder that causes severe, potentially life-threatening bleeding episodes.

Hemab’s Presentations at ISTH 2023

HMB-001 in Factor VII Deficiency:

  • Oral Presentation 07.4: HMB-001, a Bispecific anti-FVIIa/anti-TLT-1 Antibody Demonstrates Effect in Models of FVII Deficiency
    • Presenting Author: Henrik Østergaard, PhD, MSc, Vice President of Research, Hemab Therapeutics
    • Date/Time: Saturday, June 24, 2023, 1:45-2:00 p.m. ET

First-of-Its-Kind Study of Glanzmann Thrombasthenia:

  • Poster 0228: A Prospective, Observational Study of Bleeding and Quality of Life in Patients with Glanzmann Thrombasthenia in the United Kingdom: A First Report
    • Presenting Author: Catherine Rea, MD, PhD, Senior Director of Clinical Research, Hemab Therapeutics
    • Date/Time: Sunday, June 25, 2023, 6:30-7:30 p.m. ET
  • Poster 1375: Menstrual Bleeding in Women with Glanzmann’s Thrombasthenia – Results from the Glanzmann’s 360 Study (GT360)
    • Presenting Author: Kate Khair, RN, RSCN, PhD, Director of Research, Haemnet
    • Date/Time: Tuesday, June 27, 2023, 6:30-7:30 p.m. ET
  • Poster 1377: Living with Glanzmann’s Thrombasthenia: An Interim Report from the Glanzmann’s 360 International Patient Survey
    • Presenting Author: Kate Khair, RN, RSCN, PhD, Director of Research, Haemnet
    • Date/Time: Tuesday, June 27, 2023, 6:30-7:30 p.m. ET
  • Poster 1393: Living with Glanzmann’s Thrombasthenia: An Interim Report on 14 Qualitative Interviews from the Glanzmann’s 360 Study
    • Presenting Author: Kate Khair, RN, RSCN, PhD, Director of Research, Haemnet
    • Date/Time: Tuesday, June 27, 2023, 6:30-7:30 p.m. ET

About HMB-001

HMB-001 is bispecific antibody that binds and stabilizes endogenous factor VIIa (FVIIa) with one antibody arm and TLT-1 on activated platelets with the other arm. This allows for accumulation of FVIIa in the body, recruitment of FVIIa directly to the surface of the activated platelets where it is known to facilitate clotting, and avoidance of clotting activity in the absence of tissue damage. HMB-001 was designed to be a first-in-class prophylactic treatment for Glanzmann Thrombasthenia (GT) with potential for other debilitating rare bleeding disorders, including Factor VII deficiency.

HMB-001 entered Phase 1/2 clinical evaluation in late 2022 for GT, with initial data expected 2H 2023.

About Hemab Therapeutics

Hemab is a clinical-stage biotech company developing the first prophylactic therapeutics for serious, underserved bleeding and thrombotic disorders. Based in the US and Denmark, Hemab is progressing a pipeline of monoclonal and bispecific antibody-based therapeutics to transform the treatment paradigm for patients with high unmet need. The company’s strategic guidance, Hemab 1-2-5TM, targets the development of 5 clinical assets by 2025 to deliver long-awaited innovation for patients with high unmet need blood clotting disorders like Glanzmann Thrombasthenia, Factor VII Deficiency, Bernard Soulier Syndrome, Von Willebrand Disease and other serious disorders. Learn more at hemab.com.

iFactor VII deficiency – About the Disease – Genetic and Rare Diseases Information Center (nih.gov), accessed June 12, 2023.

SOURCE: Hemab Therapeutics