HMB-001 was well tolerated with no drug-related adverse or thromboembolic events; dose-dependent improvements in blood-clotting activity support the potential of HMB-001 as a first-in-class prophylactic treatment for Glanzmann Thrombasthenia and other blood clotting disorders
Preclinical HMB-001 findings were published in the February 2024 issue of Nature Cardiovascular Research
COPENHAGEN, DENMARK AND CAMBRIDGE, MASS., US – February 9, 2024 – Hemab Therapeutics, a clinical-stage biotechnology company developing novel prophylactic therapeutics for serious, underserved bleeding and thrombotic disorders, today presented initial results from Phase 1 of its ongoing evaluation of HMB-001. A novel bispecific antibody, HMB-001 is in development as a prophylactic treatment for the bleeding disorder Glanzmann Thrombasthenia (Glanzmann). The data were presented as one of 10 abstracts selected for the SLAM oral presentation session at the 17th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD) held this week in Frankfurt, Germany.
“The first clinical data for HMB-001 in Glanzmann suggest that the demonstrated mechanism is suitable as a new prophylactic treatment for people with neglected blood clotting disorders who face severe, potentially life-threatening bleeds every day,” said Joe Vogel, Senior Director and Program Lead for HMB-001 at Hemab. “With Phase 2 already underway, we are committed to advancing clinical evaluation of HMB-001 toward bringing life-changing preventative treatments to improve patients’ quality of life.”
The Phase 1/2 first-in-human open-label study in patients with Glanzmann is evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of HMB-001. As part of the UK-based Phase 1 single-ascending dose, seven patients received subcutaneous HMB-001 at 0.2 mg/kg, (n=1), 0.5 mg/kg (n=3) or 1.25 mg/kg (n=3). Over a 56-day observation period, HMB-001 was well tolerated; the most common adverse events (AEs) were mild or moderate in severity. No AEs or serious adverse events were deemed related to HMB-001. There were no dose-limiting toxicities and no thromboembolic events reported.
Treatment with HMB-001 resulted in a dose-dependent pharmacodynamic effect of endogenous Factor VIIa accumulation that was associated with decreases in prothrombin time and improvement in exploratory thrombin generation analyses. The pharmacokinetic profile and half-life of HMB-001 support dosing every two weeks or a less-frequent dosing regimen.
“People living with bleeding disorders like Glanzmann face devastating bleed events and considerable psychosocial impacts—from severe pain and social stigmatization to depression and isolation—but have no approved preventative treatments to turn to,” said Suthesh Sivapalaratnam, MD, PhD, Queen Mary University of London, Barts Health NHS Trust. “These Phase 1 data support further investigation into the promise of HMB-001 for patients and providers across the globe who are awaiting innovation to improve the standard of care.”
Hemab has begun dosing and is actively enrolling in Phase 2, the multiple-ascending dose of the study, which will be expanded to sites across Europe and the U.S. For more information, visit clinicaltrials.gov (NCT06211634).
In addition, Hemab announced that preclinical research findings of HMB-001 are now available online as part of the February 2024 issue of Nature Cardiovascular Research. The study results demonstrate the ability of HMB-001 to accumulate and potentiate the activity of endogenous Factor VIIa selectively on activated platelets, providing a sustained and localized procoagulant activity that may support prophylactic treatment of Glanzmann or other bleeding disorders. Read the paper here.
About Glanzmann Thrombasthenia
Glanzmann Thrombasthenia (Glanzmann) is a rare and severe bleeding disorder associated with debilitating and sometimes life-threatening bleeding episodes. Initial findings from the international Glanzmann’s 360 (GT360) natural history study—Hemab’s research initiative in partnership with UK specialist research consultancy Haemnet—found that 87% of the 104 respondents reported experiencing at least one bleed in the previous week, with 37% of those bleeds requiring medical treatment.
These bleeding episodes significantly impact the mental health and quality of life of people living with Glanzmann. Low mood, emotional problems, and social isolation were reported by participants (66%, 50%, and 44% respectively), and 80% reported that they missed school or work due to bruising or bleeding. To date, there are no effective prophylactic treatment options for Glanzmann.
About HMB-001
HMB-001 is bispecific antibody that binds and stabilizes endogenous Factor VIIa with one antibody arm and binds to TLT-1 on activated platelets with the other arm. This allows for accumulation of endogenous Factor VIIa in the body, recruitment of Factor VIIa 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 is designed to be a first-in-class prophylactic treatment for Glanzmann Thrombasthenia with the potential to treat other debilitating rare bleeding disorders. The U.S. Food and Drug Administration granted Fast Track Designation to HMB-001 for the treatment of Glanzmann.
About Hemab Therapeutics
Hemab is a clinical-stage biotech company developing novel prophylactic therapeutics for serious, underserved bleeding and thrombotic disorders. Based in Cambridge, MA and Copenhagen, 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 assets by 2025 to deliver long-awaited innovation for patients with high unmet need blood-clotting disorders like Glanzmann Thrombasthenia, Factor VII Deficiency, Von Willebrand Disease, and others. Learn more at hemab.com. Follow us on LinkedIn and X (formerly known as Twitter).
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Media Contact:
Lia Dangelico
lia.dangelico@vergescientific.com
540-303-0180
COPENHAGEN, DENMARK AND CAMBRIDGE, MASS., US – January 4, 2024 – Hemab Therapeutics, a clinical-stage biotechnology company developing novel prophylactic therapeutics for serious, underserved bleeding and thrombotic disorders, today announced the appointment of Akshay Vaishnaw, MD, PhD, to its Board of Directors.
The company also announced CEO Benny Sorensen, MD, PhD, will present an update on Hemab’s progress and outlook for 2024 at the 42nd Annual J.P. Morgan Healthcare Conference on Wednesday, January 10, at 4:30 PM PST/7:30 PM EST.
“In the last year, Hemab has achieved several important milestones, including raising a substantial Series B round, initiated its first Phase 2 clinical study and continued to build its pipeline of development candidates,” said John Maraganore, PhD, Board Chair. “With the appointment of Akshay to the Board, we add a biotech veteran who brings deep R&D experience at a time when Hemab will be advancing multiple clinical programs across a range of blood-clotting disorders. We welcome Akshay and the expertise he brings to Hemab and its mission.”
Dr. Vaishnaw is the Chief Innovation Officer at Alnylam Pharmaceuticals. Since joining the company in 2006 he has served in positions of increasing responsibility across Research and Development (R&D), and most recently as President of Alnylam. Prior to Alnylam, Dr. Vaishnaw was Senior Director, Translational Medicine at Biogen. Dr. Vaishnaw received a bachelor’s degree from University College Cardiff, UK, he received his MD from the University of Wales College of Medicine, UK, and a PhD from the University of London, UK, in Molecular Immunology. He is a Fellow of the Royal College of Physicians, UK. Dr. Vaishnaw is a member of the Board of Directors for Editas Medicine Inc. and Scholar Rock Inc.
“Hemab’s product development approach allows for a spectrum of modalities to be utilized, which holds immense promise for transforming the treatment of multiple blood-clotting disorders like Glanzmann Thrombasthenia, Factor VII Deficiency, and Von Willebrand Disease that remain urgently in need of novel prophylactic treatments,” said Dr. Vaishnaw. “I am excited to join Hemab’s Board of Directors and work with the leadership team who are clearly driven by patient need in their mission to deliver life-changing treatments for many people.”
“Akshay joins our Board at a time when his experience leading translational research, clinical development and delivering regulatory success will be invaluable,” said Dr. Sorensen. “I am thrilled to have his partnership and to bring his passion for science and commitment to building people-focused cultures to Hemab.”
About Hemab Therapeutics
Hemab is a clinical-stage biotech company developing novel prophylactic therapeutics for serious, underserved bleeding and thrombotic disorders. Based in Cambridge, MA and Copenhagen, 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 independent assets by 2025 to deliver long-awaited innovation for patients with high unmet need blood-clotting disorders like Glanzmann Thrombasthenia, Factor VII Deficiency, Von Willebrand Disease and other serious disorders. Learn more at hemab.com.
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Media Contact:
Lia Dangelico
lia.dangelico@vergescientific.com
540-303-0180
HMB-001 is a novel bispecific antibody designed to be the first prophylactic treatment for Glanzmann Thrombasthenia (GT) and other debilitating bleeding disorders
Phase 1 was successfully completed in the UK; Hemab plans additional sites in Europe and the U.S. for Phase 2
The U.S. FDA has cleared the Investigational New Drug (IND) application and granted Fast Track Designation to HMB-001 for the treatment of GT
COPENHAGEN, DENMARK AND CAMBRIDGE, MASS., US – December 11, 2023 – Hemab Therapeutics, a clinical-stage biotechnology company developing novel prophylactic therapeutics for serious, underserved bleeding and thrombotic disorders, announced today that it has completed Phase 1, the single ascending dose part, and transitioned to Phase 2, the multiple ascending dose part, of its Phase 1/2 clinical study of HMB-001 in Glanzmann Thrombasthenia (GT), a platelet disorder that causes severe, potentially life-threatening bleeding episodes.
The company also announced that the U.S. Food and Drug Administration (FDA) has cleared Hemab’s investigational new drug application (IND) for HMB-001 in GT, enabling enrollment in the U.S. Phase 1 of the clinical study was completed in the UK, and Phase 2 will include additional sites in Europe as well as the U.S.
In addition, the FDA granted Fast Track designation to HMB-001, emphasizing the seriousness and high unmet need for treatments for GT. The Fast Track program enables Hemab to have more frequent interactions with the FDA to facilitate the development of HMB-001.
“People living with Glanzmann Thrombasthenia can experience frequent, sometimes severe bleeds that can be life-threatening and compromise their quality of life. Currently, there are no prophylactic treatment options that would reduce or prevent these bleeding episodes,” said Benny Sorensen, MD, PhD, CEO of Hemab. “The completion of Phase 1 on time and transitioning to Phase 2 is an important milestone for HMB-001 and Hemab. Furthermore, expanding our clinical study into the U.S., following clearance of the IND, and Fast Track designation are a testament to the importance of advancing prophylactic treatment for people living with Glanzmann Thrombasthenia.”
The Phase 1/2 clinical study evaluates the safety, tolerability, pharmacodynamics, and pharmacokinetics of HMB-001. Initial efficacy signals based on an assessment of changes in bleeding frequency will also be measured. The study is composed of three parts: Part A, single ascending dose, Part B, multiple ascending dose, and Part C, extended dosing. Hemab plans to report data from the Phase 1, single ascending dose portion, at an international scientific conference in early 2024.
The Phase 1/2 study design was detailed in the company’s poster presentation (number 1225), “A Phase 1/2, First-in-Human, Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Participants with Glanzmann Thrombasthenia,” at the 65th American Society of Hematology Annual Meeting and Exposition.
About Glanzmann Thrombasthenia
Glanzmann Thrombasthenia (GT) is a rare and severe bleeding disorder associated with debilitating and sometimes life-threatening bleeding episodes. Initial findings from the international Glanzmann’s 360 (GT360) natural history study, Hemab’s research initiative in partnership with UK specialist research consultancy Haemnet, found that 87% of the 104 respondents reported experiencing at least one bleed in the previous week, and 37% of those bleeds required medical treatment.
These bleeding episodes have a significant impact on the mental health and quality of life of people living with GT. Low mood, emotional problems, and social isolation were reported by participants (66%, 50%, and 44% respectively) and 80% reported that they missed school or work due to bruising or bleeding. To date, there are no effective prophylactic treatment options for people living with GT.
About HMB-001
HMB-001 is bispecific antibody that binds and stabilizes endogenous factor VIIa (FVIIa) with one antibody arm and binds to TLT-1 on activated platelets with the other arm. This allows for accumulation of endogenous 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 is designed to be a first-in-class prophylactic treatment for Glanzmann Thrombasthenia with the potential to treat other debilitating rare bleeding disorders.
About Hemab Therapeutics
Hemab is a clinical-stage biotech company developing novel prophylactic therapeutics for serious, underserved bleeding and thrombotic disorders. Based in Cambridge, MA and Copenhagen, 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 independent 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.
Media Contact
Lia Dangelico
lia.dangelico@vergescientific.com
540-303-0180
HMB-001 recognizes and binds to factor VII (FVII) protein variants associated with moderate/severe FVII deficiency and drives accumulation of endogenous FVII/FVIIa to normal ranges in in-vivo models
COPENHAGEN, DENMARK AND BOSTON, MASS., US – June 24, 2023 – Hemab Therapeutics, a clinical-stage biotechnology company developing the first prophylactic therapeutics for serious, underserved bleeding and thrombotic disorders, announced results today from preclinical research of HMB-001 in models of factor VII (FVII) deficiency at the International Society on Thrombosis and Haemostasis (ISTH) 2023 Congress in Montreal.
“We believe that HMB-001 has the potential to transform treatment in several serious bleeding disorders and have already initiated a Phase 1/2 study in Glanzmann Thrombasthenia,” said Benny Sorensen, MD, PhD, CEO and President of Hemab. “The new preclinical data presented today show HMB-001 successfully targeted and accumulated endogenous FVIIa to levels that would be expected to provide clinical benefit in FVII deficiency, supporting the potential for HMB-001 in an additional underserved bleeding disorder.”
FVII is a protein necessary in the formation of hemostatic plugs to control bleeding. 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.
HMB-001, Hemab’s lead candidate, is a bispecific antibody that binds to and stabilizes endogenous activated FVII (FVIIa) with one antibody arm and localizes FVIIa to the surface of activated platelets by binding to TLT-1 with the other arm. This allows for accumulation of FVIIa in the body and recruitment of FVIIa directly to the surface of activated platelets at the site of vascular injury where FVIIa is known to facilitate the formation of protective hemostatic plugs to stop bleeding.
The preclinical research presented at ISTH, “HMB-001, a Bispecific anti-FVIIa/anti-TLT-1 Antibody Demonstrates Effect in Models of FVII Deficiency,”assessed key requirements for HMB-001 to function in FVII deficiency, specifically its ability to bind with FVII protein variants associated with moderate/severe deficiency and the potential of HMB-001 to accumulate FVIIa in an in-vivo non-human primate model of FVII deficiency.
A panel of 12 FVII variants from the European Association for Haemophilia and Allied Disorders (EAHAD) database was produced based on high prevalence and association with moderate/severe FVII deficiency phenotype as well as proximity to the HMB-001 binding site. In subsequent binding studies, HMB-001 was shown to bind to all FVII variants at clinically relevant concentrations.
The ability of HMB-001 to accumulate endogenous FVIIa in FVII deficiency was assessed using small interfering RNA (siRNA) to knock down FVII/FVIIa to levels between 10 to 30 percent of normal in animal models (n=3). After continuous, stable knock down, HMB-001 (5 mg/kg) was administered. The total accumulation of FVIIa observed with HMB-001 was comparable to the normal range seen in healthy animals. These initial results suggest HMB-001 may have potential application as a treatment for FVII deficiency.
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.
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.
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Media Contact
Lia Dangelico
ldangelico@vergescientific.com
540-303-0180
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, MASS., US – June 15, 2023 – 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:
- Poster0228: 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.
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iFactor VII deficiency – About the Disease – Genetic and Rare Diseases Information Center (nih.gov), accessed June 12, 2023.
Media Contact
Lia Dangelico
Verge Scientific Communications
540-303-0180
COPENHAGEN, Demark and BOSTON, March 1, 2023
Hemab Therapeutics, a clinical-stage biotechnology company developing the first prophylactic therapeutics for serious, underserved bleeding and thrombotic disorders, today issued the following statement announcing the planned departure of Co-Founder and Chief Technology Officer Johan Faber, PhD, MSc, effective March 1, 2023:
“Johan Faber, PhD, MSc, was instrumental in the founding of Hemab in 2019 and as the founding CEO of the Company. Since July 2021, he has served as Chief Technology Officer. He brought to the company deep expertise in the biology of clotting as well as 14 years of experience in drug discovery and biopharmaceutical development at Novo Nordisk, including signification contributions to Novoeight®, Esperoct®, Mim8®. He is also a co-inventor of Hemab’s HMB-001 program.
‘Johan’s devoted leadership has helped shape Hemab into the company it is today, and I couldn’t be more grateful for his many contributions,’ said Benny Sorensen, MD, CEO & President of Hemab. ‘His wisdom and pioneering spirit will remain deeply ingrained in the organization as we evolve on our journey to becoming the ultimate clotting company. He is tireless in his pursuits to diligently follow the science toward creating companies and medicines that improve lives, and we are thrilled to follow his next steps.’
‘I am extremely proud of what we have built together at Hemab,’ said Johan. ‘This incredible team has centered patients with high unmet need in our work at every step. I have no doubt they will be successful in their mission to deliver targeted, preventative therapies for people with severe bleeding and thrombotic disorders who have been awaiting innovation for far too long. I look forward to their continued clinical and company success.’”
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 Factor VII Deficiency, Bernard Soulier Syndrome, Von Willebrand Disease, Hereditary Hemorrhagic Telangiectasia (or Osler-Weber-Rendu disease), Congenital Antithrombin III Deficiency, and other serious disorders. Learn more at hemab.com.
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Media Contact
Lia Dangelico
ldangelico@vergescientific.com
540-303-0180
Funding enables completion of ongoing Phase 1/2 study of bispecific antibody HMB-001 in Glanzmann Thrombasthenia, initiation of pivotal studies, start and conclusion of Phase 1/2 study of HMB-VWF in von Willebrand Disease, as well as future pipeline evolution.
COPENHAGEN, DENMARK and BOSTON, MASS., US – February 21, 2023
Hemab Therapeutics, a clinical-stage biotechnology company developing the first prophylactic therapeutics for serious, underserved bleeding and thrombotic disorders, today announced the closing of an oversubscribed $135 million Series B financing. Access Biotechnology led the round, with participation from new investors Deep Track Capital, Avoro Ventures, Invus, Rock Springs Capital, and Maj Invest Equity, as well as all current investors Novo Holdings, RA Capital Management, and HealthCap.
“Hemab is fundamentally reimagining the treatment paradigm for underserved bleeding and thrombotic disorders. This financing will allow us to progress our clinical programs for the first prophylactic treatments for Glanzmann Thrombasthenia and von Willebrand Disease, delivering functional cures for patients in need,” said Benny Sorensen, MD, PhD, CEO & President of Hemab. “We’re grateful for this robust syndicate of investors who support our approach of leveraging validated advanced technologies and deep insights into the biology of clotting to overcome decades of scientific stagnation.”
The financing will support Hemab’s scientific and corporate growth plans through 2025, including completion of an ongoing Phase 1/2 clinical study of lead candidate HMB-001 in Glanzmann Thrombasthenia, initiation of pivotal studies, start and completion of Phase 1/2 clinical evaluation for HMB-VWF in von Willebrand disease, and future pipeline evolution in accordance with the company’s Hemab 1-2-5™ strategic guidance—targeting development of 5 clinical assets by 2025.
“Strong investor confidence—in this case, an upsized round and more than $200 million in demand—is a testament to the expertise of the Hemab team, their validated scientific approach, and the opportunity to bring long-overdue innovation to patients living with severe bleeding and thrombotic diseases,” said John Maraganore, PhD, Chair of Hemab’s Board of Directors.
“As founding investor and the company’s largest shareholder, we are excited to support Hemab in the next phase of its plan to build the ultimate clotting company, with a Nordic foundation and global footprint,” said Jørgen Søberg Petersen, MD, PhD, MBA, Partner at Novo Holdings.
Hemab also announced Dan Becker, MD, PhD, Managing Director at Access, and Uya Chuluunbaatar, PhD, Partner at Avoro Ventures, will also join as Directors. Christine Borowski, PhD, Vice President at Access, will join as a Board Observer.
“We are thrilled to partner with Hemab’s exceptional leadership to advance a pipeline of transformative new medicines for areas of high unmet need in hemostatic disorders,” said Dr. Becker.
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 Factor VII Deficiency, Bernard Soulier Syndrome, Von Willebrand Disease, Hereditary Hemorrhagic Telangiectasia (or Osler-Weber-Rendu disease), Congenital Antithrombin III Deficiency, and other serious disorders. Learn more at hemab.com.
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 with potential for other debilitating rare bleeding disorders. It entered Phase 1/2 clinical evaluation in late 2022, with initial data expected 2H 2023.
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Media Contact
Lia Dangelico
ldangelico@vergescientific.com
540-303-0180
Bispecific antibody HMB-001 positioned as the first prophylactic treatment for rare bleeding disorders
CEO Benny Sorensen, MD, PhD, delivered the update during a corporate overview presented at the 41st Annual JP Morgan Healthcare Conference
COPENHAGEN, DENMARK AND BOSTON, MASS., US – January 10, 2023
Hemab Therapeutics, a clinical-stage biotechnology company developing next-generation therapeutics for serious, underserved bleeding and thrombotic disorders, today announced the first patient has been dosed in a Phase 1/2 study evaluating HMB-001 for the treatment of the severe bleeding disorder Glanzmann Thrombasthenia (Glanzmann). The update was provided during a corporate overview presented at the 41st Annual J.P. Morgan Healthcare Conference held this week in San Francisco. HMB-001 is a bispecific antibody that binds, stabilizes, and recruits endogenous factor VIIa (FVIIa) to the site of vascular injury to overcome the body’s inability to form healthy clots.
“HMB-001 is the first candidate of our emerging pipeline to reach clinical stage as we realize our mission to deliver functional cure medicines to people living with serious blood clotting disorders,” said Benny Sorensen, MD, PhD, CEO of Hemab. “This milestone is supported by preclinical data showing HMB-001 potentiates FVIIa-dependent fibrin formation on platelets in Glanzmann and accumulates FVIIa to levels that are considered therapeutically effective. We are confident clinical evaluation will confirm HMB-001’s potential and look forward to its continued clinical advancement as the first prophylaxis treatment for Glanzmann and other severe bleeding disorders.”
The Phase 1/2 first-in-human open-label study in patients with Glanzmann was designed to evaluate HMB-001 for safety, tolerability, biomarkers such as FVII levels and bleeding time before and after HMB-001, and efficacy based on assessment of changes in bleeding frequency. Facilitated in collaboration with the UK-based clinical research organization Richmond Pharmacology, the trial is expected to expand into the US and other EU countries. Initial data are expected 2H 2023.
“Many patients with Glanzmann suffer from frequent and potentially life-threatening bleed events. Despite that, we have concerningly few effective and no prophylactic treatment options to offer them, often relying on platelet transfusions, antifibrinolytics, or acute use of recombinant factor VIIa,” said Suthesh Sivapalaratnam, MD, PhD MRCP FRCPath, Consultant of Paediatric and Adult Haemostasis and Thrombosis at The Royal London Hospital, Barts Health NHS Trust. “I am eager to see HMB-001 progress through clinical evaluation toward validating its potential as a much-needed bleed-preventative treatment for patients with Glanzmann all over the world.”
In partnership with UK specialist research consultancy Haemnet, Hemab announced in mid-2022 that it had commenced a natural history study to better understand the realities of living with Glanzmann and expects to share new data from the study in early 2023.
The company is continuing to advance its strategic guidance, Hemab 1-2-5TM, to develop five clinical assets by 2025 to transform treatment for rare bleeding and thrombotic disorders with high unmet need, including Glanzmann, Factor VII Deficiency, Bernard Soulier Syndrome, Von Willebrand Disease, Hereditary Hemorrhagic Telangiectasia (or Osler-Weber-Rendu disease), Congenital Antithrombin III Deficiency.
About Hemab Therapeutics
Hemab is a clinical-stage biotech company developing next generation therapeutics for serious, underserved bleeding and thrombosis disorders. Based in Denmark and the US and backed by Novo Holdings, RA Capital, and HealthCap, Hemab aims to progress its pipeline of monoclonal and bispecific antibody-based therapeutics with the vision of transforming the treatment paradigm for patients with bleeding and thrombotic disorders with high unmet need. Learn more at hemab.com.
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 with potential for other debilitating rare bleeding disorders. It entered Phase 1/2 clinical evaluation in late 2022, with initial data expected in 2H 2023.
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Media Contact
Lia Dangelico
ldangelico@vergescientific.com
540-303-0180
Data suggest HMB-001 potentiates endogenous factor Vlla-dependent fibrin formation on platelets in Glanzmann Thrombasthenia and accumulates FVIIa to levels considered therapeutically effective
Hemab’s strategic guidance, Hemab 1-2-5TM,aims to advance 5 clinical assets by 2025 to address significant unmet need across a wide range of bleeding and thrombotic disorders
COPENHAGEN, DENMARK AND BOSTON, MASS., US – July 13, 2022
Hemab Therapeutics, a biotechnology company developing next-generation therapeutics for serious, underserved bleeding and thrombotic disorders, today presented new pre-clinical data on HMB-001, a novel bispecific antibody poised to become the first-ever prophylactic treatment option for Glanzmann Thrombasthenia (GT) and other rare bleeding conditions. Data show HMB-001 potentiates endogenous factor Vlla (FVIIa)-dependent fibrin formation on platelets in GT and accumulates FVIIa to levels that are considered therapeutically effective. The company highlighted findings in two presentations at the 2022 International Society on Thrombosis and Haemostasis (ISTH) Congress held this week in London.
“For many patients of rare bleeding and thrombosis, zero targeted preventative treatments exist, meaning the standard of care remains decades behind,” said Benny Sorensen, MD, PhD, President and CEO of Hemab. “We are encouraged by this data showing HMB-001’s promise as the first prophylactic treatment for patients with GT. We are also excited to launch our strategic guidance, Hemab 1-2-5TM, aimed at advancing 5 clinical assets by 2025 to help people facing clotting disorders who have been left behind and urgently need innovation.”
Expected to enter Phase 1/2 clinical trials in late 2022, HMB-001 binds, stabilizes, and recruits FVlla to the site of vascular injury to overcome the body’s inability to form healthy clots—building on the clinically validated mechanisms of action of recombinant FVlla with the benefit of prophylaxis.
Hemab’s oral presentation described compelling data showing HMB-001 binds FVIIa in a neutral manner, preserving native biological functions, such as autoactivation of FVII to FVIIa, FVIIa–mediated activation of Factor X, and inhibition of FVIIa by AT3 and TFPI. In studies of cynomolgus monkeys, HMB-001 administration resulted in dose-dependent endogenous FVIIa accumulation to therapeutic levels, supporting the use of HMB-001 as a prophylactic treatment for GT in weekly, biweekly, or monthly dosing.
Ex vivo data shared in a poster presentation suggest that HMB-001 further potentiates fibrin formation and fibrin-dependent platelet aggregation of GT platelets. This assay was performed in a microfluidics chamber, mimicking flowing blood to simulate in vivo conditions for clot formation.
The company also debuted its strategic guidance, Hemab 1-2-5TM,targeting development of 5 clinical assets by 2025 to transform treatment for rare bleeding and thrombotic disorders with high unmet need, including Factor VII Deficiency, Bernard Soulier Syndrome, Von Willebrand Disease, Hereditary Hemorrhagic Telangiectasia (or Osler-Weber-Rendu disease), Congenital Antithrombin III Deficiency, and others.
Presentations at ISTH Congress:
- Title: HMB-001 – a novel bispecific antibody accumulating and targeting endogenous FVIIa to activated platelets for subcutaneous prophylaxis in multiple bleeding disorders including Glanzmann Thrombasthenia
- Session Theme: Hemophilia and Rare Bleeding Disorders/Rare Bleeding Disorders
- Abstract Number: OC 78.3
- Presenter: Henrik Østergaard, PhD, MSc, Scientific Director, Hemab
- Title: The novel bispecific antibody HMB-001 enhances the haemostatic response in models of Glanzmann Thrombasthenia by targeting FVIIa to activated platelets
- Session Theme: Hemophilia and Rare Bleeding Disorders/Rare Bleeding Disorders
- Abstract Number: PB0719
- Presenter: Minka Zivkovic, MSc, PhD Candidate in Thrombosis and Haemostasis, UMC Utrecht
About Hemab Therapeutics
Hemab is a biotech company developing next generation therapeutics for serious, underserved bleeding and thrombosis disorders. The company announced an oversubscribed $55 million Series A led by RA Capital Management, Novo Holdings and HealthCap in July 2021. Based in Denmark and the US, Hemab aims to progress its pipeline of monoclonal and bispecific antibody-based therapeutics with the vision of transforming the treatment paradigm for patients with bleeding and thrombotic disorders with high unmet need. Learn more at hemab.com.
Media Contact
Lia Dangelico
ldangelico@vergescientific.com
540-303-0180
Preclinical data demonstrate HMB-001’s promise as a preventative treatment for patients with underserved bleeding disorders, including Glanzmann Thrombasthenia
Data presented at 2022 European Association for Haemophilia and Allied Disorders Virtual Congress
Copenhagen, Denmark and Boston, Mass., February 4, 2022
Hemab Therapeutics, a biotechnology company developing next-generation therapeutics for serious, underserved bleeding and thrombosis disorders, today unveiled its lead candidate, HMB-001, a novel bispecific antibody with potential for the treatment of Glanzmann Thrombasthenia (GT) and other rare bleeding disorders. The company presented promising preclinical data on HMB-001 during the 2022 European Association for Haemophilia and Allied Disorders Virtual Congress, held February 2-4, 2022.
“Patients suffering with rare bleeding and clotting disorders deserve the same advancements in care that hemophilia patients have experienced for decades,” said Benny Sorensen, MD, PhD, President and CEO of Hemab. “We aim to reach every patient suffering from these often-unmanageable diseases and offer innovative, state-of-the-art prophylactic solutions, like HMB-001, to restore proper clotting function and help them live more healthy, active lives.”
At the conference, Hemab highlighted data from studies exploring the mechanism of action for HMB-001 in cynomolgus monkeys and experiments with platelets from GT patients. The in vivo subcutaneously administered single dosages of HMB-001 showed dose-dependent accumulation of endogenous factor VIIa (FVIIa), with durability of effect supporting weekly to once monthly dosing. TLT-1, a protein found on the surface of activated platelets at the site of injury, was confirmed to be present on GT platelets and HMB-001 was found to substantially improve FVIIa facilitated ex vivo GT platelet aggregation in a TLT-1-dependent manner.
Combining accumulation and activity potentiation, HMB-001 brings the activity of endogenous FVIIa to levels that are considered therapeutically effective based on clinical experience with recombinant factor VIIa (rFVIIa). HMB-001 is a bispecific antibody, with one arm binding FVIIa already present in the patient’s bloodstream (endogenous) and the other arm binding TLT-1 present on the surface of the activated platelet; this effectively, and specifically, recruits FVIIa to the surface of the activated platelet. The arm that binds FVIIa prevents the body from breaking it down, increasing the available concentration in the bloodstream to a new higher steady state level over the course of a few days. The neutral binding of FVIIa means it is still active and can play a role in forming hemostatic plugs. By targeting activated platelets at the site of vascular damage with a high concentration of FVIIa (via TLT-1), the body generates enough structurally sound building blocks to form healthy hemostatic plugs.
“HMB-001 is a pioneering approach that binds, amplifies, and recruits endogenous FVIIa to the site of vascular injury via binding to TLT-1 expressed on activated platelets to overcome defects in patients’ ability to form healthy clots,” said Dr. Roger Schutgens, Professor and Consulting Hematologist at University Medical Centre Utrecht, and Head of the Van Creveldkliniek, a Netherlands-based center for excellence in rare disorders of thrombosis and hemostasis. “The data show it may have broad applicability across multiple bleeding disorders, enabling subcutaneous and long-term prophylactic treatment.”
In partnership with Haemnet, which works with healthcare professionals, patients, communities, and other stakeholders to improve the lives of people with bleeding disorders through research, education, and communication, Hemab is commencing natural history studies of patients with GT through early 2022 to better understand the frequency and types of bleeds, number of individuals affected, disease variability, and impacts on life and lifespan.
Hemab will begin a Phase 1/2 clinical trial in patients with GT in late 2022 to assess HMB-001’s safety and efficacy, initially in collaboration with leading UK Phase 1 clinical research firm, Richmond Pharmacology Ltd.
About Hemab Therapeutics
Hemab is a biotech company developing next generation therapeutics for serious, underserved bleeding and thrombosis disorders. The company announced an oversubscribed $55 million Series A led by RA Capital Management, Novo Holdings and HealthCap in July 2021. Based in Denmark and the US, Hemab aims to progress its pipeline of monoclonal and bispecific antibody-based therapeutics with the vision of transforming the treatment paradigm for blood disease patients—from orphan disorders to broad indications with high unmet need.
Learn more at hemab.com.
Media Contact
Lia Dangelico
Tel: 540-303-0180
Email: ldangelico@vergescientific.com
Experts in clinical development and finance join to advance first-in-class prophylactic therapies for rare bleeding disorders and thrombosis
Copenhagen, Denmark and Boston, MASS., US – January 5, 2022
Hemab Therapeutics, a biotechnology company developing next generation therapeutics for serious, underserved bleeding and thrombosis disorders, today announced the appointment of John Maraganore, PhD, former founding CEO of Alnylam, as Board Chair, and Linda Bain, CFO of Codiak BioSciences, as Board member. The company also announced the appointment of Wendy Hill as Senior Vice President of Development and Program Management to lead its clinical development programs.
“I am humbled to have led Hemab since its inception and to see it advance the next generation of therapeutics for some of the world’s rarest forms of bleeding disorders,” said Jørgen Søberg Petersen, MD, PhD, DMSc, MBA, Partner at Novo Holdings and Hemab’s Immediate Past Chair. “We are both honored and pleased that John has accepted the role as independent Board Chair, and I personally look forward to working with John to bring Hemab’s vision to fruition.”
“We are delighted to ring in the New Year with the appointments of John, Linda, and Wendy—three incredible additions to our Board and leadership as we enter the clinic,” said Benny Sorensen, MD, PhD, President and CEO of Hemab. “John brings unprecedented experience, passion, and drive to deliver new innovative treatments to patients with underserved bleeding and thrombosis disorders. Linda brings a wealth of financial and strategic know-how to our Board, and Wendy has an established track record of advancing early- and late-stage clinical programs. Their collective expertise will be integral to progressing our pipeline of first-in-class prophylactic thrombotic treatments for patients.”
A veteran of the biotech industry, Dr. Maraganore brings decades of experience in business and scientific thought leadership and strategic product development to the role of Board Chair. In his nearly 20-year tenure as the founding CEO of Alnylam, he steered the company’s efforts to pioneer RNA interference (RNAi) therapeutics, raising over $7 billion to fund its programs and establishing partnerships with more than 25 of the leading pharmaceutical and biotechnology companies. As inventor of bivalirudin, a direct-acting thrombin inhibitor later commercialized as ANGIOMAXTM, as well as his formative contributions to Fitusiran, an RNAi therapeutic targeting antithrombin for the treatment of hemophilia A or B, he has deep knowledge of thrombosis and hemostasis research and development.
“Hemab is in a unique position to deliver truly transformative therapies for patients with rare blood disorders,” said Dr. Maraganore. “While there have been tremendous strides made in the treatment of hemophilia, for many other blood and clotting disorders, blood transfusions are still considered standard of care and mortality rates are high. Hemab’s pipeline and platform has the potential to, for the first time, offer innovative life-changing prophylactic treatment for these patients. I am honored and excited to join the Board and to work with Hemab leadership to deliver on the promise of these medicines.”
Ms. Bain will help guide Hemab’s future financial planning and strategy with extensive experience from a successful career in finance, business, and operational leadership at biotechnology and pharmaceutical companies. Prior to joining Codiak, she held senior roles at Avalanche Biotechnologies, bluebird bio, Genzyme, Fidelity Investments, and Astra Zeneca. Ms. Bain’s dedication to health equity will be key to advancing the company’s mission to aid underserved patients around the world.
“I look forward to guiding Hemab’s financial stewardship in support of its mission of meeting the unmet needs of patients across all geographies and demographics,” said Ms. Bain.
As the latest addition to Hemab’s leadership staff team, Ms. Hill will oversee the company’s clinical development and program management efforts. Previously serving as Vice President of Clinical Operations at Codiak BioSciences and Senior Director of Immuno-Oncology at Genocea, she has built and executed both early- and late-stage clinical development programs across diverse product sectors. Ms. Hill’s experience leading cross-functional teams and overseeing drug development will be invaluable in advancing Hemab’s monoclonal and bispecific antibody-based therapeutics.
About Hemab Therapeutics
Hemab is a biotech company developing next generation therapeutics for serious, underserved bleeding and thrombosis disorders. The company announced an oversubscribed $55 million Series A led by RA Capital Management, Novo Holdings and HealthCap in July 2021. Based in Denmark and the US, Hemab has exclusive licenses to antibody technologies from both Novo Nordisk and Genmab. Hemab aims to progress its pipeline of monoclonal and bispecific antibody-based therapeutics with the vision of transforming the treatment paradigm for blood disease patients—from orphan disorders to broad indications with high unmet need. Learn more at hemab.com.
Hemab Appoints Mads Behrndt as Chief Financial Officer
Copenhagen, Denmark and Boston, Mass., – September 21, 2021
Hemab ApS (“Hemab”), a biotech company developing next generation therapeutics for serious underserved bleeding and thrombosis disorders, today announces the appointment of Mads Behrndt as Chief Financial Officer.
Mads brings more than 14 years of financial experience in the international capital markets as well as in business development. Most recently Mads was a Partner at PwC’s Corporate Finance team, where he led and executed private and public company financings and M&A transactions. This appointment follows the successful closing of Hemab’s US$ 55 million Series A financing in July 2021, to enable the Company to build a platform of monoclonal and bispecific antibodies for the treatment of rare
bleeding disorders.
Benny Sorensen, Chief Executive Officer of Hemab, commented:
“I am delighted to welcome Mads to Hemab at this exciting time for the Company, as we look to accelerate progress in our pipeline and prepare our first candidate for clinical development. Mads will be responsible for advancing the strategy, planning and execution of our future financing and business development plans. Mads will play a key role in market assessment and positioning as part of our efforts to build a fully-fledged clinical company dedicated to bringing a new generation of therapies for patients with serious bleeding and thrombosis disorders.”
Mads Behrndt, Chief Financial Officer of Hemab, stated:
“I am excited to join Hemab, a company backed by a transatlantic syndicate of top tier investors and focused on developing disruptive therapies for several underserved hematological diseases. I’m particularly impressed by Hemab’s stellar team of experts and the potential of its promising pipeline of monoclonal and bispecific antibody-based therapeutics. I look forward to working with Benny and the team in guiding Hemab through its next stages of growth.”
For more information please contact:
Hemab
Benny Sorensen, CEO
Email: benny@hemab.com
About Hemab
Hemab is an emerging biotech company developing next generation therapeutics for serious, underserved bleeding and thrombosis disorders. The Company was founded by Johan Henrik Faber, Søren Bjørn, Hans Wandall, Thomas Batchelor and Mads Behrndt who secured the seed financing round with Novo Seeds, the early-stage investment and company creation team of Novo Holdings, which also invested in the Series A financing alongside HealthCap and RA Capital Management. Based in Denmark and the US, the Company is led by a team of drug developers and scientists with deep expertise in thrombosis and hemostasis. Hemab has exclusive licenses to state-of-the-art antibody technologies from both Novo Nordisk A/S and Genmab A/S. Hemab aims to progress its pipeline of monoclonal and bispecific antibody-based therapeutics with the vision to transform the treatment paradigm for blood disease patients – from orphan disorders to broad indications with high unmet need. Further information: www.hemab.com.
Benny Sorensen appointed Chief Executive Officer and Co-Founder Johan Henrik Faber appointed Chief Technology Officer
Financing led by Novo Holdings, HealthCap and RA Capital Management
Advancing pipeline of bispecific and monoclonal antibodies with prophylactic potential to avoid life-threatening bleeds
Aim to rapidly target multiple rare bleeding indications
Copenhagen, Denmark and Boston, Mass., July 22, 2021
Hemab ApS (“Hemab”), a biotech company developing next generation therapeutics for serious underserved bleeding and thrombosis disorders, today announces the successful closing of a US$ 55M Series A financing. The investment was led by Novo Holdings, HealthCap and RA Capital Management.
Benny Sorensen, MD, PhD, who served on Hemab’s Board of Directors, has been appointed Chief Executive Officer and will be based in the US. Dr Sorensen brings a wealth of patient-centred R&D experience in many therapeutic areas including thrombosis and hemostasis. Until recently, Dr Sorensen served as Head of Clinical Development at Codiak BioSciences and has moved to be on its Scientific Advisory Board. Hemab’s co-founders Johan Henrik Faber, who held leadership positions within hemophilia drug research and development at Novo Nordisk, has been appointed Chief Technology Officer; Søren Bjørn, has been appointed Scientific Advisor; and Thomas Batchelor joins the Board of Directors.
Proceeds from the financing will be used to progress the Company’s promising pipeline of monoclonal and bispecific antibody-based therapeutics into later stages of development. The pipeline will initially focus on underserved people living with rare bleeding disorders such as Glanzmann’s Thrombasthenia (GT), with plans to expand into more common disorders of hemostasis and thrombosis. The financing will also enable Hemab to further build the team and expand its operational footprint in Denmark and the US.
Benny Sorensen, MD, PhD, Chief Executive Officer of Hemab, said:
“We are very pleased to welcome high profile international life sciences investors Novo Holdings, HealthCap and RA Capital Management. This financing will enable us to accelerate the development of innovative therapeutics for long underserved patients with serious bleeding and thrombosis disorders. Despite the innovations seen in treatments for hemophilia A and B in the last five decades, treatments for other rare bleeding disorders such as, for example GT, are still limited to blood transfusions and acute treatments. We owe these patients new treatment options and Hemab is uniquely positioned to leapfrog drug development of these medicines and bring treatment paradigms into the 21st century.”
Johan Henrik Faber, MSc, PhD, Co-founder and Chief Technology Officer of Hemab, said:
“As founders, we are thrilled to reach this important milestone. Benny is an extraordinary leader and an expert in clinical drug development in hemophilia, which is exactly what Hemab needs to secure clinical proof of concept for our lead candidate. Novo Holdings, HealthCap and RA Capital Management share our vision for the Company and we look forward to advance Hemab’s preclinical portfolio with this team.”
As a result of the financing, Mårten Steen, Partner at HealthCap and Laura Tadvalkar, Principal at RA Capital Management, will join Jørgen Søberg Petersen, Partner at Novo Holdings and Hemab’s Chairman, Camilla Petrycer Hansen, Principal at Novo Seeds, and Thomas Batchelor on the Board of Directors.
Jørgen Søberg Petersen, Chairman of Hemab and Partner at Novo Holdings, said:
“Novo Seeds is focused on creating and building world class companies that are developing innovative treatments for patients with unmet medical needs. We created Hemab just over six months ago and we are very pleased to announce this significant financing backed by top tier investors from the Nordics and the US. Hemab’s novel approach to effectively treat rare bleeding disorders lacking effective therapeutic options is unique and provides potential for a breakthrough therapy across several underserved hematological diseases. I am looking forward to continuing the successful collaboration with Benny, Johan and the Hemab team.”
Mårten Steen, Partner HealthCap, said:
“We are excited to invest in Hemab, a company that fits HealthCap’s strategy, addressing significant unmet medical needs with a strong platform and potential to generate many breakthrough therapeutics in the future.”
Laura Tadvalkar, Principal RA Capital Management, said:
“We believe Hemab’s innovative approach to addressing rare bleeding disorders has the potential to make an impactful difference for patients, and we are excited to support the Company through this financing as well as in expanding their operations in the US.“
For more information please contact:
Hemab
Benny Sorensen, CEO
Email: benny@hemab.com
About Hemab
Hemab is an emerging biotech company developing next generation therapeutics for serious, underserved bleeding and thrombosis disorders. The Company was founded by Johan Henrik Faber, Søren Bjørn, Hans Wandall, Thomas Batchelor and Mads Behrndt who secured the seed financing round with Novo Seeds, the early-stage investment and company creation team of Novo Holdings, which also invested in the Series A financing alongside HealthCap and RA Capital Management. Based in Denmark and the US, the Company is led by a team of drug developers and scientists with deep expertise in thrombosis and hemostasis. Hemab has exclusive licenses to state-of-the-art antibody technologies from both Novo Nordisk A/S and Genmab A/S. Hemab aims to progress its pipeline of monoclonal and bispecific antibody-based therapeutics with the vision to transform the treatment paradigm for blood disease patients – from orphan disorders to broad indications with high unmet need. Further information: www.hemab.com.
About Novo Holdings A/S
Novo Holdings A/S is a private limited liability company wholly owned by the Novo Nordisk Foundation. It is the holding company of the Novo Group, comprising Novo Nordisk A/S and Novozymes A/S, and is responsible for managing the Novo Nordisk Foundation’s assets.
Novo Holdings is recognized as a leading international life science investor, with a focus on creating long-term value. As a life science investor, Novo Holdings provides seed and venture capital to development-stage companies and takes significant ownership positions in growth and well- established companies. Novo Holdings also manages a broad portfolio of diversified financial assets. Further information: www.novoholdings.dk.
About HealthCap
HealthCap is one of the largest specialized providers of venture capital within life sciences in Europe. Since the start in 1996, HealthCap has backed and built more than 100 companies. HealthCap’s investment strategy focuses on diseases with high unmet medical needs and breakthrough therapies which have the potential to be transformative and improve the lives of patients suffering from these conditions. Please see: www.healthcap.eu and on Twitter: @HealthCapVC
About RA Capital Management
RA Capital Management is a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare and life science companies that are developing drugs, medical devices, and diagnostics. The flexibility of its strategy allows RA Capital to provide seed funding to startups and to lead private, IPO, and follow-on financings for its portfolio companies, allowing management teams to drive value creation from inception through commercialization. https://www.racap.com/
Funded through Novo Seeds’ company creation and building efforts
Focus on rare underserved bleeding disorders with large unmet need
Brings together a strong industrial R&D team with deep expertise in hemophilia and clinically validated technologies from Novo Nordisk and Genmab A/S
Copenhagen, Denmark and Boston, Mass., December 14, 2020
Novo Seeds, the early stage investment and company creation team of Novo Holdings, announced today that it has invested in a new portfolio company Hemab ApS (Hemab), which is focused on the development of bispecific antibodies for the treatment of rare bleeding disorders.
Hemab was co-founded by Johan Faber and Søren Bjørn, who until 2018, held leadership positions within hemophilia drug research and development at Novo Nordisk A/S. Hemab has secured an exclusive license to certain intellectual property to develop a product within hemophilia and other rare bleeding disorders from Novo Nordisk A/S and an exclusive license to Genmab A/S’s proven bispecific DuoBody® platform technology, which enables the company to further develop novel therapies for ultra rare bleeding disorders. Novo Seeds has worked closely with the founders to develop a commercially attractive business plan to maximise the potential of Hemab’s promising technology platform.
Johan Faber, Co-founder and Chief Executive Officer of Hemab, said:
“We are very pleased to have Novo Seeds on board as investor and partner to accelerate the development of our exciting new technology platform. We are passionate about developing novel therapies for people with severe bleeding disorders that are in high need for a prophylactic treatment option that is effective, safe and convenient. With the hands-on support of Novo Seeds we have a strong foundation to realize our ambitions for patients with rare bleeding disorders.”
Jørgen Søberg Petersen, Novo Seeds Partner, will join Henmab as Chairman and Camilla Petrycer Hansen, Novo Seeds Senior Associate, will also join the Board. In addition, Benny Sørensen, MD, PhD, will join the Board as an Independent Non-Executive Director and plans to leverage his impressive track record of preclinical and clinical development experience from the biotech and pharmaceutical industries in both Europe and the US. Dr. Sørensen currently serves as Senior Vice President, Head of Clinical Development at Codiak BioSciences.
Jørgen Søberg Petersen, Chairman of the Board and Partner at Novo Seeds, said:
“Our mission is to create and build world class companies that are developing innovative treatments for patients with unmet medical needs. In Hemab we bring together a strong R&D team with successful industry experience and deep expertise in bleeding disorders, with clinically validated technologies from Novo Nordisk A/S and Genmab A/S. Hemab’s unique approach offers breakthrough potential for the development of preventive treatments across several underserved hematological diseases where there are currently no effective preventive treatment options.”