STOCKHOLM, Nov. 20, 2023 /PRNewswire/ -- Sobi® will present
new data at the 65th Annual Meeting of the American Society of
Hematology (ASH) in San Diego from
the 9th to the 12th of December 2023. During the meeting several
analyses will be presented in patients with haemophilia A,
paroxysmal nocturnal hemoglobinuria (PNH), immune thrombocytopenia
(ITP), relapsed or refractory diffuse large b-cell lymphoma,
myelofibrosis, and haemophagocytic lymphohistiocytosis.
"We take pride in our expanded commitment to individuals
affected by rare diseases, which we are pleased to highlight at
this year's ASH meeting, with research that spans a range of rare
and debilitating conditions. We are continuing our strong legacy of
elevating standards of care for haemophilia A with two oral
presentations. Additionally, we mark our entry into the
myelofibrosis field with several poster presentations," said
Lydia Abad-Franch, MD, MBA, Head of
Research, Development, and Medical Affairs (RDMA), and Chief
Medical Officer at Sobi. "We look forward to collaborating and
connecting in person at this year's meeting."
Key data to be presented at ASH 2023
Haemophilia
A
|
Efanesoctocog
Alfa
|
Once-Weekly
Efanesoctocog Alfa Prophylaxis Provided High Sustained Factor VIII
Activity Levels, Independent of Blood Group, in Children <12
Years of Age with Severe Hemophilia A
|
Oral
presentation.
#506
Session: 322
Sunday, December 10,
2023, 12:00 PM - 1:30
PM
Presentation Time:
12:15 PM
|
Experiences with
Efanesoctocog Alfa: Exit Interviews with Caregivers of Previously
Treated Patients with Hemophilia A from the XTEND-Kids Phase 3
Clinical Trial
|
Oral
presentation.
#507
Session: 322
Sunday, December 10,
2023, 12:00 PM - 1:30
PM
Presentation Time: 12:30
PM
|
Experience with
Accelerometer Activity Tracking in Patients with Hemophilia A:
Results from the XTEND-1 Efanesoctocog Alfa Phase 3
Trial
|
Poster
presentation.
#2360
Session: 904
Saturday, December 9,
2023, 5:30 PM - 7:30
PM
|
Treatment of Bleeding
Episodes with Efanesoctocog Alfa in Children with Severe Hemophilia
A in the XTEND-Kids Phase 3 Study
|
Poster
presentation.
#3993
Session: 322
Monday, December 11,
2023, 6:00 PM - 8:00 PM
|
Haemophilia
A
|
|
Real-World Unmet Needs
in Patients with Hemophilia A Without Inhibitors in the US: Results
from the Picnic Health Database
|
Poster
presentation.
#2380
Session: 904
Saturday, December 9,
2023, 5:30 PM - 7:30
PM
|
Investigating the
Relationship between Endogenous Factor VIII Levels and Annual Bleed
Rates and Health-Related Quality of Life in Patients with
Hemophilia A Not Treated with Factor VIII Prophylaxis
|
Poster
presentation.
#5125
Session: 904
Monday, December 11,
2023, 6:00 PM - 8:00 PM
|
Paroxysmal Nocturnal
Hemoglobinuria
|
Empaveli®
(pegcetacoplan)
|
Efficacy and Safety Is
Maintained in Adult Patients with Paroxysmal Nocturnal
Hemoglobinuria Receiving Pegcetacoplan for up to 3 Years
|
Oral
presentation.
#574
Session: 508
Sunday, December 10, 2023,
4:30 PM - 6:00 PM
Presentation Time: 5:15
PM
|
Immune
Thrombocytopenia
|
Doptelet®
(avatrombopag)
|
Interim Baseline
Characteristics of Adult Patients with Immune Thrombocytopenia
Enrolled in the Observational Multicenter Phase 4 ADOPT Study to
Evaluate the Use and Effectiveness of Avatrombopag
|
Poster
presentation.
#1226
Session: 311
Saturday, December 9,
2023, 5:30 PM - 7:30
PM
|
Interim Analysis of
Platelet Response in a Prospective Phase 4 Study in Adult Immune
Thrombocytopenia (ITP) Subjects after Switching from Eltrombopag
(ELT) or Romiplostim (ROM) to Avatrombopag (AVA)
|
Poster
presentation. #2577
Session: 311, Sunday,
10 December 2023, 6:00 PM - 8:00 PM
|
Interim Analysis of
Treatment satisfaction from a Prospective Phase 4 Study in Adult
Immune Thrombocytopenia (ITP) Subjects after Switching from
Eltrombopag or Romiplostim to Avatrombopag
|
Poster
presentation.
#3954
Session: 311
Monday, 11 December
2023, 6:00 PM - 8:00 PM
|
Real-World Treatment
Patterns and Outcomes in Patients with Immune Thrombocytopenia
Treated with Avatrombopag in the United States: REAL-AVA 2.0 Study
Design
|
Poster
presentation.
#5127
Session: 904
Monday, December 11,
2023, 6:00 PM - 8:00 PM
|
Relapsed/Refractory
Diffuse Large B-Cell Lymphoma
|
Zynlonta®
(loncastuximab tesirine)
|
Early and Sustained
Circulating Tumor DNA Response Dynamics after Loncastuximab
Tesirine for Relapsed/Refractory Diffuse Large B-Cell
Lymphoma
|
Poster
presentation.
#3133
Session: 627
Sunday, December 10,
2023, 6:00 PM - 8:00
PM
|
Myelofibrosis
|
Vonjo®
(pacritinib)
|
Impact of Symptom
Benefit and Transfusion Response on Survival in Myelofibrosis
Patients Treated with Pacritinib: PERSIST-2 Landmark Survival
Analysis
|
Poster
presentation.
#3207
Session:
634
Sunday, December 10,
2023, 6:00 PM - 8:00 PM
|
Platelet Response in
Pacritinib-Treated Patients with Cytopenic Myelofibrosis: a
Retrospective Analysis of PERSIST-2 and PAC203 Studies
|
Poster
presentation.
#4554
Session: 634
Monday, 11 December
2023, 6:00 PM -8:00 PM
|
Retrospective Analysis
of the Relationship between Transfusion Independence and Bone
Marrow Fibrosis Reduction in Patients with Myelofibrosis Treated
with Pacritinib Versus Ruxolitinib
|
Poster
presentation.
#4566
Session: 634
Monday, 11 December
2023, 6:00 PM -8:00 PM
|
An Analysis of
Ruxolitinib Dosing for Myelofibrosis in Real-World
Practice
|
Poster
presentation.
#5186
Session: 906
Monday, December 11,
2023, 6:00 PM - 8:00 PM
|
Haemophagocytic
Lymphohistiocytosis
|
Gamifant®
(emapalumab)
|
Emapalumab, a Fully
Human Anti-Interferon Gamma Monoclonal Antibody, in Pediatric
Patients With Primary Hemophagocytic Lymphohistiocytosis: Long-Term
Follow-up of a Phase 2/3 Study
|
Poster
presentation.
#1174
Session: 203
Saturday, December 9,
2023, 5:30 PM - 7:30 PM
|
Real-World Treatment
Patterns and Outcomes Among Patients with Primary Hemophagocytic
Lymphohistiocytosis with and without Infection at Diagnosis and
Treated with Emapalumab: The REAL-HLH Study
|
Poster
presentation.
#2534
Session: 201
Sunday, December 10,
2023, 6:00 PM - 8:00
PM
|
Real-World Treatment
Patterns and Outcomes Among Patients with Secondary Hemophagocytic
Lymphohistiocytosis Treated with Emapalumab in the United States:
The REAL-HLH Study
|
Poster
presentation.
#3909
Session: 201
Monday, December 11,
2023, 6:00 PM - 8:00 PM
|
About efanesoctocog alfa
Efanesoctocog alfa [Antihemophilic Factor (Recombinant),
Fc-VWF-XTEN Fusion Protein] (formerly BIVV001) is a novel and
investigational recombinant factor VIII therapy with the potential
to deliver near-normal factor activity levels for a significant
parts of the week, improving bleed protection in a once-weekly dose
for people with haemophilia A. Efanesoctocog alfa builds on the
innovative Fc fusion technology by adding a region of von
Willebrand factor and XTEN® polypeptides to extend its time in
circulation. It is the only therapy that has been shown to break
through the von Willebrand factor ceiling, which imposes a
half-life limitation on current factor VIII therapies. It was
approved as ALTUVIIIO™ [Antihemophilic Factor (Recombinant),
Fc-VWF-XTEN Fusion Protein-ehtl] by Sanofi in the US in
February 2023.
About the Sobi and Sanofi collaboration
Sobi and Sanofi collaborate on the development and
commercialisation of Alprolix® and Elocta®/Eloctate®. The companies
also collaborate on the development and commercialisation of
efanesoctocog alfa, an investigational factor VIII therapy with the
potential to provide high sustained factor activity levels with
once-weekly dosing for people with haemophilia A. Sobi has final
development and commercialisation rights in the Sobi territory
(essentially Europe, North Africa, Russia and most Middle Eastern markets).
Sanofi has final development and commercialisation rights in
North America and all other
regions in the world excluding the Sobi territory.
About Aspaveli®/ Empaveli®
Aspaveli/Empaveli (pegcetacoplan) is a targeted C3 therapy
designed to regulate excessive activation of the complement
cascade, part of the body's immune system, which can lead to the
onset and progression of many serious diseases. Pegcetacoplan
is approved for the treatment of paroxysmal nocturnal
haemoglobinuria (PNH) as EMPAVELI®/ASPAVELI in the United States, European Union, and other
countries globally. Aspaveli/Empaveli is also under investigation
for several other rare diseases across haematology and
nephrology.
About the Sobi and Apellis collaboration
Sobi and Apellis have global co-development rights for systemic
pegcetacoplan. Sobi has exclusive ex-US commercialisation rights
for systemic pegcetacoplan, and Apellis has exclusive US
commercialisation rights for systemic pegcetacoplan and retains
worldwide commercial rights for ophthalmological pegcetacoplan,
including for geographic atrophy (GA).
About Doptelet®
Doptelet (avatrombopag) is an orally administered thrombopoietin
receptor agonist (TPO-RA) that mimics the biologic effects of TPO
in stimulating the development and maturation of megakaryocytes,
resulting in increased platelet count. It is approved in over 30
countries worldwide, including the EU and the US, for the treatment
of severe thrombocytopenia in adult patients with chronic liver
disease who are scheduled to undergo an invasive procedure, and for
the treatment of thrombocytopenia in adult patients with primary
chronic immune thrombocytopenia (ITP) who have had an insufficient
response to a previous treatment. Chronic ITP is a rare autoimmune
bleeding disorder characterised by low number of platelets. The
incidence of primary ITP in adults is 3.3/100,000 adults per year
with a prevalence of 9.5 per 100,000 adults1.
1. Lambert et al. Blood 2017.
About Zynlonta®
Zynlonta (loncastuximab tesirine) is a CD19-directed antibody
drug conjugate. Once bound to a CD19-expressing cell, Zynlonta is
internalised by the cell, where enzymes release a
pyrrolobenzodiazepine payload. The potent payload binds to DNA
minor groove with little distortion, remaining less visible to DNA
repair mechanisms. This ultimately results in cell cycle
arrest and tumour cell death. Zynlonta® is a registered trademark
of ADC Therapeutics SA. Zynlonta is currently approved for the
treatment of adult patients with relapsed or refractory diffuse
large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma
(HGBL), after two or more lines of systemic therapy, in
the United States, European Union
and Great Britain.
About ADC Therapeutics
ADC Therapeutics (NYSE: ADCT) is a commercial-stage
biotechnology company improving the lives of those affected by
cancer with its next-generation, targeted antibody drug conjugates
(ADCs). The Company is advancing its proprietary PBD-based ADC
technology to transform the treatment paradigm for patients with
hematologic malignancies and solid tumours.
ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San
Francisco Bay Area and New
Jersey. For more information, please visit
adctherapeutics.com and follow the Company on
Twitter and LinkedIn.
About Vonjo®
VONJO is approved for the treatment of adults with intermediate-
or high-risk primary or secondary (post-polycythemia vera or
post-essential thrombocythemia) myelofibrosis with a platelet count
below 50 × 109/L. This indication is approved under FDA accelerated
approval based on spleen volume reduction. Continued approval for
this indication may be contingent upon verification and description
of clinical benefit in a confirmatory trial(s). CTI is conducting
the Phase 3 PACIFICA study of VONJO in patients with myelofibrosis
and severe thrombocytopenia as a post-marketing requirement. For
more information, please visit
www.ctibiopharma.com.
About Gamifant®
Gamifant (emapalumab) is an anti-interferon gamma (IFNγ) monoclonal
antibody that binds to and neutralises IFNγ. In the USA, Gamifant is indicated for the treatment
of adult and paediatric (newborn and older) patients with primary
haemophagocytic lymphohistiocytosis (HLH) with refractory,
recurrent or progressive disease or intolerance with conventional
HLH therapy. Primary HLH is a rare syndrome of hyperinflammation
that usually occurs within the first year of life and can rapidly
become fatal unless diagnosed and treated. The FDA approval is
based on data from the phase 2/3 studies (NCT01818492 and
NCT02069899). Gamifant is indicated for administration through
intravenous infusion over one hour twice per week until
haematopoietic stem cell transplantation (HSCT).
Sobi®
Sobi is a specialised international biopharmaceutical company
transforming the lives of people with rare diseases. Providing
sustainable access to innovative medicines in the areas of
haematology, immunology and specialty care, Sobi has approximately
1,800 employees across Europe,
North America, the Middle East and Asia. In 2022, revenue amounted to
SEK 18.8 billion. Sobi's share
(STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi
at sobi.com, LinkedIn and YouTube.
Contacts
For details on how to contact the Sobi Investor Relations Team,
please click here. For Sobi Media contacts, click here.
The following files are available for download:
https://mb.cision.com/Main/14266/3878298/2438628.pdf
|
Sobi to present new
data at ASH 2023 Annual Meeting
|
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