Sobi to present new data at ISTH 2023

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Sobi® will present new scientific data at ISTH 2023, the 31st Congress of the International Society on Thrombosis and Haemostasis. This event, taking place from 24th to 28th June, will be held both online and in Montreal. ISTH provides an exceptional platform for the dissemination of cutting-edge advancements, fostering the exchange of scientific knowledge, and facilitating comprehensive discussions on clinical applications tailored to enhance patient care within the field of haematology. Nine abstracts have been accepted for presentation (8 posters and 1 oral). They show new evidence on efanesoctocog alfa and also confirm Sobi's commitment to advancing standards of care by further expanding the existing body of evidence for the extended half-life FVIII and FIX treatments, Elocta and Alprolix .

“We are very proud of the upcoming presentations of new data at the ISTH, especially the new data on haemophilia prophylaxis from the XTEND program with efanesoctocog alfa. We look forward to meeting with the community online and in Montreal,” said Tony Hoos, MD, PhD, Head of Research & Development and Chief Medical Officer. “The data presented further demonstrate Sobi’s unwavering commitment to advancing care for those affected by haemophilia around the world and underscore our dedication to enhancing understanding of the condition.”

Key Sobi data to be presented at ISTH 2023

Haemophilia

Elocta®/Eloctate® (efmoroctocog alfa) – Sobi

Final data from A-MOVE: 12-Month Prospective Multicentre Study to Investigate the Impact of Systematic Joint Examination on Treatment Management Decisions in Patients with Hemophilia A in France

Poster presentation number: PB0638

Session date and time: Monday June 26, 2023

6:30 PM - 7:30 PM EST

Elocta®/Eloctate® (efmoroctocog alfa) – Sobi

A-SURE: Intra-patient Comparison of Prophylactic Effectiveness of a Recombinant Factor VIII Fc Fusion Protein Versus Standard Half-life Factor VIII in Hemophilia A

 

Poster presentation number: PB0624

Session date and time: Monday June 26, 2023

6:30 PM - 7:30 PM EST

Elocta®/Eloctate® (efmoroctocog alfa) – Joint Sobi/Sanofi

Final Analysis of Long-term Clinical Outcomes of Prophylaxis With a Recombinant Factor FVIII Fc Fusion Protein in Adults Aged ≥50 Years With Severe Hemophilia A

 

Poster presentation number: PB0630

Session date and time: Monday June 26, 2023

6:30 PM - 7:30 PM EST

Elocta®/Eloctate®  – Joint Sobi/Sanofi

Prospective, Observational Study of the Clinical Characteristics of Adults and Adolescents With Severe Hemophilia A

 

Poster presentation number: PB1249

Session date and time: Tuesday June 27, 2023

6:30 PM - 7:30 PM EST

Alprolix® (eftrenonacog alfa) – Joint Sobi/Sanofi

Final Analysis of Long-term Clinical Outcomes of Recombinant Factor IX Fc Fusion Protein Prophylaxis in Adults Aged ≥50 Years With Severe Hemophilia B

 

Poster presentation number: PB0669

Session date and time: Monday June 26, 2023

6:30 PM - 7:30 PM EST

Efanesoctocog Alfa Oral Presentation – Joint Sobi/Sanofi

Outcomes in Adult and Adolescent Patients With Severe Hemophilia A in the Phase 3 XTEND-1 Study Who Switched to Efanesoctocog Alfa Prophylaxis From an Observational Study With Factor VIII Prophylaxis

 

Oral presentation number: OC 69.5

Session date and time: Wednesday June 28, 2023

10:15 AM - 11:30 AM EST

Efanesoctocog Alfa – Joint Sobi/Sanofi

Efanesoctocog Alfa Versus Extended Half-Life Factor VIII Therapies for Prophylaxis in Adolescents and Adults with Severe Hemophilia A: A Matching-Adjusted Indirect Comparison and Meta-Analysis

 

Poster presentation number: PB0201

Session date and time: Sunday June 25, 2023

6:30 PM - 7:30 PM EST

Efanesoctocog Alfa – Joint Sobi/Sanofi

Efanesoctocog alfa versus emicizumab in prophylactic treatment of adolescents and adults with severe hemophilia A without inhibitors: A matching-adjusted indirect comparison

 

Poster presentation number: PB0195

Session date and time: Sunday June 25, 2023

6:30 PM - 7:30 PM EST

Efanesoctocog Alfa – Joint Sobi/Sanofi

Prophylactic use of efanesoctocog alfa versus standard half-life therapies in adolescent and adult patients with hemophilia A without inhibitors: A matching-adjusted indirect comparison

 

Poster presentation number: PB0213

Session date and time: Sunday June 25, 2023

6:30 PM - 7:30 PM EST

All abstracts are accessible through the official ISTH website. However, any late-breaking abstracts will only be made available at a later time.

About Alprolix®

Alprolix® (eftrenonacog alfa) is a recombinant clotting factor therapy developed for haemophilia B using Fc fusion technology to prolong circulation in the body. It is engineered by fusing factor IX to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body), enabling Alprolix to use a naturally occurring pathway to extend the time the therapy remains in the body (half-life). Alprolix is manufactured using a human cell line in an environment free of animal and human additives. Alprolix is approved and marketed by Sobi for the treatment of haemophilia B in the EU, the UK, Iceland, Kuwait, Liechtenstein, Norway, Saudi Arabia and Switzerland. It is also approved in the United States, Canada, Japan, Australia, New Zealand and other countries where Sanofi has the marketing rights.

 

About Elocta®/Eloctate®

Elocta®/Eloctate® (efmoroctocog alfa) is a recombinant clotting factor therapy developed for haemophilia A using Fc fusion technology to prolong circulation in the body. It is engineered by fusing factor VIII to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body), enabling Elocta to use a naturally occurring pathway to extend the time the therapy remains in the body (half-life). Elocta is manufactured using a human cell line in an environment free of animal and human additives. Elocta is approved and marketed by Sobi for the treatment of haemophilia A in the EU, the UK, Iceland, Kuwait, Liechtenstein, Norway, Saudi Arabia and Switzerland. It is approved and marketed as Eloctate® (Antihemophilic Factor [Recombinant], Fc Fusion Protein) by Sanofi in the United States, Canada Japan, Australia, New Zealand and other countries, where Sanofi has the marketing rights.

 

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. It is not approved in any country outside the US.

 

About the Sanofi and Sobi collaboration
Sobi and Sanofi collaborate on the development and commercialization of Alprolix® and Elocta®/Eloctate®. The companies also collaborate on the development and commercialisation of efanesoctocog alfa or ALTUVIIIO™ in the US. 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 Sanofi®
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

 

Sobi® 
Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,600 employees across Europe, North America, the Middle East, Asia and Australia. 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.

 

 

Swedish Orphan Biovitrum AB (publ)
Postal address SE-112 76 Stockholm, Sweden
Phone: 46 8 697 20 00     www.sobi.com