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LUND, Sweden, July 2, 2020 /PRNewswire/ — Hansa Biopharma (“Hansa”), the chief in immunomodulatory enzyme expertise for uncommon IgG mediated illnesses, introduced right now that it has entered into an settlement with Sarepta Therapeutics Inc. (“Sarepta”), the chief in precision genetic drugs for uncommon illnesses, by way of which Sarepta is granted an unique, worldwide license to develop and promote imlifidase as a pre-treatment to allow Sarepta gene remedy therapy in Duchenne muscular dystrophy (DMD) and Limb-girdle muscular dystrophy (LGMD). The pre-treatment is meant for sufferers with pre-existing neutralizing antibodies (NAb-positive sufferers) to adeno-associated virus (AAV), the expertise that’s the foundation for Sarepta’s gene remedy merchandise.
Sarepta shall be chargeable for conducting pre-clinical and medical research with imlifidase and any subsequent regulatory approvals. Sarepta can even be accountable for the promotion of imlifidase as a pre-treatment to Sarepta’s gene therapies following potential approval.
Beneath the phrases of the settlement, Hansa will obtain a USD 10 million upfront cost, and is eligible for a complete of as much as USD 397.5 million in improvement, regulatory and gross sales milestone funds. Hansa will e-book all gross sales of imlifidase, and earn excessive single-digit to mid-teens royalties on Sarepta’s incremental gene remedy gross sales when treating NAb-positive sufferers enabled by way of pre-treatment with imlifidase.
Søren Tulstrup, President & CEO of Hansa Biopharma feedback,
“We see important potential for our enzyme expertise within the gene remedy house general, and we’re excited to associate with Sarepta, a number one participant within the area, to make use of the distinctive options of imlifidase to probably allow gene remedy therapy in sufferers who right now aren’t eligible for these breakthrough therapies as a result of pre-existing neutralizing antibodies in two situations with a really excessive unmet medical want.”
Doug Ingram, President & CEO, Sarepta Therapeutics mentioned,
“As we increase our management place in genetic drugs and construct out our gene remedy engine, one in every of Sarepta’s central ambitions is to search out scientific options that convey our probably life-saving therapies to the best variety of the uncommon illness sufferers we serve. One of many present limitations of gene remedy is the shortcoming to deal with sufferers who’ve pre-existing neutralizing antibodies to the AAV vector. Whereas our AAVrh74 vector has been related to a low display screen out fee for neutralizing antibodies, even that low fee is inconsistent with our mission.
In pre-clinical and medical fashions, Hansa’s expertise has proven the power to clear the IgG antibodies that stop dosing AAV-based gene therapies. If profitable, this might provide the potential of extending our gene remedy remedies to DMD and LGMD sufferers who would in any other case have been denied entry as a result of pre-existing antibodies.”
Hansa Biopharma shall be internet hosting a convention name with President & CEO Søren Tulstrup, CSO & COO Christian Kjellman and CFO Donato Spota.
Convention Name “Partnership settlement with Sarepta Therapeutics”
A convention name will happen July 2nd, 2020 at 10:00am CET. The audio solid shall be recorded and subsequently be out there on the Hansa web site https://hansa.eventcdn.net/202007
Individuals dial-in numbers
SE: + 46 81 241 09 52
UK: + 44 203 769 6819
US: + 1 646 787 0157
That is data that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation.
Imlifidase is a singular antibody-cleaving enzyme originating from Streptococcus pyogenes that particularly targets IgG and inhibits IgG-mediated immune response. It has a speedy onset of motion, cleaving IgG-antibodies and inhibiting their exercise inside hours after administration. CHMP/EMA has adopted a optimistic opinion, recommending conditional approval of imlifidase for the desensitization therapy of extremely sensitized grownup kidney transplant sufferers with a optimistic crossmatch in opposition to an out there deceased donor. Endorsement of the optimistic opinion by the European Fee is predicted within the third quarter of 2020.
Hansa has additionally reached an settlement with the FDA on a regulatory path ahead for imlifidase in kidney transplantation of extremely sensitized sufferers within the U.S. and has three ongoing part 2 trials in autoimmune illnesses and post-transplant indications.
About gene remedy and neutralizing antibodies
Gene remedy is a rising and revolutionizing therapy expertise by which wholesome gene sequences are inserted into cells of a affected person. The remedies are probably healing in monogenic illnesses like hemophilia and muscular dystrophy by way of a single dose. Innocent recombinant viruses are used to hold the wholesome genes into the cell. As a result of partial viral origin of the gene remedy constructs, a sure subset of sufferers carry neutralizing anti-AAV antibodies in the direction of gene remedy merchandise, relying on what AAV serotype getting used, forming a barrier for therapy eligibility. Antibodies stop efficient switch of wholesome gene sequence and generally is a security concern. Imlifidase as a pre-treatment might have the potential to eradicate neutralizing antibodies previous to gene remedy. Equally, imlifidase might have the potential to allow any probably needed re-dosing of gene remedy for all sufferers.
About Duchenne Muscular Dystrophy (DMD)
Duchenne muscular dystrophy is a uncommon genetic illness brought on by mutation within the DMD gene, encoding for the protein dystrophin. Duchenne is an irreversible, progressive illness that causes the muscle groups within the physique to turn into weak and broken over time. It’s finally deadly and there’s no remedy. DMD impacts one in 3,500 to five,00Zero males born worldwide (roughly 400-500 annual instances within the US) and causes muscle groups within the physique to turn into weak and most sufferers use wheelchair by the age of 12.
About Limb-Girdle Muscular Dystrophy (LGMD)
Limb-girdle muscular dystrophy or (LGMD) is a genetically and clinically heterogeneous group of uncommon muscular dystrophies. It’s characterised by progressive muscle losing which impacts predominantly hip and shoulder muscle groups. LGMD has an autosomal sample of inheritance and at the moment has no identified remedy or therapy. It may be brought on by a single gene defect that impacts particular proteins throughout the muscle cell, together with these chargeable for preserving the muscle membrane intact. LGMD has a world prevalence of roughly 1.63 per 100,00Zero people worldwide.
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