Lund, Sweden January 3, 2022. Hansa Biopharma AB, “Hansa”, (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announced that it has entered into an agreement with Asklepios BioPharmaceutical, Inc. (“AskBio”), a fully integrated AAV gene therapy company and a fully owned subsidiary of Bayer AG dedicated to developing medicines that improve the quality of life for patients with genetic diseases.

The collaboration will evaluate the potential use of imlifidase as a pre-treatment prior to the administration of AskBio’s gene therapy in Pompe disease in a pre-clinical and clinical feasibility program for patients with pre-existing neutralizing antibodies (NAbs) to adeno-associated virus (AAV).

Pompe disease is a rare genetic and often fatal metabolic disorder that occurs in 1 in every 40,000 births. The disease is caused by the deficiency of an enzyme called acid alpha-glucosidase (GAA) and results in the accumulation of glycogen in organs and tissues, especially muscles, which impairs their ability to function normally.

Under the terms of the agreement, Hansa will receive a USD 5 million payment upon execution of the agreement and  AskBio will have an exclusive option to enter into a full development and commercialization agreement following evaluation of the results from an initial Phase I/II study. AskBio will be responsible for conducting the pre-clinical and clinical studies with imlifidase under the feasibility program and Hansa will supply its materials and additional support set forth in the feasibility program.

“Neutralizing antibodies against AAV vectors used in a broad range of investigational gene therapies remain a major challenge and we see significant potential for our antibody-cleaving enzyme technology to help overcome this barrier. This collaboration with AskBio marks another important step in the implementation of our partnership strategy in the gene therapy space,” said Søren Tulstrup, President & CEO of Hansa Biopharma.

This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact persons set out below, at 18:35 CET on January 3 2022.

About Hansa Biopharma

Hansa Biopharma is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life altering treatments for patients with rare immunological conditions. Hansa has developed a first-in-class immunoglobulin G (IgG) antibody cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients. Hansa has a rich and expanding research and development program, based on the Company’s proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in transplantation, autoimmune diseases, gene therapy and cancer. Hansa Biopharma is based in Lund, Sweden and has operations in Europe and the U.S. The Company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at https://hansabiopharma.com.

About AskBio

Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG acquired in 2020, is a fully integrated AAV gene therapy company dedicated to developing medicines that improve the quality of life for patients with genetic diseases. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular and metabolic disease indications with a clinical-stage pipeline that includes therapeutics for Pompe disease, Parkinson’s disease and congestive heart failure, as well as out-licensed clinical indications for hemophilia and Duchenne muscular dystrophy. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, U.K., the company has generated hundreds of proprietary third-generation AAV capsids and promoters, several of which have entered clinical testing. Founded in 2001 and an early innovator in the gene therapy field, the company holds more than 800 patents in areas such as AAV production and chimeric and self-complementary capsids.

About Pompe disease

Pompe disease is a rare genetic, often fatal, disorder affecting 1 in 40,000 births in the United States. It is caused by a defect in a gene making an enzyme called acid alpha-glucosidase (GAA). GAA is used to break down glycogen (a sugar used to store energy in cells) and a defect GAA enzyme leads to accomulation of glycogen in the body's cells. The glycogen accumulation in certain organs and tissues, especially muscles, liver and heart, result in severe impact on the normal organ function. Up to 300 different mutations resulting in Pompe disease are identified and the severity and age of onset is related to the specific mutations. The most severe forms (early onset or infantile form) result in for example enlarged heart, muscle weakness, respiratory difficulties and most patients with the infantile form dies from cardiac or respiratory failure before their first birthday. The late onset or juvenile/adult form initially shows muscle weakness progressing to respiratory weakness and death from respiratory failure after several years. While enzyme replacement therapy (ERT) has shown promise in patients with infantile-onset Pompe disease, no curative therapy is available.

About imlifidase

Imlifidase is a unique antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets IgG and inhibits IgG-mediated immune response. It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration. Imlifidase has conditional marketing approval in Europe and is marketed under the trade name Idefirix^® for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.