Hansa Biopharma AB and Asklepios BioPharmaceutical, Inc. are collaborating to evaluate the potential of imlifidase as a pretreatment before the administration of gene therapy in Pompe disease, according to a press release by Hansa Biopharma.

Imlifidase is an antibody-cleaving enzyme from the bacteria Streptococcus pyogenes, which targets immunoglobulin G (IgG) and inhibits IgG-mediated immune response.

Imlifidase will be evaluated in a preclinical and clinical feasibility program for patients with Pompe disease who have pre-existing neutralizing antibodies against the adeno-associated virus (AAV), which is the vector used to deliver gene therapy to the body.

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“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,” Søren Tulstrup, president and chief executive officer of Hansa Biopharma said.

“This collaboration with AskBio marks another important step in the implementation of our partnership strategy in the gene therapy space.”

Read more about Pompe disease etiology

The company will receive $5 million upon the execution of the agreement and AskBio will have the option to enter into a development and commercialization agreement after the results of an initial phase 1/2 clinical trial are evaluated, according to the release.

Pompe disease is caused by a mutation in the gene encoding acid alpha-glucosidase (GAA), which is essential for the breakdown of glycogen. If the GAA enzyme does not function properly, glucogen accumulates inside cells causing damage.

Currently, the only available disease-modifying treatment for Pompe disease is enzyme replacement therapy. But this approach has many drawbacks including the development of neutralizing humoral immune responses against the therapy reducing its effectiveness.

Research continues to develop new treatments for the disease including gene therapy, which involves incorporating a functional copy of the gene encoding the GAA enzyme inside affected tissues using an AAV.


Hansa Biopharma enters into agreement with AskBio to evaluate feasibility of imlifidase as pre-treatment ahead of gene therapy in Pompe disease. News release. Hansa Biopharma; January 3, 2022.