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Hansa Biopharma Announces Selection of NiceR Lead Candidate

21 Mar 2019, 08:00
Regulatory information
Next Generation Enzyme Technology Platform Offers Potential for Repeat Dosing

Lund, Sweden, March 21, 2019– Hansa Biopharma AB (NASDAQ Stockholm: HNSA), the leader in immunomodulatory enzyme technology for rare IgG-mediated diseases, announced today that the company has selected a lead candidate for clinical development from its NiceR program (Novel IgG Cleaving Enzymes for Repeat dosing).

“Hansa’s enzyme technology platform has applications in many IgG-mediated conditions, and now with a lead candidate from the NiceR program, we believe our new drug candidate will have even broader value as a potential treatment for unmet needs that require repeat dosing, including relapsing autoimmune diseases, chronic transplant rejection, oncology and repeat dosing of gene therapy,” said Søren Tulstrup, Chief Executive Officer of Hansa Biopharma.

Within Hansa’s NiceR program, novel IgG degrading enzymes are developed by structural refinement of imlifidase and similar molecules, taking advantage of the experience from clinical development of imlifidase. The aim of the development is to create novel IgG inactivating drugs that can be used for repeat dosing in medical conditions where patients benefit from more than one dose of an IgG-modulating enzyme, including relapsing autoimmune diseases, chronic transplant rejection, oncology and repeat dosing of gene therapy.

A broad repertoire of novel immunoglobulin cysteine endopeptidases has been developed and patented within the program. This is the first IgG eliminating enzyme from the NiceR program that Hansa intends to advance into clinical development. Development of a GMP-manufacturing process for the lead NiceR candidate has been initiated and preparations for toxicology studies and a clinical Phase 1 study are now ongoing.

“The selected molecule is an IgG-degrading enzyme based on the amino acid sequence of a homolog to imlifidase. We selected the molecule from our NiceR research program, which is focused on  engineering completely novel IgG cleaving enzymes with altered characteristics, such as lowered immunogenicity. The NiceR lead candidate is a molecule that we have developed to enable repeat dosing in several indications with significant unmet medical need,” said Christian Kjellman, Ph.D., Chief Scientific Officer at Hansa Biopharma. 

This is information that Hansa Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below at 08:00am CET on March 21, 2019.

About Hansa Biopharma

Hansa Biopharma AB (NASDAQ Stockholm: HNSA) is harnessing its proprietary immunomodulatory enzyme technology platform to develop treatments for rare immunoglobulin G (IgG)-mediated autoimmune conditions, transplant rejection and cancer. The Company’s lead product, IDEFIRIX (imlifidase), is a unique antibody-degrading enzyme in late-stage clinical development to enable kidney transplantation in highly sensitized patients, with additional clinical studies in acute autoimmune indications. Hansa’s research and development program is advancing the next generation of the Company’s technology to develop novel IgG-cleaving enzymes with lower immunogenicity, suitable for repeat dosing in relapsing autoimmune diseases and oncology. Hansa Biopharma is based in Lund, Sweden.

For further information, please contact:

Emanuel Björne, Vice President Business Development and Investor Relations
Hansa Biopharma AB (Publ) Mobile: +46 70 717 5477

Swedish Investor and Media Relations:

Cord Communications Mikael Widell
+46 70-311 99 60

U.K. Investor and Media Relations:

FTI Consulting
Simon Conway / Natalie Garland-Collins
+44 (0)20 3727 1000

U.S. Investor and Media Relations:

Argot Partners
Stephanie Marks / David Rosen (media)
+1 212 600 1902