On April 21, 2022 Hansa Biopharma, the pioneer in immunomodulatory enzyme technology for rare IgG mediated diseases, reported its business update and interim report for January to March 2022 (Press release, Hansa Biopharma, APR 21, 2022, View Source;march-2022-301529853.html [SID1234612887]).

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Highlights for the first quarter 2022

Solid sales growth in the first quarter with SEK 24.2m in product sales; total revenue amounted to SEK 30.3m.
Commercial launch activities and market access efforts for Idefirix in Europe continued to progress as planned during Q1 2022 with market access secured in France through a reimbursed Early Access Program and in Germany through commercial access on negotiated terms. Additional market access procedures are ongoing in 11 countries, including Spain, Italy and the U.K.
Hansa and Medison Pharma announced that a marketing authorization in Israel for Idefirix has been granted for desensitization treatment of highly sensitized kidney transplant patients.
Key data from a Phase 2 program of imlifidase in anti-Glomerular Basement Membrane (anti-GBM) disease patients were published in the Journal of American Society of Nephrology (JASN). The publication recognizes the study’s significance in autoimmune diseases as it suggests that deactivation of autoantibodies could alter the course of an autoimmune disease.
In January, Hansa and AskBio entered into an agreement to evaluate the potential use of imlifidase as a pre-treatment prior to the administration of AskBio’s investigational gene therapy in Pompe disease in a preclinical and clinical feasibility program for patients with pre-existing neutralizing antibodies (NAbs). As part of the agreement, Hansa received a USD 5 million upfront payment, while AskBio has received an exclusive option to negotiate a full development and commercialization agreement.
The partnership with Sarepta investigating imlifidase in gene therapy and the preclinical collaboration with argenx exploring the potential for combination therapy with imlifidase moved forward according to plan.
Clinical pipeline update

U.S. ConfIdeS: 16 patients have been enrolled for randomization in our pivotal U.S. open-label, randomized, controlled trial "ConfIdeS" with the aim of completing enrollment by the end of this year, as previously guided.
AMR: In the Antibody Mediated Rejection (AMR) Phase 2 trial, 28 out of a target of 30 patients have been enrolled, and completion of enrollment is expected in the first half of 2022, as previously guided.
GBS: In the Guillain Barré Syndrome (GBS) Phase 2 trial, 16 patients out of a target of 30 patients have been enrolled. The COVID-19 pandemic has significantly impacted the enrollment rate in our GBS trial at the participating hospitals. To accelerate enrollment rate, we have implemented a number of initiatives to address the current situation and we expect these intiatives to support the completion of enrollment of GBS patients in H2 2022.
Events after the reporting period

Anti-GBM: On April 19, 2022, Hansa announced that the US FDA has accepted Hansa’sInvestigational New Drug (IND) application to proceed with a Phase 3 study of imlifidase in 50 patients across EU and the U.S. The first patient is expected to be enrolled in 2022, as previously guided.
Financial summary

SEKm, unless otherwise stated – unaudited

Søren Tulstrup, President and CEO of Hansa Biopharma, comments

"Hansa’s commercial launch activities and market access efforts for Idefirix in Europe continue to progress as planned. During the first quarter of 2022, we have seen additional key transplant centers becoming both clinically and commercially ready to use Idefirix and solid sales growth. Market access were secured in two of the five major European markets, namely in France on an early access basis and in Germany – two countries with more than 5,600 kidney transplants annually, of which approximately 75% are transplanted from a deceased donor.

We are very pleased to have reached these important agreements with both the German payer association, National Association of Statutory Health Insurance Funds (GKV-SV), and the early access granted by the French Haute Autorité de Santé (HAS). We expect to complete additional agreements in the course of the year as we have market access procedures ongoing in 11 countries, including Spain, Italy and the U.K. During 2021, market access was secured in Sweden and the Netherlands, as well as on an individual hospital basis in Finland and Greece.

Looking beyond our core markets, I am also pleased to see that our new collaboration with Medison Pharma is off to a good start with the recent marketing authorization obtained in Israel for Idefirix for the treatment of highly sensitized kidney transplant patients. Beyond Israel, our collaboration with Medison also covers Poland, Hungary, Croatia and Slovenia.

In the beginning of March, key data from the investigator-initiated open-label Phase 2 study of imlifidase in patients with anti-glomerular basement membrane (anti-GBM) disease were published in the leading nephrology publication Journal of the American Society of Nephrology (JASN). The publication recognizes the study’s significance in autoimmune diseases as it suggests that deactivation of autoantibodies could alter the course of an autoimmune disease, allowing restoration of kidney function. These results highlight the potential of imlifidase as we expand beyond kidney transplantation.

Speaking about anti-GBM, we are also pleased to share the positive news that the U.S. FDA recently accepted Hansa’s Investigational New Drug (IND) application to proceed with a pivotal Phase 3 study of imlifidase in approximately 50 patients across EU and the U.S. The first patient is expected to be enrolled later this year, as previously guided.

In the U.S., our pivotal ConfIdeS trial in kidney transplantation is progressing with 16 out of a target of 64 patients enrolled for randomization. The ConfIdeS study is evaluating imlifidase as a potential desensitization therapy to enable kidney transplants in highly sensitized patients waiting for a deceased donor kidney through the U.S. kidney allocation system. We have now initiated enrollment at nine sites and expect participation by up to 15 leading transplantation centers across the U.S., with the aim of completing enrollment by the end of this year.

Turning to our ongoing Phase 2 programs for GBS and AMR, we have enrolled 28 out of a target of 30 patients in the AMR study, while 16 out of a target of 30 patients have been enrolled in the GBS study.

With respect to our GBS program, we have seen how the impact of the COVID-19 pandemic and the emergence of the new variants have negatively affected the enrollment rate across a number of trial centers. To mitigate this situation we have recently implemented several significant initiatives to increase the enrollment rate and we expect these initiatives will support the completion of enrollment of GBS patients in the second half of 2022.

Last, we were pleased to announce at the beginning of January that Hansa and AskBio, a subsidiary of Bayer AG, have entered into a collaboration to evaluate imlifidase in a preclinical and clinical feasibility program as pre-treatment ahead of gene therapy in Pompe disease in patients with pre-existing neutralizing antibodies (NAbs). We see significant potential for our antibody-cleaving enzyme technology to help overcome this barrier in gene therapy as NAbs against adeno-associated virus remain a major challenge.

We have commenced another exciting year with several important milestones to be achieved across our platform and franchises, and I look forward to making further progress in the remainder of the year towards the vision that we are pursuing with single-minded focus: A world where patients with rare immunologic diseases can lead long and healthy lives."

Upcoming milestones and news flow

H1 2022 AMR Phase 2 study: Complete enrollment

2022 NiceR: Completion of GLP tox studies

2022 Anti-GBM: Initiation of phase 3 study

H2 2022 GBS Phase 2 study: Complete enrollment

H2 2022 Kidney transplantation US: Complete enrollment

H2 2022 AMR Phase 2 study: First data read out

H1 2023 GBS Phase 2 study: First data read out

2023 Long-term follow-up data 5-years out in kidney transplantation

H2 2023 Kidney transplantation US: complete 12 months follow-up

H1 2024 Kidney transplantation US: BLA submission

Conference call details

Hansa Biopharma will host a telephone conference today Thursday April 21 14:00 CET / 8:00am EST.

The presentation will be held in English and be hosted by Hansa Biopharma’s CEO, Søren Tulstrup, and CFO, Donato Spota. Slides used in the presentation will be live on the company website during the call under "Events & Presentation" and will also be made available online after the call.