Søren Tulstrup, President and CEO of
"2020 was a highly successful and transformative year for Hansa Biopharm - a year where we saw significant progress across all areas important to building a leading biopharmaceutical company: Pipeline development, medical and commercial operations and organizational development.
Most notably, we received conditional approval of Idefirix® by the
In July, we achieved a landmark milestone with the exclusive agreement with
There is ongoing strong interest from companies active in the gene therapy space in using our IgG-cleaving enzymes as a potential preconditioning therapy to enable gene therapy in patients that are not eligible today due to NAbs against AAV vectors. Our enzymes, used as a pre-treatment before the introduction of gene therapy, could potentially improve both the efficacy and safety of gene therapy and enable a larger group of patients to benefit from the very promising gene therapies now being investigated and becoming available. We see the gene therapy setting as an important value driver for
In 2020, we also announced positive high-level data from an investigator-initiated phase 2 trial with imlifidase in anti-GBM antibody disease, a serious, ultra-rare disease with no approved therapies on the market. We are very encouraged by the positive outcome, which demonstrated that two-thirds of the anti-GBM patients in the trial achieved dialysis independence six months after treatment. These positive results mark another important milestone for
The COVID-19 global pandemic materially impacted our pipeline activities during 2020, as patient recruitment in the GBS and AMR Phase 2 programs was temporarily halted for a large part of the year Enrollment was reinitiated in
In the
In addition to the multiple opportunities to develop imlifidase as a drug candidate for a variety of indications, we see significant potential for our next generation enzymes from the NiceR program that we are developing for repeat dosing. Drug candidates from this program have the potential to address high unmet medical needs within chronic autoimmune diseases, transplantation, repeat dosing gene therapy and oncology. Throughout the past year we have worked on completing a GMP process for our lead candidate and expect to commence IND-enabling toxicology studies during the first half of 2021. Once the toxicology studies are completed, we anticipate to move forward into human trials with this very promising program.
Again in 2020, we were able to productively expand the organization by attracting highly talented and experienced life science professionals across a range of functional areas. We are building a purpose driven, agile high-performance team, and we are very pleased to see our strong culture and work ethics reflected in the certification in 2020 of
We are also taking steps to sharpen our focus and commitment in advancing
We will build on the strong foundation laid through our accomplishments in 2020 and are well positioned to execute successfully on our key priorities and objectives for 2021, which are to:
- Ensure the successful launch of Idefirix® (imlifidase) in leading transplantation centres in select European markets
-
Initiate a randomized, controlled clinical study in the
U.S. to support a future filing of a Biologics License Application (BLA) for imlifidase in highly sensitized patients waiting for a kidney transplant in theU.S. - Continue to build on the strong momentum behind our efforts to advance our pipeline of drug candidates within autoimmune diseases and gene therapy
I look forward to updating you on our progress as we deliver on our mission to bring lifesaving and life altering therapies to patients with rare diseases who need them, while generate value to society at large."
This is information that
The information was submitted for publication at
For further information, please contact:
Mobile: +46 (0) 709-298 269
E-mail: klaus.sindahl@hansabiopharma.com
Head of Corporate Communications
Mobile: +46 (0) 768-198 326
E-mail: katja.margell@hansabiopharma.com
About
https://news.cision.com/hansa-biopharma-ab/r/hansa-biopharma-publishes-annual-report-2020,c3321341
https://mb.cision.com/Main/1219/3321341/1398421.pdf
(c) 2021 Cision. All rights reserved., source