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Hansa Medical Interim Report January–March 2018

25 Apr 2018, 08:01
Regulatory information
IdeS (INN: imlifidase) continues to demonstrate its unprecedented ability to enable transplantation for highly sensitized patients

January-March 2018 in brief

  • Søren Tulstrup appointed new President and CEO of Hansa Medical, effective March 20, 2018. He has broad and extensive experience as senior executive in the global biopharma industry. Hansa Medical’s acting CEO Ulf Wiinberg reverts to his former role as Chairman of Hansa Medical and Birgit Stattin Norinder reverts to her former role as board member.
  • Completed enrollment in Hansa Medical’s international multicenter Phase II study Highdes with lead candidate IdeS. The primary objective of the study – to turn a positive crossmatch test into a negative and thereby enable kidney transplantation – was accomplished in all 18 treated patients. All patients will be monitored for six months.
  • Intermediate clinical results from seven of the 18 patients in the Highdes study were published in an abstract ahead of the 138th Annual Meeting of the American Surgical Association (ASA) in Phoenix, Arizona, end of April, 2018. No serious adverse events were reported in the intermediate results and all seven patients had functioning kidneys at a median follow up of 171 days (5.5 months).
  • Finalized enrollment in US investigator-initiated Phase II study with IdeS in highly sensitized patients. IdeS effectively reduced levels of donor specific antibodies (DSAs) in all 17 treated patients and turned the crossmatch tests from positive to negative, thereby enabling transplantation for all patients. All patients will be followed for six months to monitor safety, kidney function and DSA levels.
  • The FDA granted orphan drug designation to IdeS for the treatment of Guillain-Barré syndrome. The FDA Orphan Drug Act (ODA) grants special status to a drug or biological product to treat a rare disease that affects fewer than 200,000 people in the US. Orphan drug designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits, protocol assistance and up to seven years of orphan drug exclusivity.
  • Clinical results from Hansa Medical’s first Phase II study ( Identifier: NCT02224820) IdeS were published by the American Journal of Transplantation (AJT), the monthly peer reviewed medical journal published by the American Society of Transplant Surgeons and the American Society of Transplantation. The publication describes the design and results from Hansa Medical’s initial clinical study in sensitized patients, during which the first transplantation through IdeS-based desensitization was performed. Stable kidney function has been maintained in this very first patient for more than three years.

Financial summary for the first quarter

KSEK, unless otherwise statedQ1 2018Q1 2017Year 2017
Net revenue5881,0583,442
Operating profit/loss-46,622-44,827-176,083
Net profit/loss-46,498-44,994-176,660
Earnings per share before and after dilution (SEK)-1.23-1.27-4.97
Shareholders’ equity591,805240,065630,661
Cash flow from operating activities-44,094-43,739-150,105
Cash and cash equivalents including short term investments575,049209,351616,061

CEO statement
I am excited and honored to join Hansa Medical. The company has created an exciting proprietary drug development platform based on IgG-modulating enzymes for transplant related indications and acute autoimmune diseases. The team at Hansa Medical has successfully designed and managed a series of clinical studies with its lead compound IdeS, demonstrating its ability to enable lifesaving kidney transplantation in highly sensitized patients, an indication area where there is significant unmet medical need. With a growing body of clinical evidence, opportunities to broaden the use of IdeS to a multitude of indications and next-generation drug candidates in development, Hansa is well positioned to become a fast growing biopharmaceutical company.

At the beginning of the year, enrollment was finalized in the two ongoing Phase II studies with IdeS in highly sensitized kidney transplant patients. A total of 18 patients were enrolled in the international multicenter study Highdes, and 17 patients were enrolled in the US investigator-initiated study at Cedars-Sinai Medical Center led by principal investigator, Professor Stanley Jordan. Treatment with IdeS enabled kidney transplantation for all 35 patients in the two studies by turning positive cross-match tests for donor specific antibodies into negative cross-match tests. The unique and novel mechanism of action of IdeS in depleting IgG antibodies enabled kidney transplantation for the patients in these two studies where previous attempts at desensitization had failed. We have managed to transplant patients that have been on dialysis for more than 20 years. All treated patients will be monitored for six months to collect follow-up data with respect to safety, kidney function and frequency of antibody mediated rejection (AMR). We expect to have the six-month follow up data from all 35 patients by end of third quarter this year.

Meanwhile, we are preparing for meetings with both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) to discuss a potential route towards filing of a BLA (Biologics License Application) in the US and/or filing of an MAA (Market Authorization Application) in Europe at end of 2018 or early 2019. In addition to the compelling data demonstrating the efficacy and safety of IdeS in enabling kidney transplantation, important items for these discussions will be the six-month follow-up data, validation of the IdeS manufacturing process, and the significant medical need for these highly sensitized patients who today have very limited chances, if any, to be transplanted.

In parallel with our progress in kidney transplantation, we are equally determined to pursue the therapeutic potential of IdeS in other indications. We believe that the fast onset and efficacy of IdeS has the potential to significantly contribute to the critical care in several transplant-related indications and acute autoimmune diseases.

A Phase II study is ongoing in anti-GBM antibody disease, a rare and acute autoimmune kidney disease, where approximately two thirds of patients lose their kidney function, resulting in the need of chronic dialysis. As of end of March, 2018, seven patients had been included in the investigator-initiated Phase II study in severe anti-GBM. Limited follow-up data is currently available from five of these seven patients who have all responded favorably. IdeS appears to be well tolerated. The study aims to enroll approximately 15 patients at clinics across Europe.

In February, the FDA granted orphan drug designation to IdeS for the treatment of Guillain-Barré syndrome (GBS), a rare acute autoimmune neurological disease. The ability of IdeS to fast and effectively cleave IgG antibodies has significant treatment potential in GBS, and we are planning a Phase II study with IdeS in this acute neurological disease.

Through my career, I have gained extensive experience in building organizations and teams in both Europe and the United States in various pharmaceutical companies, including fast growing bio- pharma companies – a scenario that I think Hansa Medical is also facing now since we are getting close to a potential launch. We will continue to strengthen our organization both in Europe and the US, naturally within R&D but we will also put a lot of emphasis on grow- ing our commercial and medical affairs infrastructure to provide further insight into currently published data from clinical studies with IdeS and prepare for a successful launch.

Hansa Medical has continued to make strong progress in delivering on its strategy and has successfully achieved several important clinical and regulatory milestones according to plan. The foundations are in place to achieve our vision of becoming a world-leading IgG-modulating company providing important, life-saving products to patients across a range of conditions where IgG plays a key role in disease progression or forms a barrier for patients to receive appropriate treatment. I look forward to updating you on our continued progress.

Søren Tulstrup
President and CEO of Hansa Medical

For further information, please contact:
Emanuel Björne, Vice President Business Development and Investor Relations, Hansa Medical AB (publ)
Mobile: +46707175477

About Hansa Medical AB
Hansa Medical is a biopharmaceutical company developing novel immunomodulatory enzymes for transplantation and acute autoimmune diseases. The lead product, IdeS, is a proprietary antibody-degrading enzyme currently in late-stage clinical development for kidney transplant patients, with significant potential for further development in other solid organ transplants and in acute autoimmune indications. The company also has a strong pipeline of preclinical projects that may provide a second wave of potential drugs. Under the project name NiceR, novel immunoglobulin cleaving enzymes are developed for repeat dosing with the objective of treating relapsing autoimmune diseases and potentially cancer. Hansa Medical is based in Lund, Sweden, and its shares are listed on Nasdaq Stockholm (ticker: HMED).