On July 19, 2022 Hansa Biopharma, the pioneer in immunomodulatory enzyme technology for rare IgG mediated diseases, reported its business update and interim report for January to June 2022 (Press release, Hansa Biopharma, JUL 19, 2022, View Source [SID1234616782]).
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Highlights for the second quarter 2022
Continued solid sales in the second quarter with SEK 19.5m in product sales; total revenue amounted to SEK 26.4m.
On June 16, 2022, the National Institute for Health and Care Excellence (NICE) recommended Idefirix for desensitization of highly sensitized adult patients prior to kidney transplant from a deceased donor. NICE considers Idefirix to be a clinically and cost-effective treatment Market access has now been secured in 7 European countries and procedures are ongoing in 11 countries, including Spain and Italy.
On May 13, 2022, Hansa announced that the Swiss Agency for Therapeutic Products (Swissmedic) granted temporary marketing authorization for Idefirix in adult patients with a positive crossmatch against an available organ from a diseased donor.
On April 20, 2022, Idefirix was granted ASMR 3 rating by the Transparency Commission (TC) of the French National Authority for Health (HAS) following the reimbursed AP2 early access program in France, which potentially can enable a faster commercial access process. In addition to ASMR 3 status, Idefirix also received designation as SMR Important (Service Médical Rendu), reflecting the actual medical benefit.
Annual General Meeting held on June 30, 2022, where all resolutions proposed by the board of directors were approved by shareholders, including the appointment of Peter Nicklin as the new Chairman of the Board of Directors. Peter Nicklin is currently chairman of the boards of Versantis AG (CH), Sciensus Ltd (U.K.), and Tunstall Group Ltd (U.K.). Peter Nicklin was recently the CEO at Amann Girrbach. He has also held senior executive positions at Baxter, Bayer Healthcare, Novartis and Bristol Myers Squibb, amongst others.
Clinical pipeline update
U.S. ConfIdeS: 22 patients have been enrolled for randomization in our pivotal U.S. open label, randomized, controlled trial of imlifidase in kidney transplant with the aim of completing enrollment by the end of this year, as previously guided.
AMR: On-time completion of enrollment in the Antibody Mediated Rejection (AMR) Phase 2 trial; A first data read out is expected in the second half of 2022, as previously guided.
GBS: In the Guillain Barré Syndrome (GBS) Phase 2 trial, 18 out of a target of 30 patients have been enrolled. Hansa expects to complete enrollment of GBS patients in the second half of 2022 based on several initiatives taken to support enrollment including measures such as simplifying the protocol and increasing capacity.
Anti-GBM: Preparations to commence Phase 3 study later this year as previously guided are on track.
Events after the closing period
On July 11, 2022, the first patient was treated in Hansa’s post approval efficacy study (PAES). The PAES is an obligation under the European conditional marketing authorization and will be used to further investigate the long-term graft survival in 50 highly sensitized kidney transplant patients treated with Idefirix.
On July 18, 2022 Hansa concluded a USD 70 million non-dilutive financing transaction with NovaQuest Capital Management to support the continued development of the Company’s antibody-cleaving enzyme technology platform across multiple therapeutic areas while extending the expected cash runway through 2024.
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 second quarter of 2022, we have seen continued solid sales and achievement of the important milestone of becoming the first and only product recommended by NICE for the desensitization of highly sensitized patients waiting for a kidney transplant from a deceased donor in England, Wales and Northern Ireland. Additionally, NICE also highlighted Idefirix as a clinically and cost-effective treatment, which is rare for orphan drugs. This recommendation is an important step forward for Hansa’s commercialization efforts and for patients in England, Wales and Northern Ireland, who have been struggling to find a donor match and in most cases had no other alternative but to remain on long-term dialysis.
Beyond the U.K., we are also pleased that Idefirix was granted ASMR 3 rating by the Transparency Commission (TC) of the French National Authority for Health (HAS). Less than 6% of all new medicines are granted ASMR 3, and so the achievement of this status is a testament to the importance and medical benefit of Idefirix as a new transformative therapy. Moreover, we are also pleased that the Swiss Agency for Therapeutic Products (Swissmedic) granted temporary marketing authorization in Switzerland for Idefirix in kidney transplantation in addition to the already received marketing authorizations in the EU, the U.K. and Israel.
Turning to our clinical development programs, at the end of May we announced the completion of enrollment in our imlifidase Phase 2 study in antibody mediated rejection (AMR) episodes post kidney transplantation. 30 patients with active or chronic active AMR episodes post kidney transplantation have been enrolled across 14 centers in France, Germany, Austria, Australia, and the U.S. Acute AMR episodes post kidney transplantation occur in 5-7% of patients, with significant risk of patients losing graft function. There is no approved treatment for AMR. The on-time completion of enrollment marks an important milestone for Hansa as we explore the potential of imlifidase in the post transplantation setting. First data read out is expected in the second half of 2022, as previously guided.
In the U.S., our pivotal ConfIdeS trial in kidney transplantation is progressing with 22 out of a target of 64 patients now 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 ten 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.
In anti-GBM, we expect to commence a pivotal Phase 3 study of imlifidase following FDA’s acceptance of Hansa’s Investigational New Drug (IND) application earlier this year. The new study is expected to enroll approximately 50 patients across the EU and U.S, with the first patient expected to be enrolled later this year, as previously guided.
With respect to our GBS Phase 2 program, which has been impacted by the pandemic, we have recently implemented several significant initiatives to increase the enrollment rate. As of July 19, 2022, 18 out of a target of 30 patients were enrolled and we expect to see a further acceleration in recruitment of patients during the second half of the year, which will help to complete enrollment towards the end of 2022, as previously guided.
Lastly, I am also pleased to see the appointment of Peter Nicklin as new Chairman of the Board of Directors. Peter Nicklin brings significant global experience from both non-executive and senior executive roles within the life-science industry at companies such as Baxter, Bayer Healthcare, Novartis and Bristol-Myers Squibb. Peter Nicklin is currently chairman of the boards of Versantis AG (CH), Sciensus Ltd (U.K.), and Tunstall Group Ltd (U.K.). Whilst having spent significant time living and working across the globe, Peter now lives in Europe.
I look forward to keeping you updated on our continued progress with several upcoming and important milestones to be achieved across our platform and franchises as we continue the development of new, transformative medicines for patients suffering from serious, rare immunologic diseases."
Conference call details
Hansa Biopharma will host a telephone conference today Tuesday July 19, 2022, 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.