RICS:HNSA.ST

Hansa Biopharma announces encouraging high-level results for first-in-human trial of HNSA-5487

Retrieved on: 
Monday, October 9, 2023
Pharmacokinetics, Male, Enzyme, Antibody, Female, Hansa, Immunoglobulin G, Safety, Transplant, Flare, Repeat, Fragment antigen-binding, PD, Neutron, Patient, Pharmaceutical industry

LUND, Sweden, Oct. 9, 2023 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announced high-level results from NICE-01, the first-in-human trial for HNSA-5487. Results showed the molecule was safe and well tolerated. Fast and complete depletion of immunoglobulin G (IgG) antibodies was observed at increasing doses in all subjects. Pharmacokinetics (PK) was in line with expectations and pharmacodynamics (PD) (efficacy on IgG cleavage) showed a fast and complete cleavage of IgG to F(ab')2- and Fc-fragments with increasing doses.

Key Points: 
  • LUND, Sweden, Oct. 9, 2023 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announced high-level results from NICE-01, the first-in-human trial for HNSA-5487.
  • Fast and complete depletion of immunoglobulin G (IgG) antibodies was observed at increasing doses in all subjects.
  • Søren Tulstrup, President and CEO, Hansa Biopharma said, "This is encouraging data as we continue to explore the potential for HNSA-5487 and better understand how this powerful, new enzyme could benefit patients and clinicians.
  • This analysis will serve as key input in determining the further clinical development program, including selection of indications.

Hansa Biopharma announces encouraging high-level results for first-in-human trial of HNSA-5487

Retrieved on: 
Monday, October 9, 2023
Pharmacokinetics, Male, Enzyme, Antibody, Female, Hansa, Immunoglobulin G, Safety, Transplant, Flare, Repeat, Fragment antigen-binding, PD, Neutron, Patient, Pharmaceutical industry

LUND, Sweden, Oct. 9, 2023 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announced high-level results from NICE-01, the first-in-human trial for HNSA-5487. Results showed the molecule was safe and well tolerated. Fast and complete depletion of immunoglobulin G (IgG) antibodies was observed at increasing doses in all subjects. Pharmacokinetics (PK) was in line with expectations and pharmacodynamics (PD) (efficacy on IgG cleavage) showed a fast and complete cleavage of IgG to F(ab')2- and Fc-fragments with increasing doses.

Key Points: 
  • LUND, Sweden, Oct. 9, 2023 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announced high-level results from NICE-01, the first-in-human trial for HNSA-5487.
  • Fast and complete depletion of immunoglobulin G (IgG) antibodies was observed at increasing doses in all subjects.
  • Søren Tulstrup, President and CEO, Hansa Biopharma said, "This is encouraging data as we continue to explore the potential for HNSA-5487 and better understand how this powerful, new enzyme could benefit patients and clinicians.
  • This analysis will serve as key input in determining the further clinical development program, including selection of indications.

Dr. Hitto Kaufmann appointed Chief Scientific Officer of Hansa Biopharma

Retrieved on: 
Friday, September 1, 2023
Swiss Federal Institute of Technology, Swiss, Braunschweig, Scripps Research, Therapy, Biopharmaceutical, Ibete, Anticalin, CSO, Institute of technology, Biotechnology, Hansa, United States Air Force Scientific Advisory Board, Research, Science, Boehringer Ingelheim, Natural science, Executive Committee, Immunoglobulin G, Walter, Biology, Ghassan Hitto, Research fellow, Industrial Affairs Committee (Iceland), Technical University of Braunschweig, Swiss Federal Institute of Aquatic Science and Technology, Fine chemical, Sanofi

LUND, Sweden, Sept. 1, 2023 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, announced today that Dr. Hitto Kaufmann has been appointed as Hansa's Chief Scientific Officer (CSO) effective 1 December 2023.

Key Points: 
  • LUND, Sweden, Sept. 1, 2023 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, announced today that Dr. Hitto Kaufmann has been appointed as Hansa's Chief Scientific Officer (CSO) effective 1 December 2023.
  • Dr. Kaufmann joins Hansa from Pieris Pharmaceuticals where he has served as Chief Scientific Officer since 2019.
  • Søren Tulstrup, President and CEO, Hansa Biopharma said, "We are thrilled to welcome Hitto to Hansa at this pivotal time.
  • Dr. Hitto Kaufmann has served as Chief Scientific Officer at Pieris Pharmaceuticals since 2019.

Dr. Hitto Kaufmann appointed Chief Scientific Officer of Hansa Biopharma

Retrieved on: 
Friday, September 1, 2023
Swiss Federal Institute of Technology, Swiss, Braunschweig, Scripps Research, Therapy, Biopharmaceutical, Ibete, Anticalin, CSO, Institute of technology, Biotechnology, Hansa, United States Air Force Scientific Advisory Board, Research, Science, Boehringer Ingelheim, Natural science, Executive Committee, Immunoglobulin G, Walter, Biology, Ghassan Hitto, Research fellow, Industrial Affairs Committee (Iceland), Technical University of Braunschweig, Swiss Federal Institute of Aquatic Science and Technology, Fine chemical, Sanofi

LUND, Sweden, Sept. 1, 2023 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, announced today that Dr. Hitto Kaufmann has been appointed as Hansa's Chief Scientific Officer (CSO) effective 1 December 2023.

Key Points: 
  • LUND, Sweden, Sept. 1, 2023 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, announced today that Dr. Hitto Kaufmann has been appointed as Hansa's Chief Scientific Officer (CSO) effective 1 December 2023.
  • Dr. Kaufmann joins Hansa from Pieris Pharmaceuticals where he has served as Chief Scientific Officer since 2019.
  • Søren Tulstrup, President and CEO, Hansa Biopharma said, "We are thrilled to welcome Hitto to Hansa at this pivotal time.
  • Dr. Hitto Kaufmann has served as Chief Scientific Officer at Pieris Pharmaceuticals since 2019.

Idefirix (imlifidase) receives provisional approval in Australia as desensitization treatment in highly sensitized patients prior to kidney transplantation

Retrieved on: 
Tuesday, July 11, 2023
Panel-reactive antibody, EU, University, Person, EMA, Patient, Kidney transplantation, Kidney, TGA, Transplant, University of Sydney, Safety, Pharmaceutical industry, Dentistry

LUND, Sweden, July 11, 2023 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announced that the Australian Therapeutic Goods Administration ("TGA") has provisionally approved Idefirix (imlifidase) as desensitization treatment for highly sensitized patients prior to kidney transplantation from both living and deceased donors. The provisional approval has a duration of two years and was based on data from Hansa's phase 2 studies1-4 that included highly sensitized patients who received a kidney from either a living (17%) or deceased donor (83%) following desensitization treatment with imlifidase. 

Key Points: 
  • The provisional approval has a duration of two years and was based on data from Hansa's phase 2 studies1-4 that included highly sensitized patients who received a kidney from either a living (17%) or deceased donor (83%) following desensitization treatment with imlifidase.
  • Søren Tulstrup, President and CEO, Hansa Biopharma said, "With nearly 28 percent5 of kidney transplant candidates in Australia considered highly sensitized, the approval of Idefirix represents an important innovation in kidney transplantation care for patients and clinicians.
  • There is a high unmet need for very highly sensitized kidney transplant candidates in Australia.
  • University of Sydney Clinical Professor Kate Wyburn said, "Innovation in kidney transplantation has been quite limited for highly sensitised patients.

Idefirix (imlifidase) receives provisional approval in Australia as desensitization treatment in highly sensitized patients prior to kidney transplantation

Retrieved on: 
Tuesday, July 11, 2023
Panel-reactive antibody, EU, University, Person, EMA, Patient, Kidney transplantation, Kidney, TGA, Transplant, University of Sydney, Safety, Pharmaceutical industry, Dentistry

LUND, Sweden, July 11, 2023 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announced that the Australian Therapeutic Goods Administration ("TGA") has provisionally approved Idefirix (imlifidase) as desensitization treatment for highly sensitized patients prior to kidney transplantation from both living and deceased donors. The provisional approval has a duration of two years and was based on data from Hansa's phase 2 studies1-4 that included highly sensitized patients who received a kidney from either a living (17%) or deceased donor (83%) following desensitization treatment with imlifidase. 

Key Points: 
  • The provisional approval has a duration of two years and was based on data from Hansa's phase 2 studies1-4 that included highly sensitized patients who received a kidney from either a living (17%) or deceased donor (83%) following desensitization treatment with imlifidase.
  • Søren Tulstrup, President and CEO, Hansa Biopharma said, "With nearly 28 percent5 of kidney transplant candidates in Australia considered highly sensitized, the approval of Idefirix represents an important innovation in kidney transplantation care for patients and clinicians.
  • There is a high unmet need for very highly sensitized kidney transplant candidates in Australia.
  • University of Sydney Clinical Professor Kate Wyburn said, "Innovation in kidney transplantation has been quite limited for highly sensitised patients.

Hansa Biopharma to host conference call to provide half year results for January-June 2023 and a Business Update

Retrieved on: 
Thursday, July 6, 2023
CFO, Conference, CCO, Arms industry

LUND, Sweden, July 6, 2023 /PRNewswire/ -- Hansa Biopharma AB (Nasdaq Stockholm: HNSA) will publish its interim report for January-June 2023 at 8:00 CET on July 20, 2023.

Key Points: 
  • LUND, Sweden, July 6, 2023 /PRNewswire/ -- Hansa Biopharma AB (Nasdaq Stockholm: HNSA) will publish its interim report for January-June 2023 at 8:00 CET on July 20, 2023.
  • All interested parties are invited to participate in a telephone conference, which will include a presentation of the interim results and a business update, on the same date at 14:00 CET/8:00am EST.
  • The event will be hosted by Hansa Biopharma's CEO, Søren Tulstrup, CCO and US President, Matthew Shaulis and CFO, Donato Spota.
  • Link to presentation
    To participate in the telephone conference, please use the dial-in details provided below:
    Aug 23, 2023            Carnegie non-deal road show, Stockholm
    Aug 24, 2023            Erik Penser Company Day, Stockholm
    Sept 6-7, 2023          CITI Annual BioPharma Conference, Boston
    Sept 11, 2023 HC Wainwright Annual Global Investment Conference, NYC
    Sept 11-12, 2023      MorganStanley Global Healthcare Conference, NYC
    Sept 14, 2023           Pareto Annual Healthcare Conference, Stockholm
    Sept 14, 2023           Erik Penser Company Day, Malmö
    Nov 21, 2023            SEB Healthcare Seminar 2023, Stockholm
    Nov 22, 2023           Ökonomisk Ugebrev Life Science Event, Copenhagen

Hansa Biopharma to host conference call to provide half year results for January-June 2023 and a Business Update

Retrieved on: 
Thursday, July 6, 2023
CFO, Conference, CCO, Arms industry

LUND, Sweden, July 6, 2023 /PRNewswire/ -- Hansa Biopharma AB (Nasdaq Stockholm: HNSA) will publish its interim report for January-June 2023 at 8:00 CET on July 20, 2023.

Key Points: 
  • LUND, Sweden, July 6, 2023 /PRNewswire/ -- Hansa Biopharma AB (Nasdaq Stockholm: HNSA) will publish its interim report for January-June 2023 at 8:00 CET on July 20, 2023.
  • All interested parties are invited to participate in a telephone conference, which will include a presentation of the interim results and a business update, on the same date at 14:00 CET/8:00am EST.
  • The event will be hosted by Hansa Biopharma's CEO, Søren Tulstrup, CCO and US President, Matthew Shaulis and CFO, Donato Spota.
  • Link to presentation
    To participate in the telephone conference, please use the dial-in details provided below:
    Aug 23, 2023            Carnegie non-deal road show, Stockholm
    Aug 24, 2023            Erik Penser Company Day, Stockholm
    Sept 6-7, 2023          CITI Annual BioPharma Conference, Boston
    Sept 11, 2023 HC Wainwright Annual Global Investment Conference, NYC
    Sept 11-12, 2023      MorganStanley Global Healthcare Conference, NYC
    Sept 14, 2023           Pareto Annual Healthcare Conference, Stockholm
    Sept 14, 2023           Erik Penser Company Day, Malmö
    Nov 21, 2023            SEB Healthcare Seminar 2023, Stockholm
    Nov 22, 2023           Ökonomisk Ugebrev Life Science Event, Copenhagen

Hansa Biopharma announces positive reimbursement decision for Idefirix (imlifidase) in Belgium as desensitization treatment for highly sensitized patients in kidney transplantation

Retrieved on: 
Thursday, June 1, 2023
Face, Hansa, Hope, Antibody, Dialysis, Nephrology, Patient, Kidney transplantation, UZ Leuven, Transplant, Kidney, Dentistry

LUND, Sweden, June 1, 2023 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announced that it has attained reimbursement in Belgium for its first-in-class treatment, Idefirix, for the desensitization treatment of highly sensitized adult patients prior to kidney transplant from a deceased donor.

Key Points: 
  • LUND, Sweden, June 1, 2023 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announced that it has attained reimbursement in Belgium for its first-in-class treatment, Idefirix, for the desensitization treatment of highly sensitized adult patients prior to kidney transplant from a deceased donor.
  • Idefirix is available for eligible highly sensitized patients starting today, June 1, 2023.
  • Idefirix is the first and only product approved for use in highly sensitized patients waiting for a kidney transplant in Belgium.
  • Including Belgium, we now have positive access and reimbursement decisions in twelve countries in Europe – a testament to our commitment to ensure access to Idefirix for highly-sensitized patients waiting for a kidney transplant.

Hansa Biopharma and Genethon announce collaboration to develop imlifidase as pre-treatment to gene therapy in Crigler-Najjar syndrome patients with anti-AAV antibodies

Retrieved on: 
Thursday, April 27, 2023
Nerve, Priority, Deafness, Hansa, Crigler–Najjar syndrome, Research, AAV, Trial of the century, Intellectual, Paralysis, EMA, Muscle weakness, Patient, Lethargy, MAA, Lance, BLA, DSM-IV codes, Safety, Pharmaceutical industry, Vaccine

The presence of circulating NAbs today excludes patients from entering clinical studies with potentially curative gene therapy treatments and from future access to approved gene therapies.

Key Points: 
  • The presence of circulating NAbs today excludes patients from entering clinical studies with potentially curative gene therapy treatments and from future access to approved gene therapies.
  • This research collaboration further validates Hansa's commitment in gene therapy and underscores the important role that our antibody-cleaving enzyme technology can play in ensuring that even more patients can benefit from life-saving gene therapies".
  • Through the collaboration announced today, patients with Crigler-Najjar and pre-formed antibodies to AAV8 will be enrolled in a study with similar design where imlifidase is evaluated as a pre-treatment to enable gene therapy treatment with GNT-0003.
  • Crigler-Najjar syndrome is an ultra-rare disease affecting less than one case per one million people per year.1
    Frédéric Revah, CEO, Genethon added: "Patients with pre-existing neutralizing antibodies against AAV vectors cannot today benefit from gene therapy.