Webcast Monday April 4, 2016 at 18:00 CET
Amsterdam, The Netherlands, March 29, 2016, – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces it will host a webcast on Monday April 4, 2016 at 18:00 CET to discuss the full dataset on the primary endpoint (Transplant Related Mortality at 6 months post transplantation) of its single-dose Phase II trial (NCT01794299/EudraCT 2012-004461-41) with its lead product ATIR101™. During the webcast, the data will also be put into perspective with other current approaches in the literature for patients lacking a fully matched donor, such as the Baltimore approach using post-transplant cyclophosphamide.
The webcast will be hosted by Manfred Rüdiger, Chief Executive Officer and Jeroen Rovers, Chief Medical Officer, together with Dr. Denis-Claude Roy*, Professor of Medicine at the University of Montreal and principal investigator for the study.
To register for the webcast, please visit the homepage of Kiadis Pharma at: www.kiadis.com.
To view the webcast, please call the appropriate number below, 10 minutes prior to the start time:
The Netherlands: 020 716 8427
Toll-free The Netherlands: 0800 265 8619
Belgium: 02 401 2722
Toll-free Belgium: 0800 50 562
United Kingdom: 0203 139 4830
Toll-free United Kingdom: 0808 23 700 30
United States: 1718 873 9077
Toll-free United States: 1866 928 7517
Conference ID: 25282024#
The webcast will be conducted in English and viewers will have the opportunity to submit questions during the Q&A portion of the live webcast. A replay of the webcast will be made available on Kiadis Pharma’s website.
The detailed data will be presented for the first time at the 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) in Valencia, Spain on Monday April 4, 2016 at 16:05 CET.
*Dr. Denis-Claude Roy is fully independent to Kiadis Pharma.
About ATIR101™
For patients suffering from blood cancers, an allogeneic hematopoietic stem cell transplantation (HSCT) is generally regarded as the most effective curative approach. During an HSCT treatment, the bone marrow, harbouring the diseased cancer cells, is completely destroyed and subsequently replaced by stem cells in the graft from a healthy donor. After an HSCT treatment it usually takes the patient at least six to twelve months to recover to near-normal blood cell levels and immune cell functions. During this period, the patient is highly vulnerable to infections caused by bacteria, viruses and fungi but also to disease relapse.
ATIR101™ (Allodepleted T-cell ImmunotheRapeutics) provides for a safe donor lymphocyte infusion (DLI) from a partially matched (haploidentical) family member without the risk of causing severe Graft-versus-Host-Disease (GVHD). The T-cells in ATIR101™ will help fight infections and remaining tumour cells and thereby bridge the time until the immune system has fully re-grown from stem cells in the transplanted graft.
In ATIR101™, T-cells that would cause GVHD are eliminated from the donor lymphocytes using Kiadis Pharma’s photodepletion technology, minimizing the risk of GVHD and eliminating the need for prophylactic immune-suppression. At the same time, ATIR101™ contains potential cancer killing T-cells from the donor that could eliminate residual cancer cells and help prevent relapse of the disease, known as the Graft-versus-Leukaemia (GVL) effect.
Therefore, ATIR101™, administered as an adjunctive immuno-therapeutic on top of HSCT, provides the patient with functional, mature immune cells from a partially matched family donor that can fight infections and tumour cells but that do not cause GVHD. ATIR101™ thus has the potential to make curative HSCT a viable option to many more patients.
The Company estimates that approximately 35% of patients who are eligible and in urgent need of HSCT will not find a matching donor in time. A partially matched (haploidentical) family donor, however, will be available to over 95% of patients.
ATIR101™, consisting of donor T-cells that fight infections and residual tumour cells while not eliciting severe GVHD, is designed to result in low relapse rates and low rates of death due to infections, in the absence of severe acute GVHD.
About Kiadis Pharma
Kiadis Pharma is a clinical stage biopharmaceutical company focused on research, development and future commercialization of cell-based immunotherapy products for the treatment of blood cancers and inherited blood disorders. The Company believes that its innovative products have the potential to address the current risks and limitations connected with allogeneic hematopoietic stem cell transplantation (HSCT), being graft-versus-host disease (GVHD), cancer relapse, opportunistic infections and limited matched donor availability. HSCT is generally regarded as the most effective curative approach to blood cancers and certain inherited blood disorders and the Company expects that HSCT could become a first-choice treatment for blood cancers and inherited blood disorders once current risks and limitations are addressed, thereby meeting a significant unmet medical need with its products.
The Company’s product ATIR101™ is being tested using a single-dose regimen in an open-label fully enrolled Phase II trial in patients with blood cancer who have not found a matching donor and where a partially matched (haploidentical) family member is used as donor for HSCT. The primary endpoint for the final patient in this trial will be reached at the end of Q1, 2016 and top-line results will be announced in April 2016. Very encouraging and positive interim data of this trial was presented recently at ASH2015.
In addition, the Company is enrolling blood cancer patients in a further Phase II clinical trial to study the safety and efficacy of administrating a second dose of ATIR101™ to further improve the HSCT outcome.
The European Medicines Agency (EMA) has issued an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data to the Company, and to date Kiadis Pharma is one of only five companies that have received such a certificate.
ATIR101™ has been granted Orphan Drug Designations both in the US and Europe.
ATIR201™ will be developed for inherited blood disorders with an initial focus on thalassaemia, an inherited blood disorder which results in improper oxygen transport and destruction of red blood cells in a patient. ATIR201™ is expected to enter Phase I/II clinical development for thalassaemia in the first quarter of 2016. Kiadis Pharma recently announced a collaboration with the Thalassaemia International Federation (TIF), an internationally renowned organisation that seeks to address the needs of patients, carers, healthcare professionals and the general public in the area of thalassaemia.
Kiadis Pharma is based in Amsterdam, the Netherlands and its shares are listed on Euronext Amsterdam and Euronext Brussels. Further information can be found at: www.kiadis.com
Amsterdam, The Netherlands, March 29, 2016, – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces it will host a webcast on Monday April 4, 2016 at 18:00 CET to discuss the full dataset on the primary endpoint (Transplant Related Mortality at 6 months post transplantation) of its single-dose Phase II trial (NCT01794299/EudraCT 2012-004461-41) with its lead product ATIR101™. During the webcast, the data will also be put into perspective with other current approaches in the literature for patients lacking a fully matched donor, such as the Baltimore approach using post-transplant cyclophosphamide.
The webcast will be hosted by Manfred Rüdiger, Chief Executive Officer and Jeroen Rovers, Chief Medical Officer, together with Dr. Denis-Claude Roy*, Professor of Medicine at the University of Montreal and principal investigator for the study.
To register for the webcast, please visit the homepage of Kiadis Pharma at: www.kiadis.com.
To view the webcast, please call the appropriate number below, 10 minutes prior to the start time:
The Netherlands: 020 716 8427
Toll-free The Netherlands: 0800 265 8619
Belgium: 02 401 2722
Toll-free Belgium: 0800 50 562
United Kingdom: 0203 139 4830
Toll-free United Kingdom: 0808 23 700 30
United States: 1718 873 9077
Toll-free United States: 1866 928 7517
Conference ID: 25282024#
The webcast will be conducted in English and viewers will have the opportunity to submit questions during the Q&A portion of the live webcast. A replay of the webcast will be made available on Kiadis Pharma’s website.
The detailed data will be presented for the first time at the 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) in Valencia, Spain on Monday April 4, 2016 at 16:05 CET.
*Dr. Denis-Claude Roy is fully independent to Kiadis Pharma.
About ATIR101™
For patients suffering from blood cancers, an allogeneic hematopoietic stem cell transplantation (HSCT) is generally regarded as the most effective curative approach. During an HSCT treatment, the bone marrow, harbouring the diseased cancer cells, is completely destroyed and subsequently replaced by stem cells in the graft from a healthy donor. After an HSCT treatment it usually takes the patient at least six to twelve months to recover to near-normal blood cell levels and immune cell functions. During this period, the patient is highly vulnerable to infections caused by bacteria, viruses and fungi but also to disease relapse.
ATIR101™ (Allodepleted T-cell ImmunotheRapeutics) provides for a safe donor lymphocyte infusion (DLI) from a partially matched (haploidentical) family member without the risk of causing severe Graft-versus-Host-Disease (GVHD). The T-cells in ATIR101™ will help fight infections and remaining tumour cells and thereby bridge the time until the immune system has fully re-grown from stem cells in the transplanted graft.
In ATIR101™, T-cells that would cause GVHD are eliminated from the donor lymphocytes using Kiadis Pharma’s photodepletion technology, minimizing the risk of GVHD and eliminating the need for prophylactic immune-suppression. At the same time, ATIR101™ contains potential cancer killing T-cells from the donor that could eliminate residual cancer cells and help prevent relapse of the disease, known as the Graft-versus-Leukaemia (GVL) effect.
Therefore, ATIR101™, administered as an adjunctive immuno-therapeutic on top of HSCT, provides the patient with functional, mature immune cells from a partially matched family donor that can fight infections and tumour cells but that do not cause GVHD. ATIR101™ thus has the potential to make curative HSCT a viable option to many more patients.
The Company estimates that approximately 35% of patients who are eligible and in urgent need of HSCT will not find a matching donor in time. A partially matched (haploidentical) family donor, however, will be available to over 95% of patients.
ATIR101™, consisting of donor T-cells that fight infections and residual tumour cells while not eliciting severe GVHD, is designed to result in low relapse rates and low rates of death due to infections, in the absence of severe acute GVHD.
About Kiadis Pharma
Kiadis Pharma is a clinical stage biopharmaceutical company focused on research, development and future commercialization of cell-based immunotherapy products for the treatment of blood cancers and inherited blood disorders. The Company believes that its innovative products have the potential to address the current risks and limitations connected with allogeneic hematopoietic stem cell transplantation (HSCT), being graft-versus-host disease (GVHD), cancer relapse, opportunistic infections and limited matched donor availability. HSCT is generally regarded as the most effective curative approach to blood cancers and certain inherited blood disorders and the Company expects that HSCT could become a first-choice treatment for blood cancers and inherited blood disorders once current risks and limitations are addressed, thereby meeting a significant unmet medical need with its products.
The Company’s product ATIR101™ is being tested using a single-dose regimen in an open-label fully enrolled Phase II trial in patients with blood cancer who have not found a matching donor and where a partially matched (haploidentical) family member is used as donor for HSCT. The primary endpoint for the final patient in this trial will be reached at the end of Q1, 2016 and top-line results will be announced in April 2016. Very encouraging and positive interim data of this trial was presented recently at ASH2015.
In addition, the Company is enrolling blood cancer patients in a further Phase II clinical trial to study the safety and efficacy of administrating a second dose of ATIR101™ to further improve the HSCT outcome.
The European Medicines Agency (EMA) has issued an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data to the Company, and to date Kiadis Pharma is one of only five companies that have received such a certificate.
ATIR101™ has been granted Orphan Drug Designations both in the US and Europe.
ATIR201™ will be developed for inherited blood disorders with an initial focus on thalassaemia, an inherited blood disorder which results in improper oxygen transport and destruction of red blood cells in a patient. ATIR201™ is expected to enter Phase I/II clinical development for thalassaemia in the first quarter of 2016. Kiadis Pharma recently announced a collaboration with the Thalassaemia International Federation (TIF), an internationally renowned organisation that seeks to address the needs of patients, carers, healthcare professionals and the general public in the area of thalassaemia.
Kiadis Pharma is based in Amsterdam, the Netherlands and its shares are listed on Euronext Amsterdam and Euronext Brussels. Further information can be found at: www.kiadis.com
