New research results presented on retention of potential cancer killing T-cells
in lead product ATIR101™
Amsterdam, The Netherlands, May 18, 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 that four abstracts have been accepted for presentation at the International Society for Cellular Therapy (ISCT) 2016 Annual Meeting on May 25-28, 2016 in Singapore.
These abstracts provide key clinical data on Kiadis Pharma’s lead product ATIR101™ and on the ATIR101™ development program through one oral presentation and three poster presentations. One of the three poster presentations shows research results on the retention of potential cancer killing T-cells from the donor in ATIR101™ that could eliminate residual cancer cells in a transplanted patient and help prevent relapse of blood cancer, known as the Graft-versus-Leukemia (GVL) effect. The abstract selected for oral presentation is entitled: “Phase II clinical trial of Allodepleted T-cell Immunotherapy (ATIR101) post-transplant results in decreased transplant related mortality and improved survival in acute leukemia patients undergoing T-depleted haploidentical stem cell transplantation” and will be delivered in Room 331 on Friday, May 27, 2016 between 10:45 and 12:15 SGT by Dr. Denis-Claude Roy, Professor of Medicine at the University of Montreal and principal investigator for Kiadis Pharma’s ongoing single-dose Phase II clinical trial (NCT01794299/EudraCT 2012-004461-41) with its lead product ATIR101™.
In addition, Jurjen Velthuis, the Company’s Vice-President CMC, will give a presentation on ‘Defining critical process parameters’ during the Session “Quality and Operations Track 5 - CMC Process Characterization and Parameters”. This presentation will be delivered in Room 330 on Friday, May 27, 2016 between 13:45 and 15:15 SGT.
Oral presentation, speaker and poster presentations at ISCT:
Oral Presentation
Friday May 27, 2016 between 10:45 and 12:15 SGT (Room 331)
Title: Phase II clinical trial of Allodepleted T-cell Immunotherapy (ATIR101) post-transplant results in decreased transplant related mortality and improved survival in acute leukemia patients undergoing T-depleted haploidentical stem cell transplantation
Presenting author: Dr. Denis-Claude Roy
Speaker
Friday May 27, 2016 between 13:45 and 15:15 SGT (Room 330)
Title: Defining critical process parameters
Session: Quality and Operations Track 5 - CMC Process Characterization and Parameters
Speaker: Jurjen Velthuis
Poster Presentations
Friday May 27, 2016 between 17:00 and 18:30 SGT, Exhibit Hall
- P238: Title: Application of Quality by Design in allogeneic cell-based therapy processes and assay development Presenting author: Wouter Harink
- P189: Title: Leukemia-associated antigen reactive T-cells in ATIR101, a recipient-specific allodepleted T-cell product to reduce relapse rates and GVHD after haplo-HSCT
Presenting author: Jurjen Velthuis
- P188: Title: Selective depletion of alloreactive T-cells while retaining virus-specific and memory T-cells from haploidentical donor lymphocytes
Presenting author: Jurjen Velthuis
The four abstracts are scheduled to be available at the Company’s website on Tuesday, May 24, 2015. In addition, the abstracts will be published in a supplemental version of Cytotherapy, the official journal of ISCT.
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, harboring 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 tumor 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-Leukemia (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 tumor 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 tumor 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 focused on cell-based immunotherapy products for the treatment of blood cancers and inherited blood disorders. The Company’s products have the potential to address the risks and limitations connected with allogeneic hematopoietic stem cell transplantation (HSCT), namely graft-versus-host disease (GVHD), cancer relapse, opportunistic infections and limited matched donor availability. The Company believes that HSCT could become a first-choice treatment for blood cancers, inherited blood disorders and possibly autoimmune diseases and solid organ transplantations.
In April 2016, the Company reported positive Phase II results with its lead product ATIR101™ in patients with blood cancer. The data confirmed that ATIR101™ does not cause grade III-IV GVHD and significantly reduces Transplant Related Mortality while Overall Survival is significantly improved. ATIR101™ has been granted Orphan Drug Designations both in the US and Europe. The Company’s second product candidate, ATIR201™, addresses inherited blood disorders with an initial focus on thalassemia, a disease which results in destruction of red blood cells in patients. ATIR201™ is expected to enter Phase I/II clinical development in the second half of 2016.
Kiadis Pharma, based in Amsterdam, The Netherlands, was granted an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data by the European Medicines Agency (EMA). The Company’s shares are listed on Euronext Amsterdam and Euronext Brussels. For more information visit www.kiadispharma.com
Amsterdam, The Netherlands, May 18, 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 that four abstracts have been accepted for presentation at the International Society for Cellular Therapy (ISCT) 2016 Annual Meeting on May 25-28, 2016 in Singapore.
These abstracts provide key clinical data on Kiadis Pharma’s lead product ATIR101™ and on the ATIR101™ development program through one oral presentation and three poster presentations. One of the three poster presentations shows research results on the retention of potential cancer killing T-cells from the donor in ATIR101™ that could eliminate residual cancer cells in a transplanted patient and help prevent relapse of blood cancer, known as the Graft-versus-Leukemia (GVL) effect. The abstract selected for oral presentation is entitled: “Phase II clinical trial of Allodepleted T-cell Immunotherapy (ATIR101) post-transplant results in decreased transplant related mortality and improved survival in acute leukemia patients undergoing T-depleted haploidentical stem cell transplantation” and will be delivered in Room 331 on Friday, May 27, 2016 between 10:45 and 12:15 SGT by Dr. Denis-Claude Roy, Professor of Medicine at the University of Montreal and principal investigator for Kiadis Pharma’s ongoing single-dose Phase II clinical trial (NCT01794299/EudraCT 2012-004461-41) with its lead product ATIR101™.
In addition, Jurjen Velthuis, the Company’s Vice-President CMC, will give a presentation on ‘Defining critical process parameters’ during the Session “Quality and Operations Track 5 - CMC Process Characterization and Parameters”. This presentation will be delivered in Room 330 on Friday, May 27, 2016 between 13:45 and 15:15 SGT.
Oral presentation, speaker and poster presentations at ISCT:
Oral Presentation
Friday May 27, 2016 between 10:45 and 12:15 SGT (Room 331)
Title: Phase II clinical trial of Allodepleted T-cell Immunotherapy (ATIR101) post-transplant results in decreased transplant related mortality and improved survival in acute leukemia patients undergoing T-depleted haploidentical stem cell transplantation
Presenting author: Dr. Denis-Claude Roy
Speaker
Friday May 27, 2016 between 13:45 and 15:15 SGT (Room 330)
Title: Defining critical process parameters
Session: Quality and Operations Track 5 - CMC Process Characterization and Parameters
Speaker: Jurjen Velthuis
Poster Presentations
Friday May 27, 2016 between 17:00 and 18:30 SGT, Exhibit Hall
- P238: Title: Application of Quality by Design in allogeneic cell-based therapy processes and assay development Presenting author: Wouter Harink
- P189: Title: Leukemia-associated antigen reactive T-cells in ATIR101, a recipient-specific allodepleted T-cell product to reduce relapse rates and GVHD after haplo-HSCT
Presenting author: Jurjen Velthuis
- P188: Title: Selective depletion of alloreactive T-cells while retaining virus-specific and memory T-cells from haploidentical donor lymphocytes
Presenting author: Jurjen Velthuis
The four abstracts are scheduled to be available at the Company’s website on Tuesday, May 24, 2015. In addition, the abstracts will be published in a supplemental version of Cytotherapy, the official journal of ISCT.
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, harboring 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 tumor 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-Leukemia (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 tumor 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 tumor 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 focused on cell-based immunotherapy products for the treatment of blood cancers and inherited blood disorders. The Company’s products have the potential to address the risks and limitations connected with allogeneic hematopoietic stem cell transplantation (HSCT), namely graft-versus-host disease (GVHD), cancer relapse, opportunistic infections and limited matched donor availability. The Company believes that HSCT could become a first-choice treatment for blood cancers, inherited blood disorders and possibly autoimmune diseases and solid organ transplantations.
In April 2016, the Company reported positive Phase II results with its lead product ATIR101™ in patients with blood cancer. The data confirmed that ATIR101™ does not cause grade III-IV GVHD and significantly reduces Transplant Related Mortality while Overall Survival is significantly improved. ATIR101™ has been granted Orphan Drug Designations both in the US and Europe. The Company’s second product candidate, ATIR201™, addresses inherited blood disorders with an initial focus on thalassemia, a disease which results in destruction of red blood cells in patients. ATIR201™ is expected to enter Phase I/II clinical development in the second half of 2016.
Kiadis Pharma, based in Amsterdam, The Netherlands, was granted an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data by the European Medicines Agency (EMA). The Company’s shares are listed on Euronext Amsterdam and Euronext Brussels. For more information visit www.kiadispharma.com
