~ LLS will fund the Phase II development via an equity investment in Kiadis Pharma ~
Amsterdam, The Netherlands, February 1, 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 it has entered into a partnership with The Leukemia & Lymphoma Society (LLS) under which LLS will fund the Phase II development of Kiadis Pharma’s lead product, ATIR101™, through an equity investment of approximately $1 million.
LLS is investing via its Therapy Acceleration Program (TAP), a strategic initiative to partner directly with biotechnology companies to help accelerate the development of promising therapies, and the funds will be used to finance Kiadis Pharma’s second ongoing Phase II trial in leukemia patients. The Company intends to continue this trial into a randomized controlled Phase III pivotal study that is planned to start later this year. This ongoing Phase II trial is investigating the repeated dosing of ATIR101™ as an adjunctive treatment to a T-cell depleted haploidentical hematopoietic stem cell transplantation (HSCT) (donor cells from a half-matched related donor) in adult patients with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL). The trial (CR-AIR-008; NCT02500550 / EudraCT 2015-002821-20) is conducted under an IND of the United States Food and Drug Administration and is set up to enroll patients in the United States as well as other countries, including Canada, Belgium and the United Kingdom.
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “We are pleased to be partnering with the world’s largest voluntary health agency focused on blood cancers. We see this as another validation of our innovative product candidate ATIR101™. The extensive network and expertise of The Leukemia & Lymphoma Society will be extremely valuable to us as we prepare to set up the pivotal Phase III study later this year. The fact that LLS is investing into Kiadis Pharma with equity is also a strong sign of confidence in what we do and our goal remains to be to bring this important product to patients as quickly as possible.”
Louis J. DeGennaro, Ph.D., LLS’s President and CEO, added: Stem cell transplantation is one of the most effective curative treatments for blood cancer patients, but it comes with great risk of life-threatening infection and graft versus host disease (GVHD). Kiadis Pharma’s ATIR101™ shows promise in fighting these infections by boosting the patient’s immune system whilst also reducing GVHD. LLS is enthusiastic about supporting this program which we hope will improve outcomes for patients with blood cancers.”
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 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.
Currently, the Company’s product ATIR101™ is being tested using a single dose regimen in an open-label 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. Kiadis Pharma announced full enrolment of this trial in July 2015. The primary endpoint for the last patient in this trial will be reached at the end of Q1, 2016, top-line results to follow at the beginning of Q2, 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 thalassemia, an inherited blood disorder which results in improper oxygen transport and destruction of red blood cells in a patient. ATIR201™ is expected to enter clinical development for thalassemia with a Phase I/II trial in the first quarter of 2016.
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
About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society® (LLS) is the world’s largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, multiple myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care.
Founded in 1949 and headquartered in White Plains, NY, United States of America, LLS has chapters throughout the United States and Canada. To learn more, visit www.LLS.org. Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m. ET.
