Kiadis Pharma announces enrolment of first patient in its repeat-dosing Phase II clinical trial with ATIR101™

Regulatory News:

Kiadis Pharma N.V. ("Kiadis Pharma” or "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 the first patient has been enrolled into its repeat-dosing Phase II clinical trial, CR-AIR-008, with its lead product ATIR101™. The patient was enrolled in Hamilton, Canada within a month of receiving regulatory approval for the study from the Canadian authorities.

In this new trial the safety and efficacy of administrating a second dose of ATIR101™ after the initial stem cell transplantation to patients with blood cancer, to further improve the outcome of their stem cell transplantation, will be studied (NCT02500550 / EudraCT 2015-002821-20).

The study has now been approved by authorities in Canada, Belgium and the United Kingdom, with approval pending in Germany. The Company also plans to expand the study to the USA pending regulatory approval. A total of 15 leukaemia patients with acute myeloid leukaemia (AML), acute lymphoblastic leukaemia (ALL) or myelodysplastic syndrome (MDS) will be enrolled.

Dr. Irwin Walker, Professor of Medicine at the McMaster University in Hamilton and Principal Investigator of the study, commented: "We are very excited about participating in this repeat dosing study with ATIR101™. Already, a single-dose administered in the previous Phase II study had shown very promising data. We are therefore keen on contributing to this next development step.”

Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, commented: "We are very pleased about the dynamics in our ATIR101™ development and the progress we have made on-track since our recent IPO. We believe that this new study will add additional important data for the outline of a best study design for a Phase III trial that we anticipate to start in the second half of next year. We believe that ATIR101™ has the potential to add significant value in reducing infections and relapse rates and to avoid severe acute GVHD that is seen with other current approaches.”

About ATIR101™

During an allogeneic hematopoietic stem cell transplantation (HSCT) treatment, the bone marrow, harbouring the diseased cancer cells, is completely destroyed and subsequently replaced by stem cells from a healthy donor. After an HSCT treatment it usually takes at least six to twelve months to recover to near-normal blood cell levels and immune cell functions in a patient that has received a transplant. During this period, the patient is highly susceptible and vulnerable to infections caused by bacteria, viruses and fungi. Immune cells in ATIR101™ (Allodepleted T-cell ImmunotheRapeutics) will help fight these opportunistic infections and bridge the time until the immune system has fully re-grown from stem cells in the transplanted graft.

In ATIR101™, T-cells that cause Graft-versus-Host-Disease (GVHD) are eliminated from the donor lymphocytes, which minimises the risk of GVHD and any related morbidity and mortality. At the same time, ATIR101™ contains potential cancer killing T-cells from the donor that could eliminate residual cancer cells and avoid the return of the disease, known as the Graft-versus-Leukaemia (GVL) effect. ATIR101™ allows the use of haploidentical grafts that are almost entirely depleted of T-cells, which eliminates the need for immunosuppressive drugs. ATIR101™ subsequently provides the patient with immune cells that do not cause GVHD and that will be able to attribute to the GVL effect. As a result, ATIR101™ solves the problem of not finding a matched donor in time, and, where a transplantation takes place with the graft of a partially matched (haploidentical) family donor, ATIR101™ solves the problem of GVHD and contributes to the GVL effect. 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 for, and who are 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. The use of haploidentical donor grafts without ATIR101™ is only feasible in conjunction with severe immunosuppression which renders the patient highly vulnerable to infections with severe clinical complications, resulting potentially in death.

About Kiadis Pharma

Kiadis Pharma is a clinical stage biopharmaceutical company focused on research, development and future commercialisation 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). 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, 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.

In addition, the Company has recently initiated a further Phase II clinical trial to study the safety and efficacy of administrating a second dose of ATIR101™ to patients with blood cancer to further improve the HSCT outcome.

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

Forward Looking Statements

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect Kiadis Pharma’s or, as appropriate, Kiadis Pharma’s directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, Kiadis Pharma expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither Kiadis Pharma nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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