Kiadis Pharma Announces Its Decision to File for Marketing Authorization with the European Medicines Agency (EMA) for ATIR101™ in Blood Cancers
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 a regulatory strategy update that, based on positive Phase II data, it has taken the decision to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead product ATIR101™ for use in blood cancers to reduce relapse rates, Transplant Related Mortality (TRM) and Graft-versus-Host-Disease (GVHD) in the context of a hematopoietic stem cell transplantation using a haploidentical donor. The Company will now start compiling an MAA document and anticipates submitting the application to EMA in Q1, 2017.
An EMA rapporteur and co-rapporteur (who will jointly co-ordinate the evaluation of Kiadis Pharma’s MAA submission) were appointed in early 2015. In addition, in April 2015 Kiadis Pharma received a certificate for its (manufacturing) quality and non-clinical data from EMA.
Positive clinical data from Kiadis Pharma’s single dose Phase II trial (NCT01794299/EudraCT 2012-004461-41) with ATIR101™ was announced on April 4, 2016 at the Annual Meeting of the European Society of Blood and Marrow Transplantation (EBMT) in Valencia, Spain. The data showed that ATIR101™ significantly reduced TRM and significantly improved Overall Survival in comparison to a historical control group of patients that underwent a similar T-cell depleted haploidentical donor transplantation but without the addition of ATIR101™. In addition, ATIR101™ did not elicit grade III-IV GVHD in any patient.
Recently, meetings were held with the EMA rapporteur and co-rapporteur during which Kiadis Pharma presented safety and manufacturing data as well as clinical data from this Phase II trial, a trial that was designed on the basis of scientific advice previously given by EMA.
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “We are excited about the progress we have made with ATIR101™ over the past year. The Company is again entering into a new phase in its development as we are starting preparations for commercialization. The submission of an MAA in Q1, 2017 was our ambitious upside-plan communicated at the time of our IPO, now a year ago, and we are moving nicely ahead with good momentum. A launch of ATIR101™ in Europe could be possible as early as 2018 if marketing authorization is granted by EMA. We are also fully committed to starting the enrollment of patients into our planned randomized, international controlled Phase III trial where we will compare the ATIR101™ approach with post-transplant cyclophosphamide (Baltimore approach) in the context of haploidentical transplantation. I look forward to the future with tremendous excitement in this next phase.”
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 showed that ATIR101™ significantly reduced Transplant Related Mortality and significantly improved Overall Survival. In addition, ATIR101™ did not elicit grade III-IV GVHD in any patient. 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
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.
Manfred Rüdiger, CEO
Tel. +31 20 314 02 50
International Media and Investor Contact:
Consilium Strategic Communications
Mary-Jane Elliott, Lindsey Neville, Hendrik Thys
Tel: +44 (0) 203 709 5708
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Department for International Trade: Life Sciences at the Heart of UK Economy18.7.2018 12:38 | Pressemelding
The Government will today (Wednesday 18 July) host the second in a series of roundtables with stakeholders from key life science businesses, demonstrating the importance of the sector to the UK economy. The Chancellor, International Trade Secretary, Business Secretary and Health and Social Care Secretary will be amongst those that meet with senior representatives from leading UK and international life sciences companies as the UK positions itself as the global home of health innovation, welcoming overseas investment and seeking to boost exports in the process. Discussions at the roundtable will focus on how the future of the Life Sciences sector will be supported by the delivery of our modern Industrial Strategy, ensuring that the UK is ‘open for business’ with a positive business environment, our ambitions for a comprehensive agreement with the EU on our future relationship and the development and implementation of our independent trade policy. To date, the government has engaged sign
Universal Laser Systems Expands Its Materials Database with 3M, Victrex and Dexmet Materials18.7.2018 12:05 | Pressemelding
Universal Laser Systems (ULS) announces the addition of 3M™, Victrex® and Dexmet materials to its materials database, the most extensive repository of laser material processing parameters for materials in the range of 10 watts to 500 watts. The 3M, Victrex and Dexmet materials new to the ULS materials database were specifically added for laser processing with the ULTRA and XLS platforms, suited for high accuracy and precision laser cutting, laser ablation and laser surface modification. The materials include: 3M™ Extreme Sealing Tape 4412N 3M™ Thermally Conductive Silicone Interface Pad 5516 Victrex® APTIV® PEEK Film Dexmet PolyGrid® 8PTFE10-125ST Expanded PTFE Dexmet MicroGrid® AL 25 Expanded Aluminum Laser processing notes, describing the results of the laser-material interaction for these materials, are also available in the Materials Library on the ULS website to help potential customers explore the advantages of deploying laser technology within their manufacturing, research and d
Sterigenics Expands European Capacity With New State-of-the-Art Gamma Sterilization Facility in the UK18.7.2018 12:00 | Pressemelding
Sterigenics, a Sotera Health company and leading global provider of mission-critical sterilization solutions and expert advisory services, announced today it is building a new facility in Markham Vale North in Chesterfield/Derbyshire, UK. The facility will significantly expand Sterigenics’ footprint in Europe to help meet the growing sterilization needs of its customers and support the company’s mission of Safeguarding Global HealthTM. Scheduled for completion in the fourth quarter, 2018, the facility will include the installation of a state-of-the-art Nordion JS10000 gamma irradiator with a research loop. The new 60,000-square-foot facility will add gamma sterilization capabilities in the UK to complement Sterigenics’ existing ethylene oxide (EtO) facility based in Somercotes/Derbyshire. “Sterigenics is committed to being the world’s leading provider of sterilization services and partnering with our customers to eliminate threats to human health,” said Philip Macnabb, President of Ste
Smiths Detection Technology Chosen for Standard 3 Upgrade at Helsinki Airport18.7.2018 09:05 | Pressemelding
Smiths Detection has been selected by Finnish airport operator, Finavia Corporation, to support the transition to Standard 3 at Helsinki Airport with approved hold baggage screening systems. Included in the contract are eight high-speed, HI-SCAN 10080 XCT scanners, which combine high resolution X-ray technology, computed tomography (CT) and advanced detection algorithms to increase both security and operational efficiency significantly. Security, speed and efficiency are critical to the extensive development programme underway at the airport, which will allow the airport to serve 30 million passengers annually and increase baggage handling capacity by 50%. “Any financial investment in upgrading security equipment has to be balanced against operational improvement, particularly when part of a major expansion. Airports need assurance that efficiencies will be gained and systems can be further updated as necessary to detect evolving explosive threats and handle ever higher volumes,” comme
Norsk Titanium Continues to Grow in the State of New York18.7.2018 07:00 | Pressemelding
Norsk Titanium (Norsk), the world’s first FAA-approved supplier of aerospace-grade, additive manufactured, structural titanium components, announced another major milestone in qualified production. Norsk’s Plattsburgh Development and Qualification Center (PDQC) site was officially added to the Spirit AeroSystems Approved Suppliers List (ASL) in anticipation of the start of qualified production later this year. Partnered with the recent announcements of PDQC being added to the Boeing’s Qualified Producer’s List (QPL) list and its certification under AS9100D, this new qualification is key to furthering the availability of Norsk’s disruptive technology in the aerospace market. Spirit AeroSystems is the world’s largest independent aerostructures manufacturer. “These significant achievements have been made possible by the foresight and commitment made to Norsk by the State of New York and Empire State Development. We are extremely proud of our PDQC quality and operations teams and appreciat
The Best User Interface in Mobile and Web Tracking Just got Better18.7.2018 06:00 | Pressemelding
ThriveTracker, a leading web and mobile tracker for media buyers and performance marketers, today announced the general availability of its latest release featuring an all-new user interface (UI). Inspired by feedback from customers and partners, ThriveTracker designed the new UI to accelerate user adoption, improve usability and increase productivity. ThriveTracker focused on the user experience for all users regardless of device, (Desktop, Mobile, etc.), making it more intuitive and accessible. Improved navigation provides simplified access to frequently used functions in the platform, increases customer awareness of more advanced functionality and delivers fast access to detailed content when necessary. Cleaner, simpler, modern UI Clear, consistent navigation focuses your attention on where you are and what you can do Improved layout delivers common functions intuitively Simplified views provide faster access to relevant content Mobile Friendly Mobile responsive based on device New