To date, PCT has provided engineering and process development services for Kiadis which included optimizing its manufacturing process to incorporate functionally closed processing. Work is currently underway at PCT's Allendale, New Jersey facility to expand its clean room capacity by 60% and to develop and implement cell therapy specific pharmaceutical grade quality systems.
"We are pleased to select PCT as our contract manufacturing organization in the United States," said Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis. "The manufacture and supply of study medication for our Phase 3 clinical trial with ATIR101™ in the United States and Canada is a critical component to the successful and smooth running of our clinical study and having a partner who is well established and highly experienced, like PCT, is very important. PCT has been an excellent advisor and provider of process development to Kiadis in the past and we look forward to leveraging those efforts as we begin to broaden the activities of Kiadis in the United States."
"We are pleased to expand our relationship with Kiadis to help bring new cell therapies to patients in need. Our Kiadis partnership is an excellent example of PCT's growth strategy in motion - initiation of process and manufacturing development partnerships that subsequently expand to clinical manufacturing projects. Our strategy is for our partnerships to culminate, upon regulatory approval of client products, with commercial-scale manufacturing and advancement towards the cell therapy factory of the future," said Robert A. Preti, PhD, President of PCT, and Senior Vice President, Manufacturing and Technical Operations and Chief Technology Officer of Caladrius Biosciences. "A growing number of cell therapy developers are partnering with PCT to take advantage of our quality, scalable, innovative, reliable, and cost-efficient manufacturing platforms and services to advance commercialization of cellular therapies."
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.kiadis.com.
About Caladrius Biosciences
Caladrius Biosciences, Inc., through its subsidiary, PCT, is a leading development and manufacturing partner to the cell therapy industry. PCT works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. PCT and Hitachi Chemical Co., Ltd. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise. Around the core expertise of PCT, Caladrius strategically develops select product candidates, which currently includes an innovative therapy for type 1 diabetes based on a proprietary platform technology for immunomodulation. For more information, visit www.caladrius.com.
Forward Looking Statements
To read more Press Release articles, click here.