17.APRIL 2019 AT 07:00:00 CET

Kiadis to Acquire CytoSen Therapeutics, Inc.

  • Transaction creates leader in cell-based cancer immunotherapy, with complementary T-cell and NK-cell platforms focused initially on hematopoietic stem cell transplants (HSCT)
  • CytoSen’s lead NK-cell therapy candidate, CSDT002-NK, is expected to enter clinical development in 2020 building on successful clinical proof-of-concept studies in 25 patients at the MD Anderson Cancer Center (MDACC)
  • The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) to support clinical development in leading US transplant centers
  • Dr. Carl Junea pioneer in the development of CAR T-cell therapy, to join Kiadis’ Scientific Advisory Board
  • Conference call for analysts and investors today at 3:00pm CEST (9:00am EDT)

Amsterdam, The Netherlands, April 17, 2019 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company, today announced that it has entered a definitive agreement to acquire US-based CytoSen Therapeutics, Inc. (“CytoSen”), subject to Kiadis’ shareholder approval and customary closing conditions. 

Privately held CytoSen has developed a proprietary natural killer (NK)-cell platform to enable NK-cell therapy with broad anti-cancer potential. It was founded on technology exclusively licensed from the University of Central Florida (UCF) and further developed at Nationwide Children’s Hospital (NCH). The company’s founders, including Dean Lee, Stefan Ciurea and Robert Igarashi, are leading physicians and scientists at NCH, MDACC and UCF, respectively. Following the transaction, Dr. Carl June, a pioneer in the development of CAR T-cell therapy and current scientific advisor to CytoSen, will join Kiadis’ Scientific Advisory Board.

The transaction creates a leader in cell-based cancer immunotherapy. The combined company has a complementary development pipeline focused on improving outcomes for patients undergoing hematopoietic stem cell transplants (HSCT). Kiadis’ lead T-cell product ATIR101 is in EU registration and a global Phase 3 clinical trial;  CytoSen’s lead NK-cell product candidate, CSDT002-NK, building on promising clinical proof-of-concept studies in 25 patients carried out at MD Anderson Cancer Center, is expected to enter the clinic in the US in 2020. The unique combination of proprietary and synergistic NK-cell and T-cell therapy platforms has the potential to revolutionize HSCT and enables Kiadis to create a pipeline with novel cancer treatments. 

Arthur Lahr, CEO of Kiadis commented: “Our vision is to leverage the strengths of the human immune system to help patients with life-threatening diseases. With the addition of CytoSen, we can create cell therapy treatments that combine the innate and adaptive arms of the immune system. The ATIR T-cell and CSDT002-NK-cell programs each have the potential to make transplants safer and more effective. In combination, they have the potential to revolutionize HSCT, making it suitable for an even wider group of patients. This transaction will transform Kiadis into a unique company with two synergistic proprietary cell-based immunotherapy platforms and the opportunity to create a pipeline of innovative treatments for cancer patients.”

Carl H. June, MD, Richard W. Vague Professor in Immunotherapy in the Department of Pathology and Laboratory Medicine at the University of Pennsylvania, commented: “NK-cell therapy could significantly advance the field of immuno-oncology. Also, I believe the fields of NK-cells and T-cells are enormously synergistic and the combination could potentially help patients with devastating diseases. I am pleased to be joining the Scientific Advisory Board of Kiadis.”

Dean A. Lee, MD, PhD, co-founder of CytoSen and director of the Cellular Therapy and Cancer Immunology Program at Nationwide Children’s Hospital (NCH), commented: “CytoSen has the most advanced NK-cell technology to enable NK-cell therapy with broad anti-cancer potential. The strong experience, infrastructure, and competencies of Kiadis in cell therapy will accelerate our delivery of NK-cells to patients, and the new opportunities for exploring NK-cell and T-cell synergies will enable disruptive innovation in the cell therapy space. I am excited to collaborate with Kiadis to bring this innovation to patients.”   

NK-cells are one of the body’s first lines of immunological defense with an innate ability to rapidly and selectively destroy abnormal cells, such as cancer or virally-infected cells. Advancing research into the biology of NK-cells, as well as emerging early-stage clinical evidence, has increasingly shown that NK-cell immunotherapy has the potential to be at the forefront of cancer immunotherapy. CytoSen’s patented nanoparticle processing technology enables improved ex vivo expansion and activation of NK-cells supporting multiple high dose infusions with potent anti-cancer cytotoxicity. 

CytoSen’s lead program, CSTD002-NK in HSCT, is built on proof-of-concept studies in 25 patients carried out at MDACC. First results of these studies demonstrated a relapse rate of 8% and progression-free survival (PFS) of 66% (published in Blood[1], with follow up data presented at the American Society of Hematology (ASH) annual meeting in 2018). The upcoming clinical study with CSDT002-NK, expected to start in 2020, has been designed with and will be supported by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). The study will enroll high-risk acute myeloid leukemia (AML) patients undergoing a haploidentical HSCT at a consortium of leading US transplant centers in the BMT CTN network. Additionally, CytoSen’s NK-cell therapy will be investigated for other cancer treatments based on an 8-patient proof-of-concept study conducted at MDACC in refractory AML. 

Transaction Details:
At closing, CytoSen shareholders will receive upfront consideration of 1.94 million shares of Kiadis stock. The upfront consideration constitutes approximately 7.4% of Kiadis’ shares outstanding after the transaction. In addition, CytoSen shareholders are eligible to receive potential future consideration of up to 5.82 million additional shares of Kiadis stock upon the achievement of six clinical development and regulatory milestones, with the final milestone being first FDA approval of an NK-cell product based on CytoSen’s technology. The majority of the Kiadis shares issued to the CytoSen shareholders, including to its Executive Chairman and founders, will be subject to a lock-up for a period of two years from closing. At signing, CytoSen held approximately USD 6 million in net cash, which will remain in the combined company. Saola Healthcare Partners acted as financial advisor to Kiadis in the transaction.

Shareholder Approval:
The transaction is subject to the approval of Kiadis’ shareholders. The Company has called an extraordinary meeting of shareholders (EGM) to be held on Wednesday, May 29, 2019, at which the proposal supporting the transaction will be voted upon. Kiadis’ two largest shareholders (funds represented by and/or affiliated with Life Sciences Partners and Draper Esprit), together representing 31.5% of Kiadis stock, have executed voting agreements in favor of the transaction. In the event that the transaction does not complete because the General Meeting withholds its approval, CytoSen is entitled to a USD 1 million break fee to be paid in cash or Kiadis shares.

Kiadis Business Update:

  • Kiadis previously submitted a marketing authorization application (MAA) to the EMA for ATIR101 which is currently under review. The Company plans to respond to the day 180 outstanding issues by the end of May 2019, allowing for potential EU approval and launch by the end of 2019.
  • The global Phase 3 trial for ATIR101, CR-AIR-009, will compare ATIR101 to the post-transplant cyclophosphamide (PTCy) or ‘Baltimore’ protocol. Completion of enrollment and an interim analysis of the primary endpoint is expected in 2021.
  • Kiadis’ cash position was EUR 60.3 million as of December 31, 2018 and EUR 49.0 million as of March 31, 2019.  

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