Author: Willem van Lawick

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 June, a 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.  

Amsterdam, The Netherlands, October 19, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announces that it has raised gross proceeds of €31.2 million through a private placement of 3.9 million new shares to institutional investors via an accelerated bookbuilding process as announced on October 18, 2018 (the “Placing”). The Placing was completed at a subscription price of €8.00 per share and represented approximately 19% of the issued share capital of the Company prior to the transaction. The new ordinary shares will rank pari passu in all respects with the currently outstanding shares of the Company and are expected to be listed and traded on Euronext Amsterdam and Euronext Brussels on October 23, 2018. Following the Placing, the issued share capital of the Company will consist of 24,341,410 ordinary shares. (more…)

– Potential CHMP opinion moved from Q4 2018 into H1 2019
– Guidance for initial EU commercial launch in H2 2019 unchanged
– FDA meeting held under RMAT status
– Phase 3 study on track with over 20 open sites expected by end 2018, of which several in US

Amsterdam, The Netherlands, October 12, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announces a regulatory and clinical update for ATIR101.

Europe EMA
Following recent meetings of the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), Kiadis Pharma received a Day 180 second List of Outstanding Issues relating to its marketing authorization application (MAA) for ATIR101. Kiadis Pharma has completed its evaluation of these remaining Day 180 questions. Addressing the questions will require additional analyses of existing clinical data. As expected, no new experimental or new clinical data needs to be generated. EMA has accepted the Company’s request for the time needed to respond to the remaining questions. As a result, the timing of the expected CHMP opinion has moved from the fourth quarter of 2018 into the first half of 2019. Following potential EU approval, which typically follows a positive CHMP Opinion within 67 days, Kiadis Pharma intends to commercially launch ATIR101 in a first EU member state in the second half of 2019, which is unchanged versus previous guidance.

US FDA
In 2017, the US Food and Drug Administration (FDA) granted ATIR101 the Regenerative Medicine Advanced Therapy (RMAT) designation. Similar to a Breakthrough Therapy designation, RMAT status allows companies developing regenerative medicine therapies to interact with the FDA more frequently, and RMAT-designated products may be eligible for priority review and accelerated approval. As part of its RMAT status, Kiadis Pharma is benefitting from productive interactions with the US FDA, including a recent meeting.

Phase 3 clinical trial
The Company is on track with the ongoing Phase 3 clinical study to enroll 250 patients at leading transplant centers globally. The Company has now enrolled 22 patients and has 14 sites open in 7 countries. Kiadis Pharma expects to have over 20 sites open by the end of 2018, including several US sites. An interim analysis of the Phase 3 study is expected in the second half of 2020. (more…)

Amsterdam, The Netherlands, August 31, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announces its unaudited interim Financial Results for the six months ended June 30, 2018, which have been prepared in accordance with IAS 34 as adopted by the European Union.

Arthur Lahr, CEO of Kiadis Pharma, commented: “We have made tremendous progress in the last six months: ATIR101 is now very close to potential CHMP opinion in 2018, we are on track with our Phase 3 trial, and obtained further confirmatory data from our Phase 2 trials. To allow us to ramp up our Phase 3 trial and prepare for commercialization in the EU we also raised substantial equity and debt facilities that extended our cash runway into the third quarter of 2019, and, upon positive CHMP opinion, potentially into the first quarter of 2020. We have also significantly strengthened our organization in medical, operations, commercial and finance functions. Kiadis is in great shape and well positioned to deliver on the promise of ATIR101.” (more…)

Amsterdam, The Netherlands, August 30, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announces that Robbert van Heekeren is stepping down as Chief Financial Officer, or CFO, and as member of the Management Board. Scott A. Holmes has been appointed as new CFO. Mr. Holmes, who currently serves as Senior Vice President and CFO at Keryx Biopharmaceuticals, will join the Company following the completion of Nasdaq-listed Keryx Biopharmaceuticals’ recently announced merger with Akebia Therapeutics, which is expected to close by the end of 2018. (more…)