Author: Willem van Lawick

• Kiadis no longer expects EU conditional marketing authorization for ATIR101 in 2020
• Kiadis plans to refile at the conclusion of the ongoing phase 3 trial 

Amsterdam, The Netherlands, 17 October 2019 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announced that it no longer expects to receive EU conditional marketing authorization for ATIR101 in 2020. The Company expects that European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) will issue a negative opinion and recommend against conditional marketing authorization at the next CHMP meeting in November 2019.  

Arthur Lahr, CEO of Kiadis Pharma commented, “Today’s news is very disappointing, especially for patients who could benefit from treatment with ATIR101. We filed a marketing authorization application (MAA) in 2017 with our phase 2 ATIR101 data and historical T-cell deplete haploidentical hematopoietic stem cell transplant (HSCT) control data based on input from EMA that these were considered adequate for review. Feedback from the EMA now indicates that the phase 2 data and historical T-cell deplete control data do not provide adequate support for a marketing authorization due to the evolution of the standard of care with the post-transplant cyclophosphamide (PTCy, aka Baltimore) protocol.” 

Kiadis is currently enrolling a global, 250 patient, randomized phase 3 trial, comparing patients treated with ATIR101 after a T-cell deplete HSCT to patients treated with a T-cell replete haploidentical HSCT based on the PTCy protocol. Completion of enrolment and interim readout of the phase 3 study are expected in 2021. If positive, the study will be the basis for filing of a biologics license application (BLA) with the US Food and Drug Administration (FDA) and a new MAA with the EMA. 

Mr. Lahr continued, “The randomized phase 3 trial, if positive, should address EMA’s concerns, as it compares ATIR101 to the current standard of care, the PTCy protocol. HSCT patients are in need of new treatment options and we will work diligently to advance our HSCT programs, while also pursuing cancer therapeutics with our NK-cell platform.”  

Scott Holmes, CFO of Kiadis Pharma added, “We do not believe that this setback significantly changes the long-term revenue potential for ATIR or the near-term cash needs of Kiadis. Revenue expectations in the initial years of European launch were minimal and would not have provided a positive operating margin. Importantly, we planned for and are enrolling the phase 3 study necessary for potential regulatory approval in the United States, and now the European Union.”   

About ATIR101 and KNK002 
Kiadis has two cell-based therapeutics in development for patients with late-stage blood cancer undergoing a hematopoietic stem cell transplant: T-cell based ATIR101 and NK-cell based KNK002. Administered as adjunctive immunotherapeutics on top of HSCT, ATIR101 and KNK002 provide lymphocyte infusions with functional, mature and potent immune cells from a haploidentical family member. The T-cells in ATIR101 and NK-cells in KNK002 will help fight infections and remaining tumor cells until the immune system has fully re-grown from stem cells in the transplanted graft. 

In ATIR101, T-cells that would cause GVHD are depleted from the donor lymphocytes, using our photodepletion technology. 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. Our NK-cell nanoparticle processing technology enables improved ex vivo expansion and activation of NK-cells supporting multiple high-dose infusions with potent anti-cancer cytotoxicity. 

In addition, Kiadis is developing NK-cell based therapies for the treatment of relapse/refractory AML and has pre-clinical programs evaluating NK-cell therapy for the treatment of solid tumors.

28.JUNE 2019 AT 18:10:51 CET

Kiadis updates status of marketing authorization application for ATIR101

Amsterdam, The Netherlands, June 28, 2019 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announced that it has received feedback from the European Medicines Agency (EMA) related to the marketing authorization application (MAA) seeking approval of ATIR101 in hematopoietic stem cell transplant (HSCT). As previously announced, Kiadis submitted responses to the second Day 180 list of outstanding issues for ATIR101 to EMA in May 2019.  

As part of the review process, EMA today informed Kiadis that it will convene a Scientific Advisory Group (SAG) in September, comprising of experts in hematology and HSCT to assist EMA in arriving at a determination. 

“We appreciate the feedback from EMA and look forward to continuing our interaction with them during the review of our MAA for ATIR101,” said Arthur Lahr, CEO, of Kiadis Pharma. “With the SAG meeting now preceding the subsequent CAT and CHMP meetings as part of the EMA approval process, we are changing our guidance to potential EU conditional approval in 2020.”

While initial launch in the EU is delayed, Kiadis is on track to complete enrollment in the Phase 3 ATIR101 HSCT study in 2021 to support potential marketing approval in the US. Additionally, the company is  also on track to start the Phase 1/2 studies of CSDT002 in HSCT and relapse and refractory acute myeloid leukemia in 2020. With a novel cell-based cancer immunotherapy platform consisting of both T-cell and NK-cell technologies, Kiadis has the opportunity to potentially revolutionize transplants and develop novel cancer cell therapies.

06.JUNE 2019 AT 07:30:00 CET

Amsterdam, The Netherlands, June 6, 2019 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company, today announces that it has closed the previously announced acquisition of CytoSen Therapeutics, Inc. (“CytoSen”). 

The transaction creates a leader in cell-based cancer immunotherapy with proprietary and synergistic NK-cell and T-cell therapy platforms that have the potential to revolutionize HSCT and create a pipeline with novel cancer treatments. Kiadis now has a complementary development pipeline focused on improving outcomes for patients undergoing hematopoietic stem cell transplants (HSCT) with a T-cell therapy (ATIR101; in EU registration and a global Phase 3 clinical trial) and a NK-cell therapy (CSTD002; expected to enter the clinic in the US in 2020).

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 and through this acquisition we can now create novel cell therapies that combine the innate and adaptive arms of the immune system. This transaction is transformative for Kiadis as we now have two synergistic proprietary cell-based immunotherapy platforms and the ability to create a pipeline of innovative treatments for cancer patients.”

Total upfront consideration paid to the holders of CytoSen shares and options on closing consists of 1,513,052 newly issued Kiadis shares and 159,778 options to acquire Kiadis shares. Upon acceptance by aforementioned parties of the shares issued to them, the newly issued Kiadis shares shall be admitted to trading on Euronext Amsterdam and Euronext Brussels on the basis of the listing prospectus within the meaning of Directive 2003/71/EC, as amended and Directive 2010/73/EU consisting of the registration document approved by the Netherlands Authority for the Financial Markets (Autoriteit Financiële Markten, “AFM”) dated May 31, 2019 and the summary and securities note approved by the AFM dated May 31, 2019 that have been made generally available. Of the 1,513,052 newly issued Kiadis shares, 874,129 shares (57.8%) are subject to lock-up restrictions during a two-year period, and the other 638,923 shares (42.2%) are subject to lock-up restrictions during a 180-day period. 

Further to the abovementioned 1,513,052 newly issued Kiadis shares, the holders of CytoSen shares have a conditional entitlement to receive 267,012 newly issued Kiadis shares – the Holdback Shares as defined in the listing prospectus. The Holdback Shares serve as a source for the satisfaction of indemnification and other claims that Kiadis may have on the CytoSen shareholders pursuant to the acquisition agreement. Subject to reduction in respect of these indemnification and other claims, the Holdback Shares will be issued 18 months from the completion date. Also, as per the acquisition agreement, the holders of CytoSen shares and options are eligible to potential future consideration of up to 5,819,460 additional Shares upon the achievement of six clinical development and regulatory milestones.

22.MAY 2019 AT 20:11:16 CET

Amsterdam, The Netherlands, May 22, 2019 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announced that it has submitted a response to the European Medicines Agency’s (EMA) second Day 180 list of outstanding issues for ATIR101. Kiadis submitted a marketing authorization application (MAA) to the EMA in 2017 seeking approval of ATIR101 as an adjunctive immunotherapy for hematopoietic stem cell transplant (HSCT) in adults with late-stage blood cancer. 
     
The second Day 180 List of Issues was focused on one remaining major observation. In drafting the company’s response, Kiadis has thoroughly analyzed this observation and have created multiple analyses of existing clinical data to address this observation, including analyses of various (pooled) ATIR and historical control data.

“We received the EMA’s day 180 second list of outstanding issues in the fourth quarter of 2018, and have spent the past few months conducting additional analysis of existing data to support our response,” said Arthur Lahr, CEO, of Kiadis Pharma. “With this submission complete, we aim to receive an opinion from Committee for Medicinal Products for Human Use (CHMP) in 2019. If the CHMP opinion is positive, it would enable us to receive a conditional marketing approval from the European Commission, followed by commercial use of ATIR101 in a first patient in a European country at the end of 2019.”

22.MAY 2019 AT 18:00:00 CET

Collaboration will support Phase III clinical trial of cell therapy product ATIR101(TM) for blood cancers
 
MINNEAPOLIS & AMSTERDAM, May 22, 2019 – Be The Match BioTherapies®, an organization offering solutions for companies developing and commercializing cell and gene therapies, and Kiadis Pharma N.V. (“Kiadis”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company, today announced a strategic collaboration to support clinical evaluation of an innovative cell therapy product with potential to make haploidentical hematopoietic stem cell transplantations (HSCT) safer and more effective for patients. 
 
Under the terms of the collaboration agreement, Be The Match BioTherapies will provide logistical and technological solutions to support Kiadis’ Phase III clinical trial for ATIR101, an adjunctive immunotherapeutic designed to address key risks and limitations of HSCT in the treatment of blood cancers. 
 
Kiadis’ multinational Phase III clinical trial is evaluating the safety and efficacy of ATIR101 as an adjunctive treatment to HSCT from a half-matched (haploidentical) family donor compared to post-transplant cyclophosphamide (PTCy or “Baltimore” protocol) in adult patients with blood cancers. The Phase III study is currently enrolling patients in the EU, Canada, Israel and the U.S.
 
The collaboration will leverage Be The Match BioTherapies’ industry-leading expertise in cell delivery logistics and supply chain case management, including the company’s MatchSource® end-to-end supply chain management software, to manage the transport and processing of cellular products for use at Kiadis’ clinical trial sites in the U.S. and Canada.
 
“Kiadis’ quest to provide better treatment outcomes for patients receiving stem cell transplants is one we deeply share, given the foundational role that our parent company, the National Marrow Donor Program^®/Be The Match^®, has played in improving stem cell transplantation for more than three decades,” said Chris McClain, vice president of Sales and New Business Development, Be The Match BioTherapies. “We look forward to utilizing our cell therapy expertise to advance Kiadis’ important work.”
 
“We’re pleased to partner with Be The Match BioTherapies to progress our clinical investigation of ATIR101 and to expedite its availability to patients,” said Andrew Sandler, chief medical officer of Kiadis Pharma. “We believe this therapeutic approach could allow family members to serve as stem cell donors for those patients who would otherwise not find a matching donor in time, ultimately saving lives.”