Press Release

Kiadis Pharma announces FDA clearance of clinical study by The Ohio State University in R/R AML with off-the-shelf NK cells from universal donors

February 26, 2020 at 2:30 AM EST

Amsterdam, The Netherlands, February 26, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company, and The Ohio State University - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (“OSU” or “OSUCCC-James”), today announced the launch of a first-in-human clinical trial in patients with relapsed/refractory acute myeloid leukemia (R/R AML) with off-the-shelf Natural Killer (“NK”) cells manufactured using Kiadis’ FC21 mbIL21 feeder cells and proprietary universal donor platform. The trial is expected to provide further clinical proof-of-concept of Kiadis’ K-NK003 product.

The investigator-sponsored trial will be conducted at OSUCCC – James, a National Cancer Institute (NCI)-designated comprehensive cancer center and freestanding cancer hospital located in Columbus, Ohio, in the United States. The OSUCCC – James team received Food and Drug Administration (FDA) approval for an investigational new drug application to begin this trial and expects to begin enrolling patients in March 2020. Kiadis will support the study through a collaborative research agreement with OSUCCC-James. Additionally, OSU and Kiadis plan to work together to initiate a company sponsored trial with off-the-shelf K-NK003 cells expanded with Kiadis’ particle production platform (PM21) in the same patient population later this year.

The study entitled “A Phase I Clinical Trial Testing the Safety of IL-21-Expanded, Off-the-shelf, Third-party Natural Killer Cells for the Induction of Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome” will evaluate the NK cell product in up to 56 patients, ages 18 – 80 who have primary refractory AML, relapsed AML, or myelodysplastic syndromes (MDS). The goal of this study is to establish safety of the NK cell therapy for the induction of remission in patients with Relapsed/Refractory (“R/R”) AML or MDS and to determine the optimal dosing and overall response rate. Patients enrolled in the study will receive six doses of NK cells of 1 x 10cells/kg to 1 x 10cells/kg after receiving reinduction chemotherapy.

“NK cells given outside the setting of transplantation have shown to induce remissions. Relapsed/refractory AML and MDS patients have a high chance of progression while waiting for manufacturing of expanded directed-donor NK cells, so having an easily accessible product, and one that does not require administration of cytokines, may be an attractive approach for these patients,” stated Sumithira Vasu, MBBS, a hematologist scientist and Medical Director of the Cell Therapy Lab at OSUCCC - James who will serve as principal investigator of the clinical trial.  Vasu is also an associate professor at The Ohio State University College of Medicine. “This trial uses a novel off-the-shelf, readily available product to treat what is traditionally a very sick and difficult-to-treat group of patients. I look forward to the collaboration with Kiadis to help accelerate development of this cell therapy.”  

“We are very pleased to be working with OSU and Dr. Vasu on the first clinical evaluation of our off-the-shelf universal donor K-NK-cell therapy in R/R AML as part of our K-NK003 cell therapy product program,” says Andrew Sandler, MD, chief medical officer of Kiadis. “While this study will use our FC21 technology, we plan to leverage this study to initiate a company sponsored study at OSU and other sites with our particle production platform (PM21) in the same patient population later this year. Our proprietary PM21 platform is the only technology that produces NK-cell therapy without the use of feeder cell lines, which carry the risk of tumor cells and DNA in the final product.”

The NK cell product will be manufactured in the OSU Cell Therapy Lab under the direction of Lynn O’Donnell, PhD, Director of Cell Therapy Engineering at OSUCCC - James Pelotonia Institute for Immuno-Oncology.

O’Donnell notes this off-the-shelf NK cell therapy is unique in several ways:

  • It is derived from normal human donors who have undergone the full FDA-mandated screening process and are demonstrating excellent NK cell expansion using the Kiadis FC21 technology.
  • The OSUCCC – James team is able to bank the cells ahead of patient enrollment. “Because of this, we do not need to wait for QC/QA release or ‘matching’ the donor to the recipient, saving weeks of critical time for patients with aggressive disease, “ says O’Donnell, who also serves as an associate professor at The Ohio State University College of Medicine. 
  • The NK cells are not genetically engineered like CAR-T cells, CAR-NK cells, or other allogeneic NK cell products, which O’Donnell notes eliminates the need for long-term follow up of patients, and reduces the overall regulatory burden.
  • NK cells are not derived from induced pluripotent stem cells or an irradiated tumor cell line, eliminating another source of risk for the patients long-term.

Vasu and O’Donnell have no potential financial conflicts of interest related to Kiadis or this study to disclose.

About Kiadis

Founded in 1997, Kiadis Pharma is building a fully integrated biopharmaceutical company committed to developing innovative therapies for patients with life-threatening diseases. With headquarters in Amsterdam, the Netherlands, and offices and activities across the United States, Kiadis Pharma is reimagining medicine by leveraging the natural strengths of humanity and our collective immune system to source the best cells for life.

Kiadis Pharma is listed on the regulated market of Euronext Amsterdam and Euronext Brussels since July 2, 2015, under the symbol KDS. Learn more at kiadis.com.

Kiadis Contacts:

Kiadis Pharma:

Maryann Cimino, Manager, Corporate Affairs
Tel: +1 (617) 710-7305
m.cimino@kiadis.com

 
Optimum Strategic Communications:
Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 203 950 9144
David Brilleslijper (Amsterdam)
Tel: +31 610 942 514
kiadis@optimumcomms.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 officers’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of known and unknown risks, uncertainties and assumptions that could cause actual results, performance, achievements or events to differ materially from those expressed, anticipated 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, regulation, competition and technology, can cause actual events, performance, achievements or results to differ significantly from any anticipated or implied 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 projections, 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 anticipated or implied developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

DISCLAIMER – IMPORTANT

THE MATERIALS YOU ARE SEEKING TO ACCESS ARE BEING MADE AVAILABLE ON THIS WEBPAGE BY KIADIS PHARMA N.V. IN GOOD FAITH AND FOR INFORMATION PURPOSES ONLY. THE MATERIALS CONTAINED HEREIN ARE NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, OR DIRECTED AT OR ACCESSIBLE BY PERSONS LOCATED IN AUSTRALIA, CANADA, JAPAN, SOUTH AFRICA, THE UNITED STATES OR ANY OTHER JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION
.

Please read this notice carefully - it applies to all persons who view this webpage. Please note that the disclaimer set out below may be altered or updated. You should read it in full each time you visit the site.

Non-Dutch persons
Viewing the materials contained herein may not be lawful in certain jurisdictions. In other jurisdictions, only certain categories of person may be allowed to access such materials. Any person resident outside the Netherlands who wishes to access these materials must first satisfy themselves that they are not subject to any local requirements that prohibit or restrict them from doing so.

In particular, unless otherwise determined by Kiadis Pharma N.V. and permitted by applicable law and regulation, it is not intended that any offering by Kiadis Pharma N.V. of the securities mentioned in such materials (the "Securities") would be made, or any documentation be sent, directly or indirectly, in or into Australia, Canada, Japan, South Africa or the United States.

The materials do not constitute or form a part of any offer or solicitation to purchase or subscribe for the Securities in any jurisdiction or jurisdictions in which such offers or sales are unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

The offer and sale of the Securities has not been and will not be registered under the US Securities Act of 1933, as amended (the "US Securities Act"), or under the securities laws of any state or other jurisdiction of the United States and may not be offered, sold, resold, taken up, exercised, renounced, transferred or delivered, directly or indirectly, within the United States except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the US Securities Act. No public offering of the Securities is being made in the United States.

The Securities will not be registered under or offered in compliance with applicable securities laws of any state, province, territory, county or jurisdiction of Australia, Canada, Japan or South Africa. Accordingly, unless an exemption under the relevant securities law is applicable, any such securities may not be offered, sold, resold, taken up, exercised, renounced, transferred or delivered, directly or indirectly, in or into Australia, Canada, Japan, South Africa or any other jurisdiction if to do so would constitute a violation of the relevant laws of, or require registration thereof in, such jurisdiction.

If you are not permitted to view materials on this webpage or are in any doubt as to whether you are permitted to view these materials, please exit this webpage.

Basis of access
Access to these materials is being made available on this webpage by Kiadis Pharma N.V. in good faith and for information purposes only. Any person seeking access to this webpage represents and warrants to Kiadis Pharma N.V. that they are doing so for information purposes only.

None of the materials made available on this website constitutes an offer to sell, an invitation to induce an offer or the solicitation of an offer to acquire, securities in Kiadis Pharma N.V. and cannot be relied upon for any investment contract or decision. Further, such materials do not constitute a recommendation by Kiadis Pharma N.V. or any other party to sell or buy securities in Kiadis Pharma N.V.

Unless otherwise determined by Kiadis Pharma N.V. and permitted by applicable law and regulation, copies of the contents of the following pages (including documents posted thereon) are not being, and must not be, released or otherwise forwarded, distributed or sent in or into Australia, Canada, Japan, South Africa, the United States or any other jurisdictions where their extension or availability (and/or any transaction contemplated thereby) would breach any applicable law, and persons receiving such documents (including custodians, nominees and trustees) must not distribute or send them in, into or from Australia, Canada, Japan, South Africa, the United States or any other jurisdiction where to do so would breach any applicable law.

Confirmation of understanding and acceptance of disclaimer
I certify that I am not located or resident in, nor is the partnership or corporation on whose behalf I am accessing the website organised or incorporated under the laws of, Australia, Canada, Japan, South Africa or the United States or any other jurisdiction where the release, publication or distribution of these materials would be unlawful.

I will not transmit or otherwise send any materials contained in this website to any person located or resident in (or organised or incorporated under the laws of) Australia, Canada, Japan, South Africa or the United States.

I have read and understood the disclaimer set out above and agree to be bound by its terms.

I confirm that I am permitted under applicable law and regulation to proceed to the electronic versions of these materials and receive information of the kind contained in this website.

Agree Disagree