Kiadis announces U.S. FDA approval of the Abigail Wexner Research Institute at Nationwide Children’s Hospital’s IND for a COVID-19 clinical trial with off-the-shelf K-NK cells using Kiadis’ proprietary platforms

Amsterdam, The Netherlands, September 14, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company developing innovative cell-based medicines for the treatment of life-threatening diseases, today announces a collaboration with the Abigail Wexner Research Institute (AWRI) at Nationwide Children’s Hospital to develop Kiadis-NK cells (K-NK cells) as a post-exposure pre-emptive therapy for COVID-19. The U.S. Food and Drug Administration (FDA) approved AWRI’s investigational new drug application (IND) for a study in an adult population with off-the-shelf natural killer (NK) cells produced with Kiadis’ proprietary Universal Donor and PM21 technologies. Kiadis and AWRI are developing the plan for initiation of the clinical study.

Kiadis has exclusively licensed from AWRI intellectual property related to NK cells for treatment of microbial infections, including SARS-CoV-2. The Company has recently initiated the preclinical and clinical development of its K-NK-ID101 COVID-19 program and is expecting to receive US government funding for this program.

Arthur Lahr, CEO of Kiadis commented, “This is the second IND approved by the U.S. FDA for K-NK cells produced with our PM21 platform, and the second IND approved for K-NK cells based on our Universal Donor off-the-shelf platform. We are excited to study whether K-NK cells have the anti-viral properties, safety profile and manufacturing scalability to be widely deployed as an off-the-shelf global countermeasure against COVID-19 and future pandemic threats. This FDA approval marks rapid progress with our K-NK-ID101 COVID-19 program and demonstrates the potential expansion with our K-NK cells into infectious disease.”

“The coronavirus pandemic has had a significant impact on our world, but has also created opportunities for innovation and forward thinking,” says Dean Lee, MD, PhD, Director of the Cellular Therapy and Cancer Immunotherapy program at Nationwide Children’s Hospital. “Data from patients with COVID-19 have demonstrated an important role for NK cells in this disease. Our previous collaborations with Kiadis in developing NK cells for cancer enabled us to design a novel Phase I/II clinical trial that meets FDA rigor in testing whether adoptive transfer of NK cells is safe and effective in mitigating progression of this virus in high-risk patients.”

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