On November 5, 2021Glycostem Therapeutics B.V., a leading clinical-stage company focused on the development of therapeutic allogeneic off-the-shelf Natural Killer (NK) cells, reported that the abstract on the initial findings of the first two patients treated in its phase I/IIa WiNK trial have been accepted and will be presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2021), which will take place 11th – 14th December 2021 in Atlanta, GA, USA (Press release, Glycostem Therapeutics, NOV 5, 2021, View Source [SID1234594626]). oNKord is the company’s first-generation off-the-shelf allogeneic NK cell therapy under clinical development. Glycostem is furthermore developing a range of CAR-NK, combination therapy and TCR-NK products in-house.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The accepted abstract is published today and available on the ASH (Free ASH Whitepaper) website: www.hematology.org.
Title: Allogeneic, CD34+, Umbilical Cordblood-Derived NK Cell Adoptive
Immunotherapy for the Treatment of Acute Myeloid Leukemia Patients With
Measurable Residual Disease
Abstract #: 1745
Session Name: 704. Cellular Immunotherapies: Clinical: Poster I
Date: Saturday, 11th December 2021
Presentation Time: 5:30 PM – 7:30 PM (EST)
Location: Georgia World Congress Center, Hall B5, Atlanta, GA, USA
"We are very excited to share the first clinical data from our WiNK phase I/IIa trial of oNKord in patients with Acute Myeloid Leukemia. We are very pleased to see that these first positive results with a single dose infusion with our off-the shelf and allogeneic NK cell product, are confirming our observations from our past clinical trial," said Kai Pinkernell, MD, Chief Medical Officer of Glycostem.
The first patient converted to measurable residual disease (MRD) negativity (<0.1%) as assessed by multiparametric flowcytometry (MFC) on bone marrow on day 0, which was sustained at 1, 2, 3 and 6 months. NPM1 MRD, which was detectable by next generation sequencing (MRD-NGS) up to month 1 in peripheral blood (PB), became undetectable by month 2, 3 and 6 in PB (<0.01%VAF). Results in BM showed that NPM1 MRD was detectable at month 1 but was cleared at months 3 and 6.
The second patient showed MRD positivity in BM by MFC at screening and on day 0, which turned to MRD negativity at month 1, turning positive again at month 2 and 3. Assessments in PB and BM by MRD-NGS showed that a IDH2 and a SRSF2 clone persisted after preconditioning and GTA002 infusion, but that a PTPN11 clone became undetectable in PB by Day 0 and in BM by month 2 and month 3.
The most recent available follow up will be presented at time of presentation.