On July 1, 2021 XNK Therapeutics AB ("XNK") reported that the first patient has been included in a Phase II clinical study to treat patients with Multiple myeloma using XNK’s leading autologous natural killer (NK) cell-based candidate drug in combination with Sanofi’s anti-CD38 antibody Sarclisa (Isatuximab).
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"Having the first patient included in this clinical study is a key step in XNK’s development", said Johan Liwing, CEO of XNK Therapeutics. "While our leading drug candidate is now entering into Phase II, we are in parallel dedicated to progressing our clinical development plan into other indications building on a Phase I/II first-in-human study".
The present investigator-initiated, open, randomized, controlled, Phase II study ISA-HC-NK (EudraCT: 2020-000994-26) compares XNK’s leading candidate drug combined with Sanofi’s anti-CD38 antibody Isatuximab with Isatuximab alone as a consolidation treatment following autologous stem cell transplantation in patients with newly diagnosed Multiple myeloma. The clinical study takes place at the Karolinska University Hospital at its Huddinge site, and encompasses at total of 60 patients with 30 patients in each treatment arm.
"Combining NK cells that mediate antibody dependent cellular cytotoxicity (ADCC) with targeted antibodies is an appealing concept. The idea envisaged is a synergetic effect with possible reduced toxicity, helping the Multiple myeloma patients maintaining a disease-free stage. This study is unique as it is the first investigator-initiated study randomizing patients to an NK cell-based therapy", said Hareth Nahi, Associate Professor at Karolinska Institutet and Principal Investigator for the study.
XNK Therapeutics and Sanofi are both collaborative industrial partners within NextGenNK, a recently established Competence Center for the development of next-generation NK cell-based cancer immunotherapies coordinated by Karolinska Institutet and supported by Sweden’s Innovation Agency (Vinnova).