Nanexa has started the Phase 1 study of NEX-20 according to plan
Nanexa AB (publ) today announced that the first dose of NEX-20 has been administrated in the Phase 1 study NEX-20-01.
NEX-20-01 is a phase 1 study dosing a single injection of NEX-20 to healthy volunteers to follow the pharmacokinetic profile, safety, and tolerability. The study is designed to study different dose levels in sequential dose groups, based on data evaluated during the course of the study.
“Having completed the preclinical program for NEX-20, we will in this study now be able to confirm the depot length of our first PharmaShell® formulation of lenalidomide in humans. These data from healthy volunteers enable our continued planning for dosing of NEX-20 in patients with the life-threatening blood cancer disease multiple myeloma. This is another big step forward for Nanexa on our way to reducing the treatment burden for patients and healthcare providers with the help of PharmaShell®,” says David Westberg, CEO of Nanexa.
NEX-20 is a long-acting formulation of lenalidomide based on Nanexa’s drug delivery system PharmaShell®. Lenalidomide is an immunomodulatory compound targeting both cancer cells and their microenvironment (1). Currently patients take lenalidomide daily as an oral capsule for 21-28 days in 28-day cycles.
Studies show that many patients with multiple myeloma have poor adherence to oral lenalidomide treatment (2). One monthly injection of NEX-20 administered in the clinic would replace daily oral dosing of lenalidomide and would make sure that patients receives the correct dose during treatment. This type of customized depot preparation is promising for patients as you could expect a better clinical effect as a result of improved treatment compliance," says David Westberg.
- A review of the history, properties, and use of the immunomodulatory compound lenalidomide Zeldis et al. Ann N Y Acad Sci. 2011 Mar;1222:76-82
- Adherence to Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma. Hira Mian, Mark Fiala, Tanya M Wildes Clin Lymphoma Myeloma Leuk. 2020;20(2):98-104.e1. doi: 10.1016/j.clml.2019.09.618. Epub 2019 Oct 9. PMID: 31843543