Biopharmaceutical company Nurix Therapeutics has initiated the first of several potential Phase 1b expansion cohorts in its ongoing Phase 1 trial of its lead drug candidate targeting relapsed or refractory B-cell malignancies
The company’s lead candidate, NX-2127, is an orally administered degrader of Bruton’s tyrosine kinase (BTK) with immunomodulatory activity. Nurix had initially launched NX-2127 in a multicentre Phase I study to assess its safety, pharmacokinetics, pharmacodynamics and preliminary clinical activity, in patients with relapsed or refractory B-cell malignancies.
Now, the company is expanding NX-2127 into patients with chronic lymphocytic leukaemia (CLL). Nurix says the expansion is based on positive data from its on-going Phase 1a dose escalation study of NX-21271.
These data include a meaningful clinical benefit in patients with relapsed refractory CLL who had taken an average of six prior therapies,
The expansion cohorts will include up to 40 patients with CLL, enrolled across multiple clinical sites in the US. Patients will have received two or more prior regimens including a Bruton’s tyrosine kinase (BTK) inhibitor.
“Our decision to advance NX-2127 in patients with CLL is based on the promising efficacy, safety, pharmacokinetic, and pharmacodynamic data from the ongoing Phase 1a dose escalation trial. There is a significant unmet need for a therapeutic approach with the potential to address the growing problem of relapse due to the development of BTK inhibitor resistance. We aim to meet that need and are encouraged by the emerging data demonstrating the potential of BTK degradation to treat acquired resistance mutations for both standard of care and newly developed BTK inhibitors,” said Robert J. Brown, Executive Vice President of clinical development at Nurix.