Nurix Therapeutics (NRIX) 2024 Wells Fargo Healthcare Conference summary

Business and clinical development updates

• Planning first pivotal trial for NX-5948 in CLL in 2025, based on strong EHA data showing a 70% objective response rate in advanced, fourth-line-plus patients.

• NX-5948 addresses resistance to current BTK inhibitors, including patients resistant to pirtobrutinib, maintaining high response rates.

• Fast Track status granted by FDA for third-line-plus CLL; trial designs under consideration include accelerated approval strategies and randomized confirmatory trials.

• Expansion into second-line and first-line settings considered, with substantial patient populations in each; first-line may focus on combination therapies.

• Additional data updates for CLL and non-Hodgkin's lymphoma expected later this year, with ongoing enrollment and longer follow-up to assess durability and depth of response.

Safety and combination strategies

• NX-5948 shows a favorable safety profile with low rates of atrial fibrillation and hypertension, and improvements in cytopenias during therapy.

• Tumor lysis syndrome observed but manageable, especially in combination with venetoclax; overall, over 85 patients treated with a well-tolerated profile.

• Combination studies with venetoclax and anti-CD20 antibodies are planned, with preclinical models less informative than clinical data.

Pipeline and expansion opportunities

• Phase I-B expanded into indolent lymphomas (Waldenstrom's, marginal zone, follicular), targeting unmet needs and resistance in these populations.

• NX-5948 demonstrates CNS penetrance, with clinical activity in CNS lymphoma and CLL patients with CNS involvement, supported by preclinical and pharmacokinetic data.

• Potential expansion into autoimmune diseases, with MS and severe skin diseases under consideration; IND-enabling studies ongoing, with updates expected in 2025.

• Rapid proof-of-concept strategies considered for diseases with short readouts, such as pemphigus and CSU.