Sunday, Nurix Therapeutics Inc (NASDAQ:NRIX) announced the presentation of updated clinical data for NX-5948, an orally bioavailable degrader of Bruton's tyrosine kinase (BTK).
BTK inhibitors have become a major commercial class, with drugs such as BeiGene Inc's (NASDAQ:BGNE) Brukinsa (Zanubrutinib), Eli Lilly And Co's (NYSE:LLY) Jaypirca (Pirtobrutinib), Johnson & Johnson's (NYSE:JNJ) Imbruvica (Ibrutinib), and AstraZeneca Plc's (NASDAQ:AZN) Calquence (Acalabrutinib).
NX-5948 is being evaluated in an ongoing Phase 1a/b trial in adults with relapsed or refractory B-cell malignancies, including CLL and non-Hodgkin lymphoma (NHL).
The data presented at EHA include safety findings for all patients in the Phase 1a dose escalation study regardless of diagnosis (n=79) and efficacy findings for those patients with relapsed or refractory CLL (n=31).
Patients were treated with NX-5948 at doses ranging from 50 to 600 mg once daily by oral administration.
NX-5948 was well tolerated across all doses evaluated, with the most common treatment-emergent adverse events of purpura/contusion, thrombocytopenia, and neutropenia.
Among the efficacy-evaluable patients with CLL (n=26), NX-5948 treatment resulted in an objective response rate (ORR) of 69.2% across all doses tested.
Responses were observed as early as the first scan (8 weeks), and many patients experienced a deepening of their response with longer treatment time.
All responses remained ongoing as of the April 17 data cutoff.
Dr. Linton also presented an updated case report detailing the response of one patient who entered the study with CLL with CNS involvement after undergoing three prior therapies.
After daily treatment with 100 mg, and later 300 mg, of NX-5948, the patient exhibited a deepening response approaching complete response criteria by 36 weeks, with malignant cells eliminated in the cerebrospinal fluid (CSF) by 24 weeks.
Another case report presented by the company involved a patient who had received eleven prior lines of therapy. After daily treatment with 200 mg of NX-5948, the patient achieved a response by week 8, which deepened over time and was ongoing with over six months of follow-up.
"We intend to move rapidly forward with the goal of initiating pivotal trial(s) with NX-5948 in 2025," said Arthur Sands, president and CEO of Nurix.
Analyst Reaction:
- JP Morgan maintains Nurix with an Overweight rating, raising the price target from $30 to $31.
- Needham reiterates Nurix Therapeutics with a Buy and maintains $31 price target.
Price Action: NRIX shares are down 3.26% at $14.69 at last check Monday.
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