Trial Launches to Study a New Drug for B-Cell Malignancies

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NX-5948 may be able to pass through the blood-brain barrier in patients with B-cell malignancies, potentially making it a promising option for patients with disease in their central nervous system.

The first patient was treated in a phase 1a/b clinical trial that will evaluate NX-5948 in patients with relapsed or refractory B-cell malignancies, such as mantle cell lymphoma, chronic lymphocytic leukemia, non-Hodgkin lymphoma and more, according to Nurix, the manufacturer of the drug.

The phase 1a portion of the open-label trial will be conducted in cancer treatment centers across the United Kingdom and will analyze safety and tolerability of NX-5948 in patients with relapsed or refractory B-cell malignancies who have received two prior systemic therapies (or one therapy for patients with Waldenstrom macroglobulinemia).

Then, the phase 1b part of the trial will use the dose determined in phase 1a and look at how NX-5948 works in each of the follow patient populations:

  • Chronic lymphocytic leukemia or small cell leukemia without a BTK C481 mutation
  • Chronic lymphocytic leukemia or small cell leukemia with a BTK C481 mutation
  • Diffuse large B-cell lymphoma or mantle cell lymphoma
  • Follicular lymphoma, marginal zone lymphoma or Waldenstrom macroglobulinemia
  • Primary central nervous system lymphoma or any of the listed B-cell malignancies with central nervous system involvement

NX-5948 is an oral drug that degrades Bruton tyrosine kinase (BTK), which signals for cancer cells in B-cell malignancies to keep growing. Preclinical research (studies that have not been done in humans) showed that the drug was able to cross the blood-brain barrier and work against blood cancer cells, even when the disease is in the central nervous system.

“We are excited to have initiated the trial of a second highly selective and potent BTK degrader, that has the additional feature of being able to cross the blood brain barrier,” Dr. Robert J. Brown, executive vice president of clinical development of Nurix, said in a press release. “NX-5948 has the potential to offer a differentiated clinical profile for patients with relapsed or refractory B cell malignancies.”

It is predicted that data from the phase 1a portion of the study will be available in the latter half of 2022.

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