On Monday, Janux Therapeutics, Inc. (NASDAQ:JANX) experienced a significant surge in its stock value, climbing 54% following the release of positive interim clinical data for its prostate cancer drug candidate, JANX007. The data highlighted an encouraging efficacy and safety profile in the Phase 1a dose escalation study for patients with metastatic castration-resistant prostate cancer (mCRPC).
The clinical trial results demonstrated that JANX007 has substantial clinical activity in patients who have undergone extensive previous treatments, often referred to as 5L mCRPC patients. Notably, all patients involved in the study achieved a 50% or greater decline in prostate-specific antigen (PSA) levels, a key marker for prostate cancer. Furthermore, 63% of the patients saw a 90% decline in PSA levels, and 31% experienced a 99% decline.
The treatment also showed durability, with 75% of patients maintaining a 50% decline in PSA levels for 12 weeks or more, and half of the patients maintaining a 90% decline for the same period. The drug was well-received among patients, with most adverse events reported as manageable and primarily occurring during the first treatment cycle.
The promising data supports Janux’s clinical development strategy, aiming to expand trials to include patients who have not yet received PLUVICTO®, a treatment for mCRPC. The company has identified two once-weekly step dose regimens for the upcoming Phase 1b expansion trials targeting these pre-PLUVICTO® patients in the second and third lines of therapy.
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