On Monday, Janux Therapeutics, Inc. (NASDAQ:JANX) revealed updated interim clinical data for its JANX007 clinical program.
“These clinical data show substantial activity with JANX007 in 5L metastatic castration-resistant prostate cancer patients and provide compelling support for the doses we’ve selected for expansion trials directed at pre-PLUVICTO 2L and 3L patients,” said David Campbell, president and CEO of Janux Therapeutics.
Novartis AG (NYSE:NVS) Pluvicto is a radiopharmaceutical used to treat adults with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer.
The patients enrolled in the trial were heavily pretreated with a median of four prior lines of therapy.
High prostate-specific antigen (PSA) response rates and deep PSA declines were observed across all doses; 100% of patients achieved the best PSA50 declines, 63% achieved the best PSA90 declines, and 31% achieved the best PSA99 declines.
Durability of PSA declines at a target dose ≥ 2 mg was observed; 75% of patients maintained PSA50 declines at ≥ 12 weeks, and 50% of patients maintained PSA90 declines at ≥ 12 weeks.
Deep and durable PSA responses were observed irrespective of resistance driver aberration status or prior treatments.
Anti-tumor activity was observed with confirmed and unconfirmed partial responses in 50% (4/8) of patients.
JANX007 was well-tolerated with cytokine release syndrome (CRS) and CRS-related adverse events primarily limited to cycle 1 and grades 1 and 2. The maximum tolerable dose for JANX007 has not yet been reached.
Based on these efficacy and safety results, two once-weekly step dose regimens have been identified for Phase 1b expansion trials directed at pre-Pluvicto 2L and 3L patients.
Janux anticipates providing another update on JANX007 in 2025.
William Blair analysts, in a Tuesday research note, wrote, “We believe the results exceed even lofty investor expectations.”
The analysts increased the peak sales estimate for JANX007 in the U.S. from $1.7 billion to $3 billion based on the drug’s improving clinical profile and reiterated its Outperform rating.
Despite the strong year-to-date share appreciation, Janux shares continue to have meaningful upside potential, they said.
“The updated results with JANX007 continue to support a best-in-disease profile, with strong safety and efficacy in heavily pretreated mCRPC patients,” they added.
Price Action: JANX stock is up 69.2% at $68 during the premarket session at last check Tuesday.
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