Janux Therapeutics, Inc. (Nasdaq: JANX), a clinical-stage biopharmaceutical company developing innovative immunotherapies, announced positive interim clinical data for its JANX007 program in metastatic castration-resistant prostate cancer (mCRPC). The company will host a virtual event today at 4:30 PM ET to discuss the results.
Dr. David Campbell, President and CEO of Janux, shared, “The clinical data demonstrate substantial activity with JANX007 in 5L mCRPC patients, supporting the selected doses for expansion trials targeting pre-PLUVICTO® 2L and 3L patients. We are excited to move forward with JANX007 in second- and third-line therapies, where there is a significant unmet need. This is a significant step forward for both Janux and the prostate cancer patients we aim to serve.”
As of November 15, 2024, the Phase 1a clinical trial of JANX007 involved 16 patients with advanced mCRPC who had received a median of four prior therapies. The patients received once-weekly doses ranging from 2 mg to 9 mg. The results showed high prostate-specific antigen (PSA) response rates: 100% of patients achieved PSA50 declines, 63% reached PSA90 declines, and 31% achieved PSA99 declines. In terms of durability, 75% of patients maintained PSA50 declines for over 12 weeks, while 50% maintained PSA90 declines. Anti-tumor activity was also observed in 50% of RECIST-evaluable patients, with confirmed or unconfirmed partial responses in 4 out of 8 patients.
JANX007 was well-tolerated, with cytokine release syndrome (CRS) and CRS-related adverse events mostly limited to the first cycle and generally of grade 1 or 2 severity. Treatment-related adverse events (TRAEs) unrelated to CRS were similarly mild and mostly confined to the first cycle. The maximum tolerated dose for JANX007 has not been reached.
Based on these positive results, Janux has identified two once-weekly step-dose regimens for Phase 1b expansion trials targeting pre-PLUVICTO® 2L and 3L patients. Janux plans to provide additional updates on JANX007 in 2025.
Webcast Information
Janux will host a live webcast today at 4:30 PM ET, followed by a Q&A session. To register, click here. The webcast replay will be available for 30 days on Janux’s investor website.
About Janux Therapeutics
Janux Therapeutics is a clinical-stage biopharmaceutical company developing tumor-activated immunotherapies to treat cancer. The company’s proprietary TRACTr and TRACIr platforms aim to deliver safe and effective cancer treatments by directing the immune system to target and eradicate tumors. Janux’s pipeline includes two TRACTr therapeutics: JANX007 for prostate cancer and JANX008 for various solid tumors, including colorectal, lung, and breast cancers.
