On Monday, Janux Therapeutics Inc JANX released updated data for its JANX007 in metastatic castration-resistant prostate cancer and JANX008 in late-stage solid tumors.
JANX007 is in a Phase 1a trial in heavily pretreated subjects with advanced or metastatic prostate cancer (mCRPC).
- As of February 12, 2024, 23 subjects were treated with JANX007 in the dose escalation portion of the Phase 1a trial. An increasing depth of prostate-specific antigen (PSA) declines, RECIST responses at higher doses were observed, and a favorable safety profile was maintained.
- At a starting dose ≥ 0.1 mg, 14 of 18 (78%) subjects achieved PSA30 declines, and 10 of 18 (56%) subjects achieved PSA50 declines.
- At a starting step dose of ≥ 0.2 mg, 6 of 6 (100%) subjects achieved PSA30 declines, and 5 of 6 (83%) subjects achieved PSA50 declines.
- Initial step doses of JANX007 ≥ 0.2 mg drove deeper and more durable PSA responses, including one subject that achieved a PSA90 decline.
- Cytokine Release Syndrome (CRS) was observed to be temporary and mild, presenting only as low-grade 1 or 2 events, and was quickly managed with treatment.
- Janux anticipates providing an update on doses for expansion in the second half of 2024.
JANX008 is in a Phase 1a trial in pretreated subjects with advanced or metastatic solid tumors known to express high levels of the EGFR target, including colorectal cancer (CRC), squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC).
- Encouraging signs of clinical activity were observed while a favorable safety profile was maintained.
- In one subject with NSCLC treated with JANX008 at 0.15mg once-weekly, a confirmed partial response (PR) by RECIST criteria with 100% reduction of the target lung lesion and elimination of liver metastasis with no CRS or TRAEs has been observed.
- This subject remains on treatment, and their PR has been maintained through their week-18 scan.
- One subject with RCC experienced a 12% reduction in the size of a large RCC mass and significant clinical benefit with Grade 1 CRS.
- The company continues the dose escalation and optimization portion of the trial for JANX008.
Janux’s stock has significantly increased following the announcement of a clinical update, prompting William Blair to emphasize the significance of the validation of Janux’s T-cell engager platform.
This validation is a crucial turning point for the company, leading the analyst to reiterate an Outperform rating.
Despite the recent uptick in share value, the analyst asserts that Janux remains undervalued. This undervaluation is attributed to the untapped potential of the company’s TRACTr platform and its capability to produce conditionally active multispecific molecules.
Price Action: JANX shares are up 186.5% at $43.26 on the last check Tuesday.
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