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SAN DIEGO - Janux Therapeutics, Inc. (NASDAQ: JANX), a $1.9 billion market cap biopharmaceutical company focusing on cancer immunotherapies, has initiated a Phase 1b expansion study in the ongoing ENGAGER-PSMA-01 trial, targeting metastatic castration-resistant prostate cancer (mCRPC). According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet, crucial for supporting its ongoing clinical trials. This follows positive results from a Phase 1a dose escalation trial which showed a median radiographic progression-free survival (rPFS) of 7.5 months in 16 patients.
The Phase 1b study will enroll taxane-naïve mCRPC patients to collect further safety and efficacy data. The trial will test JANX007, a Tumor Activated T Cell Engager (TRACTr), as monotherapy at two dose regimens, with dosing once weekly or every two weeks. This study is part of Janux’s broader strategy to assess the potential of JANX007 in earlier-line mCRPC patient populations. With a current ratio of 59.2x, the company appears well-positioned to fund its clinical development programs.
In December 2024, interim data had indicated a median rPFS of 7.4 months, which has since improved marginally. The updated results also showed a 6-month rPFS of 65% for all patients, and 78% for those treated at 6mg and 9mg target doses. The safety profile remains consistent with previous reports.
Janux intends to initiate three additional Phase 1b expansion studies, evaluating JANX007 in various combinations and monotherapy settings to support dose selection for future registrational studies. The company’s Chief Medical Officer, Zachariah McIver, D.O., Ph.D., emphasized the need for novel, non-chemotherapeutic approaches for mCRPC, given the limitations of current treatments.
Further updates on JANX007, as well as JANX008, another TRACTr targeting epidermal growth factor receptor (EGFR), are expected in the second half of 2025. Janux will also host an R&D Day in mid-2025 to showcase progress from its preclinical pipeline.
Janux’s proprietary TRACTr and Tumor Activated Immunomodulator (TRACIr) platforms have generated multiple therapeutic candidates, with the first two in clinical trials targeting PSMA and EGFR for various solid tumors.
This news article is based on a press release statement from Janux Therapeutics. The company cautions that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected. With revenue growth of 31% in the last twelve months but an expected decline in net income this year, Janux continues its research and development efforts with the aim of providing new treatments for cancer patients. For detailed financial analysis and real-time updates, visit InvestingPro.
In other recent news, Janux Therapeutics has been the focus of attention due to its ongoing development of the ’007 therapy. Analyst Josh Schimmer from Cantor Fitzgerald reiterated an Overweight rating on the company, maintaining a price target of $200. The company is actively refining its Phase 3 protocols for ’007, which is being tested across various patient groups and treatment combinations. The estimated cost for each study ranges between $200 million and $250 million. Schimmer noted that early data for ’007 has shown promising results, although some clinical responses were interrupted due to treatment disruptions. Concerns have been raised over a Grade 3 cytokine release syndrome (CRS) event detailed in a patient blog post, but Schimmer suggested that this could be an isolated incident. He emphasized that if Grade 3 CRS events are infrequent, they could be managed with increased monitoring. Janux Therapeutics is also exploring a bi-weekly dosing regimen and a potential subcutaneous delivery method to improve patient access. The company is determining necessary CRS mitigation strategies for a subcutaneous option.
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