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International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
If we are unable to obtain and maintain sufficient intellectual property protection for our platform technologies and product candidates, or if the scope of the intellectual property protection is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products may be adversely affected.
Our (or the third parties with whom we work) actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation (including class claims) and mass arbitration demands; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse business consequences.
Overview We are an innovative clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying our proprietary technologies to our Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms.
Our initial focus is on developing a novel class of TRACTr therapeutics designed to target clinically validated TCE drug targets, while overcoming the liabilities associated with prior generations of TCEs.
Our first clinical candidate, JANX007, is a prostate-specific membrane antigen (PSMA) TRACTr being investigated in a Phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC).
In December 2024, we announced updated interim clinical data for JANX007 demonstrating meaningful and prolonged prostate-specific antigen (PSA) reductions, evidence of anti-tumor activity, a favorable safety profile with CRS and treatment-related adverse events (TRAEs) primarily limited to cycle 1 and lower grades, and pharmacokinetics consistent with the TRACTr mechanism of action.
In May 2025, we provided updated results from the patients reported in December 2024 that demonstrated consistent durability and safety profile supporting the initiation of Phase 1b expansion studies.
In December 2025, we announced updated interim clinical data demonstrating durability across both once-weekly (QW) and every-two-week (Q2W) Phase 1a expansion cohorts.
JANX007 continued to demonstrate a manageable safety profile, with CRS primarily limited to cycle 1 and grades 1 and 2, and preliminary Phase 1b data in taxane-na ve patients demonstrated rapid and deep PSA reductions with primarily grade 1 CRS.
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Our product candidates are based on novel technologies, which make it difficult to predict the timing, results and cost of product candidate development and likelihood of obtaining regulatory approval.
Our (or the third parties with whom we work) actual or perceived failure to comply with current or future federal, state and foreign laws, regulations, contracts, self-regulatory schemes, industry standards and other obligations relating to privacy and security could lead to regulatory investigations or actions (which could include civil or criminal penalties), private litigation (including class claims) and mass arbitration demands, adverse publicity, disruptions of our business operations and other adverse business consequences.
Overview We are an innovative clinical-stage biopharmaceutical company developing tumor-activated immunotherapies for cancer.
Our proprietary technology has enabled the development of two distinct bispecific platforms: Tumor Activated T Cell Engagers (TRACTr) and Tumor Activated Immunomodulators (TRACIr).
Our initial focus is on developing a novel class of TRACTr therapeutics designed to target clinically validated TCE drug targets, but overcome liabilities associated with prior generations of TCEs.
Our first clinical candidate, JANX007, is a prostate-specific membrane antigen or PSMA-TRACTr and is being investigated in a Phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC).
In December 2024 we announced updated interim clinical data for JANX007 which displayed meaningful and prolonged prostate-specific antigen (PSA) level drops, encouraging anti-tumor activity, a favorable safety profile including CRS and treatment-related adverse events (TRAEs) primarily limited to Cycle 1 and lower grades and PK consistent with the TRACTr mechanism-of-action.
Our second clinical candidate, JANX008, is an epidermal growth factor receptor or EGFR-TRACTr and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer.
The first patient for this trial was dosed in April 2023 and in February 2024 we announced positive early data for JANX008 that displayed anti-tumor activity in multiple tumor types with low-grade CRS and predominantly low-grade TRAEs.
We are currently assessing priorities in our preclinical pipeline.