Full Press Release Details
SAN DIEGO--(BUSINESS WIRE)--Janux Therapeutics, Inc. (Nasdaq: JANX) (“Janux”), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, today announced that it will discontinue further clinical development of JANX008, its EGFR-targeted Tumor Activated T Cell Engager (TRACTr) program.
Following completion of the Phase 1a portion of the study, which included dose escalation and expansion cohorts across multiple solid tumor indications, and an internal review of the data, the Company has determined to prioritize development resources toward other pipeline opportunities. The decision to discontinue JANX008 is program-specific and does not impact the Company’s broader TRACTr platform strategy. As part of its disciplined portfolio prioritization process, the Company evaluated the JANX008 dataset against predefined development criteria. While durable responses were observed in select patients through extended follow-up, the overall magnitude and consistency of activity were not sufficient to support continued development relative to other pipeline programs.
The study also generated insights relevant to the broader TRACTr platform. The occurrence of cytokine release syndrome (CRS) was infrequent and primarily limited to Grade 1, enabling Safety Review Committee approval for outpatient dosing. In addition, JANX008 demonstrated a differentiated tolerability profile relative to conventional EGFR-targeted therapies, with minimal gastrointestinal, dermatologic, and subcutaneous adverse events typically associated with EGFR antibodies and tyrosine kinase inhibitors. These findings, together with the ability to dose beyond the limitations of conventional T cell engagers, support the potential of the TRACTr platform to improve safety. While musculoskeletal adverse events were dose-limiting, reflecting constraints associated with the EGFR target, the TRACTr format enabled a sufficient therapeutic window to assess clinical activity across a range of doses.
“Our decision to discontinue JANX008 reflects the disciplined approach we take to advancing our pipeline,” said David Campbell, Ph.D., President and Chief Executive Officer of Janux. “We evaluate each program against a high bar for safety, activity, and differentiated profile. We prioritize resources toward programs that meet these criteria and offer opportunities to deliver best-in-class outcomes.”
“The JANX008 study enabled a rigorous evaluation of activity for this EGFR-targeted TRACTr construct,” said William Go, M.D., Ph.D., Chief Medical Officer of Janux. “We observed objective responses and disease control across treated patients. These findings provide important insight into how target biology and masking strategy define the therapeutic window and inform the continued advancement of our pipeline.”
About Janux Therapeutics
Janux is a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms.
Janux’s lead clinical candidate, JANX007, is a PSMA-targeted TRACTr being investigated in a Phase 1 clinical trial in patients with metastatic castration-resistant prostate cancer (mCRPC). The Company is also advancing additional PSMA-targeted programs, including JANX014, a double-masked PSMA TRACTr being evaluated in a Phase 1 clinical trial, and JANX013, a CD28 co-stimulatory TRACIr designed for combination with JANX007.
Beyond its prostate cancer programs, Janux’s pipeline includes JANX011, a CD19-targeted ARM being evaluated in a Phase 1 clinical trial in healthy adult volunteers for potential treatment of autoimmune diseases. Janux continues to generate additional TRACTr, TRACIr, and ARM programs for potential future development.
For more information, please visitwww.januxrx.comand follow us on LinkedIn.
Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, Janux’s ability to bring new treatments to cancer patients in need, expectations regarding the timing, scope and results of Janux’s development activities, including its ongoing and planned preclinical studies and clinical trials, the potential benefits of Janux’s product candidates and platform technologies, and expectations regarding the use of Janux’s platform technologies to generate novel product candidates. Factors that may cause actual results to differ materially include the risk that interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations, the risk that compounds that appear promising in early research do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Janux may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings and applications, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties Janux faces, please refer to Janux’s periodic and other filings with the Securities and Exchange Commission, which are available atwww.sec.gov. Such forward-looking statements are current only as of the date they are made, and Janux assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Investors:Chad RubinEndurance Advisorscrubin@enduranceadvisors.com646.319.3261
Media:Jessica Yingling, Ph.D.Little Dog Communications Inc.jessica@litldog.com858.344.8091