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Janux Therapeutics Highlights Pipeline Progress and Best-in-Class Potential of Novel Bispecific Platform for Autoimmune Diseases at Virtual R&D Day

via Business Wire
  • PSMA-TRACIr designed to be combined with potentially best-in-treatment asset, JANX007, and provide CD28 co-stimulation to further differentiate depth and durability of patient responses.
  • TROP2-TRACTr adds first-in-class and best-in-class opportunity targeting multiple solid tumors with preclinical data supporting differentiated safety and efficacy potential.
  • CD19-ARM displayed rapid, deep and durable B-cell depletion in periphery and tissues with a prolonged memory B cell reset while maintaining a large safety window in non-human primates, advancing toward first-in-human trials anticipated to begin in the first half of 2026.
  • Webcast to be held today at 1:30 PM PT.

Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technologies to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, will host its virtual R&D Day today at 1:30 PM PT. The event will highlight the company’s continued momentum in advancing its novel immunotherapy platforms—TRACTr and TRACIr, as well as ARM—designed to address significant unmet needs in oncology and autoimmune diseases.

“At Janux, we are guided by a deep commitment to scientific excellence and a belief that innovation should translate into meaningful outcomes for patients,” said David Campbell, Ph.D., President and CEO of Janux Therapeutics. “The progress we’ve shared today across our TRACTr, TRACIr, and ARM platforms reflects our disciplined strategy to focus first on maximizing the benefit and value of our clinical program JANX007, second to harness the value of our clinical experience by bringing forward TRACTrs where we can potentially be first- and/or best-in-class, and third to utilize our T cell engager development expertise to enable platform technologies that address other clear gaps in the treatment landscape.”

Creating an Opportunity to Further Differentiate JANX007 with TRACIr Combination

Janux is advancing its CD28-based TRACIr platform designed to enhance T cell activation and durability of its CD3-based TRACTr platform. TRACIr was built on the same technology with the same tumor-activation and PK design features as TRACTr and combines tumor targeting with immune costimulation. The TRACIr platform represents a strategic extension of Janux’s tumor-activated approach, designed to complement and enhance the clinical potential of its TRACTr portfolio, beginning with PSMA-TRACTr JANX007.

While JANX007 has already demonstrated differentiated clinical activity in late-stage metastatic castration-resistant prostate cancer (mCRPC) patients, the addition of a PSMAxCD28-TRACIr introduces a costimulatory signal that may further enhance durability of response within the tumor microenvironment. This combination has the potential to drive more prolonged anti-tumor effects without increasing systemic toxicity, positioning Janux to further differentiate JANX007 in the mCRPC treatment landscape. IND-enabling studies are underway for the PSMA-TRACIr, with clinical trials in combination with JANX007 expected to begin in the second half of 2026.

Expanding the TRACTr Platform into High-Value Oncology Indications

Building upon learnings from the JANX007 and JANX008 clinical programs, Janux introduced its latest trophoblast cell surface antigen 2 (TROP2) TRACTr program. This next-generation TROP2-TRACTr was engineered for potential best-in-class safety and efficacy across a broad range of TROP2-expressing tumors, including breast, lung and bladder cancers. Janux’s TROP2-TRACTr exemplifies the TRACTr technology’s ability to create high-value T cell engager (TCE) product candidates directed at tumor targets that contemporary TCE technologies have been unable to access due to broad healthy tissue expression.

Janux’s TROP2-TRACTr product candidate demonstrated strong potency across multiple tumor types, activity at low TROP2 expression levels, and was well tolerated in non-human primates with no signs of cytokine release syndrome (CRS) or healthy tissue toxicity. This preclinical data also displayed the ability to overcome limitations of existing TROP2-targeted therapies, including antibody drug conjugates. These findings support a wide therapeutic window and the potential for best-in-class performance in TROP2-expressing solid tumors. IND-enabling activities are planned in the second half of 2025.

ARM Platform Redefines T-Cell Engagers for Autoimmune Disease and Oncology

Janux also introduced its Adaptive Immune Response Modulator (ARM) bispecific platform, designed to overcome the limitations of conventional TCEs in autoimmune diseases and oncology.

  • Builds upon Janux’s expertise to redesign bispecific TCEs.
  • Differentiated non-clinical profile provides best-in-class opportunity in autoimmune diseases.
  • Potential broad applicability across multiple disease areas.
  • Large safety window and off-the-shelf format position it for higher dosing, rapid development and potential best-in-class performance.

The lead program, a CD19-ARM, has displayed rapid, deep and durable B-cell depletion in periphery and tissues with a prolonged memory B cell reset while maintaining a large safety window in non-human primates, supporting a potential best-in-class profile.

  • ARMs exhibit differentiated durable T cell activity with reduced T cell exhaustion preclinically.
    • The program demonstrated prolonged memory B-cell depletion and immune reset from a single subcutaneous dose, reflecting the durability seen with CD19 CAR-T therapies but with greater safety and convenience.
  • ARMs displayed potential to dose to maximum efficacy while enabling safer, outpatient-friendly dosing.
    • In non-human primates, CD19-ARM achieved deep and durable B-cell depletion in both blood and lymphoid tissues with a >100x CRS safety window.

The CD19-ARM is on track for first-in-human studies to begin in the first half of 2026.

Event Information

To join the webcast, please visit this link, or the Events & Presentations page of the Investors section on the Company’s website https://www.januxrx.com. A replay of the webcast will be archived and available following the event.

Participant Dial-In Numbers:

USA / International Toll +1 (646) 307-1963

USA - Toll-Free (800) 715-9871

Conference ID 9235403

Janux’s TRACTr, TRACIr and ARM Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC. Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) 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. Janux is also advancing additional CD3-based TRACTr and CD28-based TRACIr programs for future clinical development, including a PSMA-TRACIr for use in combination with our PSMA-TRACTr JANX007, and a TROP2-TRACTr for the treatment of TROP2+ solid tumors. Janux is also advancing its first ARM platform program candidate, a CD19-ARM for the potential treatment of autoimmune diseases toward clinical trials.

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 has two TRACTr therapeutic candidates in clinical trials, the first targeting PSMA is in development for prostate cancer, and the second targeting EGFR is being developed for 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. For more information, please visit www.januxrx.com and 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 clinical trials, and the potential benefits of Janux’s product candidates and platform technologies. 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 at www.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.

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