Janux Therapeutics Provides Program Update on Ongoing Phase 1 JANX008 Study

Key Terms

pharmacokinetics/pharmacodynamics medical

Pharmacokinetics/pharmacodynamics (PK/PD) describes how a drug moves through the body (absorption, distribution, breakdown and elimination) and how it affects the body (the relationship between dose and effect). Think of PK as the drug’s journey and PD as the drug’s impact at the destination; together they predict dosing, safety and effectiveness, which matter to investors because strong, predictable PK/PD data reduces development risk and informs commercial potential.

tracr medical

A tracr (short for trans-activating CRISPR RNA) is a small RNA molecule that helps the CRISPR gene-editing system find and cut specific DNA sequences, acting like an address label that attaches the editing tool to the correct spot in a genome. Investors care because tracr design influences how well gene-editing therapies work, their safety profile, intellectual property rights and regulatory hurdles—factors that materially affect a biotech company’s prospects and valuation.

mcrpc medical

mCRPC stands for metastatic castration‑resistant prostate cancer, a form of prostate cancer that has spread beyond the prostate and keeps progressing despite treatments that lower male hormones. It matters to investors because this stage is harder to treat, drives demand for new therapies, and often involves large, expensive clinical trials and regulatory decisions that can strongly influence a drug maker’s future revenue and stock value—think of it as a stubborn problem that creates both medical need and commercial opportunity.

cd3 medical

CD3 is a group of proteins on the surface of T cells, the immune system’s front-line soldiers, that act like a control panel to turn those cells on and off. It matters to investors because many modern therapies work by engaging or blocking CD3 to direct T cells against cancer or dampen harmful immune reactions; success, safety and regulatory approval of CD3-targeting drugs can significantly affect a biotech company’s prospects.

cd28 medical

A protein found on the surface of T cells that acts like a gas pedal for the immune system: when it receives the right signal it helps activate T cells to attack infections or abnormal cells. Investors care because therapies or drugs that target this protein can boost or dial back immune responses, affecting how well treatments for cancer, autoimmune disease, or vaccines work and their safety profile—key factors in drug value and regulatory risk.

trop2 medical

Trop2 is a protein found on the surface of many cancer cells that acts like a visible flag doctors and drugmakers can use to find and attack tumors. It matters to investors because drugs designed to bind Trop2 can deliver treatment directly to cancer cells, affecting how well a therapy works, which patients it helps, and the potential market and regulatory value of companies developing those targeted treatments.

SAN DIEGO--(BUSINESS WIRE)-- Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies based on its proprietary Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, today provided a program update on its ongoing Phase 1 study evaluating JANX008, its EGFR-targeted TRACTr, in multiple solid tumor indications.

JANX008 is being evaluated in an ongoing Phase 1 study (NCT05783622) designed to assess safety, pharmacokinetics/pharmacodynamics, and evidence of clinical activity. The Phase 1a dose-escalation portion of the study has been completed, and the program has initiated expansion cohorts to enable further evaluation and support continued dose optimization across selected solid tumor settings.

Janux expects to provide additional updates on JANX008 as the study progresses and data continue to mature.

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 advancing its first ARM platform program candidate, a CD19-ARM for the potential treatment of autoimmune diseases toward clinical trials. Janux is also generating a number of additional TRACTr, TRACIr and ARM programs for potential future development.

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 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 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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Investors:

Chad Rubin

Endurance Advisors

crubin@enduranceadvisors.com

646.319.3261

Media:

Jessica Yingling, Ph.D.

Little Dog Communications Inc.

jessica@litldog.com

858.344.8091

Source: Janux Therapeutics