Janux Therapeutics Announces First Patient Dosed in Phase 1 Study of JANX013

- JANX013 is a novel PSMA-targeted tumor-activated CD28 co-stimulatory bispecific designed to further enhance the durability of anti-tumor immune responses in combination with Janux’s PSMA-targeted T cell engager candidates

- Study will evaluate JANX013 in combination with Janux’s PSMA-targeted T cell engager candidates, initially JANX007, in patients with metastatic castration-resistant prostate cancer (mCRPC)

- JANX013 is designed to further differentiate Janux’s prostate cancer franchise through tumor-activated CD28 co-stimulation

SAN DIEGO--(BUSINESS WIRE)--Janux Therapeutics, Inc. (Nasdaq: JANX), a clinical-stage biotechnology company developing tumor-activated immunotherapies, today announced that the first patient has been dosed in the Phase 1 clinical trial evaluating JANX013, Janux's novel PSMA-targeted tumor-activated CD28 co-stimulatory bispecific, in patients with metastatic castration-resistant prostate cancer (mCRPC).

The program is initially being developed in combination with JANX007, with the goal of further enhancing the durability of anti-tumor immune responses through tumor-restricted CD28 co-stimulation. Over time, Janux intends to evaluate JANX013 in combination with additional candidates within its prostate cancer portfolio.

Prostate cancer is the most commonly diagnosed cancer in men, excluding skin cancers. Clinical experience with Janux's PSMA-targeted T cell engager candidates has demonstrated the potential of tumor-activated T cell immunotherapy in patients with metastatic castration-resistant prostate cancer. CD28 is a key co-stimulatory receptor involved in T-cell activation, expansion, and persistence. JANX013 is designed to selectively deliver CD28 co-stimulation within the tumor microenvironment using Janux’s proprietary tumor-activation technology, with the goal of further enhancing the durability of anti-tumor immune responses while minimizing systemic CD28 activation.

"Co-stimulation plays a critical role in promoting sustained T-cell function and persistence," said Simon Butikofer, M.D., Vice President, Clinical Development. "JANX013 is designed to selectively deliver tumor-restricted co-stimulation in combination with our CD3 T cell engagers, with the goal of extending the durability of anti-tumor immune responses."

"The initiation of the JANX013 clinical program represents an important milestone in the continued evolution of our prostate cancer franchise," said David Campbell, Ph.D., President and Chief Executive Officer of Janux Therapeutics. "By combining complementary tumor-activated immunotherapies, we believe we have an opportunity to further improve long-term outcomes for patients with prostate cancer."

The Phase 1 clinical trial (NCT07813637) is a first-in-human, open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of JANX013 in combination with JANX007 in adult patients with mCRPC. In addition to evaluating safety, the study is intended to evaluate biomarkers of immune activation, including T-cell expansion and persistence, to characterize the effects of tumor-restricted CD28 co-stimulation and inform future clinical development of JANX013.

For additional information about the study, please visit ClinicalTrials.gov using the identifier NCT07813637.

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 being evaluated in a Phase 1 clinical trial in 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 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.