Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), 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) and Tumor Activated Immunomodulator (TRACIr) platforms, today announced the first patient has been dosed in a Phase 1 clinical trial of JANX007 in subjects with metastatic castration-resistant prostate cancer (mCRPC). JANX007 is a prostate-specific membrane antigen (PSMA) directed T cell engager (TCE) and is the first product candidate utilizing Janux’s TRACTr platform to be administered in humans.

“We are excited to begin clinical evaluation of our first product candidate. Importantly, JANX007 has the potential for tumor-selective T cell activation and tumor cell killing,” said Wayne Godfrey, M.D., Chief Medical Officer at Janux. “Preclinical data have shown potent killing of tumor cells by JANX007, with less potential for systemic side effects from cytokine release when compared to an unmasked T cell engager.”

The first patient was dosed at Sarah Cannon Research Institute (SCRI). Ben Garmezy, M.D., Assistant Director of Genitourinary Research and the principal investigator from SCRI at Tennessee Oncology, notes, “PSMA is a highly expressed target in prostate cancer, so the opportunity for this therapeutic candidate to address an unmet need in late-stage prostate cancer patients would be meaningful. We look forward to exploring the safety and activity of this approach with JANX007 in prostate cancer patients.”

Janux is currently in the process of opening additional trial sites in the United States and Australia.

“The initiation of this first-in-human clinical trial represents a major milestone for Janux, as it marks the first therapeutic to be used in humans from our TRACTr platform,” said David Campbell, Ph.D., President and CEO of Janux. “Our TRACTr platform is designed to generate tumor-specific immune responses to attack and kill tumors without harming the patient’s healthy tissues. We believe these characteristics have the potential to allow JANX007 to overcome the limitations that have beset previous T cell engagers in prostate cancer. Most importantly, this trial underscores our commitment to addressing critical unmet needs for cancer patients as we pursue our mission to discover and deliver innovative immunotherapies that transform cancer patients’ lives.”

About the JANX007 Phase 1 Clinical Trial

The Phase 1 clinical trial is a multi-center, open-label dose escalation trial to evaluate ascending doses of JANX007 in patients with mCRPC. This trial will assess the safety, tolerability, pharmacokinetic, pharmacodynamic, and the preliminary efficacy of JANX007 as a single agent in adult subjects with mCRPC. For additional information about the trial, please visit clinicaltrials.gov using the identifier NCT05519449.

About Janux Therapeutics

Janux Therapeutics is an innovative clinical-stage biopharmaceutical company developing next-generation therapeutics based on applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms to better treat patients suffering from cancer. Janux’s initial focus is on developing a novel class of T cell engagers, and its lead product candidates are designed to target clinically validated drug targets. While TCE therapeutics have displayed potent anti-tumor activity in hematological cancers, developing TCEs to treat solid tumors have faced challenges due to the limitations of prior TCE technologies, namely (i) overactivation of the immune system leading to cytokine release syndrome, (ii) on-target, healthy tissue toxicities, and (iii) poor pharmacokinetics leading to short half-life. Janux is using its TRACTr platform technology to engineer product candidates designed to overcome these limitations by offering accuracy, stability, activity, modularity, and manufacturability. Janux is developing a broad pipeline with lead TRACTr programs targeting PSMA, epidermal growth factor receptor (EGFR), and trophoblast cell surface antigen 2 (TROP2). Janux is also applying its proprietary technology to develop a TRACIr costimulatory bispecific product candidate against programmed death-ligand 1 (PD-L1) and Cluster of Differentiation 28 (CD28) designed to further enhance the anti-tumor activity of T cells. For more information, please visit www.januxrx.com.

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, the potential benefits of such treatments and the progress and expected timing of Janux’s drug development programs. Factors that may cause actual results to differ materially include 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221012005257/en/