SAN DIEGO, CA, USA I December 27, 2022 IJanux 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 that the Company has submitted the investigational new drug (IND) application for JANX008 to the U.S. Food and Drug Administration, an EGFR-TRACTr in development for the treatment of EGFR-expressing solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), renal cell carcinoma (RCC), and squamous cell carcinoma of the head and neck (SCCHN).

“We are proud to announce today the submission of Janux’s second IND – a critical milestone for our TRACTr platform as we advance our broad pipeline of next generation immunotherapies,” said David Campbell, Ph.D., President and CEO of Janux. “JANX008 is uniquely designed to overcome cytokine release syndrome and known on-target EGFR healthy tissue toxicities, potentially allowing a breadth of opportunities in EGFR-expressing cancers.”

JANX008 is a double-masked TRACTr in which the EGFR-binding domain and the T cell-specific binding domain (CD3) is masked. In preclinical studies, JANX008 was well tolerated in non-human primates with limited healthy tissue toxicities and cytokine release syndrome and exhibited enhanced safety and PK properties relative to unmasked TCEs. These data along with the superior manufacturability properties of JANX008 support its further development as an attractive solid tumor therapeutic.

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 (TCEs), 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 prostate-specific membrane antigen (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

SOURCE: Janux Therapeutics