On December 27, 2022 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, reported 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) (Press release, Janux Therapeutics, DEC 27, 2022, View Source [SID1234625626]).
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"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.