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Janux Therapeutics Begins Phase I Trial of T-Cell Engager Therapy in EGFR-Positive Solid Tumors

NEW YORK – Janux Therapeutics on Thursday began a Phase I clinical trial of its EGFR-directed T-cell engager therapy JANX008 in advanced or metastatic solid tumors expressing EGFR.

Researchers will enroll up to 130 patients with EGFR-expressing colorectal, head and neck, non-small cell lung, and renal cell cancer in the study. They will assess the safety and tolerability of JANX008, along with preliminary anti-tumor activity.

"EGFR is a validated therapeutic target in several tumor types and highly expressed in many other tumor types, so the opportunity to target EGFR from the T-cell engager axis would be meaningful to address unmet medical needs in various disease types in oncology," Marwan Fakih, professor of medical oncology and therapeutics research at City of Hope and the principal investigator of the study, said in a statement.

Janux developed JANX008 using its Tumor Activated T-Cell Engager (TRACTr) platform, with which the firm can design drugs that have both a tumor antigen-binding domain and a CD3 T-cell binding domain. The drug is Janux's second candidate to enter clinical trials.

The San Diego-based firm's other clinical stage T-cell engager therapy is JANX007, which targets PSMA and is undergoing a Phase I trial in castration-resistant prostate cancer. The company also has preclinical T-cell engagers that target PD-L1 and TROP2 in solid tumors, including triple-negative breast, bladder, and lung cancer.