TRACON Seeks FDA Nod For Initial-Stage Tissue Cancer Study


TRACON Pharmaceuticals TCON has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1/2 clinical study of YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients, including patients who have not received prior therapy.

The Phase 1/2 clinical trial is designed to evaluate the safety and efficacy of YH001 and envafolimab combination with or without doxorubicin in patients with the rare sarcoma subtypes.

In this study, YH001 initially given in combination with envafolimab, and then given in combination with envafolimab plus doxorubicin in patients with advanced or metastatic sarcoma.

Charles Theuer, Chief Executive Officer, stated, "With the submission of the IND, we are one step closer to bringing our triple combination of YH001, envafolimab and doxorubicin to front-line sarcoma patients, and pending clearance of the IND.”

The company is planning to initiate the Phase 1/2 clinical trial before end of this year.

Price Action : TRACON shares are trading higher at $1.85 on Monday at the time of publication.

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