TRACON Pharmaceuticals Inc (NASDAQ:TCON) has been granted a Type B teleconference meeting with the US Food and Drug Administration on May 8 to discuss a potential pivotal trial of its drug envafolimab as a treatment for the tissue cancer sarcoma.
In a statement, the company said that, during the meeting, it expects to go over the design of the trial, which it has named ENVASARC.
In the next six months, TRACON will file an Investigational New Drug (IND) for envafolimab in order to conduct the study and apply for orphan drug designation for its use as a treatment for sarcoma.
Additionally, the company will submit a marketing application for envafolimab in China and present clinical data from its corporate partners, 3D Medicine and Alphamab Oncology.
If things go to plan, TRACON will enroll the first patient in ENVASARC within six months.
San Diego-based TRACON has positioned itself as a collaboration partner that leads the regulatory filings, clinical trials, as well as US commercialization of best-in-class drug candidates, as an alternative to expensive contract research organization (CRO) based development.
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