The clinical stage biopharmaceutical company said the FDA has agreed with its proposals regarding key elements of the pivotal ENVASARC trial for envafolimab in the soft tissue sarcoma subtypes of undifferentiated pleomorphic sarcoma and myxofibrosarcoma.
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As a result, TRACON expects to initiate enrollment in the ENVASARC trial in the second half of 2020.
Envafolimab is an antibody being developed to treat sarcoma, uncommon cancers that can affect any part of the body including muscle, bone, tendons, blood vessels and fatty tissues.
In a statement, Charles Theuer, president and chief executive of TRACON said: “We appreciate the valuable discussions and guidance from our Type B meeting discussion with the FDA and concurrence on the design for the pivotal trials of envafolimab in sarcoma.
"Following the successful completion of the regulatory meeting, we are focused on advancing envafolimab as a single agent and in combination with Yervoy (ipilimumab) for the treatment of the sarcoma subtypes of UPS and MFS, both of which have been shown to be responsive to immune checkpoint inhibition treatment. We look forward to initiating ENVASARC later this year.”
TRACON is developing target therapies for cancer including envafolimab as well as other treatments in its pipeline such as TRC253, a small molecule drug candidate for the treatment of prostate cancer; TRC102, a small molecule drug candidate being developed for the treatment of lung cancer; and TJ004309, a CD73 antibody for the treatment of advanced solid tumors.
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