TRACON Pharmaceuticals Inc (NASDAQ:TCON) announced Monday it has submitted a request for a Type B meeting with the US Food and Drug Administration to discuss the trial design for a potential pivotal ENVASARC study of envafolimab to treat sarcoma.
In a statement, the company said it plans to propose a trial with two cohorts of about 80 patients each to assess the objective response rate in sarcoma subtypes known to be responsive to checkpoint inhibition -- with one cohort receiving single-agent envafolimab and the second cohort receiving envafolimab and Yervoy (ipilimumab).
“We have taken the first step towards beginning the ENVASARC study of envafolimab in sarcoma subtypes known to respond to checkpoint inhibitors. This initiates a series of expected events that we anticipate will culminate in dosing the first patient in a potential pivotal trial in the second half of the year,” said CEO Dr Charles Theuer.
“We believe the proposed study design that utilizes two cohorts provides for greater treatment options for patients and lowers envafolimab’s clinical risk by providing two potential pathways for approval,” Dr Theuer added.
Looking ahead, TRACON said it expects to achieve several envafolimab milestones during the next six months:
- Type B meeting with the FDA to discuss the potential pivotal trial design of ENVASARC for envafolimab
- File IND for envafolimab to conduct the planned ENVASARC study
- Apply for orphan drug designation for envafolimab in soft tissue sarcoma
- Submission of regulatory approval for envafolimab in China by partners 3D Medicine and Alphamab Oncology
- Presentation of envafolimab clinical data at ASCO by 3D Medicine and Alphamab
- Enroll the first patient in ENVASARC
TRACON, based in San Diego, is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and fibrotic diseases.
Envafolimab is currently being dosed in Phase 1 trials in the US, China and Japan, a Phase 2 registration trial as a single agent in MSI-H tumor patients in China, and in a Phase 3 registration trial in biliary tract cancer in combination with gemcitabine and oxaliplatin in China.
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