The company also noted that as of May 5, it has initiated 22 US clinical sites and enrolled more than 20 patients in the pivotal ENVASARC trial of single-agent envafolimab and envafolimab combined with Yervoy, which has triggered the initial Data Monitoring Committee review of safety data from each cohort.
“We continue to be pleased with the pace of enrollment in the pivotal ENVASARC trial and remain on track to deliver interim data in the second half of this year and final data in 2022, CEO Dr Charles Theuer said in a statement.
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“We have now initiated 22 sites and have enrolled more than 20 patients which has triggered the initial Data Monitoring Committee review of safety data from each cohort, which we expect later this quarter,” Dr Theuer added.
In April, TRACON resubmitted its Orphan Drug Designation application to the US Food and Drug Administration (FDA) in response to a request for preclinical or clinical evidence of activity for its clinical-stage drug envafolimab for treating sarcoma. It expects correspondence from the FDA this quarter based on the amended application.
The company also outlined some other key upcoming milestones, including:
- Orphan Drug Designation for envafolimab in soft tissue sarcoma from the FDA in 1H 2021
- Independent Data Monitoring Committee review of ENVASARC safety data in 1H 2021
- American Society of Clinical Oncology (ASCO) presentation of ENVASARC pivotal trial design in 1H 2021
- ASCO presentation of TJ004309 Phase 1 data in 1H 2021
- Interim ENVASARC efficacy and safety data in 2H 2021
- Request FDA breakthrough therapy designation or Fast Track designation for envafolimab in 2H 2021
- Decision on the envafolimab New Drug Application (NDA) in MSI-H/dMMR cancer that is under priority review by the Chinese National Medical Products Administration (NMPA)
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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