TRACON Pharmaceuticals Inc (NASDAQ:TCON) revealed Monday that the US Food and Drug Administration (FDA) has given the go-ahead for its human trial of envafolimab for sarcoma cancer and the firm said it expects to start enrolling patients in the trial at 25 sites in the US in the fourth quarter of 2020.
The group noted that the FDA granted approval to start the pivotal ENVASARC study after it filed the protocol as part of an Investigational New Drug (IND) application on July 15 this year.
Envafolimab (KN035) is a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in registrational trials.
“Immunotherapy has radically changed the treatment paradigm for a number of cancers and our hope is envafolimab will do the same for sarcoma patients who have few treatment options,” Dr James Freddo, chief medical officer of TRACON said in a statement.
Key points in this registrational trial are:
- Multi-center, open-label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States.
- Eligible patients will have received one or two prior cancer therapies, but no prior immune checkpoint inhibitor therapy.
- Planned total enrollment of 160 patients, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy.
- Primary endpoint of objective response rate (ORR) with duration of response a key secondary endpoint.
- Open-label format with blinded independent central review of efficacy endpoint data.
TRACON Pharma shares shot up over 21% in pre-market deals to US$2.07.
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Published at Mon, 17 Aug 2020 13:25:00 +0000-TRACON Pharmaceuticals shares surge as it receives FDA nod for envafolimab trial in USA