TRACON Pharmaceuticals Inc (NASDAQ:TCON) announced Thursday its corporate partners will present positive data from a Phase 2 cancer trial of the drug envafolimab at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program.
The trial enrolled 103 patients in China with high-mutation (MSI-H) colorectal (CRC) or gastric cancer (GC) or who had deficient Mismatch Repair (dMMR) in other solid tumors. dMMR prevents cells from repairing mistakes made during the division process.
The objective response rate (ORR) of the population was 34%, the company said, of whom 80% were responding with a median follow up of 7.5 months.
READ: TRACON Pharmaceuticals believes its ENVASARC trial on envafolimab will enable a quick path to market
Specifically, the ORR in 39 patients with CRC who failed previous fluoropyrimidine, oxaliplatin and irinotecan treatments plus 11 with advanced GC who failed at least one systemic treatment with two or more tumor assessments was 30%, with the same median response rate and period.
The data will be presented in an abstract titled, “Envafolimab (KN035) in Advanced Tumors with Mismatch-Repair Deficiency” by TRACON’s corporate partners, 3D Medicines and Alphamab,
“We are impressed by the confirmed ORR of envafolimab from its pivotal trial in Chinese patients with MSI-H/dMMR cancer, which is a genetically defined tumor type,” CEO Charles Theuer said in a statement. “We believe these data are important in assessing the potential of this novel subcutaneously administered product candidate in TRACON’s initial indications in the US of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS), two soft tissue sarcoma subtypes which have responded to treatment with other checkpoint inhibitors.”
The study also showed that envafolimab was well tolerated with a safety profile comparable to currently approved PD-(L)1 checkpoint inhibitors but without the associated infusion-related reactions.
“Moreover, these data indicate that envafolimab’s activity in MSI-H cancer is similar to other checkpoint inhibitors, such as Keytruda or Opdivo but without infusion related reactions,” Theuer said. “We look forward to initiating our pivotal ENVASARC trial for envafolimab in UPS and MFS in the second half of 2020, for which we recently reached agreement on the key elements with the US FDA.”
TRACON, based in San Diego, is developing target therapies for cancer, including envafolimab. Other drug candidates in its pipeline include 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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