SAN DIEGO, June 30, 2021 (GLOBE NEWSWIRE) — TRACON Pharmaceuticals, a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., announced today the appointment of Ya Huang as Executive Director of Statistical Programming and the grant of an inducement equity award to Mr. Huang.
Mr. Huang brings more than two decades of broad statistical programming experience to TRACON, including most recently as a Senior Director at Arena Pharmaceuticals, and past roles at Halozyme Therapeutics, Gilead, and Amylin Pharmaceuticals.
“As we remain focused on preparing for the expected BLA filing for envafolimab in sarcoma, it is critical that we continue to expand our senior statistical data team,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “We are excited to have someone as highly experienced as Mr. Huang in this critical area lead our statistical programming activities.”
In connection with the appointment of Mr. Huang as Executive Director, Statistical Programming, Mr. Huang was issued an inducement award consisting of an option to purchase an aggregate of 37,000 shares of the Company’s common stock. The option was granted in accordance with Nasdaq Listing Rule 5635(c)(4) under the TRACON Pharmaceuticals, Inc. Amended and Restated 2015 Equity Incentive Plan (the “2015 Plan”) and was approved by TRACON’s Compensation Committee. The option has an exercise price per share equal to $6.94, which was the closing price of TRACON’s common stock on the Nasdaq Capital Market on the date of grant. The option vests over four years, with 25% of the option shares vesting on the first anniversary of the date of grant and the remaining 75% of the option shares vesting in monthly installments over the three years thereafter. The option has a 10-year term, and is subject to the terms and conditions of the 2015 Plan and applicable stock option agreement.
About Envafolimab
Envafolimab, a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by TRACON, has been studied in a completed Phase 2 pivotal trial as a single agent in MSI-H/dMMR advanced solid tumor patients in China and is being studied in an ongoing Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China, with both Chinese trials sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021.
About ENVASARC
The ENVASARC pivotal trial is a multi-center, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, 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. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.
About TRACON
TRACON develops targeted therapies for cancer utilizing a capital efficient, CRO independent, product development platform. The Company’s clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors. TRACON is actively seeking additional corporate partnerships whereby it leads U.S. regulatory and clinical development and shares in the cost and risk of clinical development and leads U.S. commercialization. In these partnerships TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the U.S. To learn more about TRACON and its product pipeline, visit TRACON’s website at www.traconpharma.com.
