TRACON Pharmaceuticals Inc (NASDAQ:TCON) said it has dosed the first patient in a Phase 1/2 trial evaluating the company’s CTLA-4 antibody, YH001, in combination with its PD-L1 antibody envafolimab and with doxorubicin, in front line therapy of patients with malignant tumours.
The Phase 1/2 trial will assess the safety and efficacy of the triplet combination of YH001, envafolimab and doxorubicin in the common sarcoma sub-types of leiomyosarcoma and dedifferentiated liposarcoma, according to TRACON.
In addition, the San Diego-based company said its trial will assess the safety and efficacy of the double combination of YH001 and envafolimab in patients with the rare sarcoma subtypes of alveolar soft part sarcoma and chondrosarcoma.
READ: TRACON Pharmaceuticals ends 3Q with $17M cash and equivalents to fund operations into mid-2023
TRACON CEO Dr Charles Theuer said dosing the first patient in a trial that studies envafolimab with YH001 in front line sarcoma patients, including in combination with standard of care doxorubicin, is an important step to learn which sarcoma subtypes it should enroll in its Phase 3 trial.
“At the time in 2024 when we expect to seek accelerated approval from the FDA for envafolimab in the refractory sarcoma subtypes of UPS and MFS based on data from our ongoing ENVASARC clinical trial, we expect to be enrolling a Phase 3 trial for the full approval of envafolimab with YH001 in front line sarcoma patients,” Theuer said in a statement.
TRACON is a clinical stage biopharmaceutical company using a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to form partnerships with other life science companies.
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