TRACON Pharmaceuticals
TRACON Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing and commercializing novel targeted therapies for cancer, including their lead product candidate, envafolimab, for the treatment of sarcoma.
Lead Product Candidate: Envafolimab
Envafolimab is TRACON Pharmaceuticals' lead product candidate, a novel single-domain PD-L1 antibody being developed for the treatment of sarcoma. It is administered by subcutaneous injection without the need for an adjuvant. Currently, it is dosing in the ENVASARC pivotal Phase 2 trial in the US. Approved in China by the National Medical Products Administration for MSI-H cancer patients, envafolimab is also being studied in combination with gemcitabine and oxaliplatin in a Phase 3 registration trial for biliary tract cancer.
Product Pipeline: YH001 and TRC102
TRACON Pharmaceuticals' product pipeline includes YH001 and TRC102. YH001, a CTLA-4 antibody, is in Phase 1/2 development for sarcoma treatment, demonstrating enhanced cellular cytotoxicity and superior T cell activation in preclinical studies. It is being dosed in a Phase 1 trial in China and in combination with PD-1 antibody toripalimab in Australia. TRC102 is a small molecule inhibitor of the DNA base excision repair pathway, currently in Phase 2 clinical development for mesothelioma and undergoing multiple trials.
Collaborations and Partnerships
TRACON Pharmaceuticals has executed several strategic partnerships using a novel approach, collaborating with well-known entities like J&J, 3D Medicines, Alphamab Oncology, Eucure Biopharma, and I-Mab. Significant deals include a strategic licensing collaboration with Janssen Pharmaceutica N.V. for the development of JNJ-63576253 (TRC253) for prostate cancer treatment. These partnerships reflect TRACON’s commitment to innovative clinical development and commercialization.
Clinical Trials and Development
TRACON Pharmaceuticals is committed to conducting clinical trials using a CRO-independent platform, having conducted over 15 trials across all development phases. This approach offers partners improved quality, decreased timelines, greater development control, and reduced costs. Current pivotal trials include the ENVASARC Phase 2 trial for envafolimab in the US and multiple Phase 1 and Phase 2 trials for TRC102 led by the National Cancer Institute and Case Comprehensive Cancer Center.
CRO-Independent Business Model
TRACON Pharmaceuticals operates as a CRO-independent company, offering unique benefits to its partners including enhanced quality, reduced development timelines, better control, and lower costs. Their model has attracted significant partnerships and enabled them to conduct numerous clinical trials independently. This innovative approach supports efficient clinical development and commercialization in the U.S., setting TRACON apart in the biopharmaceutical industry.