TRACON Pharmaceuticals Announces Amended ENVASARC Protocol Approved and Open at all 30 Clinical Sites in the U.S. and U.K.
In February, the FDA approved the amended ENVASARC protocol following the Independent Data Monitoring Committee (IDMC) recommendation based on the highly tolerable safety profile and the significantly higher objective response rate observed in lower weight patients in ENVASARC, to increase the dose of envafolimab to 600 mg every three weeks (Q3W), which is double the original envafolimab dose of 300 mg Q3W. Initial dosing under the amended protocol commenced in March, and more than 10 patients have been enrolled under the amended protocol at the 600 mg Q3W dose less than two months following FDA clearance. Each of the 29 U.S. cancer centers have approved the amended protocol and are open for accrual. An additional site in the
“We are pleased to have opened every site under the amended ENVASARC protocol that increases the envafolimab dose to 600 mg within two months of FDA approval in February,” said
Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first subcutaneously injected PD-(L)1 inhibitor approved by the Chinese NMPA in
About ENVASARC (NCT04480502)
The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in
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; YH001, a potential best-in-class CTLA-4 antibody in Phase 1 development; 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
Statements made in this press release regarding matters that are not historical facts are “forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding TRACON’s expectations regarding the interim ENVASARC safety and efficacy data reviews by the IDMC; TRACON's and its collaboration partners’ plans to further develop product candidates; and the potential utility of product candidates. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development and regulatory approval of novel pharmaceutical product candidates; whether TRACON or others will be able to complete or initiate clinical trials on TRACON’s expected timelines, if at all, including due to risks associated with the COVID-19 pandemic; the fact that future preclinical studies and clinical trials may not be successful or otherwise consistent with results from prior studies; the fact that TRACON has limited control over whether or when third party collaborators complete on-going trials or initiate additional trials of TRACON’s product candidates; the fact that TRACON’s collaboration agreements are subject to early termination; whether TRACON will be able to enter into additional collaboration agreements on favorable terms or at all; potential changes in regulatory requirements in
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Source: TRACON Pharmaceuticals, Inc.