TRACON Pharmaceuticals Announces Successful Type B Meeting with FDA for Pivotal Study of Envafolimab in Sarcoma
Company Reaches Agreement with Regulatory Agency on Key Elements of ENVASARC Trial
Pivotal Trial Expected to Begin in Second Half of 2020
“We appreciate the valuable discussions and guidance from our Type B meeting discussion with the FDA and concurrence on the design for the pivotal trials of envafolimab in sarcoma,” said
Type B Meeting and ENVASARC Study Design
The FDA determined the acceptability of the following key aspects of the proposed pivotal trial:
- Multi-center, open-label, randomized, non-comparative, parallel cohort study.
- Planned total enrollment of 160 patients, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B with envafolimab and Yervoy.
- Primary endpoint of objective response rate (ORR) with duration of response a key secondary endpoint.
- Open-label format with blinded independent central review of endpoint data.
- Eligible patients will have received one prior cancer therapy, but no prior checkpoint inhibitor therapy.
Envafolimab is a novel, single-domain antibody against PD-L1 that is administered by subcutaneous injection without the need for an adjuvant. Envafolimab is currently dosing in Phase 1 trials in the
TRACON develops targeted therapies for cancer utilizing a capital efficient, CRO independent, product development platform. The Company’s clinical-stage pipeline includes: Envafolimab, a subcutaneous PD-L1 single-domain antibody being developed for the treatment of sarcoma with the goal of starting a registrational trial in the
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 plans to further develop product candidates, expectations regarding the timing and scope of clinical trials and availability of clinical data, expected development and regulatory milestones and timing thereof, and TRACON’s business development strategy and goals to enter into additional collaborations. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development; 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 or other pandemics; 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 initiates 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.