TRACON Pharmaceuticals Announces Orphan Drug Designation for Envafolimab in Soft Tissue Sarcoma
Application Included Clinical Trial Data from Soft Tissue Sarcoma Patients Treated with Envafolimab in Phase 1 Trials
The Orphan Drug Designation submission for envafolimab in sarcoma included clinical data demonstrating confirmed objective partial responses by RECIST with duration of response in excess of six months, in two of five patients with refractory metastatic alveolar soft part sarcoma (ASPS) who received single agent envafolimab in Phase 1 clinical trials conducted by TRACON’s partners 3D Medicines and Alphamab Oncology. Patients with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) were not treated as part of Phase 1 trials.
“The receipt of Orphan Drug Designation is one of multiple milestones we expect this year for envafolimab, including interim efficacy data from the pivotal ENVASARC trial in the second half of 2021,” said
Orphan Drug Designation is granted by the FDA to drugs or biologics intended to treat a rare disease or condition, defined as one that affects fewer than 200,000 people in
About Envafolimab
Envafolimab (KN035), 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
About ENVASARC (NCT04480502)
The ENVASARC pivotal trial is a multi-center, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in
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
About Alphamab Oncology
Alphamab Oncology is focusing on innovation, production and commercialization of anti-tumor drugs. On
Alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its highly differentiated in-house pipeline includes fifteen tumor monoclonal antibodies and bispecific antibodies and a Covid-19 multifunctional antibody. Four products have advanced into phase I-III clinical trials or pre-marketing stage in
The Company also has state-of-the-art manufacturing capabilities designed and built to meet NMPA and EU/FDA’s cGMP standards and a complete quality system which has passed the on-site inspection of an
About 3D Medicines
3D Medicines is a clinical-stage biopharmaceutical company focused on the development of differentiated next-generation immuno-oncology drugs for cancer patients. The world's first subcutaneous injection PD-L1 antibody Envafolimab (KN035), is currently under clinical development in
Forward-Looking Statements
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 plans to further develop envafolimab, expectations regarding the timing and scope of clinical trials and availability of clinical data, expected development and regulatory milestones and timing thereof, the potential benefits of Orphan Drug Designation, 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, initiate additional trials or seek regulatory approval 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
Company Contact: | Investor Contact: |
Chief Business Officer | |
(858) 251-3492 | (212) 915-2578 |
mwiggins@traconpharma.com | britchie@lifesciadvisors.com |
Source: TRACON Pharmaceuticals, Inc.