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TRACON Pharmaceuticals, Inc. (symbol: TCON) is a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapeutics for the treatment of cancer and wet age-related macular degeneration (AMD). The firm's leading clinical-stage product is Envafolimab (KN035), an investigational PD-L1 single-domain antibody designed for the treatment of soft tissue sarcoma.
The company's portfolio also includes:
- DE-122: Currently in a randomized Phase IIa study targeting wet AMD.
- TRC102: A small molecule in Phase II clinical trials for mesothelioma, Phase I trials for solid tumors, and additional trials for lymphomas and lung cancer.
- TRC253: In Phase II clinical trials for treating metastatic castration-resistant prostate cancer.
- TJ004309: A CD73 antibody in Phase I development for solid tumors.
TRACON Pharmaceuticals operates on a cost-efficient, contract research organization (CRO)-independent product development platform. This unique approach allows the company to partner with ex-U.S. companies, facilitating the development and commercialization of innovative therapies within the United States.
The company's collaborative efforts and licensing agreements with other firms reinforce its commitment to delivering cutting-edge treatments. Financially, TRACON demonstrates resilience and strategic growth, leveraging partnerships to advance their clinical trials and ensure a pipeline of promising therapeutic candidates.
For investors, TRACON Pharmaceuticals represents a significant opportunity in the biopharmaceutical landscape, driven by a robust pipeline of investigational drugs and a strategic focus on effective, targeted cancer therapies.
TRACON Pharmaceuticals (Nasdaq: TCON) announced patient dosing has commenced for envafolimab following FDA approval of the amended ENVASARC protocol. The dose was increased to 600 mg every three weeks due to the drug's tolerability and improved response rates in low-weight patients. Interim efficacy data from the trial is expected in the second half of 2022. Envafolimab targets PD-L1 and has potential in treating sarcoma.
TRACON Pharmaceuticals (TCON) announced it will report its fourth quarter and full year 2021 financial results on March 15, 2022, after U.S. market close. Management will host a conference call the same day at 4:30 PM ET to update corporate activities and discuss results. TRACON focuses on developing targeted cancer therapeutics through a cost-efficient, CRO-independent platform, partnering with companies outside the U.S. for development and commercialization in the U.S.
TRACON Pharmaceuticals (TCON) has announced the initiation of a randomized Phase 2 trial for TRC102, aimed at patients with stage III non-squamous non-small cell lung cancer. The trial, sponsored by the National Cancer Institute, will enroll 78 patients, assessing the combination of TRC102 with standard treatments and aiming to improve one-year progression-free survival from 56% to 75%. The trial's enrollment is expected to start in June 2022, with results anticipated in 2024. This trial follows promising Phase 1 results showing a 100% response rate in 15 patients.
TRACON Pharmaceuticals (NASDAQ: TCON) announced that its President and CEO, Charles Theuer, M.D., Ph.D., will present a corporate overview at the H.C. Wainwright BIOCONNECT Virtual Conference, scheduled from January 10-13, 2022. The presentation will be accessible on-demand starting at 7:00 AM Eastern Time on January 10, 2022, via the Company’s website. TRACON focuses on developing targeted cancer therapies through a cost-efficient, CRO-independent platform, with a pipeline that includes Envafolimab, YH001, TRC102, and TJ004309.
TRACON Pharmaceuticals (TCON) announced the Independent Data Monitoring Committee's recommendation to continue the ENVASARC trial following a successful interim analysis. The analysis, conducted on 18 patients per cohort, met the objective response rate criteria and revealed that envafolimab was well tolerated, with only one Grade 3 adverse event reported. The IDMC advised increasing the envafolimab dose to 600 mg Q3W, based on encouraging efficacy data. TRACON plans to amend protocol with the FDA to implement this recommendation, aiming to enhance treatment outcomes for sarcoma patients.
TRACON Pharmaceuticals (NASDAQ:TCON) announced the marketing authorization of envafolimab, the first subcutaneous PD-L1 antibody, by China's NMPA for adult patients with MSI-H or dMMR advanced solid tumors. Envafolimab demonstrated a 44.7% objective response rate in a pivotal phase 2 trial, with durable responses and a median progression-free survival of 11.1 months. The ENVASARC trial in the U.S. continues to enroll patients, with interim efficacy results expected soon. This approval signifies a milestone in cancer treatment, offering a more convenient administration route, enhancing patient comfort.
TRACON Pharmaceuticals (NASDAQ: TCON) announced that CEO Charles Theuer will participate in a fireside chat at the Jefferies London Virtual Healthcare Conference on November 18-19, 2021. The chat will be available on-demand starting at 3:00 AM Eastern Time on November 18, 2021, accessible via the Company’s website. TRACON focuses on developing targeted cancer therapies utilizing a CRO-independent platform. Key products include Envafolimab, YH001, TRC102, and TJ004309, with ongoing corporate partnerships for U.S. regulatory and clinical development.
TRACON Pharmaceuticals (NASDAQ:TCON) reported its third-quarter financial results for 2021, highlighting a net loss of $7.0 million, up from $4.0 million in Q3 2020. Cash reserves decreased to $29.9 million from $36.1 million at the end of 2020. The company has licensed the CTLA-4 antibody YH001 and plans to initiate its clinical trials, anticipating interim efficacy data for ENVASARC by year-end. The increase in R&D and administrative expenses was largely due to legal costs from an arbitration with I-Mab. A conference call is scheduled for 4:30 PM ET today.
TRACON Pharmaceuticals (NASDAQ:TCON) announced it will report its third quarter 2021 financial and operating results on November 3, 2021, after U.S. markets close. A conference call will follow at 4:30 PM ET to update on corporate activities and financial results. The company specializes in developing targeted therapies for cancer using a cost-efficient, CRO-independent platform. Its clinical pipeline includes Envafolimab for sarcoma, YH001 and TRC102 for various cancers, and TJ004309 for solid tumors. For more details, visit their website.
TRACON Pharmaceuticals (NASDAQ:TCON) announced the appointment of Carol Lam to its Board of Directors, bringing extensive legal and governmental experience to the team. Carol has previously served as the deputy General Counsel for Qualcomm and as the United States Attorney for the Southern District of California. Her background includes handling complex legal issues in technology and fostering international relationships. TRACON is focused on developing cancer therapies, including the promising subcutaneous PD-L1 antibody envafolimab, which is currently in pivotal trials.
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