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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 (TCON) announced a definitive securities purchase agreement to raise approximately $5.0 million through a private placement of common stock and pre-funded warrants. The company will sell around 3.1 million shares at a purchase price of $1.64 each, with pre-funded warrants priced at $0.01. The proceeds will fund the ENVASARC pivotal study of envafolimab for sarcoma and support general corporate needs. The closing of this private placement is anticipated to occur around August 27, 2020.
TRACON Pharmaceuticals (NASDAQ:TCON) announced FDA clearance of the pivotal ENVASARC protocol, part of an Investigational New Drug application filed on July 15. The trial aims to evaluate envafolimab for sarcoma treatment, with patient enrollment expected to start in Q4 2020 at 25 U.S. sites. The study will involve 160 patients, focusing on objective response rate as the primary endpoint. Envafolimab is a subcutaneously injected PD-L1 inhibitor currently in other trials in China. TRACON aims to leverage partnerships to drive its product development.
TRACON Pharmaceuticals (NASDAQ:TCON) reported its Q2 2020 financial results, showing cash and equivalents at $14.5 million. The company intends to utilize existing funds into Q2 2021, with an option to extend runway into Q3 2021 through an Aspire Capital agreement. TRACON also announced the filing of the ENVASARC pivotal trial protocol with the FDA, aiming to enroll the first patient by Q4 2020 for a study on envafolimab in treating soft tissue sarcomas. The anticipated response rate in the trial is significantly higher than existing therapies, with interim data expected in 2021.
TRACON Pharmaceuticals (TCON) announced that Dr. Charles Theuer, President and CEO, will give a corporate overview at the 2020 BTIG Virtual Biotechnology Conference on August 10 at 11:30 am EDT. TRACON specializes in developing targeted cancer therapies using a cost-effective, CRO-independent platform. Their clinical pipeline includes Envafolimab for sarcoma, TRC253 for prostate cancer, TRC102 for lung cancer, and TJ004309 for advanced solid tumors. The company seeks partnerships to enhance U.S. regulatory and commercialization efforts.
TRACON Pharmaceuticals (NASDAQ:TCON) will report its Q2 2020 financial results after U.S. markets close on August 5, 2020. Management plans to host a conference call at 4:30 pm ET to discuss the results and corporate updates. TRACON is focused on developing targeted cancer therapies and has a pipeline that includes Envafolimab for sarcoma, TRC253 for prostate cancer, TRC102 for lung cancer, and TJ004309 for solid tumors. They aim to establish partnerships to lead U.S. regulatory and clinical development.
TRACON Pharmaceuticals (NASDAQ:TCON) has filed the pivotal ENVASARC protocol with the FDA as part of an IND application for envafolimab, which targets soft tissue sarcoma. Following a positive teleconference with the FDA on May 8, the trial will enroll 160 patients, with expectations to commence in late 2020. The ENVASARC study will assess the drug's efficacy in previously treated patients, comparing it to Yervoy. Envafolimab shows promising results with an objective response rate (ORR) of 28.2% in MSI-H/dMMR colorectal cancer patients, aligning closely with existing therapies.
TRACON Pharmaceuticals (TCON) will host a key opinion leader (KOL) webinar on July 17, 2020, focusing on the treatment of sarcoma with envafolimab. Dr. Robert Maki from the University of Pennsylvania will discuss the current challenges in treating sarcoma and field audience questions. TRACON's CEO, Dr. Charles Theuer, will provide updates on envafolimab, a novel PD-L1 antibody now in various trials, aiming to initiate a pivotal study for sarcoma later in 2020. The webinar registration is available through their official link.
TRACON Pharmaceuticals (TCON) announced that Charles Theuer, M.D., Ph.D., President and CEO, will present a corporate overview at the 2020 Jefferies Virtual Healthcare Conference on June 4th at 4:00 pm EDT. The company, focused on developing targeted cancer therapeutics, aims to start a registrational trial for envafolimab in the U.S. in the second half of 2020. TRACON's pipeline includes TRC253 for prostate cancer, TRC102 for lung cancer, and TJ004309 for advanced solid tumors. Live webcast access is available on the company’s website.
TRACON Pharmaceuticals recently announced the pivotal ENVASARC trial to evaluate envafolimab for treating Undifferentiated Pleomorphic Sarcoma (UPS). Scheduled to commence in the second half of 2020, the trial targets UPS patients who have had prior treatments. Previous data showed a promising 29% objective response rate for UPS patients treated with Opdivo and Yervoy. Envafolimab demonstrated a 30% objective response rate in other cancers, indicating its potential effectiveness. The company aims to establish envafolimab as a new standard of care for sarcoma patients.
TRACON Pharmaceuticals (NASDAQ:TCON) announced encouraging results from the pivotal trial of Envafolimab, reporting a 30% confirmed objective response rate (ORR) in advanced refractory MSI-H/dMMR colorectal and gastric cancer patients. The overall ORR was 34% across 103 patients. Envafolimab demonstrated favorable tolerability similar to existing PD-(L)1 inhibitors without infusion reactions. The company plans to initiate the pivotal ENVASARC trial for Envafolimab in sarcomas in the second half of 2020, marking a significant step in its development pipeline.
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