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Tracon Pharmaceuticals Halts Development of Envafolimab After Clinical Trial Failure
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Tracon Pharmaceuticals (OTCMKTS: TCON), a US-based biopharmaceutical company, has decided to cease development of its programmed death-ligand 1 (PD-L1) inhibitor, envafolimab, following disappointing results from a clinical trial. The company had obtained the rights to develop this molecule for soft-tissue sarcomas in North America through a 2019 agreement with China’s…
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3D Medicines Gains FDA Approval for Phase II Study of Envafolimab in dMMR Tumors
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China-based oncology specialist 3D Medicines (HKG: 1244) has announced receiving approval from the US FDA to conduct a single-arm, multi-center Phase II study assessing the safety and efficacy of envafolimab (KN035) in treating deficient mismatch repair (dMMR) advanced solid tumors. The study will involve one subcutaneous injection every three weeks.…
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Tracon Pharmaceuticals Provides Positive Update on Envafolimab Phase II Trial
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China-based Alphamab Oncology (HKG: 9966)’s US partner Tracon Pharmaceuticals (NASDAQ: TCON) has provided an early positive update from a Phase II trial underway for envafolimab, the Alphamab-discovered programmed death-ligand 1 (PD-L1) antibody capable of subcutaneous injection. The pivotal ENVASARC trial, being conducted by Tracon in the US and UK, is…
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Alphamab/3DMed’s Envafolimab Gains FDA Fast-Track Status for Sarcoma Treatment
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Alphamab Oncology (HKG: 9966) and 3D Medicines’ envafolimab (KN035) has obtained fast-track status from the US Food and Drug Administration (FDA) for the treatment of locally advanced, unresectable, or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) that have progressed after chemotherapy. This designation is expected to accelerate the development…
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Biocytogen and Tracon Pharmaceuticals Gain FDA IND Approval for Sarcoma Trial
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China-based Biocytogen (Beijing) Co., Ltd and US-based Tracon Pharmaceuticals Inc. (Nasdaq: TCON) announced that the US FDA has approved an IND application to conduct a clinical trial of YH001 in combination with envafolimab or doxorubicin for sarcoma patients, including those who have not been previously treated. Trial DesignThe Phase I/II…
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Biocytogen Pharmaceuticals Makes HKSE Debut with USD 70 Million IPO
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Sino-US contract research organization (CRO) Biocytogen Pharmaceuticals (Beijing) Co., Ltd has completed an initial public offering (IPO) of 21.76 million shares on the Hong Kong Stock Exchange (HKSE), raising a total of HKD 549 million (USD 69.97 million). Company Overview and Core ProductsFounded in 2009, Biocytogen has a pipeline that…
