Replace Dell Inspiron Screen On August 15 2024 the U S Food and Drug Administration FDA lifted the partial clinical hold that was placed on MediLink Therapeutics Suzhou Co Ltd MediLink Phase I trial evaluating BNT326 YL202 NCT05653752 which was announced on June 17 2024
Jun 20 2024 nbsp 0183 32 This week s partial US clinical hold on BNT326 with the FDA flagging concerns about the risk of illness or serious injury throws a spotlight on a phase 1 study presented at ASCO on this anti HER3 ADC project which BioNTech licensed from China s MediLink Therapeutics last October for 70m up front The problems with BNT326 are relevant in light of On June 17 2024 BioNTech announced that it had been informed by its partner Medilink Therapeutics that the FDA had partially suspended the Phase I clinical trial YL202 INT 101 01 of their HER3 ADC YL202 BNT326 halting the enrollment of new patients in the United States In documents submitted to the U S Securities and Exchange Commission SEC BioNTech
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Aug 19 2024 nbsp 0183 32 Good news for BioNTech SE The safety study of the ADC BNT326 YL202 developed by MediLink Therapeutics which was suspended by the FDA in mid June will continue Jun 17 2024 nbsp 0183 32 The FDA has imposed a partial clinical hold on the Phase I trial of an antibody drug conjugate ADC cancer therapy candidate being co developed by BioNTech and MedLink Therapeutics three days
Jun 17 2024 nbsp 0183 32 The hold on BioNTech and MediLink s antibody drug conjugate candidate BNT326 YL202 has halted enrollment in a Phase I U S trial in patients with non small cell lung cancer or breast cancer following multiple deaths The FDA has slapped a partial clinical hold on BioNTech and MediLink s Phase I study of an antibody drug conjugate candidate for types of Jun 17 2024 nbsp 0183 32 The FDA placed a partial clinical hold on a phase 1 trial evaluating YL202 in select patients with advanced non small cell lung cancer or breast cancer
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Jun 18 2024 nbsp 0183 32 The US Food and Drug Administration FDA has placed a partial clinical hold on BioNTech s Phase I trial evaluating the early stage antibody drug conjugate ADC BNT326 YL202 after deaths were reported BioNTech said in a Form 6 k filed with the US Securities and Exchange Commission SEC is had been informed by MediLink the trial Aug 19 2024 nbsp 0183 32 The agency put the trial on hold in mid June with BioNTech explaining at the time that the decision was linked to concerns that the candidate dubbed BNT326 YL202 may at higher doses expose
Aug 19 2024 nbsp 0183 32 The FDA has lifted the partial clinical hold on MediLink Therapeutics Phase 1 trial for BNT326 YL202 a HER3 targeting antibody drug conjugate ADC This decision announced on August 15 May 26 2024 nbsp 0183 32 In October 2023 MediLink and BioNTech entered into a strategic collaboration and global license agreement to develop BNT326 YL202 a next generation anti HER3 ADC
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Replace Dell Inspiron Screen - Jun 17 2024 nbsp 0183 32 The FDA has imposed a partial clinical hold on the Phase I trial of an antibody drug conjugate ADC cancer therapy candidate being co developed by BioNTech and MedLink Therapeutics three days