MedPath

TG-6050

Generic Name
TG-6050

Arvinas Advances Vepdegestrant into Phase 3 Trials for Breast Cancer and Updates Pipeline Milestones

• Arvinas plans to initiate two Phase 3 trials in 2025 for vepdegestrant in ER+/HER2- metastatic breast cancer, one in the first-line setting with atirmociclib and another in the second-line setting with a CDK4/6 inhibitor. • Topline data from the Phase 3 VERITAC-2 monotherapy trial of vepdegestrant in second-line-plus ER+/HER2- metastatic breast cancer is anticipated in the first quarter of 2025. • Arvinas is set to present initial data from the Phase 1 trial of ARV-393 in B-cell lymphomas and file an IND application for a novel PROTAC KRAS G12D degrader in 2025. • Phase 1 trial with PROTAC LRRK2 degrader ARV-102 in patients with Parkinson’s disease has been initiated, with data expected to be presented in the first half of 2025.

Transgene's TG4050 Shows Promise in Head and Neck Cancer Trial

• Transgene's TG4050 demonstrated a strong clinical proof of principle in adjuvant head and neck cancer, with all 16 patients remaining disease-free after 24.1 months. • The TG4050 vaccine induced specific immune responses against personalized antigen targets, showing strong immunogenicity and sustained immune responses over seven months. • BT-001, Transgene's oncolytic virus, induced tumor regression in patients unresponsive to prior anti-PD(L)-1 treatment, both as a monotherapy and in combination with pembrolizumab. • Transgene confirms financial visibility into Q4 2025, enabling continued progress and news flow on its immunotherapy portfolio.

Transgene's Immunotherapy Pipeline Advances with Key Data Readouts Expected in Q4 2024

• Transgene's TG4050, an individualized immunotherapy for head and neck cancer, shows promising Phase I data with a 24-month follow-up to be presented in Q4 2024. • BT-001, an oncolytic virus, demonstrates encouraging antitumor activity in solid tumors resistant to previous anti-PD(L)-1 treatments, as presented at ESMO 2024. • Topline results from the Phase II trial of TG4001, a therapeutic cancer vaccine for HPV-positive anogenital cancers, are anticipated in Q4 2024. • Initial Phase I data for TG6050, a novel intravenously administered oncolytic virus for advanced non-small cell lung cancer, are expected in Q4 2024.
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