Transgene Initiates Phase 1 Trial for TG4070 in Lung Cancer
Biotech company Transgene announced on Monday the initiation of a Phase 1 clinical trial for TG4070, its second candidate derived from the Myvac platform for individualized neoantigen vaccines. This program signifies the expansion of its strategy from upper aerodigestive tract cancers to non-small cell lung cancer in a resectable stage.
TG4070 Integrates Proprietary AI Capabilities and Manufacturing
TG4070 is based on Transgene's proprietary technologies, including SNIPER, an internally developed AI-based bioinformatics tool for identifying and prioritizing highly immunogenic neoantigens. The candidate also utilizes VacDesignR, the company's patented computational design engine, which optimizes genetic constructs for MVA (Modified Vaccinia Ankara) vectors. This integration strengthens Transgene's control over critical stages of the development of individualized therapeutic vaccines. The manufacturing of TG4070 uses a cell line-based process designed to be scalable and transposable. Compared to traditional manufacturing on chicken embryo fibroblasts (CEF), this optimized process allows for more efficient and automated production, with reduced timelines and improved scalability. Preclinical data demonstrate performance comparable to the CEF-based product, while significantly enhancing scalability.
Phase 1 in Combination with Nivolumab in Patients with Resectable NSCLC
The randomized Phase 1 trial assesses the safety and tolerance of TG4070 in combination with nivolumab (an immune checkpoint inhibitor) in patients with resectable non-small cell lung cancer (NSCLC), as adjuvant treatment following neoadjuvant therapy with nivolumab and chemotherapy. Patient enrollment is set to begin in the coming weeks. The program targets a clinical population at risk: approximately 65% of patients who receive chemotherapy-immunotherapy in the neoadjuvant phase do not achieve a major pathological response and remain at high risk of recurrence. TG4050, the first Myvac candidate currently in Phase 2 for upper aerodigestive tract cancer, may also transition to cell line-based manufacturing for subsequent clinical trials.
