Transgene has initiated a randomized Phase 1 trial evaluating TG4070, an individualized neoantigen therapeutic vaccine, in combination with nivolumab for the adjuvant treatment of resected non-small cell lung cancer (NSCLC). This strategic expansion of the myvac® platform aims to address high relapse risks in patients who do not achieve a major pathological response after neoadjuvant therapy. Patient screening for the trial is scheduled to start in the coming weeks.

TG4070 is the second candidate derived from the myvac® platform, following TG4050, which is currently in Phase 2 for head and neck squamous cell carcinoma. The new candidate integrates Transgene’s proprietary AI-driven bioinformatics tool, SNIPER (Specific Neoantigen Identification and Prediction of Elicited Response), for high-precision neoantigen selection. Additionally, the vaccine is produced using a scalable cell-line based manufacturing process designed to improve lead times and reproducibility compared to conventional methods.

The trial will assess the safety and tolerability of TG4070 in combination with nivolumab. Approximately 65% of early-stage NSCLC patients do not achieve a major pathological response with current perioperative immunotherapy regimens, leaving them at significant risk of relapse. The individualized vaccine approach is designed to induce specific and durable anti-tumor immune responses in this high-risk population.

Key Features of TG4070

• AI-Driven Selection: Utilizes SNIPER to identify and prioritize immunogenic neoantigens.
• Scalable Manufacturing: Employs a cell-line based process for faster vaccine supply.
• Platform Consistency: Leverages the clinically validated Modified Vaccinia Ankara (MVA) viral vector.

Transgene plans to implement cell-line based manufacturing for potential future trials of TG4050 as well. The company will host a conference call on June 29, 2026, at 3:00 p.m. CET to discuss the platform expansion and the medical need for early-stage NSCLC patients.

Transgene Biotek Ltd has closed its trading window for all insiders and designated persons effective July 1, 2026, to comply with regulatory norms ahead of its quarterly financial announcement. The restriction prevents trading in the company's securities until 48 hours after the declaration of the unaudited financial results for the quarter ending June 30, 2026. This measure is mandated by the Securities and Exchange Board of India (Prohibition of Insider Trading) Regulations, 2015 and the company's internal code of conduct.

The closure applies to all insiders and designated persons, including their immediate relatives, as defined in the company's Prohibition of Insider Trading Code. The trading window will reopen only after the stipulated period following the results declaration. The specific date for the board meeting to consider and declare the unaudited financial results for the first quarter ending June 30, 2026, has not yet been announced and will be intimated in due course.

Key Details

The company's decision aligns with standard market practices to ensure fairness and prevent potential insider trading during the sensitive period surrounding financial disclosures.