Transgene and NEC Corporation announced that new data have been presented on TG4050, an individualized neoantigen cancer vaccine, at theAmerican Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.TG4050 is based on Transgene's myvac® platform and powered by NEC's cutting-edge AI capabilities. The new positive data have been generated from patients with HPV-negative head and neck cancer who have been enrolled in an ongoing randomized Phase I trial assessing TG4050 (NCT04183166). All patients treated with TG4050 in the trial have developed a specific immune response, as demonstrated by the results of additional immunological testing, and remained disease-free to date.

TG4050 has demonstrated the ability to induce strong immune responses against targeted antigens. The data presented at ASCO 2023 show that all evaluable patients developed a specific immune response after treatment with TG4050 against multiple cancer neoantigens. These immune responses were developed in spite of patients having unfavorable systemic immunity and tumor micro-environment at baseline (with the presence of non-functional immune cells or with low or negative levels of PD-L1 expression).

These challenging characteristics are normally associated with limited responses to treatments, including immune checkpoint blockers. Two patient case studies are also being reported. In these patients who are disease-free following treatment with TG4050, immunoreactive T cell response against targeted antigens was assessed by tetramer staining.

The results confirm a large amplification of the frequency of immunoreactive T cells. These T cells were characterized as effector cytotoxic T cells, a cell population with potential anti-tumor activity. These data further demonstrate that TG4050 is able to induce an anti-tumor cellular immune response.

All patients in the trial who received TG4050 remain disease-free to date. As of May 2023, 32 patients were randomized in the head and neck cancer Phase I trial. All 16 patients who received TG4050 remained disease-free, with a median follow-up time of 10.4 months.

This compares favorably to the control arm, in which two patients with similar characteristics experienced relapse. Two other patients also showed biochemical signs of relapse, as seen in the poster. These patients are still being followed in the ongoing trial.

To date, the vaccine has been well tolerated and no related Serious Adverse Events have been reported.