New Positive Preliminary Phase I Data on TG4050, an individualized therapeutic cancer vaccine jointly developed by NEC and Transgene, was presented at the AACR 2022
The results from ongoing Phase I clinical studies of personalized cancer vaccine TG4050 was presented during a poster session at the American Association for Cancer Research (AACR) virtual meeting. TG4050, which is based on Transgene’s advanced virus engineering platform myvac® and NEC’s deep expertise in AI-empowered immunogen prediction, is being evaluated in two ongoing multicenter trials in patients with ovarian cancer and head and neck cancer.
The new data generated in the first eleven patients treated with TG4050 confirm previous demonstration of the strong potential of this individualized therapy:
- Relevant targets could be identified in all 4 patients for which evaluable samples were available.
- All 4 patients developed a robust T-cell response against multiple neoantigens with a median of 10 positive responses per patient
- T-cell responses were observed for class I and class II epitopes
(64% de novo responses & 36% amplifications of preexisting responses)
- Early signs of clinical activity are encouraging with changes of tumor markers observed in a treated patient under vaccine monotherapy
- In the ovarian trial (n=4) , one patient treated after an elevation of CA-125 experienced a normalization of CA-125 without clinical progression during 9 months until death from an unrelated chronic illness. Another patient was treated upon onset of radiological evidence of relapse and was stable for 11.4 months.
- In the head and neck trial (n=13), all 7 patients randomized to arm A (early treatment) are under treatment, including one patient who has fully completed his TG4050 administration regimen. In the arm B (delayed vaccination), 2 patients have recently experienced relapse and will soon start treatment
- Manufacturing time and drug release were compatible with the clinical course of treatment
- To date, the vaccine has been well tolerated and no related Serious Adverse Events have been reported across the two studies.