Transgene, a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation, a leader in IT, network and AI technologies, announced that new data will be presented today on TG4050, an individualized neoantigen cancer vaccine, at the American Association for Cancer Research (AACR) Annual Meeting in Orlando, Florida. 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 and ovarian cancer who have been enrolled in two ongoing Phase I trials assessing TG4050.
TG4050 has demonstrated the ability to induce strong immune responses against targeted antigens in patients, which are expected to result in extended remission periods.
Hedi Ben Brahim, CEO of Transgene, noted, "Our individualized neoantigen vaccine TG4050 continues to deliver very encouraging clinical and immune response data, combined with an excellent safety profile. These results suggest that TG4050 has the potential to extend the remission period for cancer patients who have undergone surgery, giving new hope to a patient population who currently have no treatment options available except a watchful follow-up. We are continuing to build a strong and compelling clinical data set to support the benefits of this novel personalized immunotherapy. In parallel, we, along with NEC, are preparing for a Phase II trial as part of the registration path, which could start as early as the second half of 2023 for head and neck cancer which represents a $1bn+ market opportunity for the program. TG4050 also has the potential to be developed for preventing relapses in other solid tumor indications."
Meanwhile, Masamitsu Kitase, corporate senior VP and managing director of Healthcare Life Sciences Business, NEC Corporation, commented, "It is very encouraging to see such promising clinical and immune response data contributing to the momentum of TG4050’s development. We look forward to working closely with Transgene to maintain this advancement, and we are confident that our personalized therapy will benefit the health of individual patients across the globe."
New immune data confirm the ability of TG4050 to effectively prime the immune system in patients with poor immune status. The new set of comprehensive immunological data presented at AACR 2023 shows that all evaluable patients developed a specific immune response after treatment with TG4050 against multiple cancer neoantigens and remained disease-free, in spite of having challenging immune contextures comprised of both unfavorable systemic immunity and a tumor micro-environment at baseline. These are normally associated with limited responses to treatments and, in particular, resistance to immune checkpoint blockades. This suggests that TG4050 can boost the immune system of patients with a tumor micro-environment usually characterized as an immune desert, involving the presence of non-functional immune cells or low or negative levels of PD-L1 expression.
Transgene and NEC are preparing for a Phase II trial in head and neck cancers, which could be initiated in H2 2023.
