Transgene and NEC Present New Data on TG4050, an Individualized Cancer Vaccine, Showing it Induces Specific Immune Responses against Head and Neck Carcinoma at ASCO 2023

New immunological data assessed by tetramer staining confirms the induction of T cell responses in treated patients

All trial patients treated with TG4050 monotherapy continue to remain in remission to date

Transgene and NEC are preparing a Phase II trial to further demonstrate the potential of TG4050 as an adjuvant treatment of head and neck cancer

Strasbourg, France & Tokyo, Japan, June 6, 2023, 7:30 a.m. CET/3:30 p.m. JST – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, announced that new data have been presented on TG4050, an individualized neoantigen cancer vaccine, at the American 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.

Alessandro Riva, Chairman and CEO of Transgene, added: “TG4050 is showing its potential to extend patient remission after surgery and firmly establishes Transgene among the leading pioneers in the emerging field of individualized cancer vaccines. The monotherapy data we are presenting at ASCO are a solid basis to accelerate the clinical development of this innovative therapy as an adjuvant treatment to HPV-negative head and neck carcinoma and potentially in other indications.”

Masamitsu Kitase, Corporate Senior VP, Head of Healthcare and Life Science Division, NEC Corporation, commented: “We are excited by the additional data from immunological testing that is being presented in the poster at ASCO. It is certainly an encouraging outcome for NEC’s AI prediction for neoantigens that are able to effectuate an immunological response. These are early results that underpin NEC’s AI capability of making predictions that help in making TG4050 an efficacious product for patients across the globe. We look forward to working with Transgene to develop on this asset further."

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.

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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.

The abstract and poster can be accessed on the ASCO and Transgene websites.

Final results from randomized Phase I trial expected in mid-2024 – Phase II trial to start in H2 2023

The last patient has recently been randomized in the head and neck cancer trial. Transgene and NEC plan to achieve a median follow up of 18 months in mid-2024.

Transgene and NEC are preparing for a Phase II trial in head and neck cancer, in an adjuvant setting, which could be initiated in H2 2023.