On April 9, 2024 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, reported that new data will be presented on TG4050, an individualized neoantigen cancer vaccine, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in San Diego, CA (Press release, Transgene, APR 9, 2024, View Source [SID1234641949]). These data are highlighted in the AACR (Free AACR Whitepaper) press conference being held today and in a poster presentation which will take place tomorrow, April 10, at 9:00 a.m. PDT.
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TG4050 is based on Transgene’s myvac platform and powered by NEC’s cutting-edge AI capabilities designed to optimize antigen selection.
Key findings of the poster include:
-All 16 patients who received TG4050 are disease free after a median 18.6-month follow-up. Out of the 16 patients in the control observation arm, 3 patients have relapsed. For this head and neck cancer patient population and with current standard of care, approximately 40% of patients are expected to relapse within 24 months following surgery and adjuvant therapy (chemoradiotherapy). Also, the tumor immune contexture, expression of immune factors, mutational burden, and tumor infiltrates are associated with challenging prognoses.
-Specific cellular immune responses (CD8+ and CD4+) were detected in the 16/17 patients who received TG4050 (16 patients in the treatment arm and one patient from the observation arm treated after relapse) using stringent testing criteria. Immunogenicity or the capacity of treatment to induce immune responses are key to prevent relapses.
-TG4050 induced persistent immune responses against multiple targets in several patients. T cell responses were maintained beyond 211 days (7 months) after the initiation of the treatment. The duration of the immune response is also a key factor to fight disease over time.
Alessandro Riva, Chairman and CEO of Transgene, commented:
"We are honored by AACR (Free AACR Whitepaper)’s interest in the Phase I data generated from our individualized cancer vaccine TG4050. It is exciting to note that all patients who received TG4050 remain disease-free after a median follow-up of 18.6 months, which compares favorably to the observational arm which saw 3 out of 16 patients relapse during the same period."
"More importantly, almost all treated patients developed a specific immune response against the antigen targets we selected, providing robust proof of principle for our lead candidate. TG4050 is now starting to show a potential benefit for head and neck cancer patients at high risk of relapse. We look forward to starting the Phase II part of the trial in the adjuvant setting for head and neck cancer."
Dr. Oliver Lantz, Head of the clinical immunology laboratory at Institut Curie, added:
"The immunological data generated by TG4050 demonstrate a robust and specific cellular immune response, even under stringent measurement criteria. The diversity, depth and duration of these responses were most certainly a key factor in preventing relapse in the patients treated with TG4050."
Masamitsu Kitase, Corporate SVP and Head of the Healthcare and Life Sciences Division at NEC, concluded:
"Our state-of-the-art proprietary artificial intelligence and machine learning models have allowed us to identify immunogenic and clinically relevant mutations in all head and neck cancer patients for this TG4050 randomized Phase I trial. These tumors were characterized by a low tumor mutation burden, which presents an obstacle to designing a relevant vaccine. Our powerful platform enables us to identify mutations for individualized treatments which have now shown the first signs of clinical benefit for patients. Together with Transgene, we look forward to continuing to build on these promising data through our planned Phase II trial in the adjuvant treatment of head and neck cancer."
TG4050 is being evaluated in a randomized multicenter Phase I/II trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers (NCT04183166). Based on promising data obtained in the Phase I part of the trial, Transgene and NEC are preparing a randomized Phase II extension of this trial slated to start in the second quarter of 2024.
The poster can be viewed in-person during the poster presentation at the AACR (Free AACR Whitepaper) 2024 meeting and accessed on Transgene’s website.