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Novel Individualized Cancer Vaccine Candidate Posts Positive Early Data

November 22, 2021 • 12:23 pm CST
(Precision Vaccinations)

France-based Transgene and NEC Corporation today announced positive preliminary immunogenicity and clinical data on TG4050, their jointly developed individualized neoantigen cancer vaccine.

TG4050 is an individualized immunotherapy being developed for solid tumors.

Powered by NEC's cutting-edge AI capabilities, TG4050 is evaluated in two ongoing multicenter Phase I trials in patients with ovarian and head and neck cancer.

In the ovarian cancer trial, patients receive the vaccine at first signs of asymptomatic relapse of their high-grade, advanced-stage disease (after surgery and first-line chemotherapy). Asymptomatic relapse is defined as the detection of elevated CA-125 (tumor marker of ovarian cancer frequently associated with a relapse) or as low volume radiologic disease. 

In the second phase 1 study, patients with HPV-negative, advanced-stage head, and neck cancer are at high risk of relapse after surgery and adjuvant therapy.

Overall, today's data were obtained from the first six patients who received TG4050 across the two trials.

In the ovarian cancer trial, patients receive the vaccine at first signs of asymptomatic relapse of their high-grade, advanced-stage disease (after surgery and first-line chemotherapy). Asymptomatic relapse is defined as the detection of elevated CA-125 (tumor marker of ovarian cancer frequently associated with a relapse) or as low volume radiologic disease.

The first patient was dosed in August 2020. Data have been generated from four patients treated in this trial.

Patients with HPV-negative, advanced-stage head, and neck cancer are at high risk of relapse after surgery and adjuvant therapy. Therefore, in the trial, they are randomized after completion of this primary treatment to receive vaccination (early treatment arm) or TG4050 at relapse (delayed vaccination arm). In this trial, the first patient was dosed in January 2021.

As of today, six patients were randomized in this trial, two in the early treatment arm and four in the delayed vaccination arm.

Compared to previously reported neoantigen studies, these data reinforce the rationale for TG4050's prediction system and support the validation of the MVA vector as an efficient platform for anti-tumor vaccination.

Transgene is a biotechnology company located in Strasbourg, France, focused on designing and developing targeted immunotherapies for cancer treatment. 

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