TG4001 and Avelumab Combo Shows High Efficacy against HPV-Positive Cancer

Release Date: 03-Oct-2019

On 30 September 2019, a safety and efficacy data of TG4001 in combination with avelumab (BAVENCIOandreg;) is presented by Transgene, a biotech company. Transgene is known to designs and develops virus-based immunotherapeutics against cancer. According to the data, Avelumab shows prominent effects in HPV-16+ recurrent or metastatic malignancies (including oropharyngeal cancers). 

The Phase 1b data have been presented by Transgene in a poster at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain. TG4001 is a therapeutic vaccine based on a Vaccinia vector (MVA). It is engineered in such a way that it starts expressing HPV-16 antigens (E6 and E7). During the previous trials, TG4001 has been administered to more than 300 individuals, indicating good safety, significant HPV clearance rate and promising efficacy results. Avelumab is a human anti-programmed death ligand (PD-L1) antibody.

Further, in the Phase 1b part of the trial, one of the two tested doses of TG4001 combined with a fixed dose of avelumab is introduced into 9 heavily pretreated patients. The Phase 2 part of the trial started in October 2018 and will enroll 40 patients. The trial is conducted for evaluating safety and tolerability as well as the anticancer activity of the combination. The trial is multi-center, open-label trial with approximately 50 patients of HPV-16 positive cancers who had failed at least one line of systemic treatment.

According to the Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene, These Phase 1b results with a combination treatment regimen containing TG4001 are promising. In this heavily pretreated population, the quality of the responses, in particular the duration of the responses, and the immune changes in the tumor, give us great confidence that we will see a positive outcome from the ongoing Phase 2 part of the trial.

He also added in his comment “the results also confirm our conviction that a HPV-16 targeted therapeutic vaccine would be able to stimulate the immune response, and can advantageously be combined with an immune checkpoint inhibitor. Based on these results, I believe that the combination of TG4001 and an ICI could potentially offer a much-improved treatment option than single agent immune checkpoint inhibitor for patients with HPV-16+ recurrent or metastatic malignancies. Patient accrual in the Phase 2 part of the trial is in line with our expectations and the next clinical readout is expected in 1H 2020.”