TG4001 HPV Vaccine Description
TG4001 is a therapeutic cancer vaccine candidate based on an attenuated and modified poxvirus (MVA) as a vector expressing the HPV16 E6 and E7 proteins (rendered non-oncogenic) interleukin-2, made by a type of T lymphocyte. TG4001 is developed in Human Papillomavirus (HPV)16 positive cancers, such as cervical, vaginal, and oropharyngeal squamous cell carcinoma of the head and neck. Transgene's myvac® is designed to stimulate and educate the patient's immune system to recognize and destroy tumors using their cancer-specific genetic mutations.
On September 16, 2020, Transgene, previously known as Tipapkinogen Sovacivec, announced the analysis of the efficacy data from the Phase 1b/2 trial combining TG4001 with avelumab in HPV16-positive recurrent and/or metastatic malignancies showed promising clinical activity in the overall study population (34 evaluable patients).
Transgene announced on November 2, 2022, following an interim analysis of its randomized controlled Phase II clinical study comparing TG4001 in combination with avelumab to avelumab alone in patients with HPV16-positive anogenital tumors, the Independent Data Monitoring Committee has recommended the study continue. Based on positive signals observed in the interim analysis, the trial is expected to enroll an additional 66 patients for a total trial size of 120 patients compared to the previously announced target of 150 patients.
On June 5, 2023, the Company announced data from a phase 2 clinical trial found TG4001 could induce de novo immune responses against HPV16 antigens E6 and E7 in patients with advanced HPV16-positive anogenital cancers, and patients with complete objective response showed strong vaccine-induced immunoreactivity. Furthermore, Transgene announced on June 6, 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. and 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.
Transgene is a France-based clinical-stage biotechnology company that designs and develops novel immunotherapeutics.
TG4001 HPV Vaccine Indication
TG4001 is indicated to treat HPV16+ recurrent or metastatic malignancies, including oropharyngeal cancers. Therapeutic vaccines are active and targeted immunotherapeutics. According to the Company, they induce a cascade of immune reactions that produce T cells that will only destroy specific malignant cells.
TG4001 HPV Vaccine Dosage
Dosing levels are being evaluated in ongoing clinical trials. TG4001 is designed to have a two-pronged antiviral approach: to alert the immune system specifically to cells presenting the HPV16 E6 and E7 antigens found in HPV16-related tumors and to further stimulate the infection-clearing activity of the immune system through interleukin 2 (IL-2).
TG4001 HPV Vaccine News
June 6, 2023 - Alessandro Riva, Chairman and CEO of Transgene, commented, "TG4050 has demonstrated 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 present 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."
June 5, 2023 - Transgene announced that new data confirm the ability of this novel investigational therapeutic cancer vaccine to induce immune responses against HPV16 antigens that are associated with anti-tumor response.
November 2, 2022 - Hedi Ben Brahim, Chief Executive Officer of Transgene, stated: "The IDMC's recommendation to continue the study reinforces our confidence in TG4001, which follows promising data from our earlier Phase Ib/II trial. This also enables us to reduce the number of randomized patients in the trial. We look forward to completing this trial in H1 2024 and communicating its results when available."
June 24, 2021 - Transgene announced that the first patient had been enrolled in a randomized, controlled Phase II study evaluating the combination of TG4001 with avelumab versus avelumab monotherapy in patients with HPV16-positive anogenital tumors.
March 10, 2021 - Transgene announced the initial Phase Ib/II trial conducted in France and Spain had been amended to include a randomized comparison of TG4001 with avelumab versus avelumab monotherapy in anogenital cancers. The submission of the amended protocol has been initiated in Europe. Also, Transgene received US FDA clearance for the protocol under TG4001 IND. Patient enrollment is expected to start in Q2 2021. The trial will focus on patients with recurrent or metastatic HPV16-positive anogenital cancer without liver metastases, including cervical, vulvar, vaginal, penile, and anal cancer.
October 27, 2020 - Transgene is communicating the content of the late-breaking poster abstract that will be presented at the SITC 35th Anniversary Annual Meeting (SITC 2020), to be held virtually November 9-14, 2020. The combination of TG4001 and avelumab demonstrates anti-tumor activity (23.5% ORR) in patients with previously treated recurrent and/or metastatic HPV-related cancers. In addition, liver metastases profoundly impact outcomes regarding ORR and PFS. In patients without liver metastases, an ORR of 34.8% and a median PFS of 5.6 months were achieved.
October 19, 2020 - Transgene announced that detailed results of the data from the Phase 1b/2 trial combining TG4001 would be presented in a poster presentation at the upcoming virtual meeting of the Society for Immunotherapy of Cancer taking place November 9-14, 2020.
July 22, 2020 - Transgene performed a pooled analysis of the data from the Phase 1b/2 trial combining TG4001. This analysis confirms that TG4001 can be safely combined with an immune checkpoint inhibitor and shows the clinical activity of this combination regimen. The trial is being conducted in collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer.
September 30, 2019 - Transgene presented promising safety and efficacy data of TG4001 in combination with avelumab (BAVENCIO®), a human anti-programmed death-ligand (PD-L1) antibody, in Human Papillomavirus (HPV) 16+ recurrent or metastatic malignancies, including oropharyngeal cancers.
April 4, 2019 - Study: Tipapkinogen Sovacivec therapeutic HPV vaccine's efficacy and safety in cervical intraepithelial neoplasia grades 2 and 3: Randomized controlled phase II trial with 2.5 years of follow-up.
TG4001 HPV Cancer Vaccine Clinical Trials
The Phase II study evaluates TG4001, an investigational therapeutic cancer vaccine, combined with avelumab compared to avelumab alone in patients with HPV16-positive anogenital tumors without liver metastases, through a continuing collaboration with the alliance of Merck KGaA, Darmstadt, Germany, and Pfizer, which is supplying avelumab.
Clinical Trial NCT03260023: Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers Including Oropharyngeal SCCHN.
Clinical Trial NCT01022346: A Study of RO5217790 in Participants With High-Grade Cervical Intraepithelial Neoplasia Associated With High-Risk Human Papillomavirus (HR-HPV) Infection (Completed).