TG4001, previously known as Tipapkinogen Sovacivec, is a vaccine candidate using an attenuated and modified poxvirus (MVA) as a vector expressing the HPV16 E6 and E7 proteins (rendered non-oncogenic) and interleukin-2.
TG4001 is indicated to treat Human Papillomavirus (HPV) 16+ recurrent or metastatic malignancies, including oropharyngeal cancers.
Dosing levels are being evaluated in ongoing clinical trials
June 2019: Transgene announced In a previous randomized, double-blind, placebo-controlled phase II trial TG4001 provided robust clinical response both in terms of complete histological resolution and viral DNA clearance from CIN 2/3 (Harper DM et al. 2019).
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.
Clinical Trial NCT03260023: Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers Including Oropharyngeal SCCHN (Recruiting)
The Phase 1b/2 study will consist of two parts :
- In the phase Ib part: safety will be assessed in consecutive cohorts of 3 to 6 patients at increasing doses of TG4001 in combination with avelumab according to a 3+3 design. There will be no intra-patient dose escalation.
- In the phase II part, evaluation of efficacy and further evaluation of safety of the combination of TG4001 and avelumab will be performed.
- In both parts, tumor response will be evaluated on local assessment using RECIST 1.1.
- All patients will be followed up until disease progression or death due to any cause or the date of data cut-off, whichever occurs first.
Clinical Trial NCT01022346: A Study of RO5217790 in Participants With High-Grade Cervical Intraepithelial Neoplasia (CIN) Associated With High-Risk Human Papillomavirus (HR-HPV) Infection (Completed)
- This Phase 2 randomized, double-blind, placebo-controlled, parallel-arm study will assess the safety and the efficacy of RO5217790 on the histologic resolution in participants with high-grade CIN associated with HR-HPV infection.
- Participants will be randomized to receive 3 subcutaneous injections of either placebo or RO5217790 on Days 1, 8, and 15.
- Study assessments will be made at Baseline, at Month 3 and 6, and every 6 months thereafter for an overall of 2.5 years.