Drugs / TIPAPKINOGENE SOVACIVEC
TIPAPKINOGENE SOVACIVEC
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial · 1 missed | ||||||
| Phase 1/2 | NCT03260023 | Sep 2017 → Sep 2024 overdue | anal squamous cell carcinoma, cervical carcinoma, squamous cell carcinoma of penis, vulvar squamous cell carcinoma | Transgene | Active not recruiting | Missed primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT01022346 | Aug 2009 → Sep 2013 | cervical intraepithelial neoplasia grade 2/3 | Hoffmann-La Roche | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2025-04-24 | Transgene | Results Transgene Provides Business and Financial Update for Q1 2025 transgene.com ↗
While the primary endpoint of the Phase II study was not met, positive signals in the cervical cancer subgroup have been observed and further details will be included in the poster presentation. |
| 2024-10-14 | Transgene | Results Transgene Provides Update on Phase II Trial of Therapeutic Cancer Vaccine TG4001 in Recurrent or Metastatic HPV16-Positive Cervical and Anogenital Cancers transgene.com ↗
The pre-planned subgroup analysis showed a positive efficacy trend in favor of the TG4001 containing regimen in cervical cancer patients, which requires further confirmation through additional analyses, including by PD-L1 status. |
| 2023-06-05 | Transgene | Results Transgene presents immunological data demonstrating that TG4001, a novel therapeutic cancer vaccine, can induce T-cell responses against HPV16 antigens in the ongoing Phase II trial at ASCO 2023 transgene.com ↗
58% of patients receiving TG4001 + avelumab showed an increase of immune responses against HPV antigens versus 9% in the avelumab arm. |
| 2023-05-26 | Transgene | Results Transgene to Present Data on its Two Therapeutic Cancer Vaccins at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting transgene.com ↗
TG4001 induced T-cell responses against HPV16 antigens in the ongoing Phase II trial. |
| 2022-11-02 | Transgene | Results Transgene Announces Positive Interim Analysis Results of Phase II Trial Evaluating TG4001 + Avelumab vs Avelumab in HPV-Positive Anogenital Cancers transgene.com ↗
Transgene Announces Positive Interim Analysis Results of Phase II Trial Evaluating TG4001 + Avelumab vs Avelumab in HPV-Positive Anogenital Cancers |
| 2022-09-27 | Transgene | Results R&D Day: Presentations to Highlight Transgene’s Competitive Positioning, Capabilities to Engineer Novel Immunotherapies for Patients with Cancer, and Update on Initial Clinical Data transgene.com ↗
We will provide updated data on the previous Phase Ib/II trial of TG4001 and avelumab in HPV16-positive cancer patients |
| 2020-11-09 | Transgene | Results Transgene presents e-poster outlining detailed results from the Phase 1b/2 trial of TG4001 in combination with avelumab in advanced HPV-positive cancers at SITC 2020 transgene.com ↗
Transgene presents e-poster outlining detailed results from the Phase 1b/2 trial of TG4001 in combination with avelumab in advanced HPV-positive cancers at SITC 2020 |
| 2020-11-05 | Transgene | Results Transgene reports business update and end Q3 2020 financial position transgene.com ↗
The combination of TG4001 and avelumab demonstrated anti-tumor activity (23.5% ORR) in patients with previously treated recurrent and/or metastatic HPV-related cancers. |
| 2020-10-27 | Transgene | Results Transgene announces detailed results from clinical study of TG4001 in combination with avelumab in advanced HPV-positive cancers transgene.com ↗
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. |
| 2020-10-19 | Transgene | Results Acceptance of Late Breaking Abstract at Upcoming SITC 2020 Conference, on the detailed results from clinical study of TG4001 in combination with avelumab in advanced HPV-positive cancers transgene.com ↗
As a reminder, the analysis of the trial data demonstrate d clinical activity of the combination regimen and confirmed a manageable safety profile. |
| 2020-09-16 | Transgene | Results Positive clinical results for TG4001 and TG6002 and financial visibility secured until 2022 transgene.com ↗
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 a promising clinical activity in the overall study population (34 evaluable patients). |
| 2020-07-22 | Transgene | Results Transgene Reports Results from Clinical Study of TG4001 in Combination with Avelumab in Advanced HPV-Positive Cancers transgene.com ↗
This analysis confirms that TG4001 can be safely combined with an immune checkpoint inhibitor and shows clinical activity of this combination regimen . |
| 2019-09-30 | Transgene | Results Transgene Reports First Promising Efficacy Results with TG4001 in Combination with Avelumab in HPV-Positive Cancer at ESMO 2019 transgene.com ↗
3 of the 6 patients treated with the higher dose of TG4001 showed durable partial responses1. |
| 2019-06-05 | Transgene | Results Peer-reviewed publications confirm the potential of Transgene’s TG4001 and TG6002 transgene.com ↗
Of the 129 women randomized to TG4001 and 63 to placebo, complete resolution 1 was significantly higher in the vaccine group than placebo for CIN 2/3 regardless of the 13 high -risk HPV types assayed (24% vs. 10%, p < 0.05). |
All press releases naming this drug 19 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TIPAPKINOGENE SOVACIVEC | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108714 ↗ |
| Known as | Mva-hpv-il2 vaccine | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108714 ↗ |
| Known as | RG-3484 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108714 ↗ |
| Known as | RO5217790 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01022346 ↗ |
| Known as | TG4001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03260023 ↗ |
| Known as | Tipapkinogen sovacivec | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108714 ↗ |
| Route | Subcutaneous | “RO5217790 will be administered at a dose of 5\*10\^7 pfu subcutaneously on Days 1, 8, and 15.” NCT01022346 ↗ |