Drugs / TG4010
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT03353675 | Jan 2018 → Nov 2019 | non-small cell lung carcinoma | Transgene | Completed | Missed primary |
| Phase 2 | NCT02823990 | Dec 2016 → Feb 2021 | non-small cell lung carcinoma | Megan Daly, MD | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01383148 | Apr 2012 → Jul 2015 | non-small cell lung carcinoma | Transgene | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2019-12-12 | Transgene | Results Transgene Reports on the Combination Trial of TG4010, Chemotherapy and Nivolumab in Non-Small Cell Lung Cancer transgene.com ↗
Transgene has taken the decision to stop further development of TG4010. |
| 2017-10-30 | Transgene | Results Transgene to Present Additional Immunology Data from the TIME trial with TG4010 in patients with advanced lung cancer at SITC 2017 transgene.com ↗
New Results from the Phase 2b TIME Trial, Including the Correlation of Vaccine-Induced Immunogenicity and Improved Overall Survival, Support Transgene’s Ongoing Clinical Strategy to Develop TG4010 in Lung Cancer (NSCLC) in Combination Regimens with Immune Checkpoint Inhibitors (ICIs) |
| 2017-10-12 | Transgene | Results Peer Reviewed Scientific Publications Highlight TG4010’s Ability to Induce Broad CD8+ Responses and its Synergistic Effects in Combination with Immune Checkpoint Inhibitors transgene.com ↗
It was shown that the significantly longer overall survival (OS) of patients treated with TG4010 is correlated with the diversity and intensity of CD8+ T cell responses against the MUC1 antigen. |
| 2017-09-11 | Transgene | Regulatory Transgene Receives FDA IND Approval to Begin a Clinical Trial with TG4010 + Nivolumab + Chemotherapy in the First-Line Treatment of Lung Cancer (NSCLC) transgene.com ↗
Transgene Receives FDA IND Approval to Begin a Clinical Trial with TG4010 + Nivolumab + Chemotherapy in the First-Line Treatment of Lung Cancer (NSCLC) |
| 2014-09-08 | Transgene | Results Transgene Reports Financial Results for First Six Months of 2014 and Provides Update on TG4010 transgene.com ↗
Updated TG4010 data show an improvement in overall survival consistent with improvement in progression-free survival as previously reported |
All press releases naming this drug 8 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TG4010 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02823990 ↗ |
| Modality | Vaccine | “Vaccines that are made from a gene-modified virus, such as TG4010, may help the body build an effective immune response to kill tumor cells.” NCT02823990 ↗ |
| Route | Subcutaneous | “subcutaneous injections of 10(8) plaque-forming units of TG4010 or placebo” PMID 26727163 ↗ Dec 2015 |
| Target | MUC1 | “improvement of survival under TG4010 treatment correlated with development of T cell responses against MUC1.” PMID 28923084 ↗ Sep 2017 |