Drugs / TG4050
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03839524 | Dec 2019 → Oct 2024 | fallopian tube cancer, ovarian carcinoma, peritoneal carcinoma | Transgene | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04183166 | Dec 2019 → Dec 2027 expected | head and neck squamous cell carcinoma | Transgene | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2026-09-02 | Transgene | Results Transgene and NEC Report 100% Three-Year Disease-Free Survival with TG4050 and Publish Phase 1 Results in Nature Communications transgene.com ↗
The companies also announced the publication of the Phase 1 comprehensive clinical and translational data from the study , for the first time in the peer -reviewed journal Nature Communications. |
| 2026-03-26 | Transgene | Results Transgene to Deliver an Oral Presentation on its Individualized Neoantigen Therapeutic Vaccine TG4050 at the World Vaccine Congress transgene.com ↗
We are delighted to share our positive data on our lead asset TG4050 with the scientific community |
| 2026-01-09 | Transgene | Results Transgene Publishes Phase I Data Supporting TG4050’s Potential in Preventing Head and Neck Cancer Relapse transgene.com ↗ |
| 2025-06-01 | Transgene | Results Transgene and NEC Present Durable Disease-Free Survival and Sustained T Cell Responses at 24 Months with Individualized Cancer Vaccin TG4050 transgene.com ↗ |
| 2024-11-07 | Transgene | Results Transgene and NEC Present New Data Confirming Clinical Proof of Principle for Neoantigen Cancer Vaccine, TG4050, in Head & Neck Cancer at SITC 2024 transgene.com ↗
After a median follow up of 24 .1 months, all 16 patients who received TG4050 as adjuvant immunotherapy after completion of adjuvant standard of care remain disease -free and have not relapsed. |
| 2024-04-09 | Transgene | Results Transgene and NEC Present First Clinical Benefits of Neoantigen Cancer Vaccine, TG4050, in Head & Neck Cancer at AACR 2024 transgene.com ↗
All 16 patients who received TG4050 are disease free after a median 18.6-month follow-up. |
| 2023-06-06 | Transgene | Results Transgene and NEC Present New Data on TG4050, an Individualized Cancer Vaccine, Showing it Induces Specific Immune Responses against Head and Neck Carcinoma at ASCO 2023 transgene.com ↗
All patients treated with TG4050 in the trial have developed a specific immune response, as demonstrated by the results of additional immunological test ing, and remained disease-free to date. |
| 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 ↗
100% of the patients treated with the individualized therapeutic cancer vaccine developed multiple functional T cell responses against targeted neoantigens, which may be associated with an improved outcome in patients with head and neck cancer in the adjuvant setting. |
| 2023-04-18 | Transgene | Results New Data Showing that Transgene and NEC’s Individualized Cancer Vaccine TG4050 Induces Strong and Specific Immune Responses against Tumors Presented at AACR 2023 transgene.com ↗
TG4050 has demonstrated the ability to induce strong immune responses against targeted antigens in patients, which are expected to result in extended remission periods. |
| 2023-04-04 | Transgene | Results Transgene to Host KOL Webinar on TG4050: an Individualized Cancer Vaccine for the Treatment of HPV-Negative Head & Neck Cancers transgene.com ↗
In addition, Transgene’s management team will provide a company update, highlighting new Phase I data presented at AACR on April 18, 2023 , confirming the high immunogenicity and promising efficacy profile of TG4050 , an individualized neoantigen cancer vaccine developed by Transgene in collaboration with NEC Corporation. |
| 2023-03-15 | Transgene | Results Transgene to Present Multiple Posters Highlighting the Potential of its Exciting Immunotherapy Pipeline at AACR 2023 transgene.com ↗
New Phase I data confirm high immunogenicity and promising efficacy profile of TG4050, an individualized neoantigen cancer vaccine developed by Transgene in collaboration with NEC Corporation |
| 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 ↗
which are all positive and consistent with previous findings. |
| 2022-06-06 | Transgene | Results Transgene Presented Additional Phase I Data with TG4050 (myvac® platform) at ASCO 2022 transgene.com ↗
These additional positive initial data, including molecular (ctDNA) response, have been generated from the first patients with ovarian cancer and HPV-negative head and neck cancer enrolled in the two ongoing Phase I trials assessing TG4050. |
| 2022-05-27 | Transgene | Results Transgene to Present Updated Positive Preliminary Data from the Phase I Clinical Trials with TG4050 (myvac® platform) at ASCO 2022 transgene.com ↗
The abstract reports positive immunogenicity and clinical data generated from the two ongoing Phase I trials in patients with ovarian cancer and HPV-negative head and neck cancer (NCT03839524 and NCT04183166). |
| 2022-04-08 | Transgene | Results Transgene to Present New Positive Preliminary Phase I Clinical Data at AACR 2022, Reinforcing the Potential of TG4050 transgene.com ↗
Early signs of clinical activity were observed with encouraging ongoing anti-tumor activity in the first patients under neoantigen vaccine treatment. |
| 2021-11-22 | Transgene | Results Transgene and NEC announce positive preliminary data from Phase I studies of TG4050, a novel individualized neoantigen cancer vaccine transgene.com ↗
TG4050 induced robust anti-tumor cellular immune responses against multiple neoantigen targets in all evaluable patients (4/4). |
| 2020-06-22 | Transgene | Results Transgene presents promising new data from its next-generation immunotherapy platforms at AACR 2020 transgene.com ↗
More than 86% of top ranked peptides identified were immunogenic. |
| 2020-05-15 | Transgene | Results Transgene and NEC demonstrate high accuracy of AI-based neoantigen prediction for the design of individualized cancer vaccine TG4050 transgene.com ↗
Data confirm that the prediction algorithm successfully identifies immunogenic cancer mutations, even among a large set of candidate mutations |
| 2019-09-18 | Transgene | Regulatory Transgene Confirms the Timeline of its Clinical News Flow and Presents 2019 Half-Year Results transgene.com ↗
I am also pleased that we have gained regulatory clearance to begin the clinical development of our lead myvac™ individualized immunotherapy TG4050 in both the US and Europe before the end of 2019. |
| 2019-09-16 | Transgene | Regulatory Transgene Receives Approval from the French Health Authority (ANSM) to Initiate Two Clinical Trials of its Lead myvac® Individualized Immunotherapy TG4050 transgene.com ↗ |
| 2019-07-10 | Transgene | Regulatory Transgene Receives MHRA Approval for Lead myvac® Individualized Immunotherapy, TG4050, to Commence Clinical Development in HPV Negative Head and Neck Cancers in the UK transgene.com ↗
today announces it has received the approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to proceed with a Phase 1 clinical trial of its lead myvacTM candidate TG4050. |
| 2019-05-13 | Transgene | Regulatory Financial visibility extended to Q4 2020, including $10 million revenue from collaboration with AstraZeneca to be received in Q2 2019 transgene.com ↗
Transgene received FDA IND clearance for TG4050 to commence clinical development in ovarian cancer (press release distributed on May 13, 2019). |
| 2019-05-13 | Transgene | Regulatory Transgene receives FDA IND Clearance for Lead myvac® Individualized Immunotherapy, TG4050, to Commence Clinical Development in Ovarian Cancer transgene.com ↗ |
All press releases naming this drug 37 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TG4050 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04183166 ↗ |
| Route | Subcutaneous | “Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks.” NCT03839524 ↗ |