TG4050 Cancer Vaccine Clinical Trials, Dosage, Indication, News
Transgene and NEC Corporation TG4050 is an individualized therapeutic vaccine designed to stimulate and educate patients' immune systems to recognize and destroy tumor cells. TG4050 has been designed to target up to 30 patient-specific neoantigens (cancer cell mutations), selected using NEC's Neoantigen Prediction System, an advanced AI technology.
Transgene uses its expertise in viral vectorization to incorporate the selected neoantigen sequences in the MVA viral vector genome. The Company has set up a unique in-house good manufacturing practice unit dedicated to manufacturing the individualized batches of TG4050 needed for the clinical development of this novel individualized therapeutic vaccine. The Company's clinical-stage programs consist of two therapeutic vaccines (TG4001 for the treatment of HPV-positive cancers and TG4050, the first individualized therapeutic vaccine based on the myvac® platform) as well as two oncolytic viruses (TG6002 for the treatment of solid tumors, and BT-001, the first oncolytic virus based on the Invir.IO™ platform).
TG4050 is the first myvac®-derived product being evaluated in human clinical trials. myvac® is a viral vector (MVA) based, individualized immunotherapy platform that Transgene has developed to target solid tumors. myvac®-derived products are designed to stimulate the patient's immune system and recognize and destroy tumors using the patient's cancer-specific genetic mutations.
NEC's neoantigen prediction system utilizes proprietary AI, such as graph-based relational learning, trained on multiple biological data sources to discover candidate neoantigen targets. These targets are carefully analyzed using proprietary machine learning algorithms, including in-house HLA binding and antigen presentation AI tools, to evaluate the likelihood of eliciting a robust and clinically relevant T-cell response. With NEC OncoImmunity now onboard, NEC continues strengthening its top-class neoantigen prediction pipelines to maximize the therapeutic benefits of personalized cancer immunotherapy for patients worldwide.
On June 6, 2023, the companies announced that new positive data had been generated from patients with HPV-negative head and neck cancer enrolled in an ongoing randomized Phase I trial assessing TG4050 (NCT04183166). All patients treated with TG4050 in the trial have developed a specific immune response, as demonstrated by the results of additional immunological testing, and remained disease-free to date. On January 9, 2024, the companies announced the signing of a further development collaboration agreement to continue the clinical evaluation of the individualized neoantigen cancer vaccine TG4050. They plan to extend the randomized Phase I trial into a randomized Phase I/II trial in 2024 to further demonstrate the potential of TG4050 as an adjuvant treatment for head and neck cancers.
On March 5, 2024, Transgene, NEC Corporation, and BostonGene Corporation (BostonGene) announced the expansion of their collaboration for the randomized Phase I/II trial of TG4050.
On April 9, 2024, Transgene and NEC Corporation announced that new data on TG4050 will be presented at the American Association for Cancer Research (AACR) Annual Meeting. Key findings of the poster include: All 16 patients who received TG4050 are disease-free after a median 18.6 months follow-up; Specific cellular immune responses were detected in the 16/17 patients who received TG4050 (16 patients of the treatment arm and one patient from the observation arm treated after relapse) using stringent testing conditions; TG4050 induced persistent immune responses against multiple targets in several patients. T-cell responses were maintained beyond 211 days (7 months) after the initiation of the treatment.
Transgene is a publicly traded French biotechnology company (Euronext Paris: TNG) focused on designing and developing targeted immunotherapies to treat cancer. Transgene has been awarded "Investment for the Future" funding from Bpifrance to develop its platform myvac®. NEC Corporation (NEC; TSE: 6701) is a leader in IT, network and AI technologies.
TG4050 Cancer Vaccine Indication
TG4050 is indicated for cancer patients who have already received first-line treatment. TG4050 targets a panel of patient-specific mutations selected using NEC's Neoantigen Prediction System. Therapeutic vaccines indirectly destroy diseased cells by causing a cascade of immune responses, producing "killer" T cells that specifically destroy tumor cells.
On June 28, 2021, Dr. Maud Brandely, M.D., Ph.D., Chief Medical Officer of Transgene, added, "We are delighted to start the clinical trial with our individualized myvac® immunotherapy in the UK. We have been collaborating for several years with Professor Ottensmeier on this novel therapy to target tumor cells better, and we are excited to see that our world-leading innovations are now reaching patients in different countries in Europe and the USA. We are convinced that, together with leading scientists and clinicians, we will be able to demonstrate the value of our individualized approach against head and neck cancer and leverage these future results to target other solid tumors."
TG4050 Cancer Vaccine Dosage
TG4050 will be administered in Phase 1 Clinical Trials as subcutaneous injections weekly for the first six weeks and then every three weeks.
TG4050 Cancer Vaccine Side Effects
The vaccine has been well-tolerated since November 23, 2021, and no related Serious Adverse Events have been reported across the two studies. Adverse events are consistent with previous observations made with the MVA viral vector. They mainly consist of mild and transient symptoms, mostly injection site reactions.
TG4050 Cancer Vaccine News
April 9, 2024 - Masamitsu Kitase, Corporate SVP and Head of the Healthcare and Life Sciences Division at NEC, concluded: “Our state-of-the-art proprietary artificial intelligence and machine learning models have allowed us to identify immunogenic and clinically relevant mutations in all head and neck cancer patients for this TG4050 randomized Phase I trial. These tumors were characterized by a low tumor mutation burden, which presents an obstacle to designing a relevant vaccine. Our powerful platform enables us to identify mutations for individualized treatments, which have now shown the first signs of clinical benefit for patients. Together with Transgene, we look forward to continuing to build on these promising data through our planned Phase II trial in the adjuvant treatment of head and neck cancer."
March 5, 2024 - "We are committed to supporting Transgene and NEC as they advance these clinical trials," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Our molecular and immune profiling techniques comprehensively analyze the tumor, microenvironment, and immune system to identify key predictors of response to TG4050, ultimately improving treatment outcomes."
January 9, 2024 - Alessandro Riva, Chairman and CEO of Transgene, commented: "We are pleased to announce the extension of our agreement with NEC, which marks a significant milestone in our collaboration. We look forward to continuing to treat patients with our individualized cancer vaccine TG4050. The compelling initial Phase I data presented with NEC at ASCO 2023 showed that all evaluable patients treated with TG4050 monotherapy developed a specific immune response and remained disease-free.
March 15, 2023 - NEC Corporation announced its participation in the American Association of Cancer Research Annual meeting, which will take place in Florida, USA, from April 14–19, 2023.
April 18, 2022 - New Data Showing that Transgene and NEC's Individualized Cancer Vaccine TG4050 Induces Strong and Specific Immune Responses against Tumors Presented at AACR 2023.
November 23, 2021 - Transgene and NEC Corporation announced positive preliminary immunogenicity and clinical data on TG4050, their jointly developed individualized neoantigen cancer vaccine. Positive initial data generated in the first six patients treated with TG4050 demonstrate the strong potential of this individualized immunotherapy in ovarian cancer and head and neck cancer: TG4050 induced robust anti-tumor cellular immune responses against multiple neoantigen targets in all evaluable patients (4/4); TG4050 monotherapy was also associated with the first signs of clinical activity.
June 28, 2021 - Transgene announced that the first UK patient enrolled in Phase I clinical trial of TG4050 is currently being evaluated in HPV-negative head and neck cancer patients.
May 15, 2020 - Transgene and NEC announced they would present data demonstrating that the prediction algorithm that customized TG4050 for each patient accurately identifies immunogenic cancer mutations, even among many candidate mutations.
January 7, 2020 - Transgene and NEC start two clinical trials in oncology with TG4050, an individualized therapeutic vaccine thanks to artificial intelligence.
TG4050 Cancer Vaccine Clinical Trials
As of 2023, TG4050 is being evaluated in ongoing multicenter Phase I trials in ovarian and head and neck cancer.
Clinical Trial NCT03839524: A Trial Evaluating TG4050 in Ovarian Carcinoma - This is a multicenter, open-label, single-arm phase I study evaluating the safety and tolerability of some activity parameters of TG4050 in patients with ovarian, fallopian, or peritoneal serous carcinoma. Estimated completion date: December 2021.
ClinicalTrials.gov Identifier: NCT04183166: A Clinical Trial Evaluating TG4050 in Head and Neck Cancer - This is a multicenter, open-label, two arms, randomized, Phase I study evaluating the safety and tolerability and some activity parameters of TG4050 in patients with squamous cell carcinoma of the head and neck (SCCHN). Estimated completion date: November 2021.
