TG4050 Cancer Vaccine Description
Transgene TG4050 is an individualized therapeutic vaccine designed to stimulate and educate the immune system of patients 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. The prediction system is based on more than 2 decades of expertise in AI. In addition, it has been trained on proprietary immune data, allowing it to prioritize and select the most immunogenic sequences.
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).
myvac® is a viral vector (MVA) based, individualized immunotherapy platform that has been developed by Transgene to target solid tumors. myvac®-derived products are designed to stimulate the patient’s immune system, recognize and destroy tumors using the patient’s own cancer-specific genetic mutations. Transgene has set up an innovative network that combines bioengineering, digital transformation, established vectorization know-how, and unique manufacturing capabilities. Transgene has been awarded “Investment for the Future” funding from Bpifrance to develop its platform myvac®. TG4050 is the first myvac®-derived product being evaluated in clinical trials.
Transgene is a publicly-traded French biotechnology company (Euronext Paris: TNG) focused on designing and developing targeted immunotherapies to treat cancer. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.
TG4050 Cancer Vaccine Indication
TG4050 is indicated for cancer patients who have already received first-line treatment. TG4050 is designed to target 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, which results in the production of "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 in 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 6 weeks and then every 3 weeks.
TG4050 Cancer Vaccine Side Effects
As of November 23, 2021, the vaccine has been well-tolerated 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
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 had been enrolled in Phase I clinical trial of TG4050, currently being evaluated in HPV-negative head and neck cancer patients.
May 15, 2020 - Transgene and NEC announced that they would present data demonstrating that the prediction algorithm used to customize TG4050 for each patient accurately identifies immunogenic cancer mutations even among a large set of 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
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.