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Updated Phase I Data with TG4050 Presented at ASCO 2022

Aditional preliminary Phase I data on TG4050, an individualized neoantigen cancer vaccine co-developed by NEC and Transgene, was presented by Transgene in a poster session at the American Society of Clinical Oncology (ASCO) annual meeting. TG4050 is based on Transgene’s myvac® platform and powered by NEC’s cutting-edge AI capabilities.

These additional positive preliminary data, including molecular (ctDNA) response, have been generated from the first patients with ovarian cancer and head and neck cancer enrolled in the two ongoing Phase I trials assessing TG4050. 

Clinical follow-up data continue to demonstrate the potential of TG4050 in ovarian and head and neck cancer patients

  • In the head and neck trial, patients were randomized to immediately receive vaccination with TG4050 (early treatment arm, arm A) or at relapse (delayed vaccination arm, arm B). All evaluable patients randomized to arm A (n=8) are still in complete response as of mid-May 2022. In arm B (n=8), two patients have experienced relapse. 
  • In the ovarian trial (n=5), a fifth patient initiated her treatment with TG4050 recently. One patient treated after an elevation of CA-125 experienced a normalization of CA-125 without clinical progression for 9 months until death from an unrelated chronic illness. Another patient was treated upon onset of radiological evidence of relapse and remained stable for 11.4 months. 

To date, the vaccine has been well tolerated and no related Serious Adverse Events have been reported across the two studies.

In both clinical studies, enrollment and patient dosing are progressing in line with our expectations. Overall, Transgene plans to treat 13 patients in the ovarian cancer trial and 30 patients in the head and neck cancer trial.

Immune cell response data demonstrated an effective priming of the immune system which is associated with disease regression

  • Circulating immune cells quantification (in particular monocytes, DC, NK cells, subcells of CD8, CD4, Treg) and expression of immune checkpoints (ICOS and PD1) suggest that the vaccine is able to effectively induce innate and adaptive immune responses in patients. 
  • In an ovarian cancer patient, clinical resolution, biological responses (CA-125 and ctDNA responses) were concomitant to an immune response against multiple epitopes and to the onset of markers of an effective immune response (switch in circulating CD4 and CD8 cells toward an effector phenotype, increase in CD16neg NK cells; peak in circulating cytokines).

The poster can be downloaded from the new windowASCO, AIDD and new windowTransgene websites.

Poster title: Phase 1 studies of personalized neoantigen vaccine TG4050 in ovarian carcinoma (OC) and head and neck carcinoma (HNSCC)

  • Abstract number: 2637
  • Session title: Developmental Therapeutics—Immunotherapy
  • Authors: J.P. Delord, M. Block, C. Ottensmeier, G. Colon-Otero, C. Le Tourneau, A. Lalanne, O. Lantz, KL. Knutson, G. Lacoste, A. Tavernaro, M. Brandely, N. Silvestre, B. Grellier, Y. Yamashita, K. Onoue, N. Yamagata, Y. Tanaka, B. Malone, E. Quemeneur, K. Bendjama

About the clinical trials
TG4050 is being evaluated in two Phase I clinical trials for patients with ovarian cancer (new windowNCT03839524) and HPV-negative head and neck cancers (new windowNCT04183166). 

About TG4050
TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene’s myvac® technology and powered by NEC’s longstanding artificial intelligence (AI) expertise. This virus-based therapeutic vaccine encodes neoantigens (patient-specific mutations) identified and selected by NEC’s Neoantigen Prediction System. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary data allowing it to accurately prioritize and select the most immunogenic sequences.
TG4050 is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to recognize and destroy tumor cells based on their own neoantigens. This individualized immunotherapy is developed and produced for each patient.

About NEC’s Neoantigen Prediction System
NEC's neoantigen prediction system utilizes its proprietary AI, such as graph-based relational learning, trained on multiple sources of biological data to discover candidate neoantigen targets. These targets are carefully analyzed using proprietary machine learning algorithms that include 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 to strengthen its top class neoantigen prediction pipelines with the aim of maximizing the therapeutic benefits of personalized cancer immunotherapy for patients worldwide. For more information, visit NEC at For additional information, please also visit NEC OncoImmunity at new windownew window