標準治療後の補助免疫療法としてTG4050を投与した16人の患者さん全員が、中央値24.1カ月の追跡調査後も無再発状態を維持しました。一方、観察対照群の患者さん16人のうち3人で再発を確認しました。頭頸部がんの患者層が標準的な手術および術後補助療法を受けた場合、24カ月以内に約30%が再発すると予想されており、より有効な術後補助療法には高い医療ニーズがあります。 
November 8, 2024
Transgene SA
NEC Corporation
- Both companies presented data from a 24-month follow-up survey of the Phase 1 clinical trial at the American Society for Cancer Immunotherapy (SITC 2024). In this data, we showed that all patients receiving TG4050 remained recurrence-free as additional treatment after completing standard adjuvant therapy for head and neck cancer.
- TG4050 induced specific and sustained immune responses. Currently, patient registration for phase II clinical trials is being carried out based on promising results in phase I clinical trials.
The biotechnology company Transgene SA (Transgene, hereinafter Transgene, Note 1) and NEC Corporation (hereinafter NEC, Note 2), which handles the design and development of virus-based immunotherapy for cancer treatment, conducted a randomized allocation (note 3) phase I clinical trial in which an individualized neoantigen cancer vaccine TG4050 was administered as an additional therapy for post-operative adjuvant therapy for head and neck cancer, and follow-up survey data (median value) of this trial A poster presentation will be made on 11/9 at the American Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting) for (24.1 months).
About TG4050
TG4050 is a vaccine developed using NEC's cutting-edge AI to select optimal cancer antigens on TransGene's MyVAC platform.
Data released this time: Recurrent status of head and neck cancer and status of immune response
All 16 patients who received TG4050 as adjuvant immunotherapy after standard treatment remained recurrence-free even after a median of 24.1 months of follow-up. Meanwhile, recurrence was confirmed in 3 out of 16 patients in the observation and control group. When patients with head and neck cancer receive standard surgery and adjuvant therapy, approximately 30% are expected to recur within 24 months, and there is a high medical need for more effective postoperative adjuvant therapy.
In addition, an immune response to selected neoantigens as targets was detected in all patients receiving TG4050. This indicates that TG4050 has strong immunogenicity (Note 5) for both de novo reactions and amplified reactions (Note 4). Furthermore, it was confirmed that the immune response continued over 7 months, which is the induction period and boost period.
Note, treatment-related adverse events continued to be mild to moderate.
Everyone's comments
It is very encouraging to be able to confirm clinical and immune response data for TG4050 at the time of a median follow-up of 24.1 months. There is still a high need for medical care in the area of adjuvant treatment after surgery for head and neck cancer patients. TG4050 induces an immune response to tumor antigens in “patients with locally advanced head and neck squamous cell cancer,” showing the possibility of preventing recurrence.
Institut Curie, Head of the Department of Drug Development and Innovation (D3i), and Principal Investigator, Pr. Le Tourneau
We are very encouraged to confirm that all patients who received our neoantigen vaccine TG4050 have maintained a recurrence-free state even after a median follow-up period of 24.1 months. Based on these results and ongoing immune responses over a long period of time, I am convinced that TG4050 may be beneficial to patients who are still at high risk of recurrence with current treatments. We are currently proceeding with international patient registration for phase II clinical trials with the aim of further proving these promising results.
Transgene, Chief Medical Officer, Dr. Emmanuelle Dochy
These results demonstrate the strength of our partnership with Transgene and our ability to develop individualized approaches for cancer patients by using NEC's own cutting-edge AI (artificial intelligence) /ML (machine learning) models. Now, we were able to construct a strong and compelling clinical data set that supports the merits of using TG4050 as personalized immunotherapy. NEC will continue to work on its mission to deliver new AI-based treatments to patients around the world.
NEC Executive Officer Corporate EVP and CTO Motoo Nishihara
Note that this content will be viewable on the SITC 2024 website and on Transgene's website when the poster is presented.
- SITC 2024:
- Transgene:
Based on these promising data, the randomized phase I trial was expanded to a randomized phase I/II trial (NCT04183166) in adjuvant therapy settings for head and neck cancer currently undergoing patient registration.
Poster details
Abstract number: 650
Title: Randomized phase I trial of adjuvant individualized TG4050 vaccine in patients with advanced resurrection HPV-negative head and neck squamous cell influenza (HNSCC)
Speaker: C. Le Tourneau — Institut Curie
Presentation date: November 9
over
- About clinical trials
TG4050 has been evaluated in a phase I clinical trial in patients with HPV-negative head and neck cancer (NCT04183166). In this clinical trial, individual investigational drugs tailored to each patient were designed while undergoing adjuvant therapy after surgery was completed. Half of the patients received TG4050 immediately after completion of adjuvant therapy, and the other half received TG4050 after recurrence as an additional treatment to standard treatment. This randomized clinical trial evaluates the therapeutic effect of TG4050 on patients at high risk of recurrence. The Phase I clinical trial was conducted internationally and was conducted with 32 evaluable patients. We are currently in the process of registering patients for phase II clinical trials. - About myvac
myvac is a personalized immunotherapy platform based on viral vectors (MVA-modified Vaccine Ankara) developed by Transgene to target solid cancers. Products derived from myvac-derived stimulate patients' own immune systems and are designed to recognize and eliminate tumors using genetic mutations specific to the patient's own cancer. Transgene is building an innovative network combining bioengineering, digital transformation, established vectorization know-how, and unique manufacturing capabilities. Transgene has acquired an “Investment for the Future” fund from BPIFrance for MyVAC development. MyVac's first product, TG4050, is currently being evaluated in clinical trials. - About TG4050
TG4050 is an individualized immunotherapy based on Transgene's MyVAC technology and NEC's AI. This virus-based therapeutic vaccine encodes a neoantigen (different mutation for each patient) identified and selected by NEC's neoantigen prediction system. The prediction system is based on AI expertise cultivated over 20 years and is accurately trained with unique data that enables the selection and prioritization of the most antigenic sequences. TG4050 is based on patient-specific neoantigens and is designed to stimulate patients' immune systems with the aim of triggering a T-cell response capable of recognizing and eliminating tumor cells. This personalized immunotherapy is developed and manufactured for each patient. - About NEC's Neo Antigen Prediction System
Graph-based relationship learning developed by NEC is used for neoantigen prediction, and multiple biological data are learned in order to predict target neoantigens. In order to calculate the possibility of triggering a robust T-cell response, targeted neoantigens are carefully investigated using machine learning algorithms including NEC's own HLA binding and antigen presentation AI tools. NEC OncoImmunity has been added to this, and NEC will continue to work to strengthen the world-class neoantigen prediction pipeline, aiming to maximize the therapeutic effects of personalized cancer immunotherapy for patients around the world. See below for details.
NEC's AI drug discovery business:
NEC OncoImmunity:
- (note 1)Headquarters: Strasbourg, France; CEO: Alessandro Riva
About Transgene:![Big]()
- (Note 2)Headquarters: Minato-ku, Tokyo; Director, Representative Executive Officer, President and CEO: Takayuki Morita
- (note 3)Random allocation: It is a method of randomly deciding whether to assign subjects to a target treatment group (group that administers investigational drugs to investigate effects) or a control group (group that administers control drugs, etc.). Randomization eliminates biases such as randomly assigning subjects to specific treatment groups, and can be evaluated fairly.
- (Note 4)De novo response and amplified response: The de novo response indicates a neoantigen-specific immune response newly induced by personalized cancer vaccine administration. Meanwhile, amplified response is an immune response that exists in patients even before personalized cancer vaccine administration, and indicates a neoantigen-specific immune response enhanced by personalized cancer vaccine administration.
- (note 5)Immunogenicity: It is the ability of antigens, etc. to trigger an immune response in the body.
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