Personalized Vaccine TG4050 Shows 100% Success in Cancer Trial

STRASBOURG, FRANCE – January 09, 2026 – French biotechnology firm Transgene has unveiled stunning results from a Phase I trial of its individualized cancer vaccine, TG4050, which demonstrated a 100% disease-free survival rate at two years for patients with high-risk head and neck cancer. The data, published today as a preprint on medRxiv, suggests a potential paradigm shift in preventing relapse for one of the most challenging forms of the disease.

The study focused on patients with HPV-negative head and neck squamous cell carcinoma (HNSCC) who had already undergone surgery. In the group that received TG4050 as a standalone adjuvant therapy, no patients saw their cancer return after two years. These findings provide powerful early evidence for the vaccine's ability to train a patient's immune system to hunt down and eliminate residual cancer cells, a major goal in modern oncology.

Confronting a High-Stakes Disease

The results for TG4050 are particularly significant given the grim prognosis often associated with HPV-negative HNSCC. This form of cancer, frequently linked to tobacco and alcohol use, is notoriously difficult to treat. Despite a primary treatment regimen of surgery, radiation, and chemotherapy, about one-third of patients experience a recurrence within two years. Once the cancer returns or spreads, the chances of long-term survival drop precipitously.

Current treatments for recurrent disease, including immune checkpoint inhibitors like anti-PD-1 therapies, provide durable benefits for only a small fraction of patients. The tumor microenvironment in HPV-negative cases is often highly immunosuppressive, blunting the effectiveness of existing immunotherapies and creating a critical unmet need for novel approaches. TG4050 is designed to directly address this challenge by generating a new, robust, and highly specific immune attack where previous treatments have failed.

A New Era of Personalized Immunotherapy

At the heart of TG4050's success is a deeply personalized approach that combines advanced virology with artificial intelligence. Developed on Transgene's proprietary myvac® platform, each dose of the vaccine is custom-built for a single patient.

The process begins by sequencing a patient's tumor to identify its unique genetic mutations. These mutations can produce abnormal proteins called neoantigens, which act as flags that are exclusive to the cancer cells. The challenge lies in determining which of these hundreds or thousands of neoantigens will trigger the most powerful immune response.

This is where Transgene's partnership with Japanese tech giant NEC Corporation becomes crucial. Using an AI-powered Neoantigen Prediction System trained on over two decades of machine learning expertise, up to 30 of the most promising neoantigen targets are selected. The genetic code for these targets is then inserted into a Modified Vaccinia Ankara (MVA) virus—a safe, well-established viral vector—to create the final vaccine. When administered, the vaccine instructs the patient's own cells to produce these cancer-specific neoantigens, training their immune system's elite CD8+ T cells to recognize and destroy any cancer cells bearing these markers.

Analyzing the Breakthrough Data

The comprehensive analysis from the Phase I trial, now available to the global scientific community ahead of peer review, provides a detailed look at both the clinical efficacy and the underlying biological mechanisms of TG4050. The study randomized patients to receive the vaccine either immediately after standard adjuvant treatment or at the time of disease recurrence. The 100% two-year disease-free survival was observed in the group receiving TG4050 as an immediate, preventative monotherapy.

Beyond this headline figure, detailed translational data confirmed the vaccine was working as designed. In 73% of evaluable patients, TG4050 successfully induced strong and durable T-cell responses specifically targeting the tumor neoantigens. These responses were characterized by cytotoxic and effector phenotypes, indicating the immune cells were armed and ready to kill cancer cells, with the effect lasting up to a year after the final dose. Furthermore, the treatment was well-tolerated, with no unexpected safety issues reported.

"The findings show encouraging evidence of TG4050’s ability to induce durable, neoantigen-specific immune responses and its potential in preventing relapse in patients with HPV-negative operable head and neck cancer," said Katell Bidet-Huang, Head of Translational Medicine at Transgene, in the company's official announcement. "We look forward to advancing TG4050 through Phase II with the same determination and patient-centered approach."

The Competitive Race for Cancer Vaccines

Transgene's positive results land in a fiercely competitive and rapidly advancing field. The concept of a personalized cancer vaccine has become a holy grail for many of the world's leading biotechnology firms, each employing different technologies to achieve the same goal.

Companies like BioNTech and Moderna, famous for their COVID-19 vaccines, are leveraging their mRNA platforms to develop similar individualized neoantigen therapies. BioNTech's iNeST program, in partnership with Genentech, is in Phase 2 trials for pancreatic cancer, while Moderna is advancing its own candidate in combination with Merck's checkpoint inhibitor for melanoma. These mRNA vaccines offer rapid manufacturing but use a different delivery system than Transgene's viral vector.

Other competitors, such as Gritstone bio, are exploring both personalized and "off-the-shelf" vaccines targeting shared mutations. The success or failure of these varied approaches will ultimately shape the future of personalized oncology. Transgene's use of the MVA viral vector, a platform with a long history in vaccine development, combined with NEC's cutting-edge AI, gives it a unique position in this high-stakes race.

The Path Forward: From Trial to Treatment

With these encouraging Phase I results in hand, all eyes are on the ongoing randomized Phase I/II trial. The company expects to complete patient randomization in the first quarter of 2026 and release initial immunogenicity data from the Phase II portion of the study in the second half of the year. The crucial efficacy data, measuring two-year disease-free survival for the larger cohort, is anticipated around the end of 2027 or early 2028.

Transgene appears well-positioned to see this development through. A successful fundraising campaign in late 2025 secured approximately €105 million, extending the company's financial runway into early 2028. A significant portion of these funds is earmarked for accelerating the myvac® program, optimizing the complex manufacturing process for a personalized therapy, and preparing for a potential pivotal Phase 3 trial. These strategic investments underscore the company's confidence in TG4050's potential and its commitment to navigating the complex regulatory and commercial pathways required to bring this innovative therapy to patients.