New Data Showing that Transgene and NEC’s Individualized Cancer Vaccine TG4050 Induces Strong and Specific Immune Responses against Tumors Presented at AACR 2023

• New Phase I data confirm promising immunogenicity and efficacy profile of TG4050, an individualized neoantigen cancer vaccine developed by Transgene in collaboration with NEC Corporation
• In the head and neck cancer trial to date, all patients treated with TG4050 have remained disease-free, despite unfavorable systemic immunity and tumor micro-environment before treatment
• Transgene and NEC are considering the most appropriate path towards registration in head and neck, with a Phase II trial to be initiated in H2 2023

Strasbourg, France & Tokyo, Japan, April 18, 2023, 9:00 a.m. CET/4:00 p.m. JST – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, announced that new data will be presented today on TG4050, an individualized neoantigen cancer vaccine, at the American Association for Cancer Research (AACR) Annual Meeting in Orlando, Florida. TG4050 is based on Transgene’s myvac® platform and powered by NEC’s cutting-edge AI capabilities.

The new positive data have been generated from patients with HPV-negative head and neck cancer and with ovarian cancer, who have been enrolled in two ongoing Phase I trials assessing TG4050.

TG4050 has demonstrated the ability to induce strong immune responses against targeted antigens in patients, which are expected to result in extended remission periods.

Hedi Ben Brahim, CEO of Transgene, added: “Our individualized neoantigen vaccine TG4050 continues to deliver very encouraging clinical and immune response data, combined with an excellent safety profile. These results suggest that TG4050 has the potential to extend the remission period for cancer patients who have undergone surgery, giving new hope to a patient population who currently have no treatment options available except a watchful follow up. We are continuing to build a strong and compelling clinical data set to support the benefits of this novel personalized immunotherapy. In parallel, we, along with NEC, are preparing for a Phase II trial as part of the registration path, which could start as early as the second half of 2023 for head and neck cancer, which represents a $1 billion+ market opportunity for the program. TG4050 also has the potential to be developed for preventing relapses in other solid tumor indications.”

Masamitsu Kitase, Corporate Senior VP, and Managing Director of Healthcare Life Sciences Business, NEC Corporation, commented: “It is very encouraging to see such promising clinical and immune response data contributing to the momentum of TG4050’s development. We look forward to working closely with Transgene to maintain this advancement, and we are confident that our personalized therapy will benefit the health of individual patients across the globe."

New immune data confirm the ability of TG4050 to effectively prime the immune system in patients with poor immune status

The new set of comprehensive immunological data presented at AACR 2023 show that all evaluable patients developed a specific immune response after treatment with TG4050 against multiple cancer neoantigens and remained disease-free, in spite of having challenging immune contextures comprised of both unfavorable systemic immunity and tumor micro-environment at baseline. These are normally associated with limited responses to treatments, and in particular resistance to immune checkpoint blockades.

This suggests that TG4050 can boost the immune system of patients with a tumor micro-environment usually characterized as an immune desert or involving the presence of non-functional immune cells, or with low or negative levels of PD-L1 expression. 

In addition, these data confirm that all evaluable patients developed robust T-cell responses against multiple targeted neoantigens (median of 9 positive responses per patient out of approximately 30 targets). T-cell responses were observed for class I and class II epitopes, consisting of both de novo responses and amplifications of preexisting responses.

Vaccination was well tolerated and associated with encouraging preliminary signs of anti-tumor efficacy

As of March 2023, 32 patients were randomized in the head and neck cancer trial. All 16 patients who received TG4050 remained disease-free, with a median follow-up time of 9.2 months. This compares favorably to the control arm, in which two patients with similar characteristics experienced relapse. These patients are still followed in the ongoing trial. 

Transgene expects the last patient to be treated in the coming weeks. Final results from this trial are expected in mid-2024.

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

Phase II trial to start in H2 2023

Transgene and NEC are preparing for a Phase II trial in head and neck cancers which could be initiated in H2 2023.

An abstract and poster can be accessed on the AACR and Transgene websites.

Dr Christian Ottensmeier, MD, PhD, FRCP (University of Liverpool, La Jolla Institute for Immunology) will discuss the unmet medical need and current treatment landscape for patients suffering from head and neck cancers in a live virtual event taking place on April 19, 2023 (12:00 pm ET; 6:00 pm CET). Click here to register or listen to the replay.