Transgene and NEC Corporation reported 100% three-year disease-free survival (DFS) for patients treated with TG4050 in a Phase 1 trial for head and neck cancer.

The companies also announced the publication of comprehensive Phase 1 clinical and translational data in Nature Communications. The findings highlight durable neoantigen-specific T cell responses in patients with resected, locally advanced HPV-negative head and neck squamous cell carcinoma (HNSCC).

Clinical Outcomes

Three-year follow-up data from the Phase 1 part of the randomized Phase 1/2 trial demonstrate sustained clinical outcomes in the adjuvant setting. All 16 patients treated with TG4050 remained disease-free after a median follow-up of 41 months. In contrast, three of 16 patients in the control arm experienced relapse.

TG4050, which encodes up to 30 patient-specific neoantigens, maintained a favorable safety profile with no unexpected safety findings reported during the study period.

Immune Response Data

The peer-reviewed publication details robust and persistent neoantigen-specific CD8+ T-cell responses consistent with the vaccine’s mechanism of action. Key immunological findings include:

• Vaccine-induced responses were detected in 73.3% of patients treated with TG4050.
• Responders showed a median of three responding neoantigens per patient.
• These immune responses persisted for more than one year after the last vaccination.

Alessandro Riva, Chairman and CEO of Transgene, stated that the sustained neoantigen-specific immune responses provide evidence that the individualized therapeutic vaccine approach can generate durable anti-tumor immunity.

What the Numbers Show

The divergence between the treatment and control arms is stark: while 100% of TG4050-treated patients remained disease-free at the three-year mark, the control arm saw a relapse rate of approximately 18.75% (three out of 16 patients). This separation, combined with the high responder rate (73.3%) for neoantigen-specific T cells, suggests a strong correlation between the vaccine-induced immune response and sustained clinical remission in this cohort.

Next Steps

TG4050 continues to be evaluated in the ongoing randomized Phase 1/2 clinical trial (NCT04183166). Upcoming milestones include:

• First immunological data from the Phase 2 study in H2 2026.
• Two-year efficacy data (DFS) from the Phase 2 study in Q1 2028.

Masaki Kondo, Managing Director of NEC’s Life Science Division, noted that the results demonstrate the capacity of NEC’s AI-powered neoantigen prediction to identify tumor targets capable of generating clinically meaningful immune responses.

Transgene Biotek Limited reported a standalone net loss of ₹38.90 lakh for the quarter ended June 30, 2026 (Q1FY27), a narrowing from the ₹43.37 lakh loss recorded in the same period last year. The improvement was primarily driven by a 21.2% year-on-year increase in revenue from operations to ₹6.00 lakh and a substantial reduction in other expenses. Despite the operational gains, finance costs remained elevated at ₹28.95 lakh, continuing to pressure profitability. The Board of Directors approved the unaudited financial results and the limited review report on August 7, 2026.

The company’s total income stood at ₹6.00 lakh, as other income was nil, contrasting with ₹14.99 lakh recorded in the preceding quarter (Q4FY26). Total expenses decreased significantly to ₹44.90 lakh from ₹66.13 lakh in Q4FY26. This decline was largely attributable to a drop in other expenses from ₹30.09 lakh to ₹8.45 lakh. However, finance costs increased to ₹28.95 lakh from ₹27.68 lakh in the previous quarter. Basic earnings per share showed a loss of ₹0.05, an improvement from the loss of ₹0.06 in both the prior quarter and the corresponding period last year.

Financial Performance Overview

The consolidated financial results mirrored the standalone figures, with identical revenue, expense, and loss metrics. The subsidiary, Transgene Biotek HK Ltd, contributed zero revenue and zero net loss for the quarter. M/s. Vasavi & Co., the independent auditor, issued a limited review report confirming that the financial statements disclosed all required information under Regulation 33 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Governance and Regulatory Updates

During its meeting on August 7, 2026, the Board appointed M/s. Manisha Dubey & Associates as Internal Auditors for the financial year 2026-27. Ms. Manisha Dubey, a peer-reviewed Chartered Accountant with over 24 years of experience, will lead the firm’s engagement. The Board also approved the extension of the Annual General Meeting (AGM) for the financial year 2025-26, subject to approval from the Registrar of Companies.

Several legal and regulatory matters remain pending. The Securities Appellate Tribunal (SAT) has adjourned its hearing to August 17, 2026. The Appellate Tribunal (Enforcement Directorate), New Delhi, heard arguments on July 23, 2026, and adjourned the matter to September 10, 2026. Additionally, the National Company Law Tribunal (NCLT) adjourned its hearing to September 23, 2026. In the matter involving Nitin Didwania, an order passed on July 8, 2026, directed the payment of ₹92.99 lakh with 6% interest; the company has filed an appeal at the Bombay High Court Commercial Division.

What the Numbers Show

The primary driver behind the narrowed loss in Q1FY27 was a substantial reduction in other expenses, which fell from ₹30.09 lakh in Q4FY26 to ₹8.45 lakh in Q1FY27. This decline offset the steady increase in finance costs, which rose to ₹28.95 lakh. While revenue growth is positive, it remains insufficient to cover the high fixed costs, particularly finance charges, which accounted for nearly 65% of total expenses. The absence of other income in Q1FY27, compared to ₹14.99 lakh in the previous quarter, highlights the volatility in non-operating revenues, making operational cost control critical for future profitability improvements.