Transgene provides business and financial update for Q1 2024

TG4050: Exciting Phase I data presented at AACR 2024 demonstrating first signs of clinical benefit in adjuvant setting for head and neck cancer  Phase II part of randomized trial to start in coming weeks

New clinical data expected on TG4001, TG6050 and BT-001 in H2 2024

Financial visibility until Q4 2025

Strasbourg, France, May 14, 2024, 5:45 p.m. CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today provides a business update, including its financial position as of March 31, 2024.

Key events and upcoming milestones

Transgene and its partner NEC reported updated TG4050 Phase I data at AACR 2024 (see April 9 press release here), showing first clinical benefit for patients treated in the adjuvant setting for head and neck cancer, a patient population at high risk of relapse.

Almost all treated patients (16/17) developed a specific immune response against the selected personalized antigen targets. All patients who received TG4050 remain disease-free after a median follow-up of 18.6 months, comparing favorably to the observational arm which saw 3 out of 16 patients relapse during the same period.

These data provide a robust clinical proof of principle for the Company’s lead candidate.

Additional data on the 24-month median follow up of patients will be reported in H2 2024.

Following these promising data, the randomized Phase I trial will be expanded to a randomized Phase I/II trial in the adjuvant setting of head and neck cancer. The Phase II part is expected to start enrolling patients in Q2 2024 within the framework of an extended collaboration between Transgene and NEC.

TG4050 has potential applicability across a range of solid tumors where the medical need is still significant despite the existing therapeutic option including immunotherapies.

Across 2024, Transgene expects to communicate progress and significant results on all of its clinical stage assets.

TG4050	Randomized Phase I part of trial (head and neck): 24-month patient follow up	H2 2024
	Randomized Phase II part to start (head and neck)	H1 2024
	Preliminary work to launch additional Phase I trial	2024
TG4001	Randomized Phase II: topline results	H2 2024
TG6050	Initial data from Phase I trial	H2 2024
BT-001	Initial data from combination part of Phase I	H2 2024