Transgene Reports Business Update and End Q1 2021 Financial Position

Regulatory News:

Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today announces its business update for the quarter ending March 31, 2021, and provides an update on the progress of its portfolio of clinical trials.

SIGNIFICANT PROGRESS ON ALL CANDIDATES

Since January 2021, Transgene has achieved significant milestones on all candidates of its clinical portfolio, with:

✓ the first patients dosed with TG4050, the individualized therapeutic vaccine against cancer based on Transgene’s myvac technology – the first data from the two ongoing Phase I clinical trials are expected in 4Q 2021;
✓ regulatory clearance received in the United States, in France and in Spain, which are expected to allow enrolment of patients with HPV-positive anogenital cancers in the randomized Phase II trial of TG4001 + avelumab versus avelumab alone in 2Q 2021;
✓ first patients dosed in the Phase I trial evaluating BT-001, an oncolytic virus based on the Invir.IO platform – first data are expected in 1H 2022;
✓ TG6002 initial data, presented at AACR, providing the clinical proof of concept of the intravenous administration of an oncolytic virus. After intravenous administration, TG6002 reached the tumor, multiplied within tumor cells, and induced the local expression of its payload (the FCU1 gene). These data also suggest that candidates derived from Transgene’s unique Invir.IO platform could also be given intravenously, extending the use of these therapies to a broad range of solid tumors – Next data with TG6002 are expected in 2H 2021 (intra-hepatic artery route).

SUMMARY OF KEY ONGOING CLINICAL TRIALS AND EXPECTED MILESTONES

myvac TG4050 Phase I NCT03839524	Targets: tumor neoantigens Ovarian cancer – after surgery and first-line chemotherapy ✓ Trial ongoing in the United States and in France ✓ Inclusions and patient dosing progressing in line with forecast ➲ First data expected in 4Q 2021
myvac TG4050 Phase I NCT04183166	HPV-negative head and neck cancer – after surgery and adjuvant therapy