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Transgene Receives FDA Investigational New Drug Indication to Initiate Clinical Development of TG4050, the First Individualized Immunotherapy from Myvac ™

Tuesday, May 14, 2019

Transgene, a biotechnology company that designs and develops immunotherapies based on viral vectors against cancer and infectious diseases , has received the authorization ( Investigational New Drug (IND) clearance ) from the Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial with TG4050, the first product candidate from the myvac ™ platform , in ovarian cancer patients who have undergone surgery and received chemotherapy.

TG4050 is an individualized immunotherapy based on a viral vector (MVA) from the myvac ™ platform . This product candidate is designed to stimulate the immune system of patients and enable them to recognize and destroy tumor cells. Tumor cells develop an increasing number of mutations and each patient has a combination of mutations (neoantigens) that is specific to their tumor. TG4050 is designed to target a combination of mutations specific to each patient, previously selected through the NEC neoantigen prediction system.

"We are very pleased to have obtained an FDA IND for TG4050. This allows us to begin the clinical development of the first myvac ™ platform drug candidate in ovarian cancer patients who have already received first-line treatment, " commented Dr. Maud Brandely, PhD, Director. , Clinical Development, Clinical Operations & Regulatory Affairs of Transgene."We are convinced that individualized vaccination is a promising solution that can significantly transform the treatment of many solid tumors. With TG4050, we believe that this new therapeutic option can improve patient outcomes. We look forward to sharing the progress of this clinical trial, which is expected to begin this year. "

This Phase 1 clinical trial will evaluate the safety and tolerability of TG4050 in patients with serous carcinoma of the ovary, fallopian tubes, or peritoneum. Antitumor activity will also be measured. This multi-center single-arm trial will be active in the United States and Europe.

Transgene is the sponsor of this trial, co-funded with its partner NEC. The latter also contributes to this study by participating in the design of the therapeutic vaccine and the selection of neoantigens (see press release issued March 5, 2019).

About TG4050
TG4050 is an individualized immunotherapy designed to stimulate the immune system of patients to induce a response that specifically recognizes and destroys tumor cells.
This personalized immunotherapy is designed for each patient, based on the mutations identified by sequencing tumor tissue using the myvac ™technology platformthat allows the design and manufacture of a patient-specific product under time-compatible conditions. clinics.

About myvac ™
myvac ™ is an individualized viral vector-based immunotherapy (MVA) designed to target solid tumors. The products from this platform are designed to stimulate the immune system of patients to recognize and destroy tumors using their own genetic mutations. Transgene has set up an innovative network that combines bio-engineering, digital transformation and recognized know-how in vectorization with a unique manufacturing unit.
As part of the Investments for the Future Program, Transgene is backed by Bpifrance for the development of its myvac ™platform.

About the NEC NeoAntigen Prediction System NEC's NeoAntigen Prediction
System uses a patented AI, which includes graph-based relational learning technology , combined with other technologies. sources of data to identify neo-antigen candidates. The neoantigenic candidates are studied according to many parameters, in particular with a tool for predicting major histocompatibility complex (MHC) binding affinities. This prediction system makes it possible to prioritize the identified neoantigen candidates in each patient.

About Transgene:
Transgene is a biotechnology company that designs and develops immunotherapy products against cancer and infectious diseases. These products use viral vectors to directly or indirectly kill infected or cancerous cells.
The main products in Transgene's clinical development are: TG4010, a therapeutic vaccine against non-small-cell lung cancer, Pexa-Vec, an oncolytic liver cancer virus, and TG4001, a therapeutic vaccine against HPV-positive cancers. The Company also has several other programs in clinical development, including TG1050 (chronic hepatitis B) and TG6002 (solid tumors).

With its Invir.IO ™ platform, Transgene capitalizes on its expertise in viral vector engineering to design a new generation of multifunctional oncolytic viruses.
myvac ™, an individualized viral vector-based immunotherapy (MVA) platform integrating neoantigens, complements this innovative research portfolio, with the first TG4050 product in clinical development against ovarian cancer and head and neck cancers .

More information on .
Follow us on Twitter: @TransgeneSA

About NEC Corporation
NEC Corporation is a leader in integrating IT solutions and networks for businesses and individuals around the world. With its " Solutions for Society  " offering  , the NEC Group promotes the safety, efficiency and equity of the Company. The signature "  Orchestrating a brighter world  " illustrates NEC's desire to provide answers to many societal challenges and to create social values ​​for the world of tomorrow. More information on .

Forward-looking statements
This press release contains forward-looking information and / or statements that may be subject to a number of uncertainties and uncertainties, so that actual results may differ materially from those anticipated. There is no guarantee that (i) the results of preclinical work and previous clinical trials are predictive of the results of current clinical trials, (ii) regulatory approvals for Transgene therapies will be obtained or (iii) that the Company will find partners to develop and commercialize its therapies in a reasonable time and under satisfactory conditions.
For a description of the risks and uncertainties that could affect the Company's results, financial position, performance or achievements and thus cause a change from the forward-looking statements, please refer to the "Risk Factors" section of this document. Reference Document filed with the AMF and available on the websites of the AMF ( ) and the Company ( ).
Forward-looking statements speak only as of the date of this document and Transgene does not undertake to update these forward-looking statements even if new information becomes available in the future.


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