On September 24, 2018 Transgene (Paris:TNG) (Euronext Paris: TNG) a biotechnology company that designs and develops virus-based immunotherapies against cancers and infectious diseases, reported myvacTM, an individualized, viral vector-based immunotherapy against cancer that will enter clinical development in 2019 (Press release, Transgene, SEP 24, 2018, View Source [SID1234621824]).

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myvacTM, an individualized, MVA-based immunotherapy
myvacTM is designed to stimulate and educate the immune system of patients to recognize and destroy tumor cells. The personalized immunotherapy product is based on the mutations that are identified in the patient’s own tumor. These mutations are highly relevant targets since they lead to the expression of tumor neoantigens which are known to trigger a stronger immune response than "classic"2 tumor antigens.

Once administered to the patient, myvacTM triggers a cascade of immune responses against a variety of targets found in the cancer cells.

The neoantigens which are the basis for the myvacTM approach are identified by sequencing and selected using artificial intelligence algorithms, and then integrated into the genome of the viral vector (MVA).

myvacTM differs from autologous treatments since no biological material from the patient is used in the manufacturing process and as such is much easier to manufacture; it is a truly individualized approach that uses the information that is specific to the characteristics of each patient’s tumor.

Transgene has combined its expertise in viral vectors with highly innovative technologies to develop myvacTM.

myvacTM features several key advantages:

It is expected to deliver the benefits of an individualized treatment without the disadvantages of autologous approaches (Transgene does not modify the patient’s cells but integrates the neoantigen panel into the virus);
It is based on a viral strain (MVA) whose safety, tolerability, immunogenicity and efficacy have already been demonstrated in the clinic with TG4010 and TG4001;
The myvacTM viral vector (MVA) has repeatedly shown that it can induce a strong immune response from the patient against the tumor antigens incorporated in its viral genome as well as an enlargement of the antitumoral immune repertoire (epitope spreading);
An "all-in-one" formula, requiring neither adjuvant nor association of different peptides.
Éric Quéméneur, PhD, Executive VP, Chief Scientific Officer of Transgene, said: "With myvacTM, Transgene is at the forefront of innovation in cancer immunotherapy. Based on our know-how in virotherapy, we have successfully integrated sequences coding for neoantigens to create an individualized immunotherapy. By combining sequencing and artificial intelligence with the design of the virus, myvacTM marks the entry of viral vector-based approaches in the era of digital transformation. Importantly we have also set up an organization able to design and manufacture myvacTM for each patient in a timely and cost-competitive manner. The myvacTM innovation is a logical evolution of our expertise and a new therapeutic option that promises a major improvement over existing therapies. myvacTM is also the result of our policy of open innovation which is based on working with partners developing technologies that are complementary to our expertise allowing us to benefit from a multidisciplinary approach. We look forward to demonstrating the transformative potential of myvacTM in the clinical trials we plan to start in 2019."

myvacTM, an ambitious project expected to enter the clinic in 2019
myvacTM will be administered to patients with solid tumors. Two clinical trials are being set up in Europe and in the United States, including HPV-negative head and neck cancers and ovarian cancer. These trials are expected to start in 2019.
The first preclinical and translational results will be presented soon at immuno-oncology conferences.

Our innovative network combines bioengineering and digital transformation

To design myvacTM, Transgene and its collaborative network had to overcome many scientific and technical challenges. The network’s expertise covers all the required know-how:

Institut Curie (Cancer Immunotherapy Center, led by Professor Amigorena) is involved in the generation of translational data and the characterization of the mechanism of action;
HalioDx studies biomarkers to maximize the effectiveness of the therapy;
Traaser automates, secures and manages genomic data, including predictive algorithms provided by a recognized partner in artificial intelligence;
Transgene has developed a unique manufacturing pilot unit in France to vectorize neoantigens and provide myvacTM within a timeframe compatible with clinical treatment schemes.
This innovative project has obtained the labeling of the Biovalley France and Eurobiomed French competitiveness clusters.

Transgene holds the intellectual property of the myvacTM viral vector platform and is actively working on the translational development of this innovative technology.