THE TYROMAB CONSORTIUM, HEADED BY

ELSALYS BIOTECH, OBTAINS 1.57 MILLION EUROS

FROM THE SINGLE INTERMINISTERIAL FUND (FUI)

Supported by ElsaLys Biotech, PX'Therapeutics, a subsidiary of the Aguettant group, and Centre Léon Bérard, the TYROMAB project seeks to fulfil a twofold ambition:

·                  firstly medical, as it is a question of validating a first-in-class antibody candidate against leiomyosarcoma and metastatic bladder cancer;

·                  secondly, it is technological and industrial, the aim also being to reduce production costs for this antibody.

Lyon and Illkirch-Graffenstaden, September 10, 2015

ElsaLys Biotech announced today that the FUI (Fonds Unique Interministériel - Single Interministerial Fund) has granted a 1.57 million euros subsidy to the TYROMAB (TYROsine kinase receptor Monoclonal AntiBody) project. Led by a consortium headed by ElsaLys Biotech, this project seeks to validate and industrially produce an anti-TYRO3 antibody candidate for the treatment of leiomyosarcoma and metastatic bladder cancer. This should lead to two products: a candidate drug with an original mechanism of action in oncology and a new production system reducing monoclonal antibody production costs. Original in terms of its form and substance, this project provides a response to a twofold public health challenge: speeding up the development of new therapeutic antibodies against cancers and reducing their price, which notably entails decreasing their production cost.

These two products should hit the market 3 to 5 years after the start of the FUI project for the drug candidate (sale of an exclusive license to a biopharmaceutical laboratory) and at the end of the collaborative project for the bioproduction system, i.e. at the end of the year 2018.

The TYROMAB project has received labels jointly from two competitiveness clusters - Alsace BioValley and Lyonbiopôle - and receives support from the French government, Europe's ERDF fund, the Rhône-Alpes Region, from the Alsace Region and Strasbourg, from Eurométropole, Lyon la Métropole and Grenoble-Alpes Métropole. It is supported by a consortium made up of two industrial stakeholders - ElsaLys Biotech and PX'Therapeutics, the Aguettant pharmaceuticals group's bioproduction subsidiary - as well as a world-renowned cancer care and research center, Centre Léon Bérard.

Developing a competitive subsidiary for the production of innovative therapeutic proteins in France.

For this, the TYROMAB project can take advantage of the experience of PX'Therapeutics which, for this project, is designing and developing a new royalty-free production system for therapeutic proteins. PX'Therapeutics will thus have a highly distinctive line of products, sharply reducing development costs for drugs and facilitating entry into clinical use. It is based on lower structural costs (volume capacity limited to 200 L), a technology based on a new cellular tool that avoids licensing costs and royalties for the cell lines it develops, and recognized expertise in the development of lines and bioproduction processes.

.and responding to major public health challenges

The TYROMAB project's ambition is also to develop an original therapeutic antibody: anti-TYRO3. ElsaLys Biotech has already generated a panel of antibodies that are able to target this receptor, which is overexpressed in several cancers. In its final format, the anti-TYRO3 antibody could combine 2 mechanisms of action that both:

• inhibit tumor cell growth and,
• stimulate the anti-tumor immune response.

Two indications will be assessed to obtain clinical proof of concept for this antibody: leiomyosarcoma, one of the research subjects of choice for Pr. Jean-Yves BLAY, internationally recognized sarcoma specialist and current Director General of Centre Léon Bérard (CLB), and metastatic bladder cancer, as part of a research program initiated and directed by Dr. Isabelle BERNARD-PIERROT and Dr. François RADVANYI of the Institut Curie. These two indications were selected based on the proofs of concept previously obtained by the Institut Curie and Centre Léon Bérard, medical needs, clinical feasibility, opportunities for international collaborations and the accessibility of related markets.

"The financing obtained and the excellence of the partners in the TYROMAB consortium have enabled us to speed up the development of our anti-TYRO3 program," said Dr. Christine GUILLEN, CEO and co-founder of ElsaLys Biotech. "TYROMAB is a perfect fit for our company's long-term strategy. We have signed a licensing option with the Institut Curie, which holds the patent for the target in the bladder cancer indication. A three-year collaboration has been under way since the creation of ElsaLys Biotech to test the antibodies developed in murine models of this disease and we plan to find an industrial partner for support on the clinical development of the candidate antibody that comes out of this research."

"Our company wants to provide its customers with a line of products to speed up the preclinical and clinical development of new biopharmaceuticals. This entails being able to produce therapeutic proteins on an industrial scale at a low price by developing expression systems with high productivity, without licenses or royalties," stated Dr. Eric ROUGEMOND, CEO of PX'Therapeutics and the Aguettant group. "The TYROMAB project will therefore be based on this novel line of products as well as on the great expertise at PX'Therapeutics in the field of developing bioproduction processes. It is a perfect fit for our company's development strategy dedicated to meeting the quality and competitiveness requirements of our customers, whether major groups or young biopharmaceutical companies."

Pr. Jean-Yves BLAY added, "We are very pleased to take an active part in the development of an anti-TYRO3 therapeutic antibody whose double mechanism of action is very promising. We are also delighted, of course, to work on a project that seeks to make the production of clinical batches of therapeutic antibodies more accessible to drug developers and, at the end of the day, to participate in bringing down the cost of treatment."

***

About ElsaLys Biotech

ElsaLys Biotech is a biopharmaceutical company that designs and develops innovative therapeutic antibodies against cancer and inflammatory diseases. These antibodies, called "first-in-class", aim for innovative targets involved in cellular events at the core of the pathological process: immune response, angiogenesis, survival, proliferation, adhesion and migration.

To drive these innovations, ElsaLys Biotech relies on an academic network of international standing, an R&D platform that covers validation of targets in the clinical evaluation of antibody candidates and a team of experts dedicated to developing immune-based therapies.

The company has already signed licensing option and / or collaboration agreements (Institut Curie, IGBMC-ICS, Inserm, Centre Léon Bérard, CNRS) and maturation agreements (SATT Conectus, SATT SE), and has acquired a first strategic asset. Two years after its foundation, the Company hosts three proprietary antibodies and four development programmes.

Founded in 2013 with the support of Transgene and Sofimac Partners and led by Dr Christine GUILLEN, ElsaLys Biotech consists of a team of nine people. Its head office is located in the centre of the Lyon Gerland bio-district and its laboratories are based in the Illkirch Graffenstaden Science and Technology Park.

More information on www.elsalysbiotech.com

About PX'Therapeutics

Founded in Grenoble in 2000, PX'Therapeutics, formerly known as Protein'eXpert, is a biotechnology firm that provides high value-added services in the field of biopharmaceutical development. PX'Therapeutics offers development contracts for recombinant proteins, monoclonal antibodies and recombinant vaccines, as well as bioproduction services for phase I/II clinical trials.

In 2012, PX'Therapeutics reached a key milestone toward industrialization by becoming a subsidiary of the Aguettant laboratory, a specialist in injectable drugs, with a portfolio of over 60 specialties that cover major therapeutic areas in hospitals and private practice.

More information on www.px-therapeutics.com

About the Centre Léon Bérard (CLB)

A private non-profit establishment that participates in public hospital services, the CLCC (Centre de Lutte Contre le Cancer - Anti-Cancer Center) is a member of the FNCLCC (Fédération Nationale de Lutte Contre le Cancer - National Anti-Cancer Federation) and the regional reference center for cancer treatment. Certified by the HAS (Haute Autorité de Santé - French National Health Authority) since 2005, the CLB includes an integrated oncology research center (SIRIC label from the INCa in 2011, Director: JY BLAY) and the Centre de Recherche en Cancérologie de Lyon (Lyon Cancer Research Center - Director: Pr. A. PUISIEUX / Deputy Directors: Pr. P. MEHLEN and Pr. C. DUMONTET), all at one site.

The CLB has a ISO9001-certified clinical research platform (DRCI - Direction de la Recherche Clinique et de l'Innovation/Department of Clinical Research and Innovation) coordinated by Dr. D. PÉROL) that groups together all the components needed for designing, developing, implementing, steering, monitoring, analyzing and promoting clinical studies in compliance with GCP/ICH as a research center or promotor.

The CLB received the INCa's "Centre Essai Précoce" (Early Testing Center) label in 2010.

The CLB has also set up an Immunomonitoring platform (PI3: Immunomonitoring and Immunotherapy Innovation Platform, Director: Dr. C. CAUX) for monitoring immune parameters in immunotherapy clinical trials.

More information on www.centreleonberard.fr

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