PHXM PHAXIAM THERAPEUTICS

ERYTECH Presents New Preclinical Data on ERY-MET at the 2017 ASCO GI Symposium

Regulatory News:

ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris - ERYP), the French biopharmaceutical company that develops innovative ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs (the "Company"), today announced new data supporting the second Company’s product candidate ERY-MET will be presented at the 2017 Gastrointestinal Cancers Symposium co-sponsored by the American Society of Clinical Oncology (ASCO GI), being held January 19 – 21, 2017 in San Francisco, California.

The research will be presented during the poster session of the symposium by the first author of the abstract, Dr. Vanessa Bourgeaux, the Company’s R&D Project Leader. The abstract will be available online starting on January 20, 2017 on ERYTECH’s website via http://www.erytech.com.

The findings from the preclinical studies demonstrate that ERY-MET, which is methionine gamma-lyase-encapsulated in red blood cells (RBC) developed using the Company’s proprietary ERYCAPS encapsulation platform technology, can inhibit tumor growth in a murine model of human gastric adenocarcinoma. This effect can be regulated by Vitamin B6 supplementation.

Abstract #78: Methionine gamma-lyase-encapsulated into red blood cells (ERY-MET) shows profound antitumor activity in gastric carcinoma

Author:   Vanessa Bourgeaux
Date: Thursday, January 19, 2017
Time: 12:30 – 2:00 p.m. PST
5:30 – 7:00 p.m. PST
Location: Board G12, Moscone West Building
Poster Session: A: Cancers of the Esophagus and Stomach

Methionine is an essential amino acid, which all cells need to grow and multiply. More particularly, fast-growing tumor cells exhibit very high requirements of methionine to proliferate. The enzyme methionine gamma-lyase (MGL) mediates tumor starvation via systemic lowering of methionine levels. MGL is an enzyme with a short half-life and is dependent on a co-factor, a Vitamin B6 derivative, to function. Encapsulating MGL in RBCs extends the half-life significantly and the conversion of Vitamin B6 to the co-factor happens naturally inside the RBC.

The Company’s research team determined the plasma methionine level reduction as a pharmacodynamics biomarker and analyzed the anti-tumor activity of weekly ERY-MET injections in mice. The study found that ERY-MET, in combination with daily Vitamin B6 supplementation, increased active MGL half-life in vivo, from less than 24 hours to 8-9 days. The combined ERY-MET and Vitamin B6 treatment exhibited anti-tumor activity in 100% of treated mice, with tumor growth inhibitions varying from 91% to 100% by the end of the study.

Dr. Bourgeaux stated, “We had already identified the potential of ERY-MET as a tumor starvation agent in a mouse model of glioblastoma. This work, demonstrating that ERY-MET can also induce tumor growth inhibition in mice with human gastric adenocarcinoma and achieving an almost complete regression, strengthens the Company’s current strategy to develop product candidates based upon its proprietary ERYCAPS platform as potential treatments for various oncology indications in addition to blood cancers. We believe ERY-MET shows significant promise as a new anti-tumor drug to treat gastric and other recalcitrant cancers.”

About ERYTECH: www.erytech.com

Founded in Lyon, France in 2004, ERYTECH is a clinical-stage biopharmaceutical company developing innovative therapies for rare forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS platform, which uses a novel technology to encapsulate therapeutic drug substances inside red blood cells, ERYTECH has developed a pipeline of product candidates targeting markets with high unmet medical needs. ERYTECH’s initial focus is on the treatment of blood cancers, including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), by depriving tumors of nutrients necessary for their survival. ERYTECH plans to pursue regulatory approvals for its lead product candidate, eryaspase, also known as ERY-ASP or under the trade name GRASPA®, having achieved positive efficacy and safety results from its completed Phase 2/3 pivotal clinical trial in Europe in children and adults with relapsed or refractory ALL. ERYTECH also has an ongoing Phase 1 clinical trial of eryaspase in the United States in adults with newly diagnosed ALL, and a Phase 2b clinical trial in Europe in elderly patients with newly diagnosed AML, each in combination with chemotherapy. ERYTECH believes that eryaspase also has the potential as a treatment approach in solid tumors and is conducting a Phase 2 clinical trial in Europe in patients with metastatic pancreatic cancer.

Eryaspase consists of an enzyme, L-asparaginase, encapsulated inside donor-derived red blood cells. L-asparaginase depletes asparagine, a naturally occurring amino acid essential for the survival and proliferation of cancer cells, from circulating blood plasma. ERYTECH produces eryaspase at its own GMP-approved and operational manufacturing site in Lyon (France), and at a site for clinical production in Philadelphia (USA). ERYTECH has entered into licensing and distribution partnership agreements for eryaspase for ALL and AML in Europe with Orphan Europe (Recordati Group), and for ALL in Israel with TEVA, which will market the product under the GRASPA® brand name. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have granted orphan drug designations for eryaspase for the treatment of ALL, AML and pancreatic cancer.

In addition to eryaspase, ERYTECH is developing two other product candidates that focus on using encapsulated enzymes to induce tumor starvation. The company is also exploring the use of its ERYCAPS platform for developing cancer immunotherapies and enzyme replacement therapies.

ERYTECH is listed on Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: ERYP) and is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes. ERYTECH is also listed in the U.S. under an ADR level 1 program (OTC, ticker EYRYY).

Forward-looking information

This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development plans, business and regulatory strategy, and anticipated future performance of ERYTECH and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond ERYTECH's control. There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Documents filed by ERYTECH Pharma with the French Autorité des Marchés Financiers (www.amf-france.org), also available on ERYTECH’s website (www.erytech.com) describe such risks and uncertainties. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. ERYTECH disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in ERYTECH’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by law.

EN
17/01/2017

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