ERYtech Pharma Provides Business Update And Reports Financial Results For Full Year 2015

LYON, France--(BUSINESS WIRE)--Regulatory News:

“2015 was a transformational year for ERYTECH as we executed on a variety of key strategic, clinical and operational initiatives. In the third quarter, we submitted our EMA Marketing Authorization Application for GRASPA for the treatment of ALL”

ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris: ERYP), the French biopharmaceutical company developing ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs, today provided a business update and reported its financial results for the year ended December 31, 2015.

Business Highlights

• Centralized Marketing Authorization Application (MAA) for GRASPA submitted to the European Medicines Agency (EMA) for the treatment of patients with acute lymphoblastic leukemia (ALL)
• Further development plans of ERY-ASP (GRASPA) for treatment of ALL finalized
• Third safety review completed in Phase 2b acute myeloid leukemia (AML) study
• Original recruitment objective reached in Phase 2 pancreatic cancer study; enrollment continues to further increase statistical power of study
• Preclinical development of new product candidates progressing and IP portfolio strengthened

Financial Highlights

• €25.4 million raised in successful private placement in December 2015 with prominent institutional investors in the United States and Europe
• Net loss of €15.0 million reflecting increased activity level in advancing clinical trials
• Entered 2016 with solid cash position of €45.6 million
• Level 1 ADR program in the U.S. initiated; intention to conduct registered IPO in the U.S. announced

Anticipated Key 2016 Milestones

• EU marketing authorization of GRASPA for ALL
• Completion of U.S. Phase 1 ALL study
• Results of Phase 2 study for treatment of pancreatic cancer
• Initiation of new clinical studies

“2015 was a transformational year for ERYTECH as we executed on a variety of key strategic, clinical and operational initiatives. In the third quarter, we submitted our EMA Marketing Authorization Application for GRASPA for the treatment of ALL,” said Gil Beyen, Chairman and CEO of ERYTECH. “In addition, we have made substantive progress in the clinical development of GRASPA in other indications including AML and pancreatic cancer, and advanced our preclinical product pipeline. Looking ahead to the next twelve months, we have a number of anticipated catalysts including continued progress in our ongoing studies, the initiation of new trials, the results of our Phase 2 study of GRASPA in pancreatic cancer, and our potential first product approval in Europe. We believe that our novel ERYCAPS platform technology has significant potential in transforming the treatment of rare cancers and orphan diseases. Our December 2015 private placement strengthened our balance sheet and has positioned ERYTECH for further advancing key development projects.”

Business Update

Centralized Marketing Authorization Application (MAA) for GRASPA submitted to the European Medicines Agency (EMA) for treatment of patients with acute lymphoblastic leukemia (ALL)

In September 2015, ERYTECH submitted its MAA for GRASPA to the EMA for the treatment of ALL. The MAA for GRASPA, ERYTECH’s lead product candidate, consisting of asparaginase encapsulated in red blood cells, is based on the positive findings of the GRASPALL 2009-06 study, a pivotal Phase 2/3 clinical trial comparing GRASPA to native L-asparaginase in children and adults suffering from relapsed or refractory ALL. The Company is in the process of addressing the EMA’s Committee on Human Medicinal Products (CHMP) questions, and plans to complete its responses as expeditiously as possible to target a potential approval of GRASPA by the end of the year.

In June 2015, ERYTECH reported complete results of its GRASPALL 2009-06 study in a plenary session at the 51^st Annual Meeting of the American Society of Clinical Oncology (ASCO). Additional two-year follow-up data were presented in December at the 2015 American Society of Hematology (ASH) Annual Meeting.

Further development plans of ERY-ASP (GRASPA) for treatment of ALL finalized

ERYTECH currently has two other clinical studies of ERY-ASP (GRASPA) in ALL ongoing: a dose-escalating Phase 1 study in adults newly diagnosed with ALL in the US and an Expanded Access Program (EAP) in France in ALL patients that cannot be treated with other forms of asparaginase due to the risk of developing allergic reactions or other adverse events.

Leveraging the data generated in the previous clinical studies of ERY-ASP and building on its two ongoing studies, ERYTECH is preparing two global pivotal studies in ALL patients aiming at product approval in the United States and label extension in Europe. Upon completion of the U.S. Phase 1 study, ERYTECH also intends to continue with a pivotal study in adults with newly diagnosed ALL in the U.S.

Third safety review completed in Phase 2b acute myeloid leukemia (AML) study

The ENFORCE 1 study is a multinational, randomized, controlled Phase 2b clinical trial evaluating the efficacy and tolerability of GRASPA in the treatment of newly diagnosed AML patients over 65 years of age and unfit for intensive chemotherapy. At the end of 2015, an independent Data Safety Monitoring Board (DSMB) completed its third safety assessment of data from 105 patients enrolled in the trial, based on the positive review, ERYTECH continued enrollment in the trial. Earlier safety reviews took place when 30 and 60 patients had been treated in the study. The Company is on-track to complete enrollment in 2016, with primary results expected in 2017.

Original recruitment objective reached in Phase 2 pancreatic cancer study; enrollment continues to further increase statistical power of study

The ERY-ASP pancreatic cancer Phase 2 study is a multicenter, randomized trial in second-line treatment of patients with metastatic pancreatic cancer. In this study, conducted in France, ERY-ASP in addition to the standard of care (gemcitabine or FOLFOX regimen) is being compared to the standard of care alone in a 2-to-1 randomization. The primary endpoint is progression-free survival (PFS) at 4 months. A pre-planned safety analysis of the first 24 patients treated was performed by an independent DSMB. The DSMB raised no safety concerns, and recommended the continuation of enrollment in the study. The original target enrollment of approximately 90 patients was recently reached. ERYTECH has elected to continue enrollment with a goal of increasing the statistical power of the study and better evaluating the treatment in subgroups. Primary results of the study are expected in Q4 2016.

Preclinical development of new product candidates progressing and IP portfolio strengthened

Progress has been made in the following preclinical development programs:

• The work accomplished in the government co-funded TEDAC program to broaden the use of ERYTECH’s encapsulation technology to other enzymes has led to the identification of two promising new ‘tumor starvation’ drug candidates, ERY-MET and ERY-ADI. ERY-MET consists of methionine-?-lyase (MGL) encapsulated inside red blood cells. ERY-ADI is arginine-deiminase (ADI) encapsulated in red blood cells. Based on these promising preclinical results, the Company intends to continue the development of these candidates with the goal of initiating clinical trials.
• In addition to the use of the ERYCAPS platform to encapsulate enzymes to increase their circulating activity and reduce their toxicity, the Company is expanding the use of its ERYCAPS technology to the field of immunotherapy. By loading red blood cells with specific antigens and subsequently modifying the cells’ membranes to make them target specific antigen-presenting cells in the liver or spleen, ERYTECH has observed promising proof-of-concept data in three different tumor models. It plans to continue developing this platform in order to confirm preclinical data and to determine its development strategy.

During 2015, certain of ERYTECH’s patents were granted and a patent application was filed. ERYTECH currently holds 13 patent families encompassing 136 granted patents and 90 patent applications. These patents cover the technology platform and applications thereof in and outside oncology. In addition, the Company holds an exclusive license from the National Institutes of Health (USA), covering a diagnostic method to predict the efficacy of L-asparaginase.

Financial Update

€25.4 million raised in private placement supported by prominent U.S. and European institutional investors

In December 2015, ERYTECH completed a €25.4 million private placement with a group of qualified investors in the Unites States and Europe. 940,000 ordinary shares were issued in the private placement. The proceeds from the private placement will enable ERYTECH to further expand key clinical programs, including the development of ERY-ASP/GRASPA for the treatment of ALL as a first line therapy in the United States and Europe and for the treatment of non-Hodgkin lymphoma, as well as a Phase 1 clinical trial of ERY-MET. Additionally, the funds will be used to advance certain preclinical programs, such as ERYTECH’s immuno-therapy program, support the further development of its ERYCAPS technology platform and help prepare the company for future expansion.

Net loss of €15.0 million reflecting increased activity level in advancing clinical programs

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