HYBRIGENICS : Hybrigenics' General Meeting highlights - Focus on inecalcitol recent update and achievements

Press Release

The shareholders ratified the nomination of Mr. Albert Saporta as an independent Director and renewed for two years all Directors' mandates. All the other resolutions supported by the Board have been approved with an overwhelming majority, including those related to both the statutory and consolidated financial accounts for 2012.

The focus of this general meeting was dedicated to inecalcitol. First, an update on its clinical Phase II study in chronic lymphocytic leukemia (CLL) was detailed on the five patients having already received at least 6 months of treatment, out of the total of 23 enrolled patients. The exponential increase in blood lymphocytes counts (BLCs) has remained unchanged in two patients. BLCs stopped increasing as soon as treatment was initiated in two patients and sharply decreased down to -80% at seven months in another patient.

Then, two American scientific articles recently published on two preclinical models of prostate cancer (Okamoto et al., 2012) and squamous cell carcinoma (Ma et al., 2013) were summarized showing the strong anti-proliferative and pro-apoptotic effects of inecalcitol tested alone on xenografts implanted in mice.

Finally, the strengthening and time-extension of the intellectual property definitively granted around inecalcitol during the past year were recapitulated. Three new families of patents covering an improved 14-epimerization step in the chemical synthesis of inecalcitol, its therapeutic use at high doses and new innovative tablets or new generation soft gelatin capsules are now protecting inecalcitol until 2029, 2030 or 2031, depending on the patent family.

"We thank all shareholders for their trust and support, which will allow Hybrigenics to move forward in the clinical development of inecalcitol and the growth of its other activities," said Remi Delansorne, Hybrigenics' CEO.

CLL is the most frequent form of leukemia (cancerous proliferative disease of circulating blood cells) and accounts for about 35% of all leukemic patients. Annual estimates of newly diagnosed CLL cases amount to close to 15,000 in the United States (American Leukemia Lymphoma Society, Facts 2012), 14,000 in Europe and 130,000 world-wide (Globocan 2008). CLL is designated as an orphan disease in the United
States, Europe and Japan.
People with CLL produce too many lymphocytes (mononuclear white blood cells) of one single abnormal "family" (monoclonal) which are not fully developed (immature). Over time, these circulating CLL cells (monoclonal immature lymphocytes) in excess build up in the lymphatic system and cause large, swollen lymph nodes. They may also fill the bone marrow, reducing the number of normal white cells, red cells and platelets that can be made, thereby lowering their blood counts. There is no definitive cure for CLL.

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Hybrigenics (www.hybrigenics.com) is a bio-pharmaceutical company listed (ALHYG) on Alternext (NYSE- Euronext) in Paris, focusing its internal R&D programs on innovative targets and therapies for the treatment of proliferative cancerous or non-cancerous diseases.

Hybrigenics' current development program is based on inecalcitol, a vitamin D receptor agonist active by oral administration. Oral inecalcitol has shown excellent tolerance and strong presumption of efficacy for the first-line treatment of metastastic castrate-resistant prostate cancer in combination with Taxotere®, which is the current gold-standard chemotherapeutic treatment for this indication. Oral inecalcitol is currently being tested in chronic lymphocytic leukemia patients.

Hybrigenics has a research collaboration with Servier on deubiquitinating enzymes and their inhibitors in oncology, neurology, psychiatry, rheumatology, ophthalmology, diabetes and cardiovascular diseases. Hybrigenics continues to build on its pioneer research position in the field of ubiquitin-specific proteases by exploring their role in other areas of particular relevance, such as inflammation and virology.
Hybrigenics Services (www.hybrigenics-services.com), a fully-owned subsidiary, is the market leader in Yeast Two-Hybrid (Y2H) and related services to identify, validate and inhibit protein interactions for researchers in all areas of life sciences, using its ISO 9001-certified high-throughput Y2H screening platform, its sophisticated bioinformatics tools and extensive database, along with its chemical library and chemical screening platform.

Tel.: +33 (0)1 58 10 38 00 investors@hybrigenics.com

Financial communication Julien Perez / Pierre Laurent Tel.: +33 (0)1 44 71 94 94 hybrigenics@newcap.fr

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