Mission and Field of Activity
Based on its proprietary technology - ApoCell- designed to induce immune tolerance, Enlivex aims to become a leading player in treating autoimmune and inflammatory disorders by developing, testing and marketing innovative therapeutic products. Enlivex products are targeted at indications such as - Graft versus Host Disease (GvHD), solid organ transplants, Crohn’s Disease, restenosis following stent implant and other autoimmune and inflammatory disorders- representing vast markets.
Market and Product Strategy
The category of autoimmune and inflammatory disorders is the third largest pharmaceutical market segment effecting 5%-7% of the world's population, with over $20 billion per year in sales of pharmaceutical products and high growth rate. Enlivex's first target is the GvHD market, estimated at approximately $300 million per year, with significant economic, business and time-to-market advantages due to the fact that a GvHD drug is granted with orphan drug status. 30%-80% of the patients going through bone marrow transplant develop GvHD, a devastating and in many cases fatal disease. No treatment has so far been found efficient for the prevention of GvHD, which remains the main obstacle in achieving successful bone marrow transplantation.
Successful results in phase II clinical study with GvHD will serve as human proof-of-concept and as gateway for Enlivex to additional autoimmune and inflammatory disorders.
Technology
Enlivex's technology- ApoCell- is an autologous (and/or donor in the case of GvHD) apoptotic cell-based drug and accompanying device for treating inflammatory and autoimmune conditions. ApoCell uses the most physiological and safe way to down-regulate inflammation and autoimmunity, namely, self-apoptotic cells. Injecting apoptotic cells and allowing their interaction with dendritic cells to occur in the body is the safest proven way to induce tolerance. The repeated "pulses" of treatment maintain the desired peripheral tolerance. Unlike current therapies, this mechanism is highly safe since it is physiological and does not contain any unknown factors that may trigger adverse effects. It consists of drawing an amount of blood, treating it at the cell level in order to get homogenous apoptotic process, and re-infusing it to the patient.
The treatment is expected to be efficient for a variety of autoimmune and inflammatory diseases, of which, GvHD was chosen as the first disease to show safety and efficacy.
Scientific Rationale & Mode of Action
Apoptosis, programmed cell death, is a natural and critical process in tissue homeostasis which results in immediate removal of the dying cell by macrophages and dendritic cells. Dendritic cells (DCs) are the professional antigen-presenting cells (APC) in mammals; they mature from highly phagocytic precursors in response to ‘danger’ signals that are present in a damaged or infected tissue. Immature DCs are capable of large-scale phagocytosis of apoptotic cells. The apoptotic cells' removal process was shown to induce several changes and functional activities in the engulfing APC such as tolarogenic phenotype, inflammation suppression, and regulation of immune responses, and therefore, it can act for prophylaxis of autoimmunity.
Intellectual Property
Enlivex has worldwide, exclusive, royalty-free licenses from Hadassit and Yissum (the technology transfer offices of Hadassah and Hebrew University, respectively) with the right to grant sublicenses on a portfolio of patents providing strong multi-layer IP protection. All patents have long shelf-life with oldest patent priority date of 2001. The IP consists of global IP coverage, including USA, EU, Japan, method of use patents and patents covering various stages of the ApoCell manufacturing process.
Product Development Status
The company started on Q3 2009 a phase I/IIa clinical study in GvHD in two major medical centers in Israel. The company is expecting to complete patient enrollment by Q4 2010 and finalize the clinical study by Q2 2011. Simultaneously, the Company is conducting animal models in solid organ transplant and Crohn’s Disease.
