ProtAb

ProtAb is focused on the development of novel therapeutic agents that modulate cytokine regulation, tipping the balance toward anti-inflammatory signaling pathways in the treatment of autoimmune and inflammatory diseases. ProtAb’s therapeutic approach is uniquely based on stimulating a molecule that suppresses inflammation, unlike current drugs on the market which are designed to suppress molecules that stimulate inflammation. Hence, the Company aims to provide a cure to hundreds of thousands of patients who are under-served by currently available drug classes.

The Company’s first product – Proximab – is a promising monoclonal antibody for the treatment of rheumatoid arthritis (RA). Based on its unique mechanism of action, Proximab has the potential for treatment of a wide span of autoimmune inflammatory diseases, including Inflammatory Bowel Disease (IBD) and Psoriasis. Thus far, ProtAb has established preclinical proof-of-concept for Proximab, demonstrating promising activity in various experimental autoimmune disease models of RA and IBD. Furthermore, ProtAb has successfully completed the humanization of Proximab and evaluation of efficacy both in vitro and in vivo. Advanced preclinical development is ongoing, and is aimed at completion of CHO manufacturing cell line generation, on the pathway towards GMP manufacturing, toxicology experiments and initiation of a Phase I/IIA clinical trial in RA in Q2 2011.

Market Opportunity

RA is the most common autoimmune disease, affecting between between 1-2% of the global population. RA remains one of the most lucrative fields in pharmaceuticals. The global market for RA therapeutics has experienced remarkably strong growth during the past nine years due to the introduction of the biological response modifiers (BRMs) to treatment regimens. Furthermore, the RA sector is set for additional substantial growth, due to a significant unmet clinical need, and expected to reach a value of $27 billion by 2015.

The market is currently dominated by the anti-pro-inflammatory agents that inhibit mostly TNF-alpha, which have all achieved blockbuster status, and include the monoclonal antibodies Remicade (Centocor) and Humira (Abbott) and the soluble TNF receptor, Enbrel (Amgen). These biological agents accounted for $8.6bn or 66% of the market value in 2005. New additions to the RA market over the past few years have included MabThera/Rituxan (Roche), Orencia (BMS), a T-cell Co-Stimulation Modulator, Cimzia (UCB) and Actemra (Roche), an IL-6 inhibitor, and all are predicted to reach blockbuster sales levels. Thus, the market potential for a pro-anti-inflammatory agent, such as Proximab, used as a single agent or in combination with one of the anti-pro-inflammatory agents, is enormous.

Besides the RA market, both IBD and psoriasis are prevalent autoimmune diseases, IBD affecting over 1M people in the US and psoriasis affecting an estimated 7.8 million people in North America as of 2006. The market potential in both of these additional disease indications is enormous, where the global markets were worth $2B each in 2005. In addition, anti-TNF-alpha agents have entered the markets of these disease indications, and the market share for biological agents is continually increasing.

ProtAb’s first product is Proximab, a humanized monoclonal antibody with a unique mechanism of action, which is being developed as a pro-anti-inflammatory agent for the treatment of RA and other autoimmune diseases, including IBD.

Autoimmune diseases such as RA are characterized, among other things, by an imbalance in cytokine expression. ProtAb's approach takes RA therapy one step beyond that of today's blockbuster RA medications, Enbrel, Remicade and Humira. These drugs are anti-pro-inflammatory, and act mostly by inhibiting the pro-inflammatory protein TNFa. While providing a marked improvement in symptoms, current RA drugs can only reduce symptoms by 50% (ACR50) in about half of the treated patients and are associated with serious side effects. Thus, there is a definite need for new, innovative therapeutic approaches in RA.

Proximab is directed against a 16-amino acid surface epitope (termed peptide-6) of the bacterial heat shock protein 65 (HSP65). ProtAb's scientists have found that significantly fewer RA patients have natural antibodies against peptide-6 than do healthy individuals. Furthermore, Proximab antibodies interact not only with peptide-6, but moreover they cross react directly with a surface ligand on monocytes, and this interaction is the key to the mechanism of action of these antibodies. Following binding of the Proximab antibodies to monocytes, there is activation of a signal transduction pathway that leads to an increase in production and secretion of cytokines, specifically IL-10, that instruct the body to end the inflammatory process. This tilts the balance from pro-inflammatory signals, such as TNF-alpha, to anti-inflammatory signals, such as IL-10.

Scientific & Management Team

ProtAb's scientific team is spearheaded by Prof. Yaakov Naparstek, Chairman of Medicine at Hadassah University Hospital, who is the company's founder and a pioneer in the fields of autoimmunity and arthritis.

ProtAb’s management is comprised of highly experienced individuals from Hadasit Bio-Holdings and the Israeli biotechnology industry.

ProtAb has a strong IP estate, where the core patent application (PCT/IL99/00595) has a field of interest covering HSP65 peptides and antibodies against them for use against autoimmune or inflammatory disorders, including RA among others. Furthermore, ProtAb has submitted in early September 2009 a key patent application, which covers the humanized sequences of Proximab and the various uses thereof.

Collaboration / Partnership Opportunity

ProtAb has recently raised $4M from HBL and two of the largest life science venture capital firms in Israel, Pontifax Fund and Clal Biotechnology Industries. This investment will be used for initiation and completion of process development and manufacturing, late-stage pre-clinical development of Proximab, and local and IND submissions for the initiation of a Phase I/IIA clinical trial in RA.

ProtAb welcomes collaboration and partnership discussions.