Tipping the Balance Towards More Effective Treatments for Autoimmune Diseases
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. The Company’s first product – Prozumab – is a promising monoclonal antibody with a unique mechanism of action currently in late-stage preclinical development for the treatment of Inflammatory Bowel Disease (IBD), specifically Ulcerative Colitis (UC), Rheumatoid Arthritis (RA) and other autoimmune diseases. Thus far, ProtAb has successfully completed the humanization of Prozumab and established pre-clinical proof-of-concept in various experimental disease models of the two major clinical indications – IBD and RA. Furthermore, the company has developed a CHO manufacturing cell line for Prozumab and extensive manufacturing procedures, up-scaled these to 200 liter bioreactor scale for GMP production, completed repeat-dose GLP toxicology studies in rodents and undergone a pre-IND meeting with the FDA. Late-stage development towards the clinic is upcoming, including GMP manufacturing and non-human primate toxicology experiments, whereby initiation of a Phase I clinical trial in Normal Healthy Volunteers is scheduled for Q1 2014, to be extended to both UC and RA patients in 2015.
RA is the most common autoimmune disease, affecting over 3M Americans or 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 has already reached +$30 billion in 2008.
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). 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), Simponi (Centocor Ortho Biotech), and Actemra (Roche), an IL-6 inhibitor, and all are predicted to reach blockbuster sales levels. Thus, the market potential for Prozumab, used as a single agent or in combination with one of the other treatment agents, is enormous.
Besides the RA market, IBD is also a prevalent autoimmune disease, affecting over 1.4M people in the US as of 2010. The global market for IBD is estimated at over $6 billion, such that the market potential in this field is significant. In addition, biological agents have entered the market, and the market share for these agents is continually increasing.
Science and Technology
Prozumab is a humanized monoclonal antibody with a unique mechanism of action, which is being developed for the treatment of IBD, RA and other autoimmune diseases.
Autoimmune diseases are characterized, among other things, by an imbalance in cytokine expression. Current therapeutic modalities achieve only partial efficacy, are associated with serious side effects and many patients are resistant to or unable to tolerate treatment. Thus, there is a definite need for new, innovative therapeutic approaches in IBD and RA.
Prozumab is directed against a 16-amino acid surface epitope (termed peptide-6) of the mycobacterial heat shock protein 65 (HSP65). ProtAb’s scientists originally explored natural mechanisms of resistance to the development of autoimmune experimental disease models, and discovered that certain animals possess protective immunoglobulins directed against peptide-6. Similarly, ProtAb’s scientists have found that significantly fewer patients have natural antibodies against peptide-6 than do healthy individuals. Furthermore, Prozumab antibodies interact not only with peptide-6, but moreover they cross react with a cell surface ligand on human mononuclear cells, leading to an up regulation of an overall anti-inflammatory response. This has been shown by a change in the cytokine profile, including induction of IL-10 and reduction of IFN-γ secretion from human mononuclear cells.
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. The Company’s BOD includes members from HBL, Pontifax and Clal Biotechnology Industries.
Intellectual Property Status
ProtAb has a strong IP estate, whereby the Company has received from Hadasit Ltd. an exclusive license to certain patents and patent applications relating to HSP65 peptides and antibodies against them for use against autoimmune or inflammatory disorders. Furthermore, ProtAb has submitted in 2009 a key patent application, which covers the humanized sequences of Prozumab and the various uses thereof.
Collaboration / Partnership Opportunity
In April 2010, ProtAb has raised a series A round of $4M from HBL and two of the largest life science venture capital firms in Israel, Pontifax Fund and Clal Biotechnology Industries, with follow-on funding received in 2012.
The Company is currently seeking to raise additional funds to support the clinical development of Prozumab.
ProtAb welcomes collaboration and partnership discussions.