First-in-class novel immunotherapeutic monoclonal antibody for the treatment of autoimmune inflammatory diseases
ProtAb is focused on the development of novel immunotherapeutic 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 first-in-class humanized anti-HSP60 monoclonal antibody for the treatment of autoimmune inflammatory diseases, focusing initially on inflammatory bowel disease (IBD). Prozumab works via a novel mechanism of action, which is based on a natural mechanism for immunomodulation to treat the significant unmet clinical need in IBD.
Thus far, ProtAb has successfully completed the humanization of Prozumab and established preclinical proof-of-concept (POC) for Prozumab, demonstrating a significant effect in various experimental autoimmune disease models. Furthermore, the company has developed a CHO manufacturing cell line for Prozumab and extensive manufacturing procedures, up-scaled these for GMP production, completed GLP toxicology experiments in rodents and undergone a pre-IND meeting with the FDA. ProtAb is currently seeking funding to support the late stage preclinical development of Prozumab, which will include GMP manufacturing, second species toxicology and execution of Phase I and I/IIA clinical trials.
Autoimmune diseases are inflammatory diseases that affect single/multiple organs, and affect over 5% of the worldwide population, resulting in severe morbidity, disability and mortality. These diseases are characterized by an imbalance in the cytokine network, whereby the cytokine cascade is skewed towards higher levels of pro-inflammatory cytokines, which are not fully compensated by sufficient levels of anti-inflammatory cytokines. Current therapeutic agents are mainly focused on sequestering and neutralizing specific pro-inflammatory cytokines. Overall these agents achieve only partial efficacy and certain patients are resistant or unable to tolerate the currently available drugs. Thus, there is a definite unmet clinical need for new, innovative therapeutic approaches, such as Prozumab, with its unique mechanism of immunomodulation. Autoimmune inflammatory diseases in general represent fast growing markets, whereby specifically the global IBD market is expected to reach $9.6B in 2017. Furthermore, the market share for biological agents, specifically monoclonal antibody drugs, is continually increasing.
Science and Technology
Prozumab is a humanized monoclonal antibody, targeting a 16-amino acid surface epitope (termed peptide-6) of the mycobacterial Heat Shock Protein 65 (HSP65), and its mammalian homologue, HSP60. ProtAb’s scientists originally explored natural mechanisms of resistance to the development of autoimmune experimental disease models, and discovered that certain animals naturally 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 interacts not only with peptide-6, but moreover it binds to HSP60, leading to an up regulation of an overall anti-inflammatory response. This has been shown by a modulation of the cytokine profile, including induction of secretion of anti-inflammatory cytokine IL-10 and reduction of pro-inflammatory cytokines, IFN-γ and IL-6, from human mononuclear cells.
HSP60 is a highly conserved stress protein, which activates various arms of the immune system and functions as a potent immunomodulator. HSP60 has been identified as an immune target in various chronic autoimmune inflammatory conditions, including IBD, rheumatoid arthritis, type 1 diabetes, and others. Heat shock proteins (HSPs) in generalappear to be ideal antigens for immunotherapy, because expression of HSPs is upregulated at the site of inflammation; therefore, immunotherapy directed against HSPs would be site specific. Given such, there is potential for targeting various clinical indications with a therapeutic agent such as Prozumab.
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/HSP60 peptides and antibodies against these peptides for the treatment of autoimmune diseases. Patents covering ProtAb's novel amino acid sequences, antibodies directed against these sequences and the different uses thereof, have been granted and issued in the US, Israel, Europe (including 13 countries), Canada, Japan and Australia.
Furthermore, since the inception of the Company, ProtAb has directly protected the fundamental developments of the technology. Most importantly, ProtAb has submitted a key patent application in 2009, which covers the humanized sequences of Prozumab and the various uses thereof. This patent application has already been granted in the US, China and Australia, and is in National Phase in a wide variety of countries.
Scientific & Management Team
ProtAb's scientific team is spearheaded by Prof. Yaakov Naparstek, the company's founder and a world renowned leader in the field of autoimmunity. ProtAb’s management is comprised of highly experienced individuals from the Israeli biotechnology industry, including Mrs. Shira Yair (CEO) and Dr. Dorit Landstein (VP R&D). Mrs. Yair and Dr. Landstein each have over fifteen years experience in the Israeli biotechnology industry, in various management positions. ProtAb’s management is supported by an active Board of Directors, including Mrs. Tami Kfir (HBL) and Mr. Yoram Azulai (HBL), as well as a team of first-rate advisors and consultants.
Collaboration / Partnership Opportunity
To date, ProtAb has raised $7M in seed funding and Series A from its current shareholders, and leveraged this funding with $2M in grant funding from the Israeli Office of the Chief Scientist (OCS). Current shareholders include HBL and two of the largest life science venture capital firms in Israel, Pontifax and Clal Biotechnology Industries (CBI). The holdings to date are as follows: HBL (70%), Pontifax (15%), CBI (15%).
The Company is currently seeking to raise additional funds to support the late pre-clinical and clinical development of Prozumab.
ProtAb welcomes collaboration and partnership discussions.