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Oyagen Inc. Executive SummaryThe Company
OyaGen Inc. is a development stage biopharmaceutical company founded in 2003 to commercialize novel therapies for viral illness, particularly HIV, developed from breakthrough research on the role of editing enzymes in the human cell. OyaGen has identified a unique mechanism of action, now confirmed in third party in vitro studies which address a significant unmet medical need in the fight against HIV. OyaGen’s unique approach to HIV presents a compelling long term investment opportunity.
OyaGen’s therapeutic focus is on novel treatments for Human Immunodeficiency Virus (HIV).
OyaGen is at the forefront in identifying breakthrough therapies that attack HIV through novel mechanisms of action. The intractable problem of viral resistance and treatment failure of all current therapies over time demand that new approaches to HIV be identified and drugs developed that overcome these serious challenges be brought to market.
OyaGen’s lead drug candidate protects the body’s innate immune system from an HIV protein (Vif). Vif disables the T-cell’s naturally occurring immuno-defense (Editing Enzyme-h3G). OyaGen has demonstrated in vitro that by interfering with Vif and protecting this Editing Enzyme, the Enzyme is able to interact with the HIV and catastrophically mutate the virus and halt further HIV infections. OyaGen’s in vitro testing has now confirmed this mechanism of action. OyaGen has created a pipeline of therapeutic agents that interfere with this important Vif-hA3G interaction through multiple mechanisms of action. OyaGen’s drugs have shown remarkable therapeutic promise to date. OyaGen’s therapeutic targeting of an anti-HIV Editing Enzyme is unique in regards to all other drugs under development and in clinical trials and represents an exceptional opportunity to fight HIV by enhancing the host T cell resistance to infection.
HIV opinion leaders now recognize the enormous potential of OyaGen’s patented approach. The Company has been able to attract to OyaGen’s Scientific Advisory Board (SAB) TIME magazine’s Man of the Year and Presidential Medal recipient, Dr. David Ho, CEO of Aaron Diamond AIDS Research Center, and Dr. Michael Malim of GKT Hospital, King’s College (UK), whose groundbreaking research identified the role of the hA3G Editing Enzyme in attacking HIV to join OyaGen’s Scientific Advisory Board. Over time, the Company will also draw on its core expertise in Editing Enzyme technologies and intellectual property to develop therapies with high commercial potential for other viral disease states.
HIV Market Opportunity
Currently 40 million people worldwide are living with Human Immunodeficiency Virus (HIV/AIDS) and there are five million new infections a year. The worldwide HIV/AIDS market is $6B annually and is expected to double by 2012. Despite the availability of 25 FDA approved therapies, new treatments remain greatly needed.
OyaGen’s Solution
OyaGen’s lead compound, OYA-005, ablates infectious HIV through a novel mechanism that, for the first time, significantly interferes with the disease’s ability to transmit the virus. In vitro treatment with OYA-005 resulted in the catastrophic mutation of HIV by hA3G thereby stopping the production of new viral particles capable of reproducing. If borne out in clinical testing, OYA-005 will overcome the seemingly intractable problem of HIV viral resistance and transmission. The therapeutic focus for OyaGen’s HIV drugs is keyed to newly identified mechanisms of action that prevent the interaction of Vif and the Editing Enzyme hA3G.
OyaGen has identified a series of injectable peptides that have demonstrated the ability to inhibit the dimerization of Vif and disable HIV in cell culture experiments. These peptides have been optimized for pre-clinical and clinical development. The Company has now developed the proprietary antibodies and a series of proprietary assays to measure the presence of Vif and h3G in cells as well as assays to assess the efficacy of OYA-005 for use in further development of these drugs. OyaGen is also evaluating alternative routes of administration and pursuing small molecule versions of its drug candidates.
Competition
Currently there are no anti-Vif compounds in preclinical or clinical trials. Until very recently, the role of Vif in the HIV infection cycle was not understood and therefore Vif was not regarded as “druggable”. The OyaGen patent estate provides a unique opportunity for OyaGen to exploit this important new therapeutic target with first in class drugs. OyaGen is the first Company to specifically target this unique Vif-h3G pathway. Of more commercial significance, the Company’s intellectual property broadly protects development of other compounds that act against the essential domain of the Vif hA3G interaction.
Operations Plan and Management
OyaGen has established a state of the art lab facility at the University of Rochester Medical Center. OyaGen has now optimized its lead peptide drug (OYA-005) and developed a series of novel assays that will be used to assess and evaluate the results of the pre-clinical animal testing that recently commenced. The Company expects to file an Investigational New Drug application with FDA by the first quarter of 2007. In mid-2007, the Company expects to begin Phase I/IIa clinical trials and identify an industry partner to collaborate on further clinical development and alternate formulation strategies. OyaGen will also seek small molecules and analogs that act in a similar ways as the peptide candidates.
OyaGen continues to assemble an experienced, dynamic management team headed by Thomas Fitzgerald, the President & CEO and Dr. Harold Smith, the Founder of OyaGen and Chief Science Officer. Mr. Fitzgerald has over 25 years of Biopharmaceutical experience holding senior positions with both large pharma and early stage businesses. Dr. Smith is one of the world’s foremost authorities on cellular editing enzymes and their potential as therapeutic agents. Dr. Smith is also a tenured professor of the faculty of the University of Rochester School of Medicine.
Scientific Advisory Board (SAB)
Leading HIV researchers have recognized the potential of OyaGen’s technology. In addition to Dr. David Ho and Dr. Michael Malim, the members of the OyaGen SAB are Dr. Stephen Dewhurst, Dean’s Professor of Microbiology and Immunology at the University of Rochester Medical Center and Dr. Robert Bambara, Professor and Chairman of Biochemistry and Biophysics at the University of Rochester.
Financing History and Use of Proceeds
The Company was initially financed through a $350,000 seed investment from the University Technology Seed Fund managed by Trillium Group LLC. Subsequently, OyaGen raised an additional $1.35M in equity financing through local venture investors and angels. OyaGen is currently seeking to raise $15M in a Round A equity financing to complete the animal toxicology work, prepare necessary to file the IND on OYA-005, conduct the initial clinical trials in humans, with the balance of the funds used for advancing the clinical development of OYA-005 through Phase II, initiating pre-clinical development of a follow-on compound from the Company’s therapeutic portfolio in late 2007, building the appropriate management structure for initiation of that further clinical development, strengthening and expanding the Company’s intellectual property and advancing the small molecule program.
Further information: OyaGen Inc. maintains an informative website at: www.oyageninc.com
Specific inquiries should be directed to:
Thomas Fitzgerald, President & CEO
OyaGen Inc.,
601 Elmwood Avenue
Rochester, NY 14642
Telephone: (585) 273-4816
Cell: (585) 766-3617
E-mail: tfitzgerald@oyageninc.com