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OyaGen has its origins in the science of gene editing enzymes that affect the genetic readout of cells and viruses, through the academic work of Dr. Harold C. Smith, University of Rochester, Rochester, NY (haroldsmithlab.com). Founded by Dr. Smith in 2003, OyaGen, Inc. holds exclusive Intellectual Property (IP) licensed from Thomas Jefferson University and numerous self-generated IP on the Company’s platform of drug targets and antiviral lead compounds. In 2010 OyaGen began drug discovery work on oral deliverable anti viral compounds for HIV based on a novel viral drug target and methodology that distinguished the Company’s approach from all others in the pharmaceutical space. We are the only commercial effort drugging the HIV Vif protein thereby enabling natural (innate) immunity through host cell restriction factors to effectively neutralize all clades and strains of HIV. Lead compounds under development have been tested and acknowledged for their potential as first-in-class drug candidates by the Federal Government (NIAID). In addition, the Company has a platform technology that has enabled advanced lead identification for SARS-CoV2, MERS, Ebola and Lassa virus whose safety is known in human subjects and preclinical animal studies.
OyaGen developed Oya1 (aka sangivamycin) in collaboration with NIH/NIAID as a highly potent compound that prevents the spread of infection of Coronaviruses, Ebola, Lassa virus and Pox virus. OyaGen is seeking FDA approval for its patent-protected Oya1 in the treatment of COVID-19 and have completed preIND discussions with the FDA. Oya1 is significantly more effective in stopping live SARS2 and Ebola virus infections in the laboratory than Gilead Sciences’ remdesivir but in combination with remdesivir, markedly improved the antiviral efficacy of remdesivir enabling maximal virus stopping power with lower doses for both drugs.
Coronavirus (CoV) infections with higher than expected morbidity and mortality have emerged three times in the past two decades (SARS1, MERS and SARS2). Global biomedical science is only now racing to identify vaccines for what has now been predicted to be a disease with annual reoccurrence. COVID-19 vaccines have been developed but their global deployment has faced challenges and their efficacy and potential for establishing herd immunity is hotly debated. The international focus on COVID-19 vaccine development for prevention has left an unmet need for highly active, antiviral therapies for treating people who become infected and need highly active antiviral therapies to prevent disease progress, serious side effects or death. Laboratory testing performed in collaboration with NIAID suggested that Oya1 may be the most effective treatment for COVID-19 to date.
The data support that Oya1 alone or in combination with remdesivir (and potentially other treatment regimens including monoclonal antibodies (Mab), convalescent serum and/or corticosteroids or other immune modulators) holds the potential to halt COVID-19 and the now readily apparent threat from new viral strains that may have greater virulence or resistance to Mab therapeutics and current vaccines.
OyaGen owns the patent rights to Oya1. Specifically, OyaGen has seven patents pending for this highly potent compound that prevents the spread of infection by Coronaviruses, Ebola, Lassa virus and Pox virus. The compound has been taken through late stage preclinical development by OyaGen. Then remove:prior to exclusively licensing it to Tonix Pharmaceuticals Inc, a clinical stage company who will develop Oya1 (renamed TNX-3500 by Tonix) for clinical trials and commercialization. Oya1 has been safely administered to nonhuman primates and humans in the 1960’s during the war on cancer but was abandoned as being ineffective against cancer. Oya1 is a broad-spectrum antiviral and has excellent drug-like ADMET properties and higher potency relative to remdesivir in live virus studies. Oya1 antiviral activity is additive with remdesivir when the drugs are used in combination. Oya1 potential as a preventative for viral infections is suggested by its long half-life in tissues. Oya1 holds potential as a much needed, life-saving therapeutic approach for those who cannot benefit from a vaccine or will not take a vaccine.
OyaGen will soon complete IND-enabling studies and engage the FDA in preIND discussions for its a patent-protected, first-in-class antagonist of the HIV-1 Vif protein that protects the APOBEC innate immune system and blocks HIV replication through gene editing. Formulation for oral dosing is the Company’s priority. OyaGen has developed its lead through grants and contract research with NIAID, which not only has therapeutic potential but holds the potential to reduce viral reservoir formation as part of a strategy for a cure and prevention.
OyaGen has in late-stage preclinical development a unique therapeutic lead for HIV/AIDS that is 14-16 months from a pre-IND meeting with the FDA. Despite several FDA approved treatments, HIV remains a significant health care issue with >60 million people worldwide affected. The emergence of drug resistant HIV strains, enhanced by inconsistent access to a continuum of care continues to promote the spread HIV globally. The incidence of HIV continues to grow at a double-digit rate according to the U.S. Center for Disease Control. Approximately 30% of US citizens infected with HIV are unaware they are HIV positive. While treated patients have longer survival, the failure rate for current frontline therapies is 10% and ultimately the virus’s ability to mutate continues to demand new drugs. Consequently, the international drug market is expected to continue to show sustained growth despite advances in controlling the virus for those patients with access to treatment (Cowen & Co.). Our current preclinical efforts have shown our leads to be broadly neutralizing of all strains of HIV and additive in efficacy with all commercial highly active anti-HIV therapeutics. We have developed the chemical path with CROs for producing pure compounds and are developing oral formulations that will enable sustained blood levels for once-a-day dosing.
Each first-in-class HIV drug has achieved blockbuster annual sales (Cowen & Co.). In recent years the Pharma pipeline for new classes of HIV therapeutics has dried up largely due to reduction in R&D expenditure. PimStrategus Professional Valuation Services research suggested that while OyaGen’s lead compound has great potential in HIV therapeutics and will be effective against new strains of HIV that may be resistant to current treatments, it has high potential for a block-buster status in the areas of HIV prevention (PrEP) and HIV cure. In that regard, OyaGen has initiated in vitro studies in reservoir cells assessing the potency to neutralize viremia associated with reservoir cell reactivation as proof-of-concept that OyaGen’s lead compound could be part of a functional cure strategy.
Oya1 originally was first discovered as broad microbicide and an Ebola antiviral in collaboration with NIAID. This work was recently published (Bennett et al., (2021) ‘A Novel Ebola Virus VP40 Matrix Protein-Based Screening for Identification of Novel Candidate Medical Countermeasures’ Viruses Viruses 13 https://doi.org/10.3390) and is patent protected. The published data show that Oya1 is markedly more effective than remdesivir but has significant virus stopping capability alone or in combination with remdesivir. Clinical trials showed that Mab therapy had greatest therapeutic value in treating Ebola.
OyaGen has discovered and patented first-in-class lead (O2-16) that enables our innate immunity against HIV as a treatment with curative potential for HIV/AIDS and patented best-in-class Oya1 as candidate treatment for infections due to Coronavirus, Ebola virus, Lassa virus and Pox virus. In addition, the Company’s laboratory, platform technology and broad technical know how has enabled the development of a cancer drug discovery platform based on gene editing enzymes. There are more than 20 scientists working on the Company’s projects through established contract research and co-development relationships with NIH/NIAID, Southern Research, ImQuest Biosciences, Cayman Chemical and multiple other companies. These scientists support viral testing, medicinal chemistry, cGMP compound production. OyaGen works closely with regulatory consultants and clinical CROs. This team is accelerating the preclinical medicinal chemistry, ADME and safety testing needed for filing an IND for our HIV lead and the Coronavirus and Ebola antiviral lead.
The Company has a management team and external advisors with collectively over 100 years of experience in Biopharma and the Life Sciences. Dr. David Ho, CEO of the Aaron Diamond AIDS Research Center at Rockefeller University (NYC) who was a Time Magazine Man of the Year and one of the world’s leading HIV authorities serves on the Scientific Advisory Board (SAB). Dr. Roscoe Moore, former Assistant Surgeon General and OyaGen Board member advises the company on worldwide health priorities. Dr. Richard Ogden, former Agouron/Pfizer scientist and executive is a Board member that advises the company on pharmaceutical industry trends. Kevin Phelps serves as the Chief Financial Officer and Treasurer. Amy Fix, MS. MBA, RAC and VP of regulatory affairs with Arcellx, Inc serves as the company’s regulatory consultant. Thomas Fitzgerald, Esq serves as Chief Operations Officer and legal consultant and Andrew Gonsalves, Esq with FisherBroyles serves as patent attorney consultant.
Drs. Harold C. Smith, Founder and CEO, Ryan P. Bennett, CSO and Laboratory director and Jason D. Salter, Scientist, lead the Company’s drug discovery and drug development efforts. We maintained a low overhead and sustainable footprint through association with contract laboratories, both federal and private, that perform specialized testing and validation services
The Company currently occupies 3,000 sq ft of state of the state of the art laboratory within the Rochester BioVenture Center in Rochester NY
A broad range of advanced instrumentation, controlled environments, small molecule libraries and a BLS2+ facility enable in-cell and cell-free assay development.
OyaGen is currently seeking to raise up to $50M to support the on-going lead optimization work and preclinical development which will position the Company for the more extensive animal toxicity testing necessary to file an Initial New Drug Application. The Company expects to obtain long term financing through Venture Capital firms, strategic partnerships and Federal and State grants which will provide the financial resources to complete development of clinical compounds. In addition the company is seeking support and financing through Phase II of clinical trials.
In addition to its antiviral pipeline (HIV, Coronavirus, Ebola), OyaGen has a High Content Screen (HCS) at near completion for the identification of compounds that will prevent malignant progression in follicular lymphoma. The assay is based on the editing enzyme Activation Induced Deaminase (AID). OyaGen is also developing screening assays for a broadly acting antiviral that would target flaviviruses such as Dengue, Zika, Yellow Fever, West Nile virus and coronaviruses. Moreover, OyaGen continues to innovate and use its wealth of experience in preclinical drug discovery and development against new targets both in house and as a fee-for-service.
77 Ridgeland Road, Rochester, NY 14623 USA
Cell: (585) 697-4351
E-mail: hsmith@oyageninc.com
77 Ridgeland Road, Rochester, NY 14623 USA
Telephone: (585) 413-9070
Cell: (585) 766-3617
E-mail: tfitzgerald@oyageninc.com
© 2003-2022, OyaGen, Inc.
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