OyaGen, Inc.

ROCHESTER, N.Y., Sept. 18, 2023 /PRNewswire/ -- OyaGen, Inc. Today the company announced publication in Antiviral Research of studies evaluating the mechanism of action of its proprietary COVID therapeutic in preclinical development. About OYA1. OYA1 has broad-spectrum antiviral activity in laboratory-based assays against numerous strains of Coronaviruses and the Ebola virus. Prior studies have been published in Bennett et al., (2022) JCI Insights, volume 7 and Viruses (2021) volume 13, respectively. Our recent publication shows that OYA1 becomes part of the SARS2 viral genetic code but has little or no incorporation into a host cells messenger RNA and doesn't cause genomic mutations. These findings are consistent with the safety of antiviral levels of OYA1 demonstrated in human subjects from prior National Cancer Institute studies performed in the 1960's and toxicology studies reported previously by Bennett et al., (2022). OYA1 becomes part of the viral genetic code to inhibit the spread of SARS2 infection. The precise antiviral mechanism remains to be determined. Patents have been issued for the use of OYA1 in treating patients infected with COVID (U.S. Patent Publication No. US 11,738,025 B2 August 29, 2023) and Ebola (U.S. Patent Publication No. 11,617,753 B2 April 4, 2023). "The recent publication combines the strengths of OyaGen's molecular virology platform technology with critical technical contributions from academic and corporate research organizations," said Dr. Ryan P. Bennett Chief Scientific Officer at OyaGen. The publication also demonstrated technological advancements in being able to obtain highly purified viral RNA from infected cells. This RNA was in sufficient purity and quantity for mass spectroscopy identification and quantification of how much OYA1 gets into SARS2 RNA at different doses. New chemical synthesis of OYA1 as a triphosphate nucleoside analog suitable for in vitro studies on the viral replication mechanism was also described. "Our studies to date suggest that OYA1 is a highly effective antiviral with long-acting potential due its chemical stability. The utility of OYA1 may therefore be as a preventative in addition to a treatment for infected patients. Studies also suggest that OYA1 may enhance the efficacy of other antiviral treatments for COVID and Ebola when used as a combination therapy," said Dr. Harold C. Smith, founder and CEO of OyaGen. OyaGen, Inc. will conduct further in vivo studies recommended by the FDA for the safety and efficacy of OYA1 in treating COVID-19 infection in animal model systems as a prerequisite to filing for and IND and conducting Phase I clinical studies. OyaGen Inc is a privately held Biotechnology Company founded by its CEO, Dr. Smith, and located in Rochester NY. OyaGen is focused on the identification and early development of novel therapeutics for the treatment of viral diseases including HIV, Coronavirus, Ebola and Flaviviruses. Cautionary Note Regarding Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company's control. Actual results could differ materially from those stated or implied in these forward-looking statements due to a number of factors. The forward-looking statements represent the Company's views only as of the date of this press release and do not represent the Company's views as of any subsequent date. The Company undertakes no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes in the Company's expectations or otherwise, except as required by law. For more information on OyaGen, Inc., please visit the company's website at or call OyaGen, Inc. at (585) 697-4351. SOURCE OyaGen, Inc.

Penny stock biotech Tonix Pharmaceuticals reported in an SEC filing Monday that it was ending a licensing deal with New York infectious disease and oncology startup OyaGen. Tonix was slated to in-license OyaGen’s SARS-CoV-2 inhibitor candidate sangivamycin in a deal announced in April. The move resulted in Tonix’s stock price $TNXP jumping 45%, ending the day at $1.73 a share. OyaGen had given Tonix the option to acquire the rights for anything coming out of its platform “for the prevention or treatment of Covid-19 developed by OyaGen during the term of the License Agreement,” according to the filing. It also states: Tonix also announced that it is appointing Sina Bavari, the former CSO and scientific director at the US Army Medical Research Institute of Infectious Diseases (USAMRIID), to EVP of infectious disease R&D. Tonix had been beaten down over the last few years, with its lead drug candidate TNX-102 failing multiple Phase III trials for PTSD and, more recently, fibromyalgia. The original failure of TNX-102 SL, also known as Tonmya, in PTSD sunk Tonix’s stock price by roughly 80% in 2018. The drug, a reformulation of cyclobenzaprine, a muscle relaxant that was FDA approved more than four decades ago, failed to improve PTSD when compared to placebo. According to Tonix’s most recent quarterly statement, the biotech claims to have $152 million in current assets as of March 31.

Over the weekend, the World Health Organization declared the monkeypox outbreak, so far documented in more than 70 countries, a “public health emergency of international concern [PHEIC].” Here are the initiatives some biopharma companies are taking to contain monkeypox. Tonix Moves from COVID-19 to Monkeypox One of the companies leading the charge against monkeypox is New Jersey-based Tonix Pharmaceuticals, which owns TNX-801, one of the leading vaccine candidates for the prevention of monkeypox. Tonix saw its shares rise by as much as 25% on Monday, following the WHO’s PHEIC declaration, and is up some 45% as of Tuesday morning. Based on synthesized horsepox, TNX-801 is a live virus vaccine that potentially causes fewer toxic side effects than other vaccinia-based shots for monkeypox. Molecular analysis also points to additional viral genes in TNX-801 that could help boost immune protection against monkeypox. In June, at the fourth symposium of the Canadian Society for Virology, Tonix touted TNX-801’s promising performance. All eight animal models inoculated with the vaccine candidate were fully protected against an intra-tracheal monkeypox challenge. TNX-801 shots were also well tolerated in animal studies. One week prior, the United States Patent and Trademark Office approved the company’s patent application covering the vaccine candidate. Aside from TNX-801, Tonix has also leveraged its horsepox virus-based vaccine platform against the COVID-19 pandemic. This approach has yielded two candidates for the company, TNX-1840 and TNX-1850, which were designed to induce immune protection against the Omicron variant and its BA.2 subvariant, respectively. Also under Tonix’s belt is TNX-3500 (sangivamycin), an antiviral agent against COVID-19, which the company licensed from OyaGen in April 2021. Demand Soars for SIGA's Smallpox Drug Another beneficiary of the WHO’s PHEIC announcement is SIGA Technologies, whose shares jumped as much as 27% Monday. The reason for the industry’s avid interest in the New York-based, commercial-stage company is TPOXX (tecovirimat), SIGA’s small molecule drug against smallpox infection. Meant to be taken orally, TPOXX disrupts the maturation of the variola virus, the agent responsible for smallpox. TPOXX is the first FDA-approved drug for smallpox. Though specifically indicated for smallpox in adults and children who weigh at least 13 kg, TPOXX’s mechanism of action can also interrupt the viral cycle of other poxviruses such as monkeypox. Last month, SIGA announced that it had received around $13 million in procurement orders for TPOXX. Of this sum, $11 million were from two overseas markets that were buying the drug for the first time as part of their countries’ responses to the monkeypox outbreak. Earlier in July, the United Kingdom approved TPOXX for the treatment of monkeypox. The US FDA has yet to give the drug its regulatory nod for monkeypox. TEMBEXA Delivers for Chimerix, Emergent BioSolutions Joining Tonix and SIGA are Chimerix and Emergent BioSolutions, which entered into an acquisition agreement in May over TEMBEXA (brincidofovir), an FDA-approved antiviral agent against smallpox. Under the terms of the deal, Chimerix is handing over TEMBEXA for $225 million upfront and up to $100 million in milestone payments. The Durham, NC-based company remains eligible for a 20% royalty on gross sales in the U.S. and a 15% royalty on profit overseas. Since the acquisition was announced, TEMBEXA has raked in money for Chimerix. In June, a third party outside of North America placed a $9.3 million order for the drug. The following day, the Public Health Agency of Canada awarded the company a $25.3-million contract to procure TEMBEXA. Chimerix expects to fulfill both orders as these are set to complete before the closing date of its deal with Emergent. Monkeypox’s PHEIC designation bumped Chimerix’s shares by as much as 24%, and Emergent’s by as much as 7.4%.