The strength and frequency of COVID variants have created a whack-a-mole approach for pharmaceutical companies trying to provide effective pre-exposure protection and therapies for both the general public and immunocompromised individuals. A new variant pops up, and doctors must essentially go back to the drawing board to develop new monoclonal antibodies to counter the new variant effectively.
Tonix Pharmaceutical’s (NASDAQ: TNXP) CEO Seth Lederman, MD told the audience at the 2023 Biotech Showcase earlier this month in San Francisco that a new class of more mutant-resistant pre-exposure antibody therapies for patients at high-risk of Covid-19 is urgently needed and their development is within reach of Tonix’s technology.
For immunocompromised individuals, SARS-CoV-2 is especially a real and dangerous threat. People who are immunocompromised are more likely to get COVID, could be sick for an extended period of time and have higher rates of hospitalization.
Due to these increased comorbidity factors, pharmaceutical companies came out with therapeutic and pre-exposure monoclonal antibody-based medicines for people with higher risk factors. However, with the onslaught of new variants almost all of the monoclonal antibody drugs have become obsolete. Currently, the only monoclonal antibody therapy remaining on the market is EVUSHELDTM, which is the pre-exposure drug that can be taken every six months to help prevent COVID.
“Although four therapeutic monoclonals and one preventative monoclonal were approved under the FDA’s Emergency Use regulations, the four therapeutic monoclonal antibodies are no longer marketed in the U.S. because SARS-CoV-2 variants have rendered them ineffective. Only the single preventative monoclonal remains on the market, Now that remaining antibody drug, EVUSHELD, appears to be nearing the end of its utility because of new variants,” Dr. Lederman said.
A study in December 2022 showed that only about 24% of COVID-19 infections nationwide were from variants that have been shown to be neutralized by EVUSHELD.
Tonix Is Tackling COVID Variants From Two Angles
In addition to a rich pipeline of virus-based vaccines, Tonix is developing two monoclonal antibody platforms for COVID -- TNX-3600 for quick turnaround variant-specific therapies and TNX-3800 for potentially variant-agnostic treatments and preventatives that may provide broader protection across variants and have the potential to replace the current “whack a mole” approach.
Tonix believes that it may be possible to develop long-term antibody drugs that may retain efficacy despite the appearance of new variants. However, they also understand that in the short term, there is a need for variant-specific monoclonal antibodies until a broadly protective monoclonal antibody therapy can be created and supplied to the public.
TNX-3600 is being developed to use human cells to make fully human antibodies, which is currently the most common approach on the market, variations of which were used to develop the EUA approved treatments that were effective for a period of time. This approach has been successful, but as new variants develop, efficacy drops; this is because COVID variants may get a “head start” at evading human-derived monoclonal antibodies because the COVID variants arise to evade human immunity.
The Company’s TNX-3800 product in development differs from the EUA therapies that have been marketed because these antibodies are mouse-derived monoclonal antibodies. Mice are not infected with SARS-CoV-2 and therefore, by using mice the company believes antibodies can be produced that are effective against a range of variants that arise over time. Mice antibodies could very well be the source of mutation-resistant therapies, which are the need of the hour.
Tonix is in a strong position to develop and provide these solutions. The company has experience developing new drugs for immunocompromised individuals who would also benefit from a pre-exposure COVID drug. For example, its Phase 1 drug TNX-1500 is being developed to prevent organ transplant rejection and increase survival rates. 78% of solid organ transplant recipients who get COVID require hospitalization.
The company also has a strong foundation to develop new vaccinations. Tonix has domestic, in-house R&D facilities, as well as manufacturing sites. As of Q3 2022, the company had no debt and $140 million in cash. Tonix also has relationships with strong research organizations like Columbia University. The company has a stated goal of being a partner with other innovators and researchers, and it is always seeking world-class academic and non-profit organizations as well as other biotech companies to partner with to bring innovative therapeutics to market faster.
As new COVID variants continue to appear, the need for monoclonal antibody therapeutics that can effectively survive new variants is apparent. Tonix seems like they are on the path to creating broadly reactive COVID monoclonal antibodies for the most vulnerable populations that may be useful after drugs like EVUSHELD are made obsolete by the continued mutation of SARS-CoV-2.
Dr. Lederman noted that the Federal government is keenly aware of needs in this area and that the FDA convened a meeting of stakeholders to discuss how to speed the review of new anti-SARS-CoV-2 monoclonal antibody candidates.
To watch a recording of the event, click here.
Important notice, please read: Certain statements in this document are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the “SEC”) on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Tonix Pharmaceuticals Holding Corp. for investor relations services, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein.
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Tonix Pharmaceuticals Holding Corp.
Jessica Morris (corporate)