Tonix CEO calls for a new class of Covid-19 pre-exposure and therapeutic antibodies for high-risk populations

Tonix CEO calls for a new class of Covid-19 pre-exposure and therapeutic antibodies for high-risk populations
Tonix CEO calls for a new class of Covid-19 pre-exposure and therapeutic antibodies for high-risk populations

Chatham, NJ –News Direct– Tonix Pharmaceuticals Holding Corp.

by Faith Ashmore – Benzinga

Tonix mAb technology aims to expand utility and durability of COVID drugs for immunocompromised and other at-risk populations

The strength and frequency of COVID variants has created a knock-on approach for pharmaceutical companies trying to provide effective pre-exposure protection and therapies to the general public and immunocompromised individuals. A new variant emerges and doctors essentially have to go back to the drawing board to develop new monoclonal antibodies to effectively counter the new variant.

Tonix Pharmaceuticals (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 high-risk Covid-19 patients is urgently needed and their development is within the reach of Tonix technology.

For immunocompromised people, SARS-CoV-2 is especially a real and dangerous threat. Immunocompromised people are more susceptible to contracting COVID, may be sick for an extended period of time, and have higher hospitalization rates.

Because of these increased comorbidity factors, pharmaceutical companies have developed monoclonal antibody-based therapeutic and pre-exposure drugs for people with higher risk factors. However, with the onslaught of new variants, almost all monoclonal antibodies have become obsolete. Currently, the only monoclonal antibody therapy remaining on the market is EVUSHELDMTwhich is the pre-exposure medication that can be taken every six months to help prevent COVID.

“Although four therapeutic monoclonals and one preventive monoclonal have been approved under FDA emergency use regulations, the four therapeutic monoclonal antibodies are no longer marketed in the United States because the SARS-CoV-2 variants rendered ineffective. Only the preventative monoclonal remains on the market, now that the remaining antibody drug, EVUSHELD, appears to be nearing the end of its usefulness due to new variants,” Dr. Lederman said.

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A December 2022 study showed that only about 24% of COVID-19 infections nationwide came from variants that were shown to be neutralized by EVUSHELD.

Tonix tackles 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 fast-turnaround variant-specific therapies and TNX-3800 for treatments and potentially variant-independent preventatives that can provide broader protection across variants and have the potential to replace the current “hit a mole” approach.

Tonix thinks it might be possible to develop long-term antibodies that could retain their effectiveness despite the appearance of new variants. However, they also understand that in the near term, there is a need for variant-specific monoclonal antibodies until broadly protective monoclonal antibody therapy can be created and delivered 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, variants of which have been used to develop the treatments approved by the EUAs that have been effective for some time. This approach has been successful, but as new variants develop, the effectiveness decreases; this is because COVID variants may have a “head start” in evading human-derived monoclonal antibodies because COVID variants arise to evade human immunity.

The Company’s TNX-3800 product in development differs from EUA therapies that have been commercialized 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 emerge over time. Mouse 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 deliver these solutions. The company has experience developing new drugs for immunocompromised people who would also benefit from pre-exposure COVID medication. 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 contract COVID require hospitalization.

The company also has a solid base to develop new vaccines. Tonix has national and in-house R&D facilities, as well as manufacturing sites. As of the third quarter of 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 is always on the lookout for world-class academic and nonprofit organizations and other biotech companies to partner with. associate to bring innovative therapies to market more quickly.

As new variants of COVID continue to emerge, the need for therapeutic monoclonal antibodies that can effectively survive new variants is evident. Tonix appears to be on the way to creating broadly reactive COVID monoclonal antibodies for the most vulnerable populations that could be useful after drugs like EVUSHELD are rendered obsolete by the continued mutation of SARS-CoV-2.

Dr. Lederman noted that the federal government is acutely aware of the needs in this area and that the FDA has convened a stakeholder meeting to discuss how to expedite the review of new SARS-CoV monoclonal antibody candidates. 2.

To view a recording of the event, click here.

For more information about Tonix, click here.

Important notice, please read: Certain statements contained herein are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements can be identified by the use of forward-looking terms such as “anticipate”, “believe”, “expect”, “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 these forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and non-compliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks relating to the timing and progress of clinical development of our product candidates; our need for additional funding; uncertainties of patent protection and litigation; uncertainties of reimbursement by the government or third-party payer; limited research and development efforts and reliance on third parties; and significant competition. As with any pharmaceutical product under development, the development, regulatory approval and commercialization of new products involve significant risks. Tonix does not undertake 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 fiscal 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 as of the date hereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other caveats. The information presented here is only valid as of the date thereof. This is not a solicitation of an offer to buy or sell. Redington, Inc. is paid by Tonix Pharmaceuticals Holding Corp. for investor relations services, and its employees or their family members may from time to time hold an equity interest in the companies mentioned herein.

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Featured photo by Waldemar Brandt on Unsplash

Contact details

Tonix Pharmaceuticals Holding Corp.

Jessica Morris (company)

[email protected]

Company Website

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. CEO Tonix asks for a new class of antibodies preexposure therapeutics against Covid19 for the populations high risk

. Tonix CEO calls class Covid19 preexposure therapeutic antibodies highrisk populations

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