Tetra Collaborates with Cellvera to Develop a Potential Oral Combination Treatment for COVID-19 Patients

• Tetra and Cellvera to jointly develop an orally administered treatment, ARDS-003, in combination with the proven broad-spectrum antiviral, Qifenda 400MG (Favipiravir)
  
  
• Companies will jointly develop a combination therapeutic candidate for rapid clearance of COVID-19 infection
  
  
• The partnership aims to accelerate the global development of an innovative drug candidate to combat viral diseases by leveraging expertise and resources from both companies
  
  
• This novel combination therapy is positioned to compete with Pfizer's flagship antiviral therapeutic

OTTAWA, ON, Sept. 6, 2022 /PRNewswire/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") TBP TBPMF JAM, a leader in cannabinoid-derived drug discovery and development announced today they signed an agreement with Cellvera Global Holdings LLC ("Cellvera"), for the co-development of ARDS-003 as a combination product, with Qifenda 400MG (Favipiravir), a commercial-stage broad-spectrum antiviral drug.   

As a monotherapy, compared to placebo, ARDS-003 dose-dependently reduced signs of morbidity and mortality, including respiratory distress following SARS-CoV-2 infection in the humanized ACE2 mouse model. ARDS-003 also outperformed an antiviral drug in reducing multiple proinflammatory mediators (i.e., cytokines) involved in hyperinflammation and immune system dysfunction following viral infection. Other studies have also demonstrated dose-dependent inhibition of viral replication.

Cellvera owns the rights to the brand originator Favipiravir, which has a long and verified history of safety and efficacy and was initially developed by FujiFilm Toyama Chemical Co and approved in Japan (2014) to treat pandemic influenza. Favipiravir is a selective inhibitor of viral RNA-dependent RNA polymerase (RdRP) with potent antiviral activity against single-stranded RNA viruses, including coronaviruses. It targets the protein needed for the coronavirus to replicate, making it impossible for the virus to copy itself. The broad-spectrum antiviral drug is effective against 12 families of viruses, including Coronaviruses (COVID, MERS, SARS), Filoviruses (EBOLA, MARBURG), Flaviviruses (ZIKA, WEST NILE, DENGUE), RABIES, NOROVIRUS, and many others. 

As novel strains of the SARS-CoV-2 virus continue to emerge, preliminary studies on SARS-COV-2 Variants, Omicron and Delta, have shown that Favipiravir maintains its antiviral activity, demonstrating viruses' inability to resist Favipiravir even with prolonged exposure of virus-infected cells to the drug. Favipiravir remains an invaluable asset for emergency preparedness strategies against this constantly evolving COVID-19 virus and other potential future pandemics.  Clinical trials of Favipiravir have shown rapid viral clearance and prevention of hospitalization when administered early in the onset of the symptoms.

The parties hypothesize, based on data from AI based in-silico drug discovery platform Prepaire, that a combination product of Favipiravir and ARDS-003 has the potential to allow rapid virus clearance and provide longer-term patient benefits.  ARDS-003's cytokine reduction properties may prevent some consequences of SARS-CoV-2 infection, such as severe pulmonary inflammation.

Guy Chamberland, CEO and CRO at Tetra commented, "This partnership with a pharmaceutical company with global reach is a sign of the potential for the ARDS-003 drug asset.  We look forward to working jointly with Cellvera to bring this combination drug product forward to improve treatment options for patients worldwide."

"The ongoing complexities of COVID-19 require multiple treatment options. By joining forces with Tetra, we hope to offer this additional treatment option to patients." Stated Mary O'Brien, CEO of Cellvera. "This collaboration with Tetra supports our partnership strategy and the development of further combination therapies involving Qifenda (Favipiravir). We share a passion with Tetra to deliver innovative medicines to address this pandemic. We look forward to working with Guy and his team to investigate the potential of ARDS-003 and Qfienda (Favipiravir). By joining the Prepaire partner platform, we connect with like-minded experts from across industry, academia, and the government sector, we are better equipped to lead the way towards transforming drug discovery and development through the application of machine learning".

ARDS-003 is a novel First in Human (FIH) drug product containing the active pharmaceutical agent, Onternabez, a potent and selective full agonist of the type 2 cannabinoid receptor (CB2R), an essential immunomodulatory target. ARDS-003 is positioned to modulate acute systemic inflammation and prevent Sepsis, ARDS, and organ damage - ARDS represents the severe end of lung dysfunction resulting from systemic inflammation secondary to infectious or non-infectious clinical insult (McIntosh, 2020).  While the clinical profile of ARDS arising from viral (COVID) or bacterial sepsis can vary, hyperinflammation involving a dysfunctional immune response is a common mediator of lung damage. Tetra's pre-clinical studies have demonstrated that ARDS-003 decreases this hyperinflammatory response and slows disease progression.

Favipiravir discovered and developed by FUJIFILM Toyama Chemicals (a subsidiary of FUJIFILM Corporation (FUJIY), was first approved under the brand name Avigan by regulators in Japan in 2014 as a potent broad-spectrum antiviral treatment for influenza. This antiviral drug is effective against 12 families of viruses, including coronaviruses (COVID, MERS, SARS), Filoviruses (EBOLA, MARBURG), Flaviviruses (ZIKA, WEST NILE, DENGUE), RABIES, NOROVIRUS, and many others. Favipiravir works by inhibiting a viral enzyme called RNA polymerase, preventing viral replication within human cells. Favipiravir has potent antiviral activity against single-stranded RNA viruses, including coronaviruses. This is the protein responsible for "building" the viral proteins. Favipiravir can target the protein necessary for the coronavirus to replicate, making it impossible for the virus to copy itself.

Tetra Bio-Pharma ((TBP) ((TBPMF) (FRA: JAM1) is a leader in cannabinoid-derived drug discovery and development with an FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Their evidence-based scientific approach has enabled them to develop a pipeline of cannabinoid-based drug products for various medical conditions, including pain, inflammation, and oncology. With patients at the core of what they do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians, and insurance companies.

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Cellvera is a biopharmaceutical company focused on discovering, developing, and commercializing oral therapies and monitoring tools to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleotide chemistry, biology, biochemistry, and virology, Cellvera has built a nucleotide prodrug platform to develop novel product candidates to treat single-stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. For more information: www.cellvera.com

PREPAiRE is an Ai-powered drug discovery platform using a proprietary algorithm based on Convolutional Deep Neural Networks (CNN) and Generative Adversarial Networks (GANs) to build reactive chemical and biological fitting models enabling the identification ligands to protein targets, protein-protein interactions, generating molecular structures with specified properties combining both functionality and drug ability, as well as preparing synthetic data for specific drug discovery and personalized treatment. PREPAiRE is enabling precision medicine by integrating whole-genome sequencing with deep phenotyping to data-visualize clinical IPS panels. The platform combines the in-silico prediction with high throughput wet-lab validation in an iterative cycle that empowers continuous improvement and increases efficiency, accuracy, and reliability which are critical to drug R&D. PREPAiRE offers a partnership eco-system. The outcome of PREPAiRE accelerates all steps of drug discovery and development, including target discovery, lead optimization, toxicity assessment, and trial design.  If you would like to learn more about partnering with us, please reach out to: partners@prepaire.com
www.prepaire.com 

Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company's research and development strategies, including the success of this product  or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.

SOURCE Tetra Bio-Pharma Inc.