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[QUOTE]Originally posted by BooDog: [QB] https://pharmaboardroom.com/articles/covid-19-a-material-disruptor/ Excerpt... There are no specific therapeutics approved by the FDA to treat people with Covid-19. A robust research effort is currently under way to develop a vaccine against Covid-19. Critical to moving the field forward, even in the context of an outbreak, is ensuring that investigational products are evaluated in scientifically and ethically sound studies. Below is a list of the various coronavirus drugs and approaches that biopharmaceutical companies across the world are developing that have the potential to become major coronavirus vaccines or antivirals for treating the contagious coronavirus infection. Company Drug/ Vaccine Notes Tonix Pharmaceuticals TNX-1800 The vaccine is a modified horsepox virus developed using Tonix’s proprietary horsepox vaccine platform. [b]Innovation Pharmaceuticals Brilacidin A defensin mimetic drug candidate, as a potential treatment for coronavirus. Brilacidin has shown antibacterial, anti-inflammatory and immunomodulatory properties in several clinical trials [/b] Inovio Pharmaceuticals and Beijing Advaccine Biotechnology INO-4800 The company has started pre-clinical testing for clinical product manufacturing. The vaccine development is supported by a $9m grant from the Coalition for Epidemic Preparedness Innovations (CEPI). Inovio aims to progress the vaccine through phase one human testing in the US to test safety and efficacy. A phase one clinical trial is planned to be conducted in parallel in China, by Beijing Advaccine. Clover Biopharmaceuticals Recombinant subunit vaccine The company is developing the vaccine based on the trimeric S protein (S-Trimer) of the 2019-nCoV virus, which is responsible for binding with the host cell and causing a viral infection. Vaxart Coronavirus vaccine The company plans to develop vaccines based on the published genome of 2019-nCOV to be tested in pre-clinical models for mucosal and systemic immune responses. CytoDyn Leronlimab Leronlimab (PRO 140) is a CCR5 antagonist. The drug is already being investigated in phase two clinical trials as a treatment for HIV and has been awarded fast-track approval status by the FDA. Applied DNA Sciences and Takis Biotech Linear DNA Vaccine The Joint Venture will use Polymerase Chain Reaction (PCR)-based DNA manufacturing technology to develop the vaccine. Bioxytran BXT-25 The Company announced that it is exploring partners to develop its lead drug candidate, BX-25, as a treatment for Acute Respiratory Distress Syndrome (ARDS) in late-stage patients infected with the coronavirus. Novavax MERS coronavirus vaccine candidate It is a crucial target for coronavirus vaccine development by the Coalition for Epidemic Preparedness Innovations (CEPI) and is a priority disease for WHO. The candidate is designed to primarily bind to the major surface S-protein and developed using the company’s recombinant nanoparticle vaccine technology. Tested along with the Novavax’s proprietary adjuvant Matrix-M™, it inhibited infection by inducing immune responses in the laboratory studies. Inovio Pharma INO-4700 The investigational DNA immunotherapy, INO-4700 (GLS-5300) is being developed with partner, GeneOne Life Science. It is delivered as vaccine intramuscularly, using the Cellectra®delivery device. Gilead Sciences Remdesivir (GS-5734) An ebola drug developed by Gilead Sciences that was found to be ineffective is now being tested in phase III randomised clinical trial in partnership with China. The trials are being performed on 761 patients in a randomised, placebo-controlled, double-blind study at multiple hospitals in Wuhan, the epicentre of the novel coronavirus outbreak. The results from the trials are expected to be available over the next few weeks. Biocryst Pharma Galidesivir The antiviral drug Galidesivir (BCX4430) has shown broad-spectrum activity against a wide range of pathogens including coronavirus. It is a nucleoside RNA polymerase inhibitor that disrupts the process of viral replication. The drug has already shown survival benefits in patients against deadly viruses such as Ebola, Zika, Marburg, and Yellow fever. Regeneron REGN3048-3051 The combination of neutralizing monoclonal antibodies REGN3048 and REGN3051 is being studied against coronavirus infection in a first-in-human clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). The safety and tolerability of the drug will be studied in 48 patients. Both the antibodies bind to S-protein of MERS coronavirus. The intravenous administration of the drug in the mouse model of MERS resulted in the high-level neutralization of the MERS coronavirus in circulating blood with reduced viral loads in the lungs. Vir Biotechnology The Company announced that it has identified two monoclonal antibodies that can bind to the virus that causes Covid-19. The antibodies target the spike (S) protein of the virus by entering through the cellular receptor ACE2. The company has formed a partnership with WuXi Biologics on 25 February to commercialise the antibodies identified to treat coronavirus. Generex Vaccine The company will utilis\ze its Ii-Key immune system activation technology to produce a Covid-19 peptide for human clinical trials. Moderna mRNA-1273 The first vials of the experimental vaccine have been shipped and will be used in a planned Phase 1 study in the United States. Serum Institute of India Vaccine Serum Institute of India (SII) is collaborating with Codagenix, a US-based biopharmaceutical company, to develop a coronavirus cure using a vaccine strain similar to the original virus. The vaccine is currently in the pre-clinical testing phase, while human trials are expected to commence in the next six months. SII is expected to launch the vaccine in the market by early 2022. Zydus Cadila Vaccine Zydus Cadila announced the launch of an accelerated research programme to develop a vaccine for Covid-19 using two novel approaches. The first approach includes the development of a DNA vaccine against the viral membrane protein of the virus, while a live attenuated recombinant measles virus (rMV) vectored vaccine will be developed in the second approach. The rMV-based vaccine works by inducing specific neutralising antibodies, which will provide protection from the coronavirus infection. NanoViricides NanoViricides, a clinical-stage company, is working on developing a treatment for nCoV-2019 using its nanoviricide® technology. The company’s technology is used to develop ligands that can bind to the virus in the same way as a cognate receptor and attack various points of the virus. ImmunoPrecise Antibodies Coronavirus vaccine ImmunoPrecise Antibodies has launched a vaccine and therapeutic antibody program to develop a vaccine as well as antibodies against Covid-19. The company will use its B Cell Select™ and DeepDisplay™ discovery platforms to therapeutic compounds against the coronavirus. [/QB][/QUOTE]
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