This week, one of the key players in the COVID-19 vaccine race took a leap forward.
INO) announced that Thermo Fisher Scientific had signed a letter of intent to manufacture its DNA COVID-19 vaccine candidate, INO-4800. Thermo Fisher will be added to a list of partners that includes Richter-Helm Biologics and Ology Bioscience. This global manufacturing consortium will support the commercial production of 100 million doses of INO-4800 in 2021, should the candidate ultimately receive FDA approval.” data-reactid=”13″>On Tuesday, Inovio Pharmaceuticals (INO) announced that Thermo Fisher Scientific had signed a letter of intent to manufacture its DNA COVID-19 vaccine candidate, INO-4800. Thermo Fisher will be added to a list of partners that includes Richter-Helm Biologics and Ology Bioscience. This global manufacturing consortium will support the commercial production of 100 million doses of INO-4800 in 2021, should the candidate ultimately receive FDA approval.
Raghuram Selvaraju points out that Thermo Fisher plans to manufacture INO-4800 as well as perform the fill and finish at its commercial facilities in the U.S., which have a peak production capacity of at least 100 million doses of INO-4800 annually, so says management. On top of this, Inovio is in active discussions with additional manufacturers to join the consortium.” data-reactid=”14″>H.C. Wainwright’s Raghuram Selvaraju points out that Thermo Fisher plans to manufacture INO-4800 as well as perform the fill and finish at its commercial facilities in the U.S., which have a peak production capacity of at least 100 million doses of INO-4800 annually, so says management. On top of this, Inovio is in active discussions with additional manufacturers to join the consortium.
Weighing in on this development, Selvaraju stated, “In our view, the inclusion of Thermo Fisher in the global consortium significantly strengthens Inovio’s manufacturing capacity and represents one solid step towards potential commercialization of INO-4800 in 2021.”
As INO-4800 gears up to enter a Phase 2/3 trial later this month, another COVID-19 vaccine candidate has been attracting significant Street attention. Also on Tuesday, rumors swirled that AstraZeneca had halted the clinical trials evaluating its COVID-19 vaccine candidate, AZD1222, for an independent committee to review safety data while it investigates a “single event” case of a serious adverse reaction. The adverse reaction was transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often brought on by viral infections. It isn’t clear if the reaction is directly linked to AZD1222, a non-replicating ChAdOx1 vector-based candidate.
“If the serious adverse event is proven to be vaccine-related, it may prevent this candidate from being approved and commercialized, in our view, thus leaving the COVID-19 vaccine market to those that could pass all developmental and regulatory hurdles. Notably, nine pharmaceutical firms issued a joint pledge yesterday stating that they would not launch any vaccine until it had been thoroughly vetted for safety and efficacy,” Selvaraju commented.
Looking at the data for INO-4800, in the U.S. Phase 1 trial, interim data showed that 100% of participants demonstrated overall immunological response rates and roughly 95% of vaccinated participants had overall seroconversion, or responded with neutralization and/or binding antibodies, after two doses. Adding to the good news, almost 90% of vaccinated subjects generated strong T cell responses, including CD8+ killer T cell responses.
“In our view, the presence of T cell responses in the majority of participants could be associated with long-lasting immunity or duration of protection,” Selvaraju noted.
click here)” data-reactid=”24″>While all of the above is positive, Selvaraju takes a cautious approach for now. To this end, he reiterates his Neutral rating. Given the market valuation and volatility, he doesn’t set a specific price target. (To watch Selvaraju’s track record, click here)
See Inovio stock analysis on TipRanks)” data-reactid=”25″>According to TipRanks, the consensus on Wall Street is that INO stock is a “hold” for investors. But TipRanks might as well have said “buy” — because analysts, on average, think the stock, currently at $9.74, could zoom ahead to $19 within a year, delivering 95% profits to new investors. (See Inovio stock analysis on TipRanks)
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