Novavax: CMI Data De-risks NanoFlu Program and Shows Breadth of Immune Activity, Says Analyst, , on October 9, 2020 at 1:10 am

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Novavax (NVAX) is back in the news again, only this time, it’s not because of its COVID-19 vaccine candidate. During the 2020 World Vaccine Congress Washington last week, the vaccine maker presented data from the Phase 3 respiratory syncytial virus (RSV) and NanoFlu programs, with the latter attracting significant attention from the Street.The incremental cell-mediated immunity (CMI) data for NanoFlu, its seasonal quadrivalent influenza vaccine candidate, demonstrated that the asset was able to induce substantially higher polyfunctional CD4+ T cell responses than what had been previously reported for other “enhanced” influenza vaccines in older adults.The Phase 3 NanoFlu program was designed to show immunologic noninferiority to Sanofi-Aventis S.A.’s licensed Fluzone quadrivalent vaccine, with it enrolling 2,650 adults aged 65 years or older. Unlike the published clinical data for Fluzone, nearly all NanoFlu subjects became “CMI responders,” including older subjects with low baseline CMI.Weighing in on this for B.Riley FBR, 5-star analyst Mayank Mamtani told clients, “The new CMI data, constituting of NanoFlu’s potent induction of double cytokine+ effector CD4+ T cells and IFN-γ/double/triple/quadruple cytokine+ effector CD4+ T cells, further elucidated the clinical meaningfulness of the breadth of immune response noted with NVAX’s recombinant adjuvanted nanoparticle flu vaccine aimed at accessing more conserved epitopes through cross-reactive antibodies and inducing Th1-type effector/memory CD4 cells…We believe these NanoFlu results could help drive the influenza vaccine efficacy higher, relative to 10-20% currently observed in real-world setting in the elderly population.”The implications? According to Mamtani, this bodes well for its COVID-19 vaccine candidate, NVX-CoV-2373, with data from the Phase 1/2 older subject cohort set to read out soon.Offering further explanation, the analyst commented, “This adaptive arm of immune response is particularly relevant to older subject population where waning of humoral antibody response remains a critical challenge, as also noted with COVID-19. Given the complexity of these CMI assays and shared personnel between NanoFlu and ‘2373, CD8 T cell response assessments are next in priority to be evaluated.”To this end, the completion of a typical lot-to-lot consistency trial is expected to yield NanoFlu licensure, in Mamtani’s opinion.If that wasn’t enough, Mamtani believes that the recent update on Regeneron’s antibody cocktail approach, REGN-COV2, validates NVAX’s approach involving high neutralizing antibody titers within serum and lung compartments to correlate with clinically significant improvements in symptomatic events.Given all of the above, Mamtani sides with the bulls. To this end, he maintains a Buy rating and $257 price target. This target leaves room for shares to soar 131% in the next year. (To watch Mamtani’s track record, click here)Turning to the rest of the Street, the bulls represent the majority. With 4 Buys and 1 Sell assigned in the last three months, the word on the Street is that NVAX is a Moderate Buy. At $227.60, the average price target implies 105% upside potential. (See NVAX stock analysis on TipRanks)To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.,

Novavax: CMI Data De-risks NanoFlu Program and Shows Breadth of Immune Activity, Says AnalystNovavax (NVAX) is back in the news again, only this time, it’s not because of its COVID-19 vaccine candidate. During the 2020 World Vaccine Congress Washington last week, the vaccine maker presented data from the Phase 3 respiratory syncytial virus (RSV) and NanoFlu programs, with the latter attracting significant attention from the Street.The incremental cell-mediated immunity (CMI) data for NanoFlu, its seasonal quadrivalent influenza vaccine candidate, demonstrated that the asset was able to induce substantially higher polyfunctional CD4+ T cell responses than what had been previously reported for other “enhanced” influenza vaccines in older adults.The Phase 3 NanoFlu program was designed to show immunologic noninferiority to Sanofi-Aventis S.A.’s licensed Fluzone quadrivalent vaccine, with it enrolling 2,650 adults aged 65 years or older. Unlike the published clinical data for Fluzone, nearly all NanoFlu subjects became “CMI responders,” including older subjects with low baseline CMI.Weighing in on this for B.Riley FBR, 5-star analyst Mayank Mamtani told clients, “The new CMI data, constituting of NanoFlu’s potent induction of double cytokine+ effector CD4+ T cells and IFN-γ/double/triple/quadruple cytokine+ effector CD4+ T cells, further elucidated the clinical meaningfulness of the breadth of immune response noted with NVAX’s recombinant adjuvanted nanoparticle flu vaccine aimed at accessing more conserved epitopes through cross-reactive antibodies and inducing Th1-type effector/memory CD4 cells…We believe these NanoFlu results could help drive the influenza vaccine efficacy higher, relative to 10-20% currently observed in real-world setting in the elderly population.”The implications? According to Mamtani, this bodes well for its COVID-19 vaccine candidate, NVX-CoV-2373, with data from the Phase 1/2 older subject cohort set to read out soon.Offering further explanation, the analyst commented, “This adaptive arm of immune response is particularly relevant to older subject population where waning of humoral antibody response remains a critical challenge, as also noted with COVID-19. Given the complexity of these CMI assays and shared personnel between NanoFlu and ‘2373, CD8 T cell response assessments are next in priority to be evaluated.”To this end, the completion of a typical lot-to-lot consistency trial is expected to yield NanoFlu licensure, in Mamtani’s opinion.If that wasn’t enough, Mamtani believes that the recent update on Regeneron’s antibody cocktail approach, REGN-COV2, validates NVAX’s approach involving high neutralizing antibody titers within serum and lung compartments to correlate with clinically significant improvements in symptomatic events.Given all of the above, Mamtani sides with the bulls. To this end, he maintains a Buy rating and $257 price target. This target leaves room for shares to soar 131% in the next year. (To watch Mamtani’s track record, click here)Turning to the rest of the Street, the bulls represent the majority. With 4 Buys and 1 Sell assigned in the last three months, the word on the Street is that NVAX is a Moderate Buy. At $227.60, the average price target implies 105% upside potential. (See NVAX stock analysis on TipRanks)To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

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