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INOVIO PHARMACEUTICALS, INC.

(INO)
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INOVIO Receives Regulatory Authorization to Conduct Phase 3 Efficacy Trial of its COVID-19 DNA Vaccine Candidate, INO-4800, in Mexico

09/22/2021 | 08:00am EDT

INOVIO announced that it has received authorization from COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), the national health regulatory agency of Mexico, to conduct a clinical trial in that country as part of the Phase 3 segment of INOVIO's global Phase 2/3 trial, INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy), for its DNA vaccine candidate for COVID-19, INO-4800. INOVIO is working with its partner Advaccine Biopharmaceuticals Suzhou Co. Ltd. (Advaccine) on the INNOVATE Phase 3 segment in multiple countries. INOVIO recently announced that it has received regulatory authorization to proceed with Phase 3 clinical trials in Brazil and the Philippines and is seeking authorization to conduct trials in additional countries. The global Phase 3 segment of INNOVATE will evaluate the efficacy of INO-4800 in a two-dose regimen (2.0 mg per dose), administered one month apart, in a 2-to-1 randomization in men and non-pregnant women 18 years of age and older. The primary endpoint of this case-driven Phase 3 trial is virologically confirmed COVID-19. INNOVATE's Phase 3 segment builds upon the Phase 2 segment, which was conducted in the U.S. and funded by the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, in coordination with the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency. Phase 2 data was disclosed in a pre-print in MedRxiv in May 2021 and found INO-4800 to be well-tolerated and immunogenic in adults 18 and older. In another previously disclosed study using clinical samples, INO-4800 was also found to provide broad cross-reactive immune responses, including neutralizing antibodies and robust T cell responses, against variants of concern (alpha, beta, gamma and, in subsequent research, delta) – factors which could be critical in containing COVID-19 as it shifts from pandemic to endemic spread. INOVIO also announced in August the authorization to proceed in China with two Advaccine-sponsored clinical trials investigating the safety, tolerability, and immunogenicity of heterologous boost combinations with INO-4800 and Sinovac Biotechnology's CoronaVac®, an inactivated COVID-19 vaccine developed by Sinovac and authorized for emergency use by the World Health Organization.


© S&P Capital IQ 2021
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Financials (USD)
Sales 2021 4,71 M - -
Net income 2021 -272 M - -
Net Debt 2021 - - -
P/E ratio 2021 -5,41x
Yield 2021 -
Capitalization 1 481 M 1 481 M -
Capi. / Sales 2021 315x
Capi. / Sales 2022 15,0x
Nbr of Employees 262
Free-Float 98,3%
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Inovio Pharmaceuticals, Inc. Technical Analysis Chart | INO | US45773H2013 | MarketScreener
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Mean consensus OUTPERFORM
Number of Analysts 10
Last Close Price 7,04 $
Average target price 13,22 $
Spread / Average Target 87,8%
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Managers and Directors
J. Joseph Kim President, Chief Executive Officer & Director
Peter D. Kies Chief Financial Officer
Simon X. Benito Chairman
Laurent M. Humeau Chief Scientific Officer
Kate E. Broderick Senior Vice President-Research & Development
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