Inovio Pharmaceuticals Inc. has “more work to do” in understanding mixed results with the DNA-based immunotherapy VGX-3100 as a treatment for cervical high-grade squamous intraepithelial lesions associated with human papillomavirus (HPV)-16 or HPV-18, said Michael Sumner, chief medical officer for the company. “We only got the data in our hands about a week ago.”
Nearly six months after ditching its phase II/III COVID-19 vaccination study to chase a booster strategy, Inovio Pharmaceuticals Inc. is now ditching the heterologous booster.
Nearly six months after ditching its phase II/III COVID-19 vaccination study to chase a booster strategy, Inovio Pharmaceuticals Inc. is now ditching the heterologous booster. The decision to stop internally funding INO-4800 as a booster was made after sifting through data on global demand for COVID-19 vaccines, the condition of the market and Inovio’s own portfolio.
Anti-SARS-CoV-2 monoclonal antibody (MAb) pair COV2-2196 (tixagevimab, class I) and COV2-2130 (cilgavimab, class III) are human neutralizing Abs (nAbs) that target nonredundant, complementary epitopes within the receptor binding domain of SARS-CoV-2 spike protein (S-RBD).
Newly appointed President and CEO Jackie Shea looks to have her work cut out for her, as Inovio Pharmaceuticals Inc. decided to ditch its phase II/III COVID-19 vaccination trial in favor of pursuing a booster strategy with INO-4800. That update, disclosed during Inovio’s first-quarter earnings late May 10 alongside a likely delay in filing for approval of HPV immunotherapy candidate VGX-3100, sent the stock (NASDAQ:INO) falling 27% May 11. Over the past year, shares have fallen more than 70%.
Zydus Cadila Group could make history after applying for approval for the first ever human DNA vaccine in India. But that could be just the start for a technology that could treat a vast array of diseases, including cancer, infectious diseases and chronic diseases.
With only days left before Inovio Pharmaceuticals Inc. planned to initiate a phase II/III trial of its COVID-19 DNA vaccine candidate, INO-4800, and its accompanying delivery device, the FDA placed a partial clinical hold on the company’s study. This is the study’s second delay as the company originally planned to begin in July or August. November is now the earliest potential start date. Inovio told BioWorld that the company and its partners are continuing to prepare for the phase II/III trial “following resolution of the FDA’s partial clinical hold.”
As the COVID-19 strain of coronavirus continues to spread around the globe, companies are scrambling to develop effective diagnostics and vaccines to contain the outbreak and reduce future threats. Among those is Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., which has been awarded a $5 million grant from the Bill & Melinda Gates Foundation to speed testing and scale of smart delivery device for its COVID-19 vaccine candidate.
BEIJING – There was encouraging news when vaccine developer Moderna Inc. announced Feb. 24 that it has shipped the first vials of its mRNA vaccine against COVID-19 for a phase I trial in the U.S. The vaccine was created just 42 days after the genetic sequence of the COVID-19 virus was released.
BEIJING – There was encouraging news when vaccine developer Moderna Inc. announced this week it that has shipped the first vials of its mRNA vaccine against COVID-19 for a phase I trial in the U.S. The vaccine was created just 42 days after the genetic sequence of the COVID-19 virus was released. That is record speed. Other vaccine developers are also working around the clock to respond to the epidemic.