FDA Partial Clinical Resolution on Inovio’s Planned Phase II-19 COVID-19 Vaccine
Published: September 28, 2020
By Alex Keown
BioSpace
Inovio Pharmaceuticals shares plummeted more than 34% in pre-market operations this morning after the company announced that the U. S. Food and Drug Administration (FDA) had suspended its planned phase II/III of the company’s COVID-19 candidate vaccine.
This morning, Pennsylvania-based Inovio said the regulatory firm had further questions about the phase II/III trial related to the candidate vaccine itself, known as INO-4800, as well as the company’s Cellectra 2000 management device. The suspension was not due to the occurrence of adverse situations related to the ongoing Phase I examination of the INO-4800 company. Boyfriend said the Phase I exam is expected to continue. In addition, partial clinical suspension does not affect the company’s other clinical programs, Inovio said in his announcement.
Beyond the few previous data, Inovio did not reveal much in relation to partial clinical intake. The company said it is running to answer questions posed through the FDA and plans to respond to the regulator in October. The FDA will have up to 30 days to respond, and tell Inovio whether or not to continue with the clinical trial. Boyfriend said he is preparing for the rehearsal to resume to play his part in the fight against the global pandemic.
At the end of June, Inovio announced a positive intermediate knowledge of the phase I INO-4800 trial. In interim knowledge, 94% of receptors demonstrated a general immune reaction at week 6 after two doses of the vaccine, the company said. 8, the vaccine gave the impression of being well tolerated and without serious adverse effects. All adverse occasions were mild, grade 1 in severity, most were redness at the injection site.
Earlier this month, an adverse occasion caused a pause in the Phase III examination of AstraZeneca’s COVID-19 vaccine, in which a UK woman who won the experimental vaccine candidate was hospitalised for severe neurological disease. discharged from the hospital and the vaccine trial has resumed in the UK, but is still suspended in the US. But it’s not the first time
INO-4800 is one of the experimental vaccines included in the US government’s Warp Speed operation. USA, which claims to have a vaccine until January 2021. Innovio has presented the candidate vaccine as the only vaccine based on solid nucleic acid at room temperature for more than a year. year and does not want shipping or garage to freeze, as mNR vaccine applicants are evolving through Moderna and Pfizer and BioNTech.
Earlier this month, Inovio partnered with Thermo Fisher Scientific to manufacture the COVID-19 vaccine. At full capacity, Thermo Fisher predicts that it could produce at least one hundred million doses of INO-4800 consistently with the year.
BioSpace Source:
https://www. biospace. com/article/inovio-plunges-after-fda-places-partial-hold-on-planned-covid-19-vaccine-study