Inovio expects COVID-19 vaccine U.S. trial data by early second quarter

(Reuters) - U.S. vaccine developer Inovio Pharmaceuticals Inc said on Monday it had completed Phase II enrolment for a mid-to-late stage U.S. trial of its COVID-19 vaccine candidate and expects to report data early in the second quarter.

FILE PHOTO: Vials labelled "COVID-19 Coronavirus Vaccine" are placed on dry ice in this illustration taken, December 5, 2020. REUTERS/Dado Ruvic/Illustration/File Photo

Inovio said it was testing the impact of its vaccine candidate, IN0-4800, on new SARS-CoV-2 variants, as well as developing next-generation COVID-19 vaccine candidates that could be tailored to known and unknown SARS-CoV-2 variants.

“The pan-COVID candidate is designed to provide protection against the U.K., South African and Brazilian stream as well as potentially the currently unknown SARS-CoV-2 variant,” Inovio senior executive Kate Broderick said.

The vaccine news did not boost Inovio shares, which were down 3% in extended trading.

The company started developing the vaccine last year, but fell behind rivals who have already received U.S. authorization, after the Food and Drug Administration put a portion of the U.S. study of IN0-4800 on hold, as it sought details on the vaccine delivery device.

Inovio said it was actively working to address FDA’s concerns and expects to begin the Phase III portion in “later part of the second quarter this year.”

The Pennsylvania-based company also said its treatment for cervical dysplasia met main and secondary goals of regression of abnormal cell growth and clearance of underlying disease-causing virus, in first of two late-stage studies.

Cervical dysplasia is a precancerous condition in which abnormal cell growth occurs on the surface lining of the cervix.

The company is also testing the usage of IN0-4800 as a seasonal booster shot. Ninety three of 120 patients from an early-stage vaccine trial have already received a third booster shot and Inovio expects to share immune response in the second quarter.

“If successful, this could extend protection against the COVID-19 virus as it becomes (an) endemic,” Broderick said.

Reporting by Mrinalika Roy in Bengaluru; Editing by Shinjini Ganguli