Middle East respiratory syndrome coronavirus vaccine(Inovio Pharmaceuticals, Inc.)

Shares in Inovio fell 3% to $2.26 in premarket trading. Inovio’s Lassa fever and Middle East respiratory syndrome (MERS) vaccine candidates have fallen short of the bar set by the biotech’s partner, prompting the collaborators to pull the plug on the programs after getting a look at clinical data. The Coalition for Epidemic Preparedness Innovations (CEPI) partnered with Inovio in 2018, committing up to $56 million to support development of DNA vaccine candidates against Lassa and MERS through to phase 2. Inovio began a phase 2 clinical trial of the MERS candidate, INO-4700, and a phase 1b study of the Lassa prospect, INO-4500, last year. CEPI footed the bill for the studies.  Inovio provided an update on the programs after the market closed Thursday, revealing the data didn’t meet CEPI’s selection criteria for further development. In response, the partners stopped work on the two vaccine candidates. In a statement, Inovio CEO Jacqueline Shea said the two vaccines “were well-tolerated” and “generated immune responses.” A clearer picture of the factors that led the partners to decide against continuing the development of the candidates should emerge when Inovio shares data from the trials. The discontinuation of INO-4700 and INO-4500 development blows a hole in Inovio’s infectious disease pipeline but leaves other key opportunities intact. The candidates accounted for half of the biotech’s clinical infectious disease prospects, with the other assets being its phase 3 COVID-19 vaccine and early-phase Ebola shot. All of the infectious disease candidates are externally funded.  Inovio is pumping its own cash into VGX-3100 and INO-3107, candidates aimed at conditions related to human papillomavirus. Data from the second phase 3 trial of VGX-3100 are due around the turn of the year. The FDA is recommending that the trial, REVEAL2, is used as an exploratory study to evaluate a biomarker population, leaving Inovio one or two new trials from having the data to support approval.  Shares in Inovio fell 3% to $2.26 in premarket trading.

PLYMOUTH MEETING, PA, USA I November 17, 2022 I INOVIO (NASDAQ: INO ), a biotechnology company focused on developing and commercializing DNA medicines to help treat and prevent infectious diseases, cancer, and diseases associated with HPV, today announced that it has agreed with its collaborator, the Coalition for Epidemic Preparedness Innovations (CEPI), to discontinue development of product candidates targeting Lassa Fever (INO-4500) and Middle East Respiratory Syndrome (MERS) (INO-4700), following initial analyses of data from studies conducted by INOVIO and funded by CEPI. Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer, said, "For the past four years, we have been pleased to collaborate with CEPI on its mission of accelerating the development of vaccines against epidemic and pandemic threats so that they can be accessible to all people in need. Although INO-4500 and INO-4700 were well-tolerated by participants in our clinical trials and generated immune responses, the two-dose regimen did not meet CEPI's selection criteria for further development. We continue to believe in the potential of our DNA medicine candidates based on their characteristics, including the ability to elicit durable T-cell responses, which could be important in the prevention and treatment of infectious diseases. INOVIO welcomes the opportunity to collaborate with CEPI in the future." The INO-4500 Lassa Fever trial was a Phase 1b study involving 220 participants in Ghana. With this trial, INO-4500 was the first product candidate to enter human clinical trials in West Africa targeting Lassa Fever. The INO-4700 trial was a Phase 2 study targeting the prevention of MERS. The first cohort of the trial involved 192 participants in Jordan, Kenya, and Lebanon. INOVIO intends to publish data to aid subsequent research. About INOVIO INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer, and infectious diseases. INOVIO's DNA medicines in development are delivered using its investigational proprietary smart device to produce immune responses against targeted pathogens and cancers. For more information, visit www.inovio.com . SOURCE: Inovio