Inovio Pharmaceu Stock Price, News & Analysis

INOVIO (NASDAQ: INO) announced the initiation of the Phase 2 segment of its INNOVATE clinical trial for its COVID-19 vaccine candidate, INO-4800, with the first subject dosed. The trial aims to enroll around 400 participants at 17 U.S. sites, focusing on safety, tolerability, and immunogenicity to confirm dosing levels for subsequent Phase 3 evaluation. Funded by the U.S. Department of Defense, the trial signifies an important step in INOVIO's response to the pandemic, leveraging its DNA technology known for its safety profile and thermostability.

INOVIO (NASDAQ: INO) has entered a partnership with Kaneka Eurogentec S.A. to manufacture its COVID-19 vaccine candidate, INO-4800, using GMP plasmid production. This collaboration enhances INOVIO's existing global manufacturing network, which includes Thermo Fisher Scientific and others, aiming to produce hundreds of millions of doses. The planned Phase 2/3 clinical trial, titled INNOVATE, is backed by DoD funding and is designed to assess the vaccine's safety and efficacy. INO-4800 boasts an impressive stability profile, requiring no freezing for transportation.

On November 23, 2020, INOVIO announced the dosing of the first subject with its DNA medicine INO-3107 in a Phase 1/2 clinical trial targeting Recurrent Respiratory Papillomatosis (RRP). This trial aims to evaluate the efficacy and safety of INO-3107, which has received Orphan Drug Designation from the FDA. RRP is a severe condition caused by HPV types 6 and 11, leading to recurring airway tumors. The trial involves 63 subjects and seeks to demonstrate an increase in time between surgical interventions. INOVIO's innovative approach may significantly alter the treatment landscape for this rare disease.

INOVIO (NASDAQ: INO) presented promising data on its DNA medicines, INO-5401 and INO-9012, combined with PD-1 inhibitor Libtayo in treating newly diagnosed glioblastoma (GBM) at the 2020 SNO Annual Meeting. The interim results demonstrated that 70% of MGMT methylated and 50% of unmethylated GBM patients survived 18 months. A significant immune response was observed, indicating potential for improved survival. This Phase 1/2 trial, involving 52 evaluable patients, is ongoing, with additional data to be released soon.

INOVIO (NASDAQ:INO) has received FDA clearance to begin the Phase 2 segment of its Phase 2/3 clinical trial for INO-4800, a COVID-19 vaccine candidate. The INNOVATE trial aims to assess safety, tolerability, and immunogenicity across various age groups. The trial will enroll around 400 participants at 17 U.S. sites and is funded by the U.S. Department of Defense. The Phase 3 segment remains on partial hold due to unresolved FDA questions regarding the delivery device. INO-4800 offers advantages such as excellent thermostability, allowing for easier distribution.

INOVIO (NASDAQ: INO) reported its third-quarter financial results for 2020, showing total revenue of $236,000, down from $867,000 in Q3 2019. Notably, the company achieved a net income of $19.2 million compared to a net loss of $23.1 million in the same period last year, primarily due to a one-time gain related to the revaluation of convertible bonds and an investment sale. R&D expenses rose to $26.5 million due to increased investment in COVID-19 vaccine development. INOVIO is focusing on its COVID-19 vaccine INO-4800, which is currently under FDA review.

INOVIO (NASDAQ: INO) will release its third-quarter 2020 financial results after market close on November 9, 2020. A conference call and webcast will follow at 4:30 p.m. ET to discuss the results and provide updates on its DNA Medicines Platform, including ongoing COVID-19 vaccine developments. Currently, INOVIO has 15 DNA medicine clinical programs targeting HPV-associated diseases, cancer, and infectious diseases. The company's innovative approach utilizes the CELLECTRA device for efficient delivery of DNA medicines, showing promise in clinical trials involving over 2,000 patients.

INOVIO (NASDAQ:INO) announced a partial clinical hold on its IND for a Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800 due to additional questions from the FDA regarding trial parameters and the CELLECTRA® 2000 delivery device. The company is addressing these inquiries and plans to respond in October, with the FDA set to make a decision within 30 days. Notably, this hold does not affect ongoing Phase 1 trials or the development of other product candidates. INOVIO continues with its coalition partners to advance INO-4800 and seeks funding for the trial.

INOVIO (NASDAQ:INO) announced a collaboration with Thermo Fisher Scientific to manufacture its DNA COVID-19 vaccine candidate, INO-4800. The partnership aims to scale up production to potentially 100 million doses in 2021, pending FDA approval. Thermo Fisher will manage the drug substance manufacturing and filling processes, joining existing partners in INOVIO's global consortium. INO-4800 has demonstrated excellent thermal stability and does not require freezing, which is crucial for global distribution. INOVIO is also preparing for Phase 2/3 trials, supported by $71 million in funding from the U.S. Department of Defense.