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Saturday, December 3, 2022

Accelerated Timeline Lifts Inovio Pharmaceuticals Inc (NASDAQ: INO)

Inovio Pharmaceuticals Inc (NASDAQ: INO) is making significant gains as the overal markets have seen their biggest drop since 2008. INO has rocketed up off its sub $3 base to highs near $10 after the Company announced it was accelerating the timeline for developing its DNA vaccine INO-4800 for coronavirus COVID-19. Inovio says it expects to initiate human trials as early as next month.

The coronavirus (COVID-19) outbreak poses a significant life-threatening and economic risk throughout the world. Over 90,000 cases have been diagnosed across more than 80 countries, including here in the U.S., resulting in over 3,000 reported deaths. In the US an $8.3 billion coronavirus emergency spending plan was just implemented.

Inovio Pharmaceuticals Inc (NASDAQ: INO) is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat, cure, and protect people from diseases associated with HPV, cancer, and infectious diseases. Inovio is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to safely produce a robust immune response to destroy and clear high-risk HPV 16 and 18, which are responsible for 70% of cervical cancer, 90% of anal cancer and 69% of vulvar cancer. In addition to HPV, Inovio’s optimized plasmid design and delivery technology have been demonstrated to consistently activate robust and fully functional T cell and antibody responses against targeted cancers and pathogens.

Inovio’s most advanced clinical program, VGX-3100, is in Phase 3 development for the treatment of HPV-related cervical pre-cancer. Also in development are Phase 2 immuno-oncology programs targeting HPV-related cancers, GBM, and prostate cancer, as well as externally funded vaccine development programs in Zika, MERS, Lassa, HIV, and COVID-19.

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In February INO reported the FDA has accepted its Investigational New Drug (IND) application to evaluate its DNA medicine INO-3107 in a Phase 1/2 trial for treatment of Recurrent Respiratory Papillomatosis or RRP. RRP is a rare disease caused by the human papillomavirus (HPV) types 6 and 11 infections, a condition that causes noncancerous tumor growths leading to life-threatening airway obstructions, and occasionally can progress to cancer.

Earlier this week INO said fourth quarter and full year 2019 financial results will be released after the market close on March 12, 2020. Following the release, the Company will host a live conference call and webcast at 4:30 p.m. ET, to provide a general business update and financial results for the fourth quarter and full year 2019.

On March 3 INO announced an accelerated timeline for developing its DNA vaccine INO-4800 to address COVID-19, the respiratory infection the World Health Organization (WHO) has designated a Public Health Emergency of International Concern of the highest level. According to WHO, approximately 89,000 cases have been reported globally with more than 3,000 deaths.

Dr. J. Joseph Kim, Inovio’s President & CEO, shared this accelerated timeline at the U.S. Coronavirus Task Force meeting at the White House on March 2. Dr. Kim said, “Inovio is the leader in coronavirus vaccine development and the only company with a Phase 2 vaccine for a related coronavirus that causes Middle East Respiratory Syndrome (MERS). Using our modern DNA medicines platform, we designed our DNA vaccine INO-4800 in three hours after the publication of the genetic sequence of the novel coronavirus that causes COVID-19. We immediately began preclinical testing and small-scale manufacture and have already shared robust preclinical data with our public and private partners. We plan to begin human clinical trials in the U.S. in April and soon thereafter in China and South Korea, where the outbreak is impacting the most people. We plan on delivering one million doses by year end with existing resources and capacity. However, we will need additional resources to scale up to make enough doses to help protect Americans from COVID-19 as well as to lead global efforts to curtail this virus.”

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Disclosure: we hold no position in INO either long or short and we have not been compensated for this article.

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