Inovio Gets FDA Nod to Begin Study on INO-3107, Stock Gains

Inovio Pharmaceuticals, Inc. INO announced that the FDA has accepted its investigational new drug (IND) application for its novel DNA medicine INO-3107. The regulatory body’s acceptance allows the company to begin a phase I/II study to evaluate INO-3107 for the treatment of patients with recurrent respiratory papillomatosis (RRP), a rare disease caused by certain types of human papillomavirus (HPV). This is a life-threatening condition characterized by noncancerous tumor growths in the airways.

Currently, there is no cure for this disease and is mostly treated by surgery, which only restores the airway temporarily. The tumor recurs and the surgery is often repeated multiple times a year, thereby impacting the quality of life for people afflicted with this dreadful disease. This condition can sometimes develop into cancer.

Per the company, the aforesaid open-label, multicenter study will evaluate the efficacy, safety, tolerability and immunogenicity of INO-3107 in RRP patients, who had minimum two prior surgical interventions per year for the past three years to remove the associated papilloma. The primary efficacy endpoint of the study is to double the time between surgical interventions following the first dose of INO-3107.

The company plans to include pediatric patients for the label expansion study. Inovio also intends to obtain an orphan disease designation for INO-3107.

Shares of Inovio were up 9.1% following the above announcement on Monday. However, the stock has plunged 25.8% in the past year compared with the industry’s decrease of 2.2%.

 

Importantly, Inovio has 15 DNA medicine programs, currently under development to address HPV-associated diseases, cancer and other infectious diseases including the novel coronavirus.

Last month, the company received a grant of up to $9 million from Coalition for Epidemic Preparedness Innovations (CEPI) for pre-clinical and phase I development of a 2019-nCoV vaccine named INO-4800.

In addition, CEPI announced a new partnership with Moderna, Inc. MRNA and the U.S. National Institute of Allergy and Infectious Diseases (NIAID) for developing a 2019-nCoV vaccine. CEPI is also coordinating with WHO to contain the spread of the new coronavirus.

Zacks Rank & Other Stocks to Consider

Inovio currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the biotech sector include Kala Pharmaceuticals, Inc. KALA and Vericel Corp. VCEL, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Kala Pharmaceuticals’ loss per share estimates have narrowed 0.9% for 2020 over the past 60 days.

Vericel’s earnings estimates have been revised 12.5% upward for 2020 over the past 60 days.

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