Shares of Inovio Pharmaceuticals, Inc. INO have declined sharply in the past three months. The stock has plunged 33.1%, wider than the industry’s decline of 4.6%.
In July, Inovio announced a restructuring process to prioritize the development of its late-stage human papillomavirus (HPV) assets and reallocate capital to develop fast-to-market product candidates. Following this, the company reduced its annual burn rate by 25% and cut workforce by 28%.
Inovio also decided to cut some early-stage R&D programs and terminated the phase I/II study on INO-5401 for the treatment of advanced bladder cancer. The news aggravated the stock’s decline.
Notably, in April, Inovio closed patient enrollment in the phase I/II study on its immuno-oncology combo of INO-5401 and INO-9012 in combination with Regeneron REGN and Sanofi’s SNY PD-1 inhibitor, Libtayo (cemiplimab), for treating newly-diagnosed patients with glioblastoma (GBM).
We would like to remind investors that VGX-3100, an HPV immunotherapy, is the most advanced candidate in Inovio’s pipeline right now, which holds untapped potential.
VGX-3100 is currently being evaluated in a phase III study (REVEAL 1) for the treatment of cervical dysplasia caused by HPV. In June, Inovio completed enrolling patients in the REVEAL 1 program. In March, the company started recruiting patients in the confirmatory REVEAL 2 study on VGX-3100 for the same indication. Based on the outcomes from REVEAL 2, Inovio plans to submit a regulatory filing, seeking approval for VGX-3100, in 2021.
Last week, the company completed enrollment in a phase II study evaluating VGX-3100 for the treatment of anal dysplasia caused by HPV. Preliminary efficacy data from the study are expected later this year. Moreover, in July, it concluded enrollment in another phase II study on VGX-3100 for the treatment of vulvar dysplasia caused by HPV. Interim data from this study are also expected by the end of the year.
Apart from VGX-3100, Inovio has several candidates in its pipeline under early-to-mid-stage development.
Inovio plans to advance MEDI0457 (a combination of Inovio’s VGX-3100 immunotherapy and a DNA-based immune activator encoded for IL-12) in combination with AstraZeneca's AZN checkpoint inhibitor for HPV-related cancers, including the phase II study to treat head and neck cancer. AstraZeneca hopes to complete this study by August 2020.
Meanwhile, Inovio is developing a novel therapy, INO-3107, for treating patients with recurrent respiratory papillomatosis (RRP), an HPV-associated disease. The company plans to initiate the next study on the candidate by mid-2020.
This apart, Inovio is progressing well with its Lassa fever vaccine candidate, INO-4500, and the Middle East respiratory syndrome (MERS) vaccine candidate, INO-4700.
Any positive development of these pipeline candidates, mainly VGX-3100, should help the stock recover in the days ahead.
Inovio Pharmaceuticals, Inc. Price
Inovio Pharmaceuticals, Inc. price | Inovio Pharmaceuticals, Inc. Quote
Inovio currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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