Inovio Pharma (INO) Stock Surges 19% This Month: Here's Why
Inovio Pharmaceuticals INO, a clinical-stage biotechnology company, is focused on developing DNA medicines to potentially treat and prevent diseases associated with human papillomavirus (HPV), cancer and infectious ailments by using its proprietary optimized plasmid design and delivery technology.
The company announced plans to reprioritize its pipeline in the second quarter of 2023 earnings release, channeling the resources to develop its lead candidate, INO-3107, as a treatment for recurrent respiratory papillomatosis (RRP).
INO-3107 is an investigational DNA medicine candidate designed to elicit a targeted T cell response against HPV-6 and HPV-11, the HPV types that cause RRP and other HPV-related diseases.
Month to date, shares of INO have surged 19.1% against the industry’s 2.2% fall.
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The uptick in the stock price of the company was driven by Inovio’s announcement in October regarding the FDA’s feedback on the data from its completed phase I/II study of INO-3107 to treat RRP. Per the FDA, the encouraging results from the early-mid-stage study of INO-3107 in RRP have the potential to support a biologics license application (BLA) by INO for review under its accelerated approval program.
The company had previously planned to initiate a pivotal phase III study for INO-3107 to treat adult patients with RRP in 2024, which the FDA has advised will not be required to support the BLA submission for accelerated approval.
Instead, the FDA has recommended that Inovio should initiate a confirmatory study before the BLA submission for INO-3107 for accelerated approval in the treatment of RRP, at the same time satisfying all other FDA filing requirements.
Per Inovio, a design for the confirmatory study of INO-3107 in RRP has not yet been finalized with the regulatory body. Subject to approval, INO-3107 will become the first DNA medicine in the United States as well as Inovio’s first approved commercial product.
The completed phase I/II study evaluated INO-3107's safety, tolerability, immunogenicity and efficacy in patients with HPV-6 and/or HPV-11-related RRP. The objective of the study was to demonstrate the reduction in the number of surgical interventions in the year following the initial administration of INO-3107 compared with the year before treatment.
Per the data announced from the study in October 2022, it was observed that 81.3% of the total patients in the study experienced a reduction in surgical interventions in the year after INO-3107 administration compared with the previous year. This statistic includes 28.1% of patients who required no surgical intervention during or after dosing with INO-3107.
Following dosing with INO-3107, a median decrease of three surgical interventions was observed. Inovio further reported that the candidate was overall well tolerated by the study participants. Treatment-related adverse events were mostly mild in severity.
RRP is a rare degenerative disease that causes small growths (papillomas) in the respiratory tract. Although non-cancerous, papillomas can cause severe and life-threatening airway obstruction and respiratory complications.
RRP takes a serious toll on the quality of life of patients by affecting the voice box and limiting the ability to speak effectively. Surgically removing papillomas is the current standard of care treatment. However, the papillomas often relapse because the underlying HPV infection still exists. This represents a serious unmet medical need.
INO-3107 is designed to target and cure the infection to potentially prevent or slow down the growth of new papillomas.
Inovio’s pipeline contains two other HPV-related product candidates, currently under mid-stage development, INO-3112 (head and neck cancer) and VGX-3100 (anal dysplasia).
Other than HPV-related product candidates, INO has several other early-mid-stage candidates in its pipeline, which are currently under development in various other indications.
Inovio Pharmaceuticals, Inc. Price and Consensus
Inovio Pharmaceuticals, Inc. price-consensus-chart | Inovio Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Inovio currently has a Zacks Rank #4 (Sell).
Some better-ranked stocks in the same industry are Dynavax Technologies DVAX, Anixa Biosciences ANIX and Adicet Bio, Inc. ACET. While DVAX sports a Zacks Rank #1 (Strong Buy), ANIX and ACET carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 24 cents to 22 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 8 cents. Month to date, shares of DVAX have lost 1.5%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 loss per share has narrowed from 33 cents to 32 cents. The estimate for Anixa Biosciences’ 2024 loss per share has narrowed from 38 cents to 37 cents. Month to date, shares of ANIX have broken even.
ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 26.29%.
In the past 30 days, the estimate for Adicet Bio’s 2023 loss per share has remained constant at $2.93. The estimate for Adicet’s 2024 loss per share has remained constant at $2.40. Month to date, shares of ACET have gained 5.1%.
ACET’s earnings beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 7.70%.
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