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Immuno-oncology Firm to Co-Develop Companion Diagnostic for Cervical Dysplasia
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The partnership news and upcoming data readouts are reviewed in an H.C. Wainwright & Co. report.

In a May 17 report, H.C. Wainwright & Co. analyst Ram Selvaraju reported that Inovio Pharmaceuticals Inc. (INO:NASDAQ) will collaborate with QIAGEN, a molecular testing solutions company, to develop a companion diagnostic test to identify cervical dysplasia patients most likely to respond to VGX-3100, an immunotherapy targeting precancerous lesions.

The liquid biopsy-based test will be based on "novel microRNA biomarkers discovered in the past by Inovio via QIAGEN Genomic Services," Selvaraju noted. Financial arrangements between the two companies concerning the collaboration have not been released to the public.

"Given QIAGEN's expertise in precision medicine in immuno-oncology and particularly human papillomavirus (HPV)-related molecular testing, we believe this collaboration is likely to produce a convenient and accurate test that would increase absolute efficacy of VGX-3100 among 30 million HPV-infected women who have progressed to the stage of precancerous cervical lesions," commented Selvaraju.

Looking further out, Selvaraju highlighted, commercialization of VGX-3100 along with a companion diagnostic test should enhance uptake of the immunotherapy in the market.

In other news, Selvaraju pointed out that the REVEAL Phase 3 trials of Inovio's VGX-3100 in HPV 16 and 18 are on schedule for data readout in 2020, which means the biopharma could submit a biologic license application to the U.S. Food and Drug Administration in 2021. REVEAL 1 should finish enrollment of 198 patients by mid-2019, and the confirmatory REVEAL 2 began recruiting patients in March 2019. "If approved, VGX-3100 would be the first immunotherapy for women with cervical dysplasia," the analyst added.

Also noteworthy about VGX-3100 is that it is being evaluated as well, in two Phase 2 trials in HPV-related vulvar and anal dysplasia in the U.S. Interim efficacy results from those studies could be released by year-end 2019. Also, the European Medicines Agency has granted VGX-3100 an advance therapy medicinal product certification for quality and nonclinical data.

Selvaraju indicated that Inovio has multiple other immuno-oncology studies underway with results due to be announced this year. They include the Phase 1/2 study evaluating MEDI0457 in combination with Imfinzi (durvalumab) in metastatic HPV-associated head and neck squamous cell cancer as well as three AstraZeneca studies of MEDI0457 in HPV-associated cancers.

Two others are Inovio's Phase 1/2 trial of INO-5401 plus INO-9012 in combination with cemiplimab (REGN2810) from Regeneron in glioblastoma and the Phase 1/2a study of INO-5401 plus INO-9012 in combination with Genentech's Tecentriq (atezolizumab) in bladder cancer. These two trials could release interim results in H2/19. "Positive efficacy data from any of the studies mentioned above could drive the valuation of the company meaningfully higher from the current level," he wrote.

H.C. Wainwright has a Buy rating and a $13 per share price target on Inovio, whose stock is trading now at around $3.45 per share.


1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
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Disclosures from H.C. Wainwright & Co., Inovio Pharmaceuticals Inc., Company Update, May 17, 2019

Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.

I, Raghuram Selvaraju, Ph.D. and Yi Chen, Ph.D. CFA, certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst's household has a financial interest in the securities of Inovio Pharmaceuticals, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of April 30, 2019 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Inovio Pharmaceuticals, Inc.

Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The Firm or its affiliates did receive compensation from Inovio Pharmaceuticals, Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Inovio Pharmaceuticals, Inc. during the past 12 months.

The Firm does not make a market in Inovio Pharmaceuticals, Inc. as of the date of this research report.

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