TICKERS: INO

Biotech Releases Initial Zika Vaccine Trial Results; Advances Combo Trials

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With multiple candidates in the pipeline advancing through clinical trials, Ram Selvaraju, an analyst with H.C. Wainwright & Co., provided insight into developments at a biotech addressing Zika virus, advanced bladder cancer and cervical dysplasia.

In an Oct. 6 research note, Selvaraju reported that the New England Journal of Medicine published the results from Inovio Pharmaceuticals Inc.'s (INO:NASDAQ) "first Phase 1 trial in humans of DNA-based Zika vaccine (GLS-5700)."

Selvaraju concluded the trial outcomes "demonstrate GLS-5700's potential efficacy in preventing Zika virus infection in humans together with a solid safety profile and bode well for the potential data readout from the second human trial around mid-2018."

In this Phase 1 study, 20 subjects received 1 mg and 20 subjects received 2 mg of GLS-5700 intradermally, Selvaraju wrote. The vaccine "induced high levels of binding antibodies in all participants after a three-dose vaccination regimen at 14 weeks," he noted, adding "neutralizing antibodies developed in 62% of the samples on Vero-cell assay."

Further, the analyst wrote, "On neuronal-cell assay, there was 90% inhibition of Zika virus infection in 70% of the serum samples and 50% inhibition in 95% of the samples. No serious adverse events were observed."

Inovio's second trial involving its Zika vaccine, another Phase 1 study (ZIKA-002), is already underway. Enrollment of 160 adults in Puerto Rico is complete. "This is a randomized, placebo-controlled, double-blind trial with 80 subjects receiving vaccine and 80 receiving placebo, designed to explore a potential trend toward clinical efficacy," Selvaraju explained.

In an Oct. 17 research report, Selvaraju commented on the initiation of a "Phase 1b/2 immuno-oncology trial in advanced bladder cancer" with a combination of INO-5401, INO-9012 and Tecentriq, produced by Genentech/Roche Holding AG (RHHBY:OTCQX).

"Approximately 80 patients with advanced unresectable or metastatic urothelial carcinoma (UC) are slated to be enrolled, the majority of whom would have previously received and failed to respond to an anti-PD-1 or PD-L1 checkpoint inhibitor alone," Selvaraju wrote. "The combination of checkpoint inhibition and [Inovio's] T cell activation could improve the response rate in this patient group, who have limited treatment options."

The analyst also noted that, "If T cell activators can indeed deliver a synergistic therapeutic effect with checkpoint inhibitors, this could immensely improve clinical outcomes by prolonging survival in patients with metastatic disease, in our view."

Near term for Inovio, another of its drug candidates, VGX-3100 for treatment of cervical dysplasia, is in enrollment for the Phase 3 REVEAL 1 trial, which is expected to begin in Q4/17. "Each study is slated to enroll 198 patients in over 100 centers globally," wrote Selvaraju.

H.C. Wainwright reiterates its Buy rating and $13 per share price target on Inovio, whose stock is currently trading at around $6.25 per share.

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Disclosure:
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.
2) Tracy Salcedo contributed to 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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