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The dream is dead

Posted on 12 months ago by Gerry Kennedy

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Roche ($ROG) and Inovio Pharmaceuticals ($INO) had hoped to develop immunotherapies to treat prostate cancer and hepatitis B when they first partnered in 2013. But now that dream is officially dead as Roche has returned the second of two candidates and discontinued its partnership with Inovio.

Inovio slipped about 8% in early trading on the news to give it a market cap of about $700 million.

Inovio just returned rights to INO-1800 to treat HBV, which is currently in an ongoing 30-site, Phase I study in the U.S. and Asia. The company expects to continue with the trial with enrollment to be completed during the first half of next year, with results to follow in the second half.

The trial is testing INO-1800, which targets HBV antigens, alone and in combination with INO-9112, an IL-12-based immune activator. The study has completed interim safety reviews with a “favorable” profile; immunology analyses are slated to begin after enrollment completion.

“While we acknowledge Roche’s strategic decision in the area of hepatitis B, we are optimistic that our potent immunotherapy platform will make a difference in this globally important chronic viral infection, similar to what we have demonstrated in HPV-related disease,” said Inovio President and CEO Dr. J. Joseph Kim in a statement. “Inovio was already managing the Phase 1 clinical trial so the study will continue on track without disruption.”       

Roche had already returned the other compound from the 2013 deal, INO-5150, to treat prostate cancer. Inovio also opted to advance that candidate, which targets prostate-specific membrane antigen (PSMA) and prostate-specific antigen (PSA), in a Phase I trial.

The original preclinical deal paid Inovio an upfront of $10 million, it also included preclinical R&D support as well as development and commercial milestones worth up to $412.5 million—most, or all, of which were not achieved.

Inovio’s most advanced program is for VGX-3100 to treat cervical dysplasia, which completed a Phase II trial in 2014 and is slated to start Phase III testing. It’s intended to treat pre-cancers and cancers caused by human papillomavirus (HPV); it targets the E6 and E7 proteins of HPV types 16 and 18.

The immunotherapy company’s most prominent partner now is AstraZeneca’s ($AZN) MedImmune business. Last year, Inovio partnered with MedImmune to gain rights to INO-3112, another HPV immunotherapy for HPV types 16 and 18 that is in clinical testing for cervical as well head and neck cancers.

The MedImmune deal included a $27.5 million upfront as well as up to $700 million in development and commercial milestones. The pharma assumed all development costs and agreed to pay up to a double-digit tiered royalty on INO-3112 sales.

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