Roche Signs Up To $422.5M Collaboration With Inovio

Roche and Inovio Pharmaceuticals said today they formed an up-to-$422.5 million partnership to develop and commercialize the latter's multi-antigen DNA vaccines INO-5150 targeting prostate cancer and INO-1800 targeting hepatitis B. Roche also agreed to license Inovio's Cellectra® electroporation vaccine delivery technology, and obtained an option to license additional vaccines that may result from the companies' oncology research collaboration.

In return, Roche will pay Inovio $10 million up front and up to $412.5 million in preclinical R&D support, as well as payments tied to both short-term regulatory milestones and longer-range development and commercial milestones, all undisclosed.

Inovio would receive up to double-digit tiered royalties on product sales, and could also see additional development milestone payments if Roche opts to pursue other indications for INO-5150 or INO-1800.

INO-5150 targets prostate-specific membrane antigen (PSMA) as well as prostate-specific antigen (PSA). A study in monkeys showed that vaccination with INO-5150 generated strong and robust T-cell immune responses that were the highest generated by a PSA-based immunotherapy in animal studies.

"INO-5150 will allow promising combination opportunities with the Roche portfolio, particularly with our emerging cancer immunotherapy molecules," Hy Levitsky, head of cancer immunology experimental medicine at Roche, said in a statement.

That portfolio includes the anti-PDL1 antibody MPDL3280A, an investigational drug designed to make cancer cells more vulnerable to the body's own immune system by interfering with the protein programmed death-ligand 1 (PD-L1). Based on promising earlier studies, Roche and Genentech are recruiting patients for five studies studies investigating MPDL3280A, accordnig to clinicaltrials.gov posts last updated September 4:

• Two Phase II studies of MPDL3280A in patients with non-small cell lung cancer-;one with the drug candidate alone, one comparing it to docetaxel.
• A Phase I study combining the drug candidate with Zelboraf (vemurafenib) in patients with previously untreated BRAFV600-mutation-positive metastatic melanoma.
• A Phase I study combining the drug candidate with Avastin (bevacizumab) plus Folfox in patients with advanced solid tumors.
• A Phase I safety, tolerability, and pharmacokinetics study of MPDL3280A given intravenously to patients with locally advanced or metastatic solid malignancies or hematologic malignancies.

Inovio has also reported preclinical data showing INO-1800 for hepatits B-generated strong T-cell and antibody responses leading to the elimination of targeted liver cells in mice. The vaccine-specific T cells, researchers observed, could migrate to and stay in the liver, causing clearance of target cells without evidence of liver injury.

"We are very excited to have this potentially very important and novel mechanism of action as part of our portfolio as we seek to address the significant unmet medical need in chronic hepatitis B infection," added Janet Hammond, head of Roche's infectious diseases discovery and translational area.

J. Joseph Kim, Ph.D., Inovio's president and CEO, said the Roche collaboration will allow the company to rapidly advance the vaccines while continuing development of its own Phase II lead product VGX-3100 for human papillomavirus-related cancers and dysplasia. Inovio says it has completed enrollment in the study, top-line results for which are expected in mid-2014.

The Phase II study is designed to build on the positive outcome of an 18-subject Phase I dose-escalation study of VGX-3011 delivered via Cellectra device. Of all Phase I trial subjects evaluated to date, all study participants reported antibody positivity to at least two vaccine antigens and 78% of the subjects showed T-cell responses to at least one vaccine antigen.

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