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Immuno-Oncology candidate yields 'impressive' early clinical results

Streetwise Reports, Streetwise Reports
0 Comments| December 7, 2017

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"Initial results from ten evaluable patients in the DPX-Survivac plus 100 mg epacadostat dosing cohort demonstrate a disease control rate of 70%, including partial responses (PR, defined as ≥30% decrease in tumor lesion size) in 30% of the patients (three out of ten)," a Dec. 5 press release from Immunovaccine Inc. (IMV:TSX; IMMVF:OTCQX) stated.

DPX-Survivac is being used "in combination with Incyte Corp. (INCY:NASDAQ) IDO1 enzyme inhibitor epacadostat, and low-dose cyclophosphamide" in a Phase 1b study in advanced ovarian cancer, the company explained. The candidate employs the DepoVax drug-delivery technology, and has fast-track status from the FDA "as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication," Immunovaccine noted.

In addition, Immunovaccine relayed the Phase 1b safety results: "To date, the combination also exhibited a well-tolerated safety profile, with the majority of adverse events (AEs) reported as Grade 1 and Grade 2, and only one potential treatment-related AE."

Andre Uddin of Mackie Research, in a Dec. 5 research report, noted, "of the ten ovarian cancer patients that completed the treatment with DPX-Survivac plus 100 mg Epacadostat, 3 had partial responses and 4 had stable diseases—yielding an impressive objective response rate."

The Mackie analyst went on to state, "The newly announced positive top-line results should justify the combined use of DPX-Survivac and Epacadostat in treating recurrent ovarian cancer and should help facilitate a licensing deal." Uddin also noted Mackie's belief that "immunotherapy agents that improve the rates of durable remission and/or have activity against chemo-resistant disease are likely to be highly sought after by big pharma."

Mackie rates Immunovaccine a speculative buy with a price target of $2.80 per share (up from $2.20). Shares currently trade at around $1.79.

In his Dec. 5 research report, Douglas Loe of Echelon Wealth Partners wrote that while it's still "early days" for the DPX-Survivac therapy, "encouraging signals that the immune therapy works as expected in ovarian cancer are already available." His company increased its one-year price target to $3.25 per share from $2.75, and maintains a speculative buy rating.

The Immunovaccine trial data indicated T-cell activation, which prompted this comment from Loe: "Importantly, we were encouraged to see that antigen-specific T-cell activation was apparent in the majority of treated patients, and with magnitude of T-cell response correlating well with magnitude of tumor regression."

In addition, Loe noted: "We cannot read Incyte's mind, but we see ample justification for locking in economic interests in DPX-Survivac, perhaps once Phase I/II ovarian cancer testing concludes by mid-F2018."

Loe also commented on the number of milestones on the horizon, including a second Phase 1/2 trial in ovarian cancer, a Phase 1/2 trial "combining DPX-Survivac with Keytruda/pembrolizumab," also in ovarian cancer, a Phase 1/2 trial in HPV-related cancer, and trials of DPX-RSV, also formulated using Immunovaccine's DepoVax delivery platform, in respiratory syncytial virus.

"Individuals with recurrent ovarian cancer, in particular, have not yet benefited from immunotherapy treatment breakthroughs in the way that those with other hard-to-treat cancers have," said CEO Frederic Ors in the company's announcement. "We are excited by the potential of DPX-Survivac to increase the number of individuals who may benefit from novel combination immunotherapies, and look forward to our continued work with Incyte and our other partners to increase the treatment options for such patients."



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