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'An incredible opportunity'

Like David against Goliath, Roswell Park Cancer Institute (RPCI) spinout Mimivax LLC is seeking to take down one of the most common and aggressive forms of primary brain cancer, and interim findings from its U.S. multicenter phase II study suggest the Buffalo, N.Y.-based company may have a shot. Key Interim results of Survaxm, its survivin peptide mimic immunotherapeutic vaccine, showed that 91 percent of patients with newly diagnosed glioblastoma multiforme (nGBM) who received the treatment in combination with standard of care achieved 12-month overall survival (OS) compared to 61 percent historical standard of care. In addition, 96 percent achieved six-month progression-free survival (PFS) on the Survaxm regimen compared to 54 percent historical standard of care.

The transnational Lazarus tale of Provenge (sipuleucel-T), a pioneering cellular immunotherapy from Dendreon Pharmaceuticals LLC, is opening what could be a significant new chapter with the initiation of a trial designed to prove the treatment can halt prostate cancer progression, reducing or delaying the need for definitive therapies such as surgery and radiation. Expected to begin enrolling later this year, top-line data from the study are due by 2023.

Amicus word due in three months

With the countdown continuing to the Aug. 13 PDUFA date for Amicus Therapeutics Inc.'s migalastat in Fabry disease, Idorsia Ltd. has enrolled its first patient in a phase III registration study investigating the oral monotherapy lucerastat in that indication as well.

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