- Thinly traded nano cap ImmunoCellular Therapeutics (OTCPK:IMUC) is up 17% premarket on modestly higher volume in response to its announcement that the FDA has approved its request to modify the protocol in its Phase 3 clinical trial assessing lead product candidate ICT-107 in newly diagnosed glioblastoma. The key change will allow patients to be randomized 30 days after the start of screening procedures, accelerating the time to randomization by ~two months. Currently, the estimated final data collection date for the primary endpoint of overall survival is December 2019.
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ICT-107 is an autologous dendritic cell immunotherapeutic that targets six different antigens associated with glioblastoma. It is designed for use following surgical tumor resection of newly diagnosed glioblastoma in combination with radiotherapy and chemotherapy.
- The company also announces the successful completion of the first milestone for its Stem-to-T-cell program, the sequencing of a selected T cell receptor (TCR) gene. When placed into a blood stem cell, the TCR gene should enhance the immune system to produce killer T cells to attack tumor cells.
- Management will provide more details on both developments later this month during the Q4 conference call.