About the Phase 1/2 Study of IGV-001 in Glioblastoma

Glioblastoma remains among the most challenging tumors to treat, and only a few therapeutic options have shown success. Deric Park, MD, neuro-oncologist at John Theurer Cancer Center, Hackensack University Medical Center, is among one of the researchers investigating a novel therapy, IGV-001, for glioblastoma.

IGV-001 is an autologous cell immunotherapy with antisense oligonucleotide targeting IGF-1R. In the phase 1b study, IGV-001 was well tolerated and showed multiple efficacy signals were observed. Now, a phase 2 study (NCT04485949) is further assessing overall and progression-free survival in glioblastoma with IGV-001.

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0:05 | So as for recurrent disease through relapsed glioblastomas, because initial diagnosis, the standard of care is radiation, along with chemotherapy, followed by chemotherapy. But most patients relapse within several months, unfortunately. So this IMVAX study, we shipped the cells to company, then radiating the cells. That was something that FDA really wanted. The company initially was not [wanting] because the biofilm chamber that put the cells in is too small for the for tumor cells to escape. But nevertheless, FDA kind of mandated the radiation.

0:40 | What the cells are, what they're inserting the cells is, it's called antisense oligonucleotide. These are, it's a chemical that's very similar to RNA. So it's blocking a particular type of signaling mechanism called on insulin growth factor receptor against that. And the idea is that by blocking this, you could stimulate the immune system to go after. The most important data for any phase 1 trial is safety. Phase 0, phase 1, phase 2, 3, 4; phase 1 is really safety, the feasibility, what are the potential toxicities and it all deemed to be safe? So that's what we're looking for the phase 2.