Immix Receives FDA Authorization to Expand Clinical Trial

Immix Biopharma announced it received a letter from the FDA authorizing it to proceed with expanding its phase 1b/2a clinical trial of IMX-110 to the United States under an IND. IMX-110 is a first-in-class combination therapy designed to inhibit cancer resistance and evolvability while inducing apoptosis.

To-date, interim readouts from the phase 1b/2a trial in Australia are 100% CBR / DCR for all patients who completed the 5th cohort and at least 2 cycles, as scheduled - with the longest duration of response being 8-months of stable disease. No treatment-related serious adverse events have been observed to-date in any cohorts and dose escalation is continuing.

"We were quite surprised and incredibly happy to see real clinical benefits of the drug at such an early stage in the trial. We are excited to explore the extent of this drug's potential as we progress with dose escalation and approach the expected optimal therapeutic dose of the drug," Immix's Interim Medical Director and CEO Ilya Rachman, MD, PhD said.

At present, Immix is finalizing selection of US clinical sites that will participate in this Phase 1b/2a multinational trial for advanced solid tumors.

Immix is also opening a call for investigator initiated studies where the company will provide its lead compound IMX-110 at no charge and is expanding its Series A financing to add more patients to the ongoing phase 1b/2a study.

IMX-110 contains NF-kB/Stat3/pan-kinase inhibitor curcumin combined with a small amount of doxorubicin encased in a nano-sized delivery system for optimal tumor penetration. The nanoparticle is tunable in that it can be bound to various targeting moieties, allowing it to deliver even more payload to tumors or other cell populations of interest, if needed. IMX-110 showed preclinical efficacy in glioblastoma, multiple myeloma, triple-negative breast, colorectal, ovarian, and pancreatic tumor models — with the mechanism of action being a 5x increase in cancer cell apoptosis compared to doxorubicin alone, and a wholesale shift in the tumor microenvironment post administration.

-----------------------------------------------------------------------
Editor's Note:

If you have any suggestion to the content, 

please email: Julia.Zhang@ubmsinoexpo.com