Immix Cleared to Expand Phase 1/2a Trial of IMX-110 to US Sites

A Phase 1/2a trial testing the advanced solid tumor treatment candidate IMX-110 in Australia has been cleared by the U.S. Food and Drug Administration to enroll participants in the United States. Immix is now selecting the medical centers that will participate in the trial.

Australia is the first country recruiting patients for Immix Biopharma‘s open-label trial (NCT04009681), with enrollment ongoing in Sydney. Information on contacts can be found here.

The study is testing the safety, tolerability, and pharmacokinetics — how the treatment behaves inside the body — of IMX-110 in people with pancreatic, breast, or ovarian cancer, among other solid tumors, whose disease progressed after standard-of-care treatment.

Preliminary results showed that all patients who completed at least two cycles with the highest dose tested to date responded to the treatment without showing any associated adverse events. The patients with the longest response time remained stable for eight months.

“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,” Ilya Rachman, MD, PhD, medical director and CEO at Immix, said in a press release.

IMX-110 is an experimental treatment that combines curcumin — the active ingredient of turmeric — and small amounts of the chemotherapeutic agent doxorubicin. The therapy is delivered in nanoparticles — a small delivery system designed to reach several parts of the tumor.

Curcumin acts synergistically with different chemotherapies, preventing the tumor from becoming resistant to the different treatments and killing the tumor cells at the same time. The nanoparticles can specifically target tumor cells or cells that prevent the body from fighting the tumor.

IMX-110 was effective against glioblastoma, multiple myeloma, pancreatic, colorectal, triple-negative breast, and ovarian cancers in animal models. It caused a reduction in tumor size by increasing tumor cells’ death up to five times that of doxorubicin alone, changing the tumor microenvironment, and increasing the immune response against the tumor.

In addition to the solid tumor trial, Immix is accepting applications for other investigator-initiated studies. The company will provide IMX-110 at no cost to the selected studies.