Immix Receives FDA Authorization to Expand Clinical Trial under US IND
- Immix receives FDA letter activating the IND for IMX-110
- IND will be expanding ongoing phase 1b/2a clinical trial testing lead candidate Imx-110 from Australia to the United States
- Interim readouts from the phase 1b portion of the trial are 100% CBR / DCR (2/2 patients) for patients who completed the 5th cohort dose and at least 2 cycles as scheduled - with the longest duration of response being 8-months of stable disease with no treatment-related adverse events.
- No treatment-related serious adverse events have been observed to-date and dose escalation is continuing.
LOS ANGELES, July 23, 2019 /PRNewswire/ -- Immix Biopharma, Inc--a clinical-stage biopharmaceutical company developing next-generation cancer therapies--announced today that 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.
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.
Immix' Interim Medical Director and CEO Ilya Rachman, MD, PhD noted, "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."
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 is a first-in-class combination therapy designed to inhibit cancer resistance and evolvability while inducing apoptosis. 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.
About the Company
Immix Biopharma, Inc. is a privately-held, biopharmaceutical firm focused on developing safe and effective therapies for cancer patients. The company was founded by Vladimir Torchilin, Ph.D., D.Sc., Director of the Center for Pharmaceutical Biotechnology and Nanomedicine at Northeastern University; physician-scientist and clinical researcher Ilya Rachman, MD, PhD, MBA; and Sean D. Senn, JD, MSc., MBA, a senior biotechnology patent attorney. Immix's founding investor is a family office focused on harnessing scientific advances in order to engineer transformative and effective cancer treatments. For more information visit www.immixbio.com.
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SOURCE Immix Biopharma, Inc.