Le Lézard
Classified in: Health
Subjects: TRI, FDA

Immix Receives FDA Authorization to Expand Clinical Trial under US IND


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.

About IMX-110
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.

Media Contact
Ryan Witt
+1 (888) 958-1084
info@immixbio.com

 

SOURCE Immix Biopharma, Inc.


These press releases may also interest you

at 16:12
SummaryProducts: Cetrotide 0.25mg Issue: One lot of Cetrotide 0.25mg is being recalled because some vials may have missing stoppers, which could make the product unsterile. What to do: Check the lot number on your product or contact your pharmacist...

at 12:00
In lieu of an in-person update to the media, Dr. Theresa Tam, Canada's Chief Public Health Officer, issued the following statement today: "There have been 105,091 cases of COVID-19 in Canada, including 8,663 deaths. 65% of people have now recovered....

at 11:00
The latest data of the evolution of COVID-19 in Québec reveal 102 new cases over the past 24 hours, bringing the total number of people infected to 55,784. During the same period, 3 new deaths were recorded, to which are added 3 deaths that occurred...

at 10:37
On Friday, the British government announced that, as of July 10th, those travelling from the Commonwealth of Dominica to England need not self-isolate for 14 days. Dominica is one of the 59 countries and 14 British Overseas Territories forming a...

at 03:05
Gilead Sciences, Inc. today announced data from an ongoing Phase 1 study, which showed that a sustained-delivery subcutaneous formulation of the company's investigational, novel inhibitor of HIV-1 capsid function, lenacapavir (GS-6207), sustained...

at 03:05
Gilead Sciences, Inc. today announced data demonstrating the safety and efficacy of the once-daily, single tablet regimen Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in virologically suppressed...



News published on 23 july 2019 at 20:45 and distributed by: