Cellics Therapeutics, Inc., a biotech startup company using the innovative Cellular Nanoparticle (CNP) Technology for the treatment and prevention of infectious and inflammatory diseases, announced today that the U.S. Food and Drug Administration (FDA) has allowed the Investigational New Drug (IND) application for its lead drug product CTI-005, Human Red Blood Cell Nanosponges, for patients hospitalized with methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-sensitive Staphylococcus aureus (MSSA) pneumonia. With the IND allowance, the company plans to start the clinical trial, which will be a multicenter, randomized, double-blind, placebo-controlled Phase 1b/2a trial investigating the safety and potential efficacy of CTI-005 in MRSA and MSSA pneumonia patients.
CTI-005 are nanoparticles made of human red blood cell membranes. Leveraging the natural receptors on the red blood cell membranes, CTI-005 can neutralize toxins secreted by MRSA or MSSA bacteria and thus enable the innate human immune system to kill the bacteria. This anti-virulence approach for the treatment of bacterial infection may overcome the drug resistance problem of traditional antibiotics and be especially effective against antibiotic-resistant bacteria such as MRSA as shown by the significant survival benefits in the preclinical pharmacology study of this IND.
“This IND allowance is an important milestone for Cellics Therapeutics and also for the CNP Technology. The CNP Technology creates a new therapeutic modality, Cellular Nanosponge, which uses human cell membranes as drug substance to treat infectious diseases and inflammatory diseases. As the same cell membrane drug substance can be made into different formulations and the same formulation can be applied to treat different diseases, the allowance of this first IND can also facilitate the IND allowance of other indications in the pipeline. It also validates the CNP technology as a clinically viable technology,” said Cellics Founder and the CNP technology inventor Dr. Liangfang Zhang.
Besides Red Blood Cell Nanosponge, Cellics is also developing Macrophage Nanosponge for the treatment of inflammatory and autoimmune diseases. In particular, Macrophage Nanosponge for the treatment of bacterial sepsis is supported by the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) for up to $15 Million.
In addition to creating Cellular Nanosponges for disease treatment, the CNP technology has also been shown as a versatile and effective drug delivery system for the delivery of small molecules and biologics such as mRNA and siRNA.
About Cellics Therapeutics
Cellics Therapeutics, Inc. is a privately held biopharmaceutical company founded by UC San Diego Professor Liangfang Zhang based on his award-winning Cellular Nanoparticle Platform Technology. Cellics was created with the goal of applying this innovative platform technology to treat and prevent serious diseases with high unmet medical needs. The Company’s primary focus is on inflammatory and autoimmune diseases and difficult-to-treat infectious diseases. Cellics also aims to develop best-in-class vaccines for various diseases.
About Cellular Nanoparticle (CNP) Platform Technology
Cellics’ proprietary core technology, the Cellular Nanoparticle (CNP) Platform Technology, was invented by Dr. Liangfang Zhang, the Joan and Irwin Jacobs Chancellor Professor at UC San Diego and the Scientific Founder of Cellics. This technology strips cell membranes from wild-type or engineered human cells, creates nanoparticles, and uses them as therapeutic products or drug delivery vehicles. By leveraging different cell membranes and functional proteins that can be expressed on the cell membranes, the CNP technology can achieve different therapeutic or vaccination results and drug delivery goals. Without any drug loading in its nanoparticle core and using cell membranes as drug substance, the CNP technology can create Cellular Nanosponges, which leverage surface protein receptors on the cell membranes to absorb and neutralize toxins, inflammatory cytokines, and viruses that attack human cells. Loading drugs into its nanoparticle core, the CNP technology can be used to significantly improve targeted delivery and intracellular delivery, extend circulation half-life, and increase overall delivery efficiency for small molecules or biologics drugs. For mRNA delivery, CNP coated with engineered cell membranes has been shown to significantly increase endosomal escape efficiency and overall delivery efficiency of mRNA molecules. Proof of Concept studies have been done for many different indications.
Cellics Therapeutics, Inc.