Pharmaceutical composition, preparation and uses thereof
Inventors
Pottier, Agnès • Levy, Laurent • Meyre, Marie-Edith • DARMON, AUDREY • Germain, Matthieu
Assignees
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Publication Number
US-11357724-B2
Publication Date
2022-06-14
Expiration Date
Abstract
The present invention relates to a pharmaceutical composition comprising the combination of (i) a biocompatible nanoparticle and of (ii) a pharmaceutical compound of interest, to be administered to a subject in need of such a compound of interest, wherein the nanoparticle potentiates the compound of interest efficiency. The longest dimension of the biocompatible nanoparticle is typically between about 4 and about 500 nm, and its absolute surface charge value is of at least 10 mV (|10 mV|). The invention also relates to such a composition for use for administering the compound of interest to a subject in need thereof, wherein the nanoparticle and the compound of interest are to be administered to said subject between more than 5 minutes and about 72 hours from each other.
Core Innovation
The invention relates to a method comprising intravenously administering a pharmaceutical compound of interest and a distinct biocompatible nanoparticle to a subject in need thereof. The biocompatible nanoparticle has a longest dimension between about 4 nm and about 500 nm, and the surface charge value is a negative charge below −10 mV. The biocompatible nanoparticle is an organic nanoparticle free of an additional therapeutic, prophylactic or diagnostic agent.
The biocompatible nanoparticle is intravenously administered to the subject between more than 5 minutes and about 72 hours before the pharmaceutical compound of interest, with a refinement in some embodiments to about 24 hours before. The combined intravenous administration maintains the therapeutic benefit of the compound of interest with reduced toxicity, or increases the therapeutic benefit with equivalent or reduced toxicity, when compared to therapeutic benefit and toxicity induced by the standard therapeutic dose.
In additional embodiments, the method includes maintenance of therapeutic/prophylactic/diagnostic benefit while reducing or not increasing toxicity, and enables at least about 10% dose reduction versus a standard dose. The described nanoparticle characteristics include size measurement and surface charge characterization, including coatings and biocompatible coatings such as PEG.
Claims Coverage
The independent claim describes a two-step intravenous co-administration regimen using a biocompatible organic nanoparticle with specified size and negative surface charge, administered within a specified pre-dosing time window. The claim set includes inventive feature refinements that tighten timing, surface-charge thresholds, and define options for nanoparticle and compound types, while also supporting a dose-reduction outcome tied to maintained or increased therapeutic benefit with reduced or equivalent toxicity.
Intravenous nanoparticle pre-dosing window
Administering the biocompatible nanoparticle intravenously to the subject between more than 5 minutes and about 72 hours before the pharmaceutical compound of interest, with a refinement to about 24 hours before administering the pharmaceutical compound of interest.
Biocompatible organic nanoparticle with defined size range
The longest dimension of the biocompatible nanoparticle is between about 4 nm and about 500 nm, and the biocompatible nanoparticle is an organic nanoparticle free of an additional therapeutic, prophylactic or diagnostic agent.
Negative surface charge below −10 mV
The surface charge value of the biocompatible nanoparticle is a negative charge below −10 mV.
Maintains therapeutic benefit with reduced toxicity or increases benefit with equivalent or reduced toxicity
The combined intravenous administration of the biocompatible nanoparticle and the compound of interest maintains the therapeutic benefit of the compound of interest with reduced toxicity, or increases the therapeutic benefit of the compound of interest with equivalent or reduced toxicity for the subject when compared to therapeutic benefit and toxicity induced by the standard therapeutic dose of said compound of interest.
Dose reduction of at least 10% versus standard therapeutic dose
A reduction of at least 10% of the administered compound therapeutic dose versus the standard therapeutic dose while maintaining the same therapeutic benefit with equivalent or reduced toxicity, or increasing therapeutic benefit with equivalent or reduced toxicity.
Nanoparticle selected from specified nanoparticle categories
The nanoparticle is selected from a lipid-based nanoparticle, a protein-based nanoparticle, a polymer-based nanoparticle, a copolymer-based nanoparticle, a carbon-based nanoparticle, and a virus-like nanoparticle.
Compound of interest selected from antibody, oligonucleotide, and synthesized peptide
The compound of interest is selected from an antibody, an oligonucleotide, and a synthesized peptide.
Across the independent claim and its refinements, the core inventive concept is a specifically constrained intravenous pre-dosing strategy using an organic biocompatible nanoparticle characterized by a defined size range and negative surface charge below −10 mV. The stated objective is to maintain therapeutic benefit with reduced toxicity or increase therapeutic benefit with equivalent or reduced toxicity versus a standard therapeutic dose.
Stated Advantages
Maintains the therapeutic benefit of the compound of interest with reduced toxicity.
Increases the therapeutic benefit of the compound of interest with equivalent or reduced toxicity.
Enables at least about 10% dose reduction versus a standard dose while maintaining therapeutic benefit with equivalent or reduced toxicity, or increasing therapeutic benefit with equivalent or reduced toxicity.
Documented Applications
In vivo tumor-growth delay in an MDA-MB-231 xenograft model, with tumor re-growth delay, using charged liposome nanoparticles with Dox-NP® (liposomal doxorubicin), where the nanoparticle was given about 4 hours prior.
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