Local delivery of antineoplastic particles in combination with systemic delivery of immunotherapeutic agents for the treatment of cancer
Inventors
diZerega, Gere S. • BALTEZOR, Michael • Campbell, Sam • DECEDUE, Charles J. • MCCLOREY, Matthew
Assignees
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Publication Number
US-11583499-B2
Publication Date
2023-02-21
Expiration Date
Abstract
Disclosed are combination therapy methods useful for the therapeutic treatment of cancer by combining local administration of compositions containing antineoplastic particles, such as taxane particles, with systemic administration of compositions containing immunotherapeutic agents. Local administration methods include topical application, pulmonary administration, intratumoral injection, intraperitoneal injection, and intracystic injection.
Core Innovation
The invention relates to treating cancer in a subject by administering a first composition comprising taxane particles directly into a solid tumor by intratumoral injection. The taxane particles comprise paclitaxel particles, docetaxel particles, cabazitaxel particles, or combinations thereof, and comprise at least 95% of the taxane, with a specific surface area (SSA) of at least 18 m2/g and a mean particle size (number) of from 0.1 microns to 5 microns.
The method additionally includes systemically administering a second composition comprising an immunotherapeutic agent. The immunotherapeutic agent comprises an immune checkpoint inhibitor, and the steps of intratumoral taxane-particle administration and systemic immune checkpoint inhibitor administration can be conducted in any order or at the same time.
The document describes local particle residence and immune activation as local adjuvants to enhance systemic immunotherapy. It also indicates an intent to reduce systemic taxane exposure and associated toxicity while improving treatment outcomes.
Claims Coverage
The independent claim coverage combines intratumoral administration of defined taxane particles into a solid tumor with systemic administration of an immune checkpoint inhibitor, and the steps may be performed in any order or at the same time. The claim features include the taxane identity, at least 95% taxane content, SSA of at least 18 m2/g, and mean particle size of 0.1 to 5 microns.
Intratumoral administration of defined taxane particles into a solid tumor
Administering a first composition comprising taxane particles directly into a solid tumor of the subject by intratumoral injection, wherein the taxane particles comprise paclitaxel particles, docetaxel particles, cabazitaxel particles, or combinations thereof, and comprise at least 95% of the taxane.
Taxane particles with defined surface area and particle size
The taxane particles have a specific surface area (SSA) of at least 18 m2/g and a mean particle size (number) of from 0.1 microns to 5 microns.
Systemic administration of an immune checkpoint inhibitor
Systemically administering a second composition comprising an immunotherapeutic agent to the subject, wherein the immunotherapeutic agent comprises an immune checkpoint inhibitor.
Any order or simultaneous intratumoral and systemic administration
Treating the cancer wherein steps (a) and (b) can be conducted in any order or at the same time.
The core inventive concept is the combination of intratumoral injection of defined taxane particles with systemic administration of an immune checkpoint inhibitor, with the two steps able to occur in any order or simultaneously.
Stated Advantages
Enhances systemic immunotherapy through local adjuvant action of local particle residence and immune activation.
Reduces systemic taxane exposure and associated toxicity.
Documented Applications
Treating cancer in a subject using intratumoral injection of taxane particles into a solid tumor combined with systemic administration of an immunotherapeutic agent comprising an immune checkpoint inhibitor.
Specific immune checkpoint inhibitor examples described include pembrolizumab and nivolumab.
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