COMPOSITION AND METHOD FOR THE TREATMENT OF CANCER USING COMBINATION THERAPY WITH NANOPARTICLES

Abstract

COMPOSITION AND METHOD FOR THE TREATMENT OF CANCER USING COMBINATION THERAPY WITH NANOPARTICLES ABSTRACT The present invention provides a composition and method for the treatment of cancer using a combination therapy involving nanoparticles. The composition comprises nanoparticles functionalized with targeting ligands for tumor-specific delivery, encapsulating both chemotherapeutic and immunotherapeutic agents. Upon administration, the nanoparticles accumulate at the tumor site and release the agents in a controlled manner, enhancing cancer cell apoptosis while activating the immune system. The method offers improved therapeutic efficacy, reduced toxicity, and a synergistic anti-cancer effect by combining chemotherapy and immunotherapy in a targeted, sustained-release nanoparticle delivery system.

Specification

Description:COMPOSITION AND METHOD FOR THE TREATMENT OF CANCER USING COMBINATION THERAPY WITH NANOPARTICLES

FIELD OF THE INVENTION

The present invention relates to the field of cancer therapy. Specifically, it pertains to a composition and method for treating cancer using a combination of therapeutic agents in conjunction with nanoparticles to enhance the delivery and efficacy of treatment while minimizing adverse side effects.

BACKGROUND OF THE INVENTION

Cancer remains one of the leading causes of death worldwide, with current treatment methods often involving surgery, chemotherapy, radiation, and immunotherapy. While these treatments can be effective, they are often associated with significant side effects, low specificity to cancer cells, and the development of drug resistance. Chemotherapy agents, for example, lack the ability to selectively target cancer cells, leading to damage of healthy tissues and organs, which results in severe toxicities.
Nanotechnology has emerged as a promising approach to address some of these challenges. Nanoparticles (NPs), by virtue of their small size, can be engineered to improve the pharmacokinetics and biodistribution of therapeutic agents. NPs can encapsulate drugs, allowing for targeted delivery to tumor cells while sparing normal tissue, thus reducing systemic toxicity. In recent studies, nanoparticles have demonstrated enhanced permeability and retention (EPR) effects, which allow them to accumulate preferentially in tumor tissue. Additionally, nanoparticles can be functionalized with ligands to further enhance targeting specificity, leading to improved therapeutic outcomes.
Despite the advances in nanoparticle-mediated therapy, there remains a need for the development of combination therapy approaches that leverage the benefits of nanoparticles while also utilizing other therapeutic modalities. The present invention addresses these needs by proposing a novel composition and method that combines nanoparticles with multiple therapeutic agents, such as chemotherapy drugs and immune-modulating compounds, for the effective treatment of cancer.

SUMMARY OF THE INVENTION

In an embodiment, the present invention provides a composition and method for treating cancer by administering a combination of nanoparticles and therapeutic agents, which may include chemotherapy drugs, immunotherapeutic agents, and targeted therapies. The nanoparticles serve as carriers for these agents, allowing for enhanced delivery to cancer cells with minimal off-target effects.
The composition includes nanoparticles functionalized with targeting ligands to bind specifically to receptors overexpressed on cancer cells. Encapsulated within these nanoparticles are one or more chemotherapeutic agents and immunotherapeutic compounds. The nanoparticles are designed to release these therapeutic agents in a controlled manner, providing sustained drug exposure to the tumor microenvironment.
The method involves administering the composition to a patient in need of cancer treatment, where the nanoparticles selectively accumulate in the tumor site, release the encapsulated agents, and exert a synergistic anti-cancer effect through the combined mechanisms of chemotherapy and immune activation. The combination therapy enhances tumor cell apoptosis, inhibits angiogenesis, and activates an immune response to further target residual cancer cells.


BRIEF DESCRIPTION OF THE FIGURES

The accompanying figures where like reference numerals refer to identical or functionally similar elements throughout the separate views and which together with the detailed description below are incorporated in and form part of the specification, serve to further illustrate various embodiments and to explain various principles and advantages all in accordance with the invention.
The accompanying figure illustrates the method of treatment, showing the targeted delivery of the nanoparticle composition to a tumor site. The figure depicts:
1. The nanoparticles carrying the therapeutic agents through the bloodstream.
2. Accumulation of nanoparticles in the tumor tissue via the enhanced permeability and retention (EPR) effect.
3. Release of the encapsulated agents within the tumor, showing chemotherapy-induced cancer cell death and immune activation.

DETAILED DESCRIPTION OF THE INVENTION

While various embodiments of the invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions may occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed. It shall be understood that different aspects of the invention can be appreciated individually, collectively, or in combination with each other.
In an embodiment, the nanoparticles used in the composition are biodegradable and biocompatible, ensuring safe degradation and clearance from the body after therapeutic action. Materials such as poly(lactic-co-glycolic acid) (PLGA), liposomes, and gold nanoparticles are preferred for constructing the nanoparticles.
Each nanoparticle is functionalized with targeting ligands, such as antibodies or peptides, designed to recognize specific cancer cell surface markers, such as HER2, EGFR, or PSMA, depending on the type of cancer being treated. This targeted delivery system enhances the specificity of drug delivery to the tumor site, minimizing the impact on healthy cells.
The therapeutic agents encapsulated in the nanoparticles can include, but are not limited to, doxorubicin, paclitaxel, cisplatin, and immune checkpoint inhibitors like anti-PD-1 or anti-CTLA-4 antibodies. The combination of chemotherapy and immunotherapy within the nanoparticles creates a dual mechanism of action, attacking the tumor cells directly while activating the immune system to recognize and eliminate residual cancer cells.
The method of treatment involves administering the nanoparticle composition via intravenous injection or other suitable delivery routes. Upon administration, the nanoparticles circulate through the bloodstream and preferentially accumulate at the tumor site due to the EPR effect. Once localized, the nanoparticles release their therapeutic cargo in a controlled manner, ensuring sustained therapeutic action over time.
The combination therapy has been shown to reduce tumor size more effectively than monotherapy approaches. By using nanoparticles as carriers, the therapy also reduces the systemic toxicity commonly associated with conventional chemotherapy, leading to improved patient outcomes and quality of life.
Embodiment 1: Multi-Functional Nanoparticles for Simultaneous Imaging and Therapy
In an embodiment, the nanoparticles described in the invention are designed not only for therapeutic delivery but also for diagnostic imaging. These multi-functional nanoparticles can be loaded with contrast agents, such as superparamagnetic iron oxide nanoparticles (SPIONs) for magnetic resonance imaging (MRI) or quantum dots for fluorescence imaging. This embodiment allows for real-time monitoring of nanoparticle distribution, accumulation at the tumor site, and the effectiveness of the treatment. The integration of both therapeutic and diagnostic functions within a single nanoparticle system, often referred to as "theranostics," improves personalized cancer treatment by enabling clinicians to assess the drug delivery in real-time and adjust the therapeutic strategy accordingly.
Embodiment 2: pH-Responsive Nanoparticles for Enhanced Drug Release
In an alternative embodiment, the nanoparticles are engineered to release their therapeutic payload in response to the acidic microenvironment of tumors. Tumor tissues often exhibit a lower pH compared to normal tissues due to increased glycolysis and hypoxia. The nanoparticles in this embodiment are designed to remain stable at physiological pH (7.4) but undergo structural changes at acidic pH levels (around 6.5 or lower), leading to the rapid release of encapsulated drugs. This pH-responsive design ensures that drug release is highly localized within the tumor site, further minimizing systemic toxicity and enhancing therapeutic efficacy. The chemotherapeutic agent, encapsulated within these nanoparticles, is released when the nanoparticles reach the acidic tumor microenvironment, providing a targeted, on-demand treatment.
Embodiment 3: Temperature-Sensitive Nanoparticles for Controlled Hyperthermia Therapy
In another embodiment, the nanoparticles are formulated to be temperature-sensitive, such that they release their therapeutic cargo upon exposure to elevated temperatures. This embodiment can be used in conjunction with hyperthermia therapy, a treatment modality that involves raising the temperature of the tumor tissue to enhance drug sensitivity and improve immune response. The nanoparticles remain inert at normal body temperature (37°C) but release their encapsulated drugs when the temperature is increased to 42°C or higher in the tumor region. This approach allows for synergistic cancer treatment, as hyperthermia enhances the cytotoxic effects of chemotherapy and the immune response induced by immunotherapy, while the nanoparticles provide localized drug delivery.
Embodiment 4: Ligand-Functionalized Nanoparticles for Multi-Targeting
In this embodiment, the nanoparticles are functionalized with multiple ligands targeting different receptors overexpressed on cancer cells. For example, a single nanoparticle could be conjugated with ligands for both HER2 and EGFR receptors, which are commonly overexpressed in certain types of breast and lung cancers. This multi-targeting strategy allows the nanoparticles to recognize and bind to a broader population of tumor cells, increasing the likelihood of successful drug delivery to heterogeneous tumors. Such an approach is especially useful in treating cancers with a high degree of molecular diversity or tumors that have developed resistance to single-target therapies.
Embodiment 5: Use of Nanoparticles in Combination with Radiation Therapy
In another embodiment, the nanoparticle composition is used in conjunction with radiation therapy to enhance cancer treatment. Nanoparticles containing radiosensitizing agents, such as gold nanoparticles, are introduced into the body. These nanoparticles preferentially accumulate in the tumor and increase the tumor cells' sensitivity to radiation by generating reactive oxygen species (ROS) upon exposure to ionizing radiation. The combination of radiation therapy and nanoparticle-mediated drug delivery leads to a more potent cytotoxic effect on cancer cells, reducing the required radiation dose and minimizing damage to healthy tissues.

Advantages of the Invention
• Targeted Drug Delivery: The use of nanoparticles functionalized with targeting ligands allows for the specific delivery of therapeutic agents to cancer cells, reducing off-target effects.
• Controlled Drug Release: Nanoparticles enable controlled and sustained release of therapeutic agents, increasing drug efficacy and reducing the frequency of administration.
• Combination Therapy Synergy: The combination of chemotherapy and immunotherapy in a single nanoparticle system enhances the overall anti-tumor effect, leading to improved treatment outcomes.
• Reduced Toxicity: By limiting drug exposure to non-cancerous tissues, the method minimizes the adverse side effects commonly associated with traditional cancer treatments.
, Claims:I/WE CLAIM:
Claim 1
A method for treating cancer, comprising:
administering to a subject a composition comprising nanoparticles functionalized with targeting ligands;
said nanoparticles encapsulating at least one chemotherapeutic agent and one immunotherapeutic agent,
wherein the nanoparticles accumulate at a tumor site and release the encapsulated agents in a controlled manner,
thereby exerting a combined therapeutic effect on the tumor.
Claim 2: The method of claim 1, wherein the nanoparticles are composed of poly(lactic-co-glycolic acid) (PLGA).
Claim 3: The method of claim 1, wherein the targeting ligands are antibodies specific to HER2 receptors.
Claim 4: The method of claim 1, wherein the chemotherapeutic agent is doxorubicin.
Claim 5: The method of claim 1, wherein the immunotherapeutic agent is anti-PD-1 antibody.
Claim 6: The method of claim 1, wherein the nanoparticles are administered intravenously.
Claim 7: The method of claim 1, wherein the nanoparticles exhibit enhanced permeability and retention (EPR) at the tumor site.
Claim 8: The method of claim 1, wherein the nanoparticles release the encapsulated agents in a sustained manner over a period of 24 to 72 hours.
Claim 9: The method of claim 1, wherein the treatment inhibits angiogenesis in the tumor microenvironment.

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