A New Era in Cancer Treatment: Targeted Solutions for Invasive Cancers

Introduction

Invasive cancers pose one of the most formidable challenges in modern medicine. Traditional treatments often involve aggressive therapies that target not only cancer cells but healthy tissue as well, leading to debilitating side effects. Our breakthrough composition and method offer a more refined approach—one that targets the cancer while minimizing damage to surrounding healthy cells.

The Challenge

Treating invasive cancers effectively without causing excessive harm to the patient has long been the goal of oncology. Current treatments like chemotherapy and radiation often come with severe side effects, as they cannot differentiate between cancerous and healthy cells. What’s needed is a more precise solution that aggressively combats cancer while minimizing collateral damage.

The Solution

Our innovative approach centers on a composition that specifically targets invasive cancer cells, disrupting their growth and survival mechanisms. This targeted therapy is designed to hone in on cancerous cells with remarkable accuracy, reducing the impact on healthy tissue. By utilizing this method, patients experience fewer side effects while receiving potent cancer-fighting treatment.

Why This Matters

  1. Precision Targeting: This method offers a highly targeted approach to cancer treatment, focusing on invasive cancer cells while sparing healthy ones. This precision helps reduce side effects, improving patient outcomes and quality of life during treatment.
  2. Versatile Application: The composition is adaptable for various types of invasive cancers, making it a versatile addition to any oncologist’s arsenal. Whether dealing with aggressive forms of lung, breast, or gastrointestinal cancers, this method provides a focused treatment option.
  3. Potential for Combination Therapies: This innovation doesn’t just stand alone—it can be integrated into existing treatment regimens, working synergistically with chemotherapy, radiation, or immunotherapy. This flexibility allows oncologists to customize treatment plans for maximum efficacy.

Why License This Technology?

By licensing this technology, you are embracing the future of oncology. This breakthrough offers your company the ability to deliver cutting-edge, targeted cancer therapies that will not only improve patient outcomes but also reduce the side effects that often accompany cancer treatments. Offering a solution that is both effective and patient-friendly can set you apart in the competitive field of cancer treatment.

The Opportunity

The fight against invasive cancer is one of the most urgent battles in healthcare. By licensing this composition and method, you can be part of the next generation of cancer treatment, offering hope and improved care to millions of patients. Step into the future of oncology and help redefine how invasive cancers are treated, with a focus on precision, safety, and efficacy.

Embodiments of the instant disclosure relate to novel methods and compositions for distinguishing high-grade ductal carcinoma in situ (DCIS) from lower-grade DCIS in a breast tissue. Other embodiments of the instant disclosure provide for methods of administering one or more appropriate breast cancer treatment regimens to a subject diagnosed with high-risk DCIS.

The invention claimed is:

1. A method of detecting ductal carcinoma in situ (DCIS) at risk of disease progression in a subject, the method comprising:

detecting in a tissue sample obtained from a subject diagnosed with DCIS the presence of one or more ion channels localized (i) at the plasma membrane in one or more cells of the tissue sample and (ii) in the cytoplasm and/or the nucleus of the one or more cells of the tissue sample; and
identifying the DCIS as having a high likelihood of becoming an invasive DCIS or an invasive breast cancer when the one or more ion channels are enriched at the plasma membrane, or
identifying the DCIS as having a low likelihood of becoming an invasive DCIS or an invasive breast cancer when the one or more ion channels are not enriched at the plasma membrane; and
using the identification of the DCIS as having a high likelihood of becoming invasive DCIS or an invasive breast cancer to treat the subject, wherein treating comprises administering to the subject chemotherapy, radiation, and/or a targeted therapy, surgically removing breast tissue from the subject, or a combination thereof.
2. The method of claim 1, wherein the one or more ion channels is ATP1A1.
3. The method of claim 1, further comprising: obtaining the tissue sample from the subject.
4. The method of claim 1, wherein detecting the presence of the one or more ion channels localized at the plasma membrane in the one or more cells of the tissue sample comprises detecting the presence of at least two ion channels localized at the plasma membrane in the one or more cells of the tissue sample.

5. The method of claim 1, further comprising calculating an invasiveness risk score

(i) by quantifying in the tissue sample the fraction of DCIS cells that have the presence of the one or more ion channels enriched at the plasma membrane, or
(ii) by quantitatively assessing in the tissue sample the level of the one or more ion channels enriched at the plasma membrane in each positive DCIS cell,
wherein a higher fraction or higher level correlates with a high invasiveness risk score.
6. The method of claim 5, wherein the quantitatively assessing the level of the one or more ion channels enriched at the plasma membrane in each positive DCIS cell comprises using a multivariate prediction model to determine whether a pattern of plasma membrane localization of the one or more ion channels is indicative of DCIS having a high likelihood of becoming invasive.
7. The method of claim 3, wherein the tissue sample is a breast tissue sample.
8. The method of claim 1, wherein detecting the presence of the one or more ion channels localized at the plasma membrane, in the cytoplasm, and/or in the nucleus comprises using immunohistochemistry, immunocytochemistry, or flow cytometry.
9. The method of claim 1, wherein detecting the presence of the one or more ion channels localized at the plasma membrane, in the cytoplasm, and/or in the nucleus comprises using antibodies or antibody fragments having binding specificity for the one or more ion channels.
10. The method of claim 9, wherein the antibodies or antibody fragments comprise a detectable label, and wherein the detectable label comprises a fluorescent marker, an enzyme, a small molecule, a contrast agent, or a second antibody.
11. The method of claim 1, further comprising confirming the presence of one or more ion channels localized at the plasma membrane by colocalization with at least one invariant control marker present at the plasma membrane.
12. The method of claim 11, wherein the at least one invariant control marker is the transferrin receptor.
13. The method of claim 1, wherein prior to the detecting step, the subject had been diagnosed with DCIS by calcification detected by mammography.
14. The method of claim 1, further comprising comparing the level of detection of the one or more ion channels at the plasma membrane to the level of detection of the one or more ion channels in the cytoplasm and/or in the nucleus.
15. The method of claim 1, further comprising confirming the presence of one or more ion channels localized in the cytoplasm and/or the nucleus by colocalization with an invariant control marker present in the cytoplasm and/or the nucleus.

16. A method of treating a subject having ductal carcinoma in situ (DCIS) at risk of disease progression, the method comprising:

identifying the DCIS as having a high likelihood of becoming an invasive DCIS or an invasive breast cancer by detecting in a tissue sample obtained from a subject the enrichment of one or more ion channels localized at the plasma membrane in one or more cells of the tissue sample, and
treating the subject by administering to the subject chemotherapy, radiation, and/or a targeted therapy, surgically removing breast tissue, or any combination thereof.
17. The method according to claim 16, wherein the one or more ion channels is ATP1A1.

18. The method according to claim 16, wherein identifying the DCIS as having a high likelihood of becoming an invasive DCIS or an invasive breast cancer comprises

detecting in a tissue sample obtained from the subject diagnosed with DCIS the presence of the one or more ion channels localized (i) at the plasma membrane in the one or more cells of the tissue sample and (ii) in the cytoplasm and/or the nucleus of the one or more cells of the tissue sample; and
comparing the level of detection of the one or more ion channels at the plasma membrane to the level of detection of the one or more ion channels in the cytoplasm and/or in the nucleus,
wherein when the one or more ion channels are enriched at the plasma membrane, the DCIS is identified as having a high likelihood of becoming an invasive DCIS or an invasive breast cancer.
19. The method of claim 10, wherein the second antibody comprises a detectable label, and wherein the detectable label comprises a fluorescent marker, an enzyme, a small molecule, or a contrast agent.

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Title

Compositions and methods for treatment of invasive cancers

Inventor(s)

Inhee Chung

Assignee(s)

George Washington University

Patent #

12013398

Patent Date

June 18, 2024

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