Novel cancer therapy
Unmet medical needs
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1st generation chemotherapy
- Cell proliferation inhibition
- Harmful to normal cells
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2nd generation targeted cancer therapy
- Target specific protein
- Resistance originated from target mutation
- Applicable for limited patients
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3rd generation immunotherapy for cancer
- Immune function enhancement
- Limited efficacy to ~20% of patients (Cold tumor)
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Next generation cancer therapy
- Expendable target disease
- Convenience of administration
- Cold tumor > Hot tumor
Over the long time, anticancer agents have evolved through three generations. 1st generation chemotherapy drugs were used to inhibit the proliferation of cancer cells. However, due to their toxicity to not only cancer cells but also normal cells, they often caused side effects such as vomiting, fatigue, hair loss, severe pain, and decreased stamina.
Subsequently, 2nd generation targeted anticancer agents emerged. Unlike first-generation agents, they selectively attack cancer cells, but they had limited applicability as they only showed effectiveness in patients with specific target, and a resistance during the treatment could render them ineffective.
3rd generation anticancer agents are immunotherapeutics that activate a patient’s immune system to eliminate cancer cells. With their novel mechanism of action, they overcome the limitations of the first and second generation anticancer therapeutics, making them applicable to a wide range of cancer types without significant side effects. However, when applied in practice, immunotherapeutics showed limited efficacy in only up to 20% of the patient population. For solid tumors, the immune system activation was hindered as immunotherapeutics could not penetrate the tumor effectively, resulting in a lack of response. This type of tumors are called as ‘cold tumor’.
INEXOPLAT, through its proprietary drug substance, transforms “cold tumors,” where the immune system is suppressed, into “hot tumors” with activated immune cells, inducing a robust immune response against cancer cells. By developing the next-generation anticancer agents that expand the application to solid tumors that conventional immunotherapeutics couldn’t cure, INEXOPLAT is committed to addressing unmet medical needs and pushing the boundaries of cancer research.
Tumor
microenvironment,
TME
![](https://inexoplat.com/wp-content/uploads/2023/07/tumor-en.png)
Cancer cells regulate the surrounding tissue/cell environment to facilitate tumor growth, which is defined as the Tumor Microenvironment (TME). Indicators of TME include the infiltration or activation level of immune cells, types of immune-related factors, oxygenation levels, Extracellular Matrix (ECM) remodeling, pH, and more.
In cold tumors, solid tumors with weakened immune systems, there is an abundance of M2 macrophages that suppress immune responses, and the function of T cells is impaired. Additionally, the TME is characterized by hypoxia and low pH, creating an environment that is difficult for external immune cells to infiltrate. As a result, cancer cells in cold tumors evade immune surveillance, leading to rapid growth or metastasis.
In contrast, hot tumors have an activated immune response with the presence of M1 macrophages, dendritic cells, and activated T cells in the TME. This forms conditions that can maximize the efficacy of immunotherapy, as immune cells are targeted towards cancer cells and can lead to the elimination of tumor cells. Therefore, converting cold tumors into hot tumors, where the immune system is activated, is considered the key to the next-generation of immunotherapies for effective cancer treatment.
Exosome
![](http://inexoplat.mycafe24.com/wp-content/uploads/2023/06/exosome.jpg)
Exosomes are extracellular vesicles derived from the endosomes of cells. They are very small, ranging in size from 30 to 200 nanometers, and are composed of a lipid bilayer structure similar with that of cells. Being secreted from cells, exosomes contain various cellular materials, including nucleic acids, proteins, enzymes, and other molecules, depending on the cell type they originate from. As a result, exosomes can exhibit similar functions to their parent cells, and it is speculated that they are generated for cell-to-cell communication and other purposes. Due to their secretion by most cells, exosomes can be found in various body fluids such as blood, saliva, urine, breast milk and tears, etc. They are typically purified from cell culture media for use.
Exosomes are gaining attention as novel drug delivery vehicles because of their stability and non-toxic nature within the body, originating from cells. When drugs are encapsulated within exosomes, they can be protected, ensuring drug stability, and may experience increased half-lives. Additionally, through modulation of the cell membrane’s proteins, exosomes can potentially achieve high delivery rates to target cells.
Process
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① Master Cell Bank
(MCB) -
② Bioreactor
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③ Filtration
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④ 1st purification
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⑤ 2nd purification
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⑥ DS/DP
Development
strategy
INEXOPLAT is conducting the development of exosome-based new drugs with a primary goal of commercialization, led by a team of biopharmaceutical development experts with EMA/FDA approval experience. From the early stages of research and development, INEXOPLAT has been focusing on CMC (Chemistry, Manufacturing, and Controls) and quality-based exosome drug development. With a distinct advantage of CQR, INEXOPLAT possesses competitive edges compared to other companies in terms of indication expansion, development speed, and product commercialization.