MDM2/MDMX Proteins are homologous proteins that act as the primary negative regulators of p53 in humans. p53 is a critical tumor suppressor that is activated by various cellular stresses. p53, upon activation, acts to prevent and repair damages that may lead to tumor development. p53 must be highly regulated as its activation may lead to cellular effects such as cellular arrest and cell death. MDM2 (murine double minute 2) binds and inhibits p53, while MDMX (murine double minute X) has its own roles with p53 but also acts to stabilize MDM2. The duo is thought to be associated with the physiology of many types of cancers, such as Acute Myelogenous Leukemia (AML), Lymphomas, Sarcoma, and others. It has been seen that MDM2 is either amplified or overexpressed in various types of cancers signaling cellular overactivity that may lead to a tumor. Hence, these could act as a biomarker for certain types of cancers as it is believed to be a prognostic biomarker of Brain early-stage low-grade glioma (LLG) cancer. Research is being conducted globally to discover new and novel MDMX/MDM2 Protein molecules that function to regulate the levels of p53 protein to be used as anticancer agents. The development and launch of new products will thus increase the revenue of the market in the forecasted years. According to the American Society of Clinical Oncology 2023 report, AML is the 2nd most common type of leukemia diagnosed in adults and children and accounts for 31% of adult leukemia cases. In 2023, it is estimated that 20,380 people in the USA will be diagnosed with AML.
Several of these inhibitors are on the market, while many are in ongoing clinical trials. Companies have various products in their pipelines, with 53 products in various stages of clinical trials. 4 products in Phase 3, 10 products in Phase 2, and 7 products are in Phase 1 of the clinical trials.
Drugs in Pipeline
- Navtemadlin (KRT-232)
- Idasanutlin (RO5503781)
- Siremadlin (HDM201)
- Eprenetapopt (APR-246)
- Milademetan (RAIN-32)
- Alrizomadlin (APG-115)
- Teprasiran (QPI-1002)
- BI 907828
- RG7112
- ALRN-6924
- Aezea (Cenersen)
- UBX0101
- EP-101 STEMVAC
- PC14586
- MI-773
- MK-8242
- APR-548
- ASTX295
- CGM097
- RG7775
- Serdemetan (JNJ-26854165) CBP-1008
Clinical Activity and Developments of MDM2/MDMX Protein
As of June 2023, companies have approximately 53 products for 537 diseases. For these diseases, many trials are being conducted by players globally. For instance,
- The University of Michigan Rogel Cancer Center is conducting a Phase 2 clinical trial to study the efficacy of a Novel MDM2 Inhibitor (APG-115) in p53 Wild-Type Salivary-gland carcinoma and is expected to complete it by January 2025.
- Kartos Therapeutics, Inc. is conducting a Phase 2 clinical study to evaluate the efficacy and safety of KRT-332 in combination with Acalabrutinib for patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma or Relapsed/Refractory Chronic Lymphocytic Leukemia and is expected to complete by March 2024.
- Kartos Therapeutics, Inc. is conducting a Phase 2 clinical study to evaluate the safety and efficacy of KRT-332 combined with a Tyrosine Kinase Inhibitor in patients with Relapsed or Refractory Ph+ Chronic Myeloid Leukemia (CML).
|
Molecule name |
Number of studies |
|
navtemadlin (KRT-232) |
22 |
|
idasanutlin (RO5503781) |
19 |
|
siremadlin (HDM201) |
15 |
|
eprenetapopt (APR-246) |
13 |
|
milademetan (RAIN-32) |
11 |
Target Indication Analysis of MDM2/MDMX Protein
MDM2/MDM2 Protein complex is said to play a major role as a modulator and negative regulator of p53 protein. It plays a dual function depending upon the environmental condition. In normal conditions, the duo suppresses p53 while in conditions of stress, they themselves are needed to be inhibited for p53 to respond to stress. Globally the prevalence rates of many types of cancers have been increasing for many years, and new therapies are being discovered globally. These are in the clinical trials for various diseases like Sarcomas, Lymphomas, AML, Acute kidney injury, and others. According to the American Cancer Society estimate, about 13,400 new soft tissue sarcomas will be diagnosed in 2023 in the USA. According to a research study, in the UK, every day, 15 people were diagnosed with Sarcoma in 2019, with the count reaching 5300 people per year. Therefore, there is a vast opportunity for the MDM2/MDMX Protein market which is expanding as the new research is being conducted globally.
MDM2/MDMX Protein Regional Analysis
MDM2/MDMX Protein Market
The global prevalence of Chronic Myeloid Leukemia (CML), according to a study in 2022, was in the range of 0.7 to 1.5 per 100,000 people. According to the American Cancer Society, in 2023, it is estimated that about 15% of all new cases of leukemia are Chronic Myeloid Leukemia (CML), and about 1 in every 526 people, which is 8,930 people, will get a CML in his/her lifetime in the USA. The incidence was about 1.1 per 100,000 people in Europe, with 4.0 per 100,000 people aged 75 years and above, according to a research article in 2022. Therefore, there is an opportunity in the MDM2/MDMX Protein market for the players to launch new products across the globe.
Latin America
Europe
Asia Pacific
Middle East
North America
Frequently Asked Questions
No MDM2/MDMX Inhibitors have been approved for the treatment of any disorder as of now by any regulatory authority globally.
These are being used in various indications like Peripheral Neuropathic Pain, Peripheral pain associated with osteoarthritis of the knee and Diabetic Peripheral Neuropathy, and others.
Kartos Therapeutics, Inc (USA), Novartis (Switzerland), Aprea Therapeutics Inc (Sweden), Rain Oncology (USA) and Ascentage Pharma (China) are some of the major market players for MDM2/MDMX Protein.
Rising incidence of diseases improvement in technologies, development of new treatment lines in the market and changing lifestyles leading to Diabetes Mellitus and nerve injuries and associated pain are the key opportunities for MDM2/MDMX Protein in the market.
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- Kartos Therapeutics, Inc (USA)
- Novartis (Switzerland)
- Aprea Therapeutics Inc (Sweden)
- Rain Oncology (USA)
- Ascentage Pharma (China)
- SBI Biotech Co., Ltd (Japan)
- Boehringer Ingelheim (Germany)
- Roche (Switzerland)
- Aileron (USA)
- Eleos Health (Israel)
- Unity Biotechnology (USA)
- EpiThany Inc (California)
- University of Washington (USA)
- PMV Pharmaceuticals Inc (USA)
- Ascenta Therapeutics, Inc (France)
- Sanofi (France)
- Merck (MSD) (USA)