This “P53 Antigen Modulators - Pipeline Insight, 2024” report provides comprehensive insights about 7+ companies and 8+ pipeline drugs in P53 Antigen Modulators pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Pidnarulex: Senhwa Biosciences Pidnarulex (CX-5461) is a first-in-class small molecule inhibitor of RNA polymerase I (Pol I) that triggers the nucleolar stress surveillance pathways to activate p53, without causing direct DNA damage. It is a synthetically derived small molecule, is supplied as a lyophilized drug with intravenous (IV) administration. The drug is in Phase II clinical studies for the treatment of breast cancer, ovarian cancer; and in Phase I clinical studies to treat hematological malignancies and prostatecancer.
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Geography Covered
- Global coverage
P53 Antigen Modulators Understanding
P53 Antigen Modulators: Overview
p53 is an important tumor-suppressor protein that is altered in most cancers. The p53 protein acts as a pivotal suppressor of inappropriate cell proliferation. By initiating suppressive effects through induction of apoptosis, cell senescence, or transient cell-cycle arrest, p53 plays an important role in cancer suppression, developmental regulation, and aging. Loss or mutation of p53 in the tumor has been shown to modulate immune recognition through mechanisms such as decreased MHC-I presentation and increased recruitment of suppressive myeloid cells and Tregs. However, p53 also has a crucial role in the stromal compartment, where it can play diverse roles in inhibiting or supporting tumor development. A number of p53 modulators, consisting of synthetic peptides, organic compounds, and natural products, have been identified that directly or indirectly restore p53 functions and reverse progression of preneoplastic lesions and uncontrolled tumor growth. The mechanism(s) of action of these p53 modulators is being extensively investigated.Report Highlights
The companies and academics are working to assess challenges and seek opportunities that could influence P53 Antigen Modulators R&D. The therapies under development are focused on novel approaches for P53 Antigen Modulators.P53 Antigen Modulators Emerging Drugs Chapters
This segment of the P53 Antigen Modulators report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.P53 Antigen Modulators Emerging Drugs
Eprenetapopt: Aprea Eprenetapopt, also known as APR-246, is an investigational, first-in-class mutant p53 reactivator. Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the European Commission for MDS, AML and ovarian cancer. The drug is in Phase III clinical studies for the treatment of myelodysplastic syndromes; in Phase II clinical studies to treat acute myeloid leukemia; and in Phase I clinical studies to treat chronic lymphocytic leukemia, mantle-cell lymphoma, non-small cell lung cancer, gastric cancer, and bladdercancer.Pidnarulex: Senhwa Biosciences Pidnarulex (CX-5461) is a first-in-class small molecule inhibitor of RNA polymerase I (Pol I) that triggers the nucleolar stress surveillance pathways to activate p53, without causing direct DNA damage. It is a synthetically derived small molecule, is supplied as a lyophilized drug with intravenous (IV) administration. The drug is in Phase II clinical studies for the treatment of breast cancer, ovarian cancer; and in Phase I clinical studies to treat hematological malignancies and prostatecancer.
P53 Antigen Modulators: Therapeutic Assessment
This segment of the report provides insights about the different P53 Antigen Modulators drugs segregated based on following parameters that define the scope of the report, such as:Major Players working on P53 Antigen Modulators
There are approx. 7+ key companies which are developing the P53 Antigen Modulators. The companies which have their P53 Antigen Modulators drug candidates in the most advanced stage, i.e. Phase III include, Aprea.Phases
This report covers around 8+ products under different phases of clinical development like- Late-stage products (Phase III and
- Mid-stage products (Phase II and
- Early-stage products (Phase I/II and Phase I) along with the details of
- Pre-clinical and Discovery stage candidates
- Discontinued & Inactive candidates
Route of Administration
P53 Antigen Modulators pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as- Infusion
- Intradermal
- Intramuscular
- Intranasal
- Intravaginal
- Oral
- Parenteral
- Subcutaneous
- Topical
Molecule Type
Products have been categorized under various Molecule types such as
- Vaccines
- Monoclonal Antibody
- Peptides
- Polymer
- Small molecule
Product Type
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.P53 Antigen Modulators: Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase III, II, I, preclinical and discovery stage. It also analyses P53 Antigen Modulators therapeutic drugs key players involved in developing key drugs.Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging P53 Antigen Modulators drugs.P53 Antigen Modulators Report Insights
- P53 Antigen Modulators Pipeline Analysis
- Therapeutic Assessment
- Unmet Needs
- Impact of Drugs
P53 Antigen Modulators Report Assessment
- Pipeline Product Profiles
- Therapeutic Assessment
- Pipeline Assessment
- Inactive drugs assessment
- Unmet Needs
Key Questions
Current Scenario and Emerging Therapies:- How many companies are developing P53 Antigen Modulators drugs?
- How many P53 Antigen Modulators drugs are developed by each company?
- How many emerging drugs are in mid-stage, and late-stage of development for P53 Antigen Modulators?
- What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the P53 Antigen Modulators therapeutics?
- What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for P53 Antigen Modulators and their status?
- What are the key designations that have been granted to the emerging drugs?
Key Players
- Aprea
- Quark-Pharmaceuticals
- Shenzhen Si BionoGeneTech
- H. Lee Moffitt Cancer Center and Research Institute
- Statera BioPharma
- Senhwa Biosciences
- PMV Pharmaceuticals
Key Products
- Eprenetapopt
- Teprasiran
- p53 gene therapy
- INGN 225
- APR-548
- CBL 137
- Pidnarulex
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Table of Contents
IntroductionExecutive SummaryP53 Antigen Modulators - Analytical PerspectiveDrug profiles in the detailed report…..Drug profiles in the detailed report…..Drug profiles in the detailed report…..Drug profiles in the detailed report…..P53 Antigen Modulators Key CompaniesP53 Antigen Modulators Key ProductsP53 Antigen Modulators- Unmet NeedsP53 Antigen Modulators- Market Drivers and BarriersP53 Antigen Modulators- Future Perspectives and ConclusionP53 Antigen Modulators Analyst ViewsP53 Antigen Modulators Key CompaniesAppendix
P53 Antigen Modulators: Overview
Pipeline Therapeutics
Therapeutic Assessment
In-depth Commercial Assessment
P53 Antigen Modulators Collaboration Deals
Late Stage Products (Phase III)
Eprenetapopt: Aprea
Mid Stage Products (Phase II)
Pidnarulex: Senhwa Biosciences
Early Stage Products (Phase I)
APR-548: Aprea
Pre-clinical and Discovery Stage Products
Drug name: Company name
Inactive Products
List of Tables
List of Figures
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Aprea
- Quark-Pharmaceuticals
- Shenzhen SiBiono GeneTech
- H. Lee Moffitt Cancer Center and Research Institute
- Statera BioPharma
- Senhwa Biosciences
- PMV Pharmaceuticals