TGF-Beta-1 Inhibitor - Pipeline Insight, 2025

This “TGF-Beta-1 Inhibitor - Pipeline Insight, 2025” report provides comprehensive insights about 8+ companies and 10+ pipeline drugs in TGF-Beta-1 Inhibitor 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.

TGF-Beta-1 Inhibitor: Understanding

TGF-Beta-1 Inhibitor: Overview

TGF-β1, one of the three isoforms of TGF-β (along with TGF-β2 and TGF-β3), plays a crucial role in regulating various biological processes. It is involved in the regulation of cell proliferation and differentiation across various tissues, has immunosuppressive properties influencing immune cell behavior, and is a key mediator in the development of fibrosis in various organs, promoting extracellular matrix production. TGF-β1 inhibitors vary widely in structure depending on their mechanism of action. Small molecule inhibitors typically resemble ATP to compete for the kinase domain of the TGF-β receptor. Monoclonal antibodies are large, protein-based drugs that specifically bind to TGF-β1 ligands or receptors, blocking their interaction. Receptor fusion proteins combine the ligand-binding domain of the TGF-β receptor with the Fc region of an antibody to neutralize TGF-β1. Peptide inhibitors mimic regions of the TGF-β1 receptor or its natural inhibitors, preventing ligand-receptor binding. Aptamers are oligonucleotide or peptide molecules with unique three-dimensional structures that bind to TGF-β1 or its receptor with high specificity and affinity, thereby inhibiting their function.

TGF-β1 inhibitors function by disrupting the TGF-β signaling pathway, which is crucial in various cellular processes and often implicated in cancer and fibrosis. These inhibitors can be categorized into several classes: monoclonal antibodies that bind directly to TGF-β1, small molecule inhibitors that target the TGF-β type I receptor (TβR1) to block its kinase activity, and ligand traps that sequester TGF-β1, preventing it from activating its receptors. For instance, small molecules like galunisertib and vactosertib inhibit the phosphorylation of Smad proteins, which are essential mediators of TGF-β signaling. By preventing TGF-β1 from binding to its receptors or inhibiting the downstream signaling cascades, these inhibitors can reduce tumor growth, enhance immune response, and mitigate fibrotic processes, ultimately aiming to improve therapeutic outcomes in various diseases.

TGF-β1 inhibitors are emerging as promising therapeutic targets due to their potential to modulate the complex roles of TGF-β1 in cancer and fibrosis. TGF-β1 exhibits a dual role, acting as a tumor suppressor in early cancer stages and a promoter of tumor progression in later stages, making it a challenging target. Strategies to inhibit TGF-β1 signaling include monoclonal antibodies, small molecule inhibitors, ligand traps, and antisense oligonucleotides, which aim to block TGF-β1's interaction with its receptors, inhibit downstream signaling pathways, or reduce TGF-β1 expression. Clinical trials have shown that targeting TGF-β1 can enhance anti-tumor immunity and improve the efficacy of existing therapies, although challenges such as adverse effects and the need for careful patient selection remain significant hurdles. Overall, the therapeutic targeting of TGF-β1 holds great promise, especially when used in combination with other treatments to maximize clinical benefits while minimizing risks.

'TGF-Beta-1 Inhibitor- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the TGF-Beta-1 Inhibitor pipeline landscape is provided which includes the disease overview and TGF-Beta-1 Inhibitor treatment guidelines. The assessment part of the report embraces, in depth TGF-Beta-1 Inhibitor commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, TGF-Beta-1 Inhibitor collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence TGF-Beta-1 Inhibitor R&D. The therapies under development are focused on novel approaches to treat/improve TGF-Beta-1 Inhibitor.

TGF-Beta-1 Inhibitor Emerging Drugs Chapters

This segment of the TGF-Beta-1 Inhibitor 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.

TGF-Beta-1 Inhibitor Emerging Drugs

AdAPT-001: EpicentRx

AdAPT-001 represents a novel investigational immunotherapy leveraging a replicative type 5 adenovirus. This adenovirus is equipped with a TGF-β receptor-immunoglobulin Fc fusion trap designed to neutralize TGF-β isoforms 1 and 3, which are implicated in fibrosis, angiogenesis, hypoxia, and immunosuppression within the tumor microenvironment. By targeting these cytokines, AdAPT-001 aims to enhance tumor sensitivity to checkpoint blockade therapies. The combination of AdAPT-001 with checkpoint inhibitors has not only improved toxicity and adverse event profiles compared to checkpoint inhibitors alone but has also demonstrated no dose-limiting toxicities, serious adverse events related to AdAPT-001, or necessary dose reductions thus far. This suggests a potentially safer and more effective treatment strategy for resistant tumors. Currently, the drug is in Phase II stage of its clinical trial.

SRK-181: Scholar Rock

SRK-181 is a selective inhibitor of TGFβ1 activation being developed to overcome primary resistance to checkpoint inhibitor therapy, such as anti-PD-(L)1 antibodies, in advanced cancer. TGFβ1 is the predominant TGFβ isoform expressed in many human tumor types. Based on analyses of various human tumors that are resistant to anti-PD-(L)1 therapy, data suggest that TGFβ1 is a key contributor to the immunosuppressive tumor microenvironment, excluding and preventing entry of cytotoxic T cells into the tumor, thereby inhibiting anti-tumor immunity. (2) SRK-181 specifically targets the latent TGFβ1 isoform in a context-independent manner, designed to enable complete inhibition of TGFβ1 in all compartments within the tumor microenvironment. Scholar Rock believes that SRK-181 has the potential to overcome this immune cell exclusion and induce tumor regression when administered in combination with anti-PD-(L)1 therapy while potentially avoiding toxicities associated with non-selective TGFβ inhibition. Currently, the drug is in Phase I stage of its clinical trial for the treatment of advanced solid tumors.

TGF-Beta-1 Inhibitor: Therapeutic Assessment

This segment of the report provides insights about the different TGF-Beta-1 Inhibitor drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in TGF-Beta-1 Inhibitor

• There are approx. 8+ key companies which are developing the therapies for TGF-Beta-1 Inhibitor. The companies which have their TGF-Beta-1 Inhibitor drug candidates in the most advanced stage, i.e. Phase II include, EpicentRx.

Phases

The report covers around 10+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

TGF-Beta-1 Inhibitor pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

TGF-Beta-1 Inhibitor: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses TGF-Beta-1 Inhibitor 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 TGF-Beta-1 Inhibitor drugs.

TGF-Beta-1 Inhibitor Report Insights

• TGF-Beta-1 Inhibitor Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

TGF-Beta-1 Inhibitor Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing TGF-Beta-1 Inhibitor drugs?
• How many TGF-Beta-1 Inhibitor drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of TGF-Beta-1 Inhibitor?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the TGF-Beta-1 Inhibitor 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 TGF-Beta-1 Inhibitor and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• MedPacto
• EpicentRx
• Sirnaomics
• Scholar Rock
• SiSaf
• Isarna Therapeutics

Key Products

• Vactosertib
• AdAPT-001
• STP707
• SRK-181
• SIS 201 CD
• Research programme: TGF-beta antisense oligonucleotides

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