Toll-like receptor 9 (TLR-9) Modulator - Pipeline Insight, 2025

DelveInsight’s, “Toll-like receptor 9 (TLR-9) Modulator - Pipeline Insight, 2025,” report provides comprehensive insights about 18+ companies and 18+ pipeline drugs in Toll-like receptor 9 (TLR-9) Modulator 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.

Geography Covered

• Global coverage

Toll-like receptor 9 (TLR-9) Modulator Understanding

Toll-like receptor 9 (TLR-9) Modulator: Overview

Toll-like Receptors (TLRs) are a type of pattern recognition receptor (PRR) that recognizes pathogen-associated molecular patterns to identify invading microorganisms (PAMPs). TLRs trigger a signaling cascade in response to PAMP engagement, which results in the generation of inflammatory mediators. TLR location, whether on the plasma membrane or in the endolysosomal compartment, has long been thought to be a key factor in determining which ligands the receptors bind to and which transduction pathways are activated. However, new observations have challenged this view by identifying complex trafficking events that occur upon TLR-ligand binding. These findings have highlighted the central role that endocytosis and receptor trafficking play in the regulation of the innate immune response. TLR-9 has the smallest tissue distribution of all the TLRs. It is only expressed on B cells and plasmacytoid dendritic cells in resting human immune cells. TLR-9 is detected in neutrophils, monocytes, and T lymphocytes after they have been activated. TLR-9 is activated by non-methylated CG motifs from nucleotide sequences. In bacterial and viral genomes, non-methylated CG motifs are common, but they are rare in human DNA.

""Toll-like receptor 9 (TLR-9) Modulator - Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Toll-like receptor 9 (TLR-9) Modulator pipeline landscape is provided which includes the disease overview and Toll-like receptor 9 (TLR-9) Modulator treatment guidelines. The assessment part of the report embraces, in depth Toll-like receptor 9 (TLR-9) Modulator 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, Toll-like receptor 9 (TLR-9) Modulator collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• A better understanding of disease pathogenesis contributing to the development of novel therapeutics for Toll-like receptor 9 (TLR-9) Modulator.
• In the coming years, the Toll-like receptor 9 (TLR-9) Modulator market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies and academics that are working to assess challenges and seek opportunities that could influence Toll-like receptor 9 (TLR-9) Modulator R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• A detailed portfolio of major pharma players who are involved in fueling the Toll-like receptor 9 (TLR-9) Modulator treatment market. Several potential therapies for Toll-like receptor 9 (TLR-9) Modulator are under investigation. With the expected launch of these emerging therapies, it is expected that there will be a significant impact on the Toll-like receptor 9 (TLR-9) Modulator market size in the coming years.
• Our in-depth analysis of the pipeline assets (in early-stage, mid-stage and late stage of development for the treatment of Toll-like receptor 9 (TLR-9) Modulator) includes therapeutic assessment and comparative analysis. This will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Toll-like receptor 9 (TLR-9) Modulator Emerging Drugs Chapters

This segment of the Toll-like receptor 9 (TLR-9) Modulator report encloses its detailed analysis of various drugs in different stages of clinical development, including phase 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.

Toll-like receptor 9 (TLR-9) Modulator Emerging Drugs

• Cobitolimod: InDex Pharmaceuticals

Cobitolimod is a new type of drug that can help patients with moderate to severe ulcerative colitis back to a normal life. It is a so-called Toll-like receptor 9 (TLR9) agonist that can provide an anti‐inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis. Cobitolimod has achieved clinical proof-of-concept in moderate to severe active ulcerative colitis, with a very favorable safety profile. Data from four placebo-controlled clinical trials indicate that cobitolimod has statistically significant effects on those endpoints that are most relevant in this disease, both from a regulatory and clinical perspective. These endpoints include the key clinical symptoms such as blood in stool, number of stools, and mucosal healing, respectively. Cobitolimod is also known as Kappaproct® and DIMS0150.

• Tilsotolimod: Idera Pharmaceuticals

Tilsotolimod (IMO-2125) is a synthetic phosphorothioate oligonucleotide that acts as a direct agonist of TLR9 to stimulate the innate and adaptive immune systems. Intratumoral injection of tilsotolimod has been shown to promote both innate (Type-I IFN, antigen presentation) and adaptive (T cells) immune activation. Tumors with an active immune response appear to respond better to checkpoint inhibitors (CPIs) than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may increase the number of patients who benefit from immunotherapy.

• Vidutolimod: Checkmate Pharmaceuticals

Vidutolimod is an immune activator that stimulates T cells to attack tumors. It is a non-infectious, biologic virus-like particle (VLP) containing CpG-A DNA. Vidutolimod works by two complementary mechanisms that together have a unique ability to drive a strong systemic anti-tumor T cell response. First, the VLP activates an immune response to the VLP, leading to the production of antibodies that deliver the VLP into plasmacytoid dendritic cells (pDC) and other immune cells via specialized receptors called FcR. This provides an initial stimulatory signal to pDC and brings the CpG-A to TLR9 (the receptor for CpG DNA) inside the (pDC). Second, CpG-A stimulates TLR9 in a manner that induces significantly higher levels of type I interferons (IFN-α and others) in pDC resulting in a stronger anti-tumor T cell response, as compared to other innate immune activators. When activated by vidutolimod by this combination of signals, pDC recruit and coordinate a variety of other immune cells, culminating in the generation of a strong anti-tumor T cell response. Vidutolimod is given in combination therapy with a PD-1 checkpoint inhibitor, which blocks the PD-1 checkpoint on the anti-tumor T cells, so that these can attack the tumor unsuppressed.

• ELI 002: Elicio Therapeutics

ELI-002 is a structurally novel AMP therapeutic vaccine targeting KRAS-driven cancers. KRAS mutations are among the most prevalent in human cancers. ELI-002 is comprised of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified immune-stimulatory oligonucleotide adjuvant. Elico Therapeutics is currently enrolling patients in AMPLIFY-201, a Phase I/II clinical trial of ELI-002 in patients with solid tumors, including colorectal cancer, or CRC, or pancreatic ductal adenocarcinoma, or PDAC. The AMPLIFY-201 trial is being conducted at multiple sites, including US cancer treatment institutions such as MD Anderson, Memorial Sloan Kettering, Sarah Cannon Research Institute, Washington University St. Louis, and Henry Ford Health System.

• CO-sTiRNA: Scopus BioPharma

Scopus BioPharma licensed gene therapy, CO-sTiRNA (DUET-01), is a dual-action STAT3 inhibitor. STAT3 is a gene that drives tumor cell growth and anti-tumor immune suppression. CO-sTiRNA is a highly selective and targeted gene therapy that silences the activity of the STAT3 gene by way of RNA interference. CO-sTiRNA also stimulates TLR9 receptors to activate the body’s immune defense to recognize and kill cancer cells.

Further product details are provided in the report……..

Toll-like receptor 9 (TLR-9) Modulator: Therapeutic Assessment

This segment of the report provides insights about the different Toll-like receptor 9 (TLR-9) Modulator drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Toll-like receptor 9 (TLR-9) Modulator

There are approx. 18+ key companies which are developing the therapies for Toll-like receptor 9 (TLR-9) Modulator. The companies which have their Toll-like receptor 9 (TLR-9) Modulator drug candidates in the most advanced stage, i.e. phase III include InDex Pharmaceuticals.

• Phases

DelveInsight’s report covers around 18+ 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

Toll-like receptor 9 (TLR-9) Modulator pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intratumoral
• Intravenous
• Rectal
• Subcutaneous
• Molecule Type

Products have been categorized under various Molecule types such as

• Antibodies
• Gene therapy
• Immunoconjugate
• Immunotherapy
• NA
• Oligodeoxyribonucleotides
• Oligonucleotide
• Small molecule
• Vaccine
• Product Type

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

Toll-like receptor 9 (TLR-9) Modulator: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Toll-like receptor 9 (TLR-9) Modulator 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 Toll-like receptor 9 (TLR-9) Modulator drugs.

Toll-like receptor 9 (TLR-9) Modulator Report Insights

• Toll-like receptor 9 (TLR-9) Modulator Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Toll-like receptor 9 (TLR-9) Modulator 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 Toll-like receptor 9 (TLR-9) Modulator drugs?
• How many Toll-like receptor 9 (TLR-9) Modulator drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Toll-like receptor 9 (TLR-9) Modulator?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Toll-like receptor 9 (TLR-9) Modulator 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 Toll-like receptor 9 (TLR-9) Modulator and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Idera Pharmaceuticals
• Checkmate Pharmaceuticals
• TriSalus Life Sciences
• Zucero Therapeutics
• Gilead Sciences
• Elicio Therapeutics
• Scopus BioPharma
• Tallac Therapeutics
• Bright Path Bio therapeutics
• LIDDS
• NapaJen Pharma
• GeneLeap Biotech
• Neuropore Therapies
• Statera Therapeutics

Key Products

• Cobitolimod
• Tilsotolimod
• Vidutolimod
• SD 101
• Pixatimod
• Lefitolimod
• ELI 002
• CO-sTiRNA
• TAC 001
• BP 1401
• IDX-9054
• NZ-TLR9
• IDX9059

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