cd40 agonist pipeline insight

DelveInsight’s, “CD40 Pipeline Insight, 2026” report provides comprehensive insights about 30+ companies and 35+ pipeline drugs in CD40 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

CD40 Understanding

CD40 Overview

Cluster of differentiation 40, CD40 (also known TNFRSF5, Tumor necrosis factor receptor superfamily member 5.) is a costimulatory protein and expresses on antigen presenting cells (APC). In human, CD40 is coded by TNFRSF5 gene and has 7 transcripts. Its ligand, CD154 (CD40L), is a protein that is primarily expressed on activated T cells and is also a member of the TNF superfamily of molecules. 
The CD40 antigen, a 45–50 kDa glycoprotein of 277 amino acids, is a member of the tumor necrosis factor receptor family. The 193 amino acid extracellular domain is composed of four imperfect repeats of approximately 40 residues, anchored by a superimposable pattern of six cysteines. This organization is found in the other members of the superfamily including: the p75 low-affinity nerve growth factor receptor; the p55/CD120a and p75/CD120b receptors for tumor necrosis factor; the receptor (TNF-R rp) for the lymphotoxin α/lymphotoxin β membrane complex; CD27 and CD30; OX40; 4-1-BB/ILA; Fas/CD95; and two viral homologs of the TNF receptors. CD40 is expressed by multiple cell types. In the hematopoietic system, it is expressed on CD34+ hematopoietic progenitors, B cell progenitors, mature B lymphocytes, plasma cells, monocytes, dendritic cells and on some T lymphocytes. CD40 is also expressed on nonhematopoietic cells such as endothelial cells, fibroblasts and epithelial cells. 

Activation of the CD40 pathway triggers multiple intracellular signaling cascades, including NF-κB, MAPK, and PI3K pathways, leading to enhanced cytokine production, antigen presentation, and immune cell proliferation. Through these mechanisms, CD40 serves as a key bridge between T-cell and B-cell responses, promoting effective immune activation. The pathway also contributes to macrophage activation and dendritic cell maturation, thereby strengthening cellular immunity and facilitating coordinated immune responses against pathogens and malignant cells.
Given its central role in immune regulation, dysregulation of CD40 signaling has been implicated in a wide range of autoimmune and inflammatory diseases, including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, and transplant rejection. Excessive CD40-mediated immune activation can drive chronic inflammation and autoantibody production, making the pathway an attractive therapeutic target for immunomodulatory interventions. Consequently, several CD40-targeting agents, including monoclonal antibodies and ligand-blocking therapies, are being investigated for autoimmune disorders and transplantation settings.

In oncology, CD40 agonists are being developed to enhance antitumor immunity by activating antigen-presenting cells and promoting T-cell–mediated immune responses. By improving antigen presentation and stimulating cytotoxic T-cell activity, CD40-targeted therapies have the potential to overcome tumor-induced immune suppression and enhance the efficacy of existing immunotherapies. As a result, the CD40 pathway has emerged as a promising therapeutic target across both immunology and cancer treatment landscapes..

"CD40 Pipeline Insight, 2026" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the CD40 pipeline landscape is provided which includes the disease overview and CD40 treatment guidelines. The assessment part of the report embraces, in depth CD40 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, CD40 collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

CD40 Pipeline Report Highlights 

The companies and academics are working to assess challenges and seek opportunities that could influence CD40 R&D. The therapies under development are focused on novel approaches to treat/improve CD40.

CD40 Emerging Drugs Analysis

This segment of the CD40 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.

CD40 Emerging Drugs

Frexalimab - ImmuNext/Sanofi

Frexalimab (SAR441344) is a first-in-class anti-CD40L monoclonal antibody being developed by Sanofi and Immunext for immune-mediated diseases and transplantation. By selectively blocking the CD40/CD40L co-stimulatory pathway, frexalimab modulates immune activation without depleting immune cells. The therapy is currently in Phase III development for relapsing and non-relapsing secondary progressive multiple sclerosis, and Kidney Transplant Rejection. The drug is also being investigated in Phase II studies for Type 1 Diabetes Mellitus and as part of a combination development program (with rilzabrutinib and brivekimig) for Focal Segmental Glomerulosclerosis (FSGS) and Minimal Change Disease (Lipoid Nephrosis).

Mitazalimab: Alligator Bioscience

Mitazalimab is a novel CD40 agonistic monoclonal antibody being developed by Alligator Bioscience for the treatment of metastatic pancreatic cancer. By activating CD40 on antigen-presenting cells such as dendritic cells, mitazalimab enhances T-cell priming and promotes a tumor-directed immune response. The candidate is currently Phase III-ready, supported by positive results from the Phase II OPTIMIZE-1 trial, in which mitazalimab combined with mFOLFIRINOX demonstrated clinically meaningful survival benefits, including a 24-month survival rate of 29.4%, a median overall survival of 14.9 months, and a confirmed objective response rate of 42.1% in previously untreated patients with metastatic pancreatic cancer.

TNX-1500: Tonix Pharmaceuticals

TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a Phase II ready, humanized monoclonal antibody that interacts with the CD40-ligand (CD40L), also known as CD154. TNX-1500 is being developed for the prevention of kidney transplant rejection and the treatment of autoimmune diseases. Anti-CD40L has multiple potential indications in addition to solid organ and bone marrow transplantation including autoimmune diseases. Collaborations are ongoing with MGH on allo-heart and -kidney transplantation in nonhuman primates, as well as prevention of xenograft rejection, preclinical studies, and prevention of allograft rejection in sensitized patients. The Phase II investigator-initiated study by MGH is expected to initiate enrollment by the second half of 2026, pending the FDA clearance of the IND, to evaluate TNX-1500 in five kidney transplant recipients. The study is designed to assess the safety, tolerability, and activity of TNX-1500 in preventing kidney transplant rejection while decreasing the exposure to conventional immunosuppressive drugs, which are associated with infection, cancer, cardiovascular side effects, and various metabolic derangements with long term use.

NG-350A: Akamis Bio

NG-350A is a clinical-stage, intravenually delivered Tumor-Specific Immuno-Gene (T-SIGn®) therapy being developed by Akamis Bio for the treatment of solid tumors, particularly mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC). NG-350A is engineered to selectively replicate within tumor cells and drive the intratumoral expression of a CD40 agonist monoclonal antibody, leading to activation of antigen-presenting cells and recruitment of T cells to generate a potent anti-tumor immune response. The candidate is currently being evaluated in the Phase Ib FORTRESS trial in combination with chemoradiotherapy for pMMR LARC and has received FDA Fast Track Designation for this indication.

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

CD40 Drug Therapeutic Assessment

This segment of the report provides insights about the different CD40 drugs segregated based on following parameters that define the scope of the report, such as:

Major CD40 Players in CD40

There are approx. 30+ key companies which are developing the therapies for CD40. The companies which have their CD40 drug candidates in the most advanced stage, i.e. phase III include, ImmuNext, Sanofi, and others.

CD40 Clinical Trial Phases

DelveInsight’s report covers around 35+ 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

CD40 Drug Route of Administration

CD40 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
• Intramuscular

CD40 Product Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide

CD40 Product Type

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

CD40 Clinical Trial Activities

The CD40 Pipeline report provides insights into different CD40 Clinical Trial within phase II, I, preclinical and discovery stage. It also analyses CD40 therapeutic drugs key players involved in developing key drugs. 

CD40 Pipeline Development Activities

The CD40 Clinical Trial Analysis report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging CD40 drugs.
 
CD40 Pipeline Report Insights

• CD40 Pipeline Analysis
• CD40 Therapeutic Assessment
• CD40 Unmet Needs
• Impact of CD40 Drugs

CD40 Report Assessment

• CD40 Pipeline Product Profiles
• CD40 Therapeutic Assessment
• CD40 Pipeline Assessment
• CD40 Inactive drugs assessment
• CD40 Market Unmet Needs

Key Questions Answered in the CD40 Pipeline Report

• Current Treatment Scenario and Emerging Therapies:
• How many companies are developing CD40 drugs?
• How many CD40 drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of CD40?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the CD40 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 CD40 and their status?
• What are the key designations that have been granted to the emerging drugs? 

CD40 Key Players

• Sanofi
• ImmuNext
• Pyxis Oncology
• Eledon Pharmaceuticals
• Alligator Bioscience
• Akamis Bio
• Tonix Pharmaceuticals
• Lyvgen Biopharma
• Shanghai Bao Pharmaceuticals
• Amgen
• Shanghai Hengrui Pharmaceutical

CD40 Key Products

• Frexalimab
• Sotigalimab
• Tegoprubart
• Mitazalimab
• NG-350A
• TNX-1500
• Dalnicastobart
• BJ047
• Dazodalibep 
• SHR 7367