CD40 is a protein receptor found on the surface of immune cells, including B cells, dendritic cells, and macrophages. It plays a crucial role in immune system regulation and activation. CD40-targeted drugs work by binding to CD40 receptors and stimulating immune responses. This activation leads to enhanced antigen presentation, cytokine production, and cytotoxic activity, making CD40 an attractive target for immunotherapy. CD40-based treatments are being investigated for a range of disease indications, including cancer, autoimmune disorders, and infectious diseases. In cancer, CD40 agonists aim to enhance anti-tumor immune responses by activating immune cells against cancer cells. Clinical trials are underway to explore the effectiveness of CD40-targeted therapies in various cancer types, such as melanoma, lymphoma, and pancreatic cancer. Additionally, CD40-targeted drugs show potential in treating autoimmune conditions like systemic lupus erythematosus and rheumatoid arthritis. According to WHO, cancer is a significant health burden in Europe and the USA. In Europe, it is estimated that there were 3.9 million new cancer cases and 1.9 million cancer-related deaths in 2020. In the USA, cancer is the second leading cause of death, with approximately 1.8 million new cancer cases and over 600,000 deaths reported annually. Autoimmune diseases also pose a considerable healthcare challenge. In Europe, it is estimated that autoimmune diseases affect up to 5% of the population. In the USA, around 23.5 million people have an autoimmune condition, with prevalence increasing over time. These statistics highlight the need for innovative therapies like CD40-targeted drugs to address the burden of cancer and autoimmune diseases.
The growth drivers of the CD40 market include the increasing understanding of the role of the immune system in disease progression and the potential of CD40-targeted therapies in enhancing immune responses. Additionally, the promising results from early clinical trials and the demand for effective and personalized treatment options drive the development and investment in CD40-targeted drugs. Companies such as Apexigen, Novartis, Celldex, Seagen, Pfizer, Horizon Therapeutics, Roche, AbbVie, Biogen, Sanofi, Biogen, and BMS cater to this category. Moreover, many companies are coming up with new molecules in this space. For instance, Seagen is conducting a clinical trial of the drug SGN-40 for the treatment of immunoproliferative disorders.
Key Developments
In March 2023, Viela Bio completed a phase-II clinical trial of Dazodalibep in Renal transplant rejection (In adults, In the elderly, Combination therapy, Prevention) in the USA
In March 2023, Horizon Therapeutics completed a Phase-II clinical trial of Dazodalibep in Sjogren's syndrome in the US, France, Hungary, India, Italy, Mexico, Peru, United Kingdom, South Korea, Taiwan, Argentina and Poland
Approved CD40 molecules
- Galepa (daleuton topical)
- TriMix-DC (ex-vivo autologous dendritic cells vaccine)
- Antova (ruplizumab)
CD40 Pipeline Molecules
- Sotigalimab (APX005M)
- Iscalimab (CFZ533)
- CDX-1140
- Dacetuzumab (SGN-40)
- CP-870893
- Dazodalibep (HZN-4920)
- Selicrelumab (RG7876)
- BI 655064
- ISF35
- Dapirolizumab pegol (CDP7657)
- Bleselumab (ASKP1240)
- Tegoprubart (AT-1501)
- CD40L cell vaccine
- YH003
- Frexalimab (SAR441344)
- 2141-V11
- RP3
- SL-172154
- Daleuton oral (DS107 oral)
- Delolimogene mupadenorepvec (LOAd703)
- Giloralimab (ABBV-927)
- Lucatumumab (CHIR 12.12)
- Mitazalimab (ADC-1013)
- GEN1042
- NG-350A
- Dalnicastobart (LVGN7409)
- AdCD40L
- BMS-986325
- BNT113
- FFP104
- KPL-404
- Lu AG22515
- OPT101
- Cifurtilimab (SEA-CD40)
- Letolizumab (BMS-986004)
- Ravagalimab (ABBV-323)
- ABBV-428
- BIIB063
- BMS-986090
- BSI-038
- HIVRI.Env
- MEDI5083
- MEM-288
- MP0317
- MUC-1 CD40L dendritic cell vaccine
- NJA-730
- PeptiCRAd-1
- RG6189
- Inezetamab (AMG 994)
Clinical Activity and Development of CD40
In the CD40 space, more than 30 companies are conducting more than 200 clinical trials in this category of drugs. For instance,
In April 2023, Apexigen presented efficacy data from a phase-I trial of Sotigalimab in malignant melanoma at the 114th annual meeting of the American Association for Cancer Research (AACR-2023)
In May 2023, Horizon Therapeutics released efficacy and biomarker data from a phase-II trial of Dazodalibep in Sjogren's syndrome released
|
Product Name |
Total Studies |
|
Sotigalimab (APX005M) |
15 |
|
Iscalimab (CFZ533) |
13 |
|
CDX-1140 |
11 |
|
Dacetuzumab (SGN-40) |
9 |
|
CP-870893 |
8 |
|
Dazodalibep (HZN-4920) |
8 |
|
Selicrelumab (RG7876) |
8 |
|
BI 655064 |
7 |
|
Bleselumab (ASKP1240) |
6 |
|
Tegoprubart (AT-1501) |
6 |
|
GM.CD40L cell vaccine |
5 |
|
YH003 |
5 |
|
Frexalimab (SAR441344) |
5 |
|
2141-V11 |
4 |
|
RP3 |
4 |
|
SL-172154 |
4 |
|
Daleuton oral (DS107 oral) |
4 |
|
Delolimogene mupadenorepvec (LOAd703) |
4 |
|
Giloralimab (ABBV-927) |
4 |
Target Indication Analysis of CD40 Agonists
Currently, CD40 agonists are in ongoing clinical trial phases for various conditions such as symptomatic multiple myeloma after first-line autologous stem cell transplantation, metastatic pancreatic ductal adenocarcinoma, esophageal cancer, fallopian tube cancer, ovarian cancer, renal cell carcinoma, breast cancer, biliary cancer, bile duct cancer, malignant epithelial neoplasms, advanced solid tumor cancer, recurrent head and neck cancer, human papilloma virus-related carcinoma, metastatic hepatocellular carcinoma, metastatic HPV related solid tumors, newly diagnosed MGMT unmethylated glioblastoma, non-muscle invasive bladder cancer, and others. For such cancer-related research, CD40 agonists are being used either alone or in combination therapy.
Regional Analysis of CD40 Agonists
CD40 Agonists Market
CD40 agonists being vital for the activation of anti-tumor immunity are primarily being developed for various lethal cancers. Globally, cancer is the 2nd leading cause of mortality after cardiovascular diseases, and it is the leading cause of death in over 50 countries. According to International cancer data, cases of incidence will increase from 19 million in 2020 to 29 million in 2040. The number of new cases is increasing most rapidly in countries with a low Human Development Index (HDI). According to a report, cases will increase by 96% between 2020 and 2040 among low HDI countries (Tanzania, Pakistan, Nigeria, Uganda, Sudan, and others), compared with an increase of only 32.2% in very high HDI countries (Switzerland, Norway, China, Australia, Denmark, Sweden, Germany, Canada, and others). According to World Health Organization data 2020, on cancer, China has the highest (8,15,563 new cases) lung cancer incidence rate, followed by the USA (2,27, 875), and for pancreatic cancer also China (1,24,994) was in the top rank, followed by the USA (56,654) and Japan (44,307). Similarly, for bladder cancer, China (85,694 new cases), USA (80,617), and Japan (36,957) are among the top countries. In the case of multiple myeloma USA (32,119 new cases) is at the top.
Latin America
Europe
Asia Pacific
Middle East
North America
Frequently Asked Questions
Sotigalimab (APX005M), Selicrelumab (RG7876), Giloralimab (ABBV-927) Mitazalimab (ADC-1013), Cifurtilimab (SEA-CD40), and Inezetamab (AMG 994) are some of the drugs in the pipeline for CD40 agonists.
BioNTech, Sino Biopharma, AbbVie, Roche, Amgen, and AstraZeneca are some of the major market players with CD40 agonists in their pipeline.
The USA, Germany, France, United Kingdom, Spain, Italy, Japan, and China are the potential markets for CD40 agonists.
Pancreatic cancer, colorectal cancer, ovarian cancer, breast cancer, lung cancer, and bladder cancer are some of the indications on which companies are focusing for the expansion of CD40 agonists market.
Key Features of the Reports
- The report provides granular level information about the market size, regional market share, historic market (2019-2023), and forecast (2024-2030)
- The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
- The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
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- The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario
- BioNTech Corporate (Germany)
- AbbVie Inc. (Chicago)
- Roche (Switzerland)
- Akamis Bio (England)
- Alligator Bioscience (Sweden)
- Amgen (USA)
- Apexigen (USA)
- AstraZeneca (Germany)
- BeiGene (USA)
- Biocytogen Pharmaceuticals (China)
- Biosion Inc. (China)
- Celldex Therapeutics (USA)
- Cellular Biomedicine (USA)
- Genmab Corporate (Denmark)
- Lyvgen Biopharma (China)
- Pfizer (USA)
- SeaGen Ltd (USA)
- Shattuck Labs (USA)
- Sino Biopharma (China)