Interleukin-12 (IL-12) Stimulators Market: Competitive Landscape, Pipeline, and Market Analysis 2023

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Interleukin-12 (IL-12) is a heterodimeric cytokine with broad immunomodulatory properties that belongs to a larger family of proteins called IL-12-related cytokines. IL-12-related cytokines are produced by five independently regulated genes that homodimerize and heterodimerize to form seven secretory family members. These proteins have both overlapping and distinct biological properties and is predominantly produced by dendritic cells, monocytes, and macrophages, and to a lesser extent by B-cells. It has been identified as an immune cell stimulant that promotes T cell differentiation and proliferation and increases interferon-gamma production. Therefore, it has been associated with the regulation of CD4+ and CD8+ T cell differentiation, host defense, autoimmunity, immune recognition of tumor cells, alloimmunization, and host response to vaccination. Therefore, IL-12 functions as a potent regulator of immunity. The type of adaptive immune response is regulated by the innate response during the infection affected by the expression of IL-12 at that time. IL-12 Stimulators are being evaluated in various clinical settings for various indications. Extensive research is being conducted globally to discover new and novel molecules to be used as IL-12 Stimulators to be used for the treatment of many indications like as Mycobacterium infections. The development and launch of new products will thus increase the revenue of the market in the forecasted years.

A number of these stimulators are in the market while many are in ongoing clinical trials. 46 companies have about 44 products in their pipelines with 34 products in various stages of clinical trials – 1 in Phase 3, 19 in Phase 2 and 24 in Phase 1 of the clinical trials.

Drugs in the Pipeline of IL-12 Stimulators

rocakinogene sifuplasmid (INO-9012)
PDS0301
Tavo (tavokinogene telsaplasmid)
Ad-RTS-hIL-12
IMNN-001
MEDI0457
HemaMax (rHuIL-12)
T3011
VG161
Trivax (AV0113)
SON-1010
Urocidin (mycobacterium cell wall-DNA complex)
Ad-TD-nsIL12
CORVax12
ExpressGraft (anti-tumor IL-12)
INO-9112
JCXH-211
M032
VG201
ADV/IL-12 gene therapy
AGX-148
ASP9801
CAR-T Targeting Nectin4/FAP
DF6002
Descartes-25
GX-051
INO-5151
INXN-3001
JCAR020
MEDI1191
MEDI9253
MVR-C5252
ONCR-177
RTX-224
RTX-321
SAR441000
TBio-6517
TG6050
WTX-330
XTX301
bacTRL-IL-12
detalimogene voraplasmid (EG-70)
dodekin (F8-IL12)
exoIL-12

Clinical Activity and Developments of IL-12 Stimulators

As of July 2023, 46 companies have approximately 44 products for 34 diseases. For these diseases, 61 trials are being conducted by players globally. For instance,

D. Anderson Cancer Center is conducting a Phase 2 clinical trial to evaluate efficacy of combination treatment with MEDI0457 (iINO-3112) and durvalumab (MEDI4736) in patients with Recurrent/Metastatic Human Papilloma Virus associated cancers that was expected to complete by December 2022.
The University of Alabama is conducting a Phase 1/2 clinical trial to study Pembrolizumab and M032 (NSC 733972), a genetically engineered HSV-1 expressing IL-12, in patients with Recurrent/Progressive and newly diagnosed Glioblastoma Multiforme, Anaplastic Astrocytoma, or Gliosarcoma that is expected to complete by March 2025.
Sonnet BioTherapeutics is conducting a Phase1/2 clinical trial to assess the combination of SON-1010 (IL12-FHAB) and Atezolizumab in patients with Platinum-resistant Ovarian Cancer that is expected to complete by May 2025.

Molecule name	Number of studies
rocakinogene sifuplasmid (INO-9012)	14
PDS0301	12
Tavo (tavokinogene telsaplasmid)	11
Ad-RTS-hIL-12	8
IMNN-001	7

Target Indication Analysis of IL-12 Stimulators

IL-12 Stimulators are being evaluated in the clinical trials since many years for the treatment of numerous malignancies and it is being evaluated as a monotherapy and/or in combination with other drugs. IL-12 has shown to show antitumor response, against Cutaneous T-cell Lymphoma and Non-Hodgkin’s Lymphoma. IL-12 administration is more effective and safer if delivered and maintained in the tumor through the use of novel delivery technologies as it generates systemic antitumor immunity from a locally initiated immune response. IL-12 deficiency has been associated with tumor growth, urinary bladder diseases, asthma, airway hyperresponsiveness, viral infections like AIDS, Chronic Hepatitis and other diseases. Therefore, these are ana important target for many disorders and their optimum level is important for normal physiological functioning of the body.

Interleukin-12 (IL-12) Stimulators Market Regional analysis

IL-12 Stimulators Market

According to the Asthma and Allergy Foundation of America (AAFA), approximately 26 million individuals in the United States will have asthma in 2022, with 21 million being adults over the age of 18 and 4.8 million being children under the age of 18. Also, the prevalence of Alzheimer's disease in the United States in 2019 was 7.3%. According to the American Lung Association report, about 1.8 billion global population are infected with Tuberculosis while 10 million people have active Tuberculosis globally. According to the National Brain Tumor Society 2023 report, Glioblastoma accounts for more than 50% of primary malignant brain tumor with more than 14,490 people expected to be diagnosed with Glioblastoma in the USA in 2023.

Latin America

Europe

Asia Pacific

Middle East

North America

Frequently Asked Questions

Currently, no IL-12 Stimulators have been approved by the FDA.

These are being evaluated in trials for the treatment of Cutaneous T-cell Lymphoma, Non-Hodgkin’s Lymphoma, Glioblastoma, Asthma Bacterial infections and others.

PDS Biotech, OncoSec Medical Inc, Alaunos Therapeutics, Imunon Inc and AstraZeneca are some of the major market players for IL-12 Stimulators.

Rising incidence of diseases improvement in technologies, development of new treatment lines in the market and rising incidence of various types of diseases like Cutaneous T-cell Lymphoma, Glioblastoma, Asthma, Mycobacterium infections and others are the key opportunities for IL-12 Stimulators in the market.

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