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)




Tavo (tavokinogene telsaplasmid)






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.

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.

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
  • The report tracks recent innovations, key developments, and start-up details that are actively working in the market
  • The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario
  • PDS Biotech
  • OncoSec Medical Inc
  • Alaunos Therapeutics
  • Imunon Inc
  • AstraZeneca
  • Karyopharm Therapeutics
  • Libo Pharma Corp
  • ImmVira Pharma
  • ViroGin Biotech Ltd
  • AOP Orphan Pharmaceuticals
  • Sonnet BioTherapeutics
  • Liminal BioSciences
  • Beijing Bio-Targeting Therapeutics
  • Mallinckrodt Pharmaceuticals Ireland Ltd
  • Immorna Biotherapeutics
  • The University of Alabama
  • Roche
  • AgonOx Inc
  • Astellas Pharma
  • Tottori University
  • Zhejiang Qixin Biotech
  • Dragonfly Therapeutics
  • Cartesian Therapeutics
  • Genexine Inc
  • Inovio Pharmaceuticals
  • Precigen
  • Alaunos Therapeutics
  • BMS
  • Eureka Therapeutics
  • Moderna
  • Oncorus
  • Rubius Therapeutics
  • Sanofi
  • BioNTech
  • Turnstone Biologics
  • Transgene Biotek Ltd
  • Werewolf Therapeutics
  • Xilio Therapeutics
  • Symvivo LLC
  • enGene Inc
  • Philogen
  • Codiak Biosciences

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