IL-2 Stimulators Market: Competitive Landscape, Pipeline, and Market Analysis 2023

IL-2 Stimulators Market Size, Share, Growth, Trends, and Global Industry Analysis: Competitive Landscape, Pipeline, and Market Size, Share, Growth, Trends, and Global Industry Analysis: Analysis 2023

IL-2 (Interleukin-2) is an interleukin which is a type of cytokine signaling molecule in the immune system. IL-2 has direct effects on T-cells, where it increases the cell-killing activity of both natural killer cells and cytotoxic T cells. The low dose and high dose of IL-2 exert opposite action to each other, while high dose IL-2 promotes T- cell proliferation and enhances effector T-cell function, low-dose IL-2 induces immune tolerance and promotes Treg (T-regulatory lymphocytes) development resulting in suppression of unwanted immune responses. IL-2 agonists bind to the IL-2 receptor and through a chain reaction stimulate the growth and differentiation of T cells. IL-2 inhibitors bind to the high affinity IL-2 receptor complex, then selectively kill the IL-2-bearing cells. IL-2 stimulators are indicated for malignant melanoma, renal cell carcinoma, cutaneous T-cell lymphoma, and peripheral T-cell lymphoma. Merck (MSD), Novartis, Eisai, Sanofi, Innovent Biologics, and Amgen are some of the major players in the IL-2 stimulators market.

Key Market Developments:

  • In Dec 2022, FDA accepted a biologics license application (BLA) for the engineered IL-2-diphtheria toxin fusion protein denileukin diftitox (I/ONTAK; E7777) for the treatment of cutaneous persistent or recurrent T-cell lymphoma.
  • In Jun 2023, Philogen entered into a clinical trial collaboration and supply agreement with Merck (MSD) for IL91L2, an IL-2 stimulator.

Approved Drug Molecules and Brand Names for IL-2 Stimulators:

  • Proleukin (Aldesleukin)
  • Ontak (Denileukin diftitox)

Drugs under the Pipeline for IL-2 Stimulators:

  • Nanrilkefusp alfa (SOT101)
  • CUE-101
  • CUG-252
  • Celeuk (Celmoleukin)
  • IBI363
  • MK-6194
  • Prostatac (PSA/IL-2/GM-CSF vaccine)
  • Cergutuzumab Amunaleukin (RG7813)
  • Tipapkinogene Sovacivec (TG4001)
  • 8MW2311
  • AB248
  • AGX-148
  • ATB-301
  • AU-007
  • AVB-001
  • BNT151
  • BNT152/BNT153
  • CUE-102
  • GI-102
  • LMW Heparin MMX (low molecular weight heparin)
  • MDNA11
  • MK-1484
  • NL-201
  • Oncoquest-CLL (ATCE vaccine)
  • Oncoquest-L (Non-Hodgkin's lymphoma vaccine)
  • P-IL-2
  • PF-06753512
  • SHR-1916
  • STK-009/SYNCAR-001
  • Saltikva (attenuated Salmonella typhimurium expressing IL-2)
  • VIS171
  • WTX-124
  • XTX202
  • Eciskafusp alfa (RG6279)
  • Losartan/Aldesleukin (IMM-01)
  • mRNA-6231

Clinical Activity and Developments of IL-2 Stimulators:

Currently, there are 57 drug molecules in the IL-2 stimulators, including 2 approved drugs in the market and others are in the clinical trial phases.

  • In Dec 2022, Clinigen released safety and pharmacodynamics data from phase-IIb MIROCALS trials in amyotrophic lateral sclerosis for Aldesleukin.
  • In May 2023, Xilio Therapeutics released updated adverse events data from a phase-I/II trial in solid tumors and also conducted phase-II clinical trials in solid tumors as a second-line monotherapy in the USA, for XTX-202, an IL-2 stimulator.

Molecule Name

Number of Studies

Nanrilkefusp alfa (SOT101)

3

CUE-101

2

CUG-252

2

Celeuk (Celmoleukin)

2

IBI363

2

MK-6194

2

Prostatac (PSA/IL-2/GM-CSF vaccine)

2

Cergutuzumab Amunaleukin (RG7813)

2

Tipapkinogene Sovacivec (TG4001)

2

8MW2311

1

AB248

1

AGX-148

1

ATB-301

1

AU-007

1

AVB-001

1

BNT151

1

BNT152/BMT153

1

CUE-102

1

GI-102

1

LMW Heparin MMX (low molecular weight heparin)

1

MDNA11

1

MK-1484

1

NL-201

1

Oncoquest-CLL (ATCE vaccine)

1

Oncoquest-L (Non-Hodgkin's lymphoma vaccine)

1

P-IL-2

1

PF-06753512

1

SHR-1916

1

STK-009/SYNCAR-001

1

Saltikva (attenuated Salmonella typhimurium expressing IL-2)

1

VIS171

1

WTX-124

1

XTX202

1

Eciskafusp alfa (RG6279)

1

Losartan/Aldesleukin (IMM-01)

1

mRNA-6231

1

Target Indication Analysis of IL-2 Stimulators

The IL-2 receptor beta subunit agonist, Aldesleukin is marketed for the treatment of malignant melanoma and renal cell carcinoma, and is in phase-II trials for amyotrophic lateral sclerosis. IL-2 receptor inhibitor, Denileukin diftitox is indicated for cutaneous T-cell lymphoma and peripheral T-cell lymphoma, is in phase-II trial for malignant melanoma, and is in phase-I/II trial for diffuse large B cell lymphoma. Some of the other drug molecules in clinical trial phases are being investigated for conditions such as B-cell lymphoma, gastrointestinal cancer, Hodgkin’s disease, malignant melanoma, mesothelioma, non-small cell lung cancer, squamous cell cancer, and others.

Key Features of the Report

  • 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 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
  • The report analyses the impact of the socio-political environment through PESTLE Analysis and competition through Porter's Five Force Analysis in addition to recent technology advancements and innovations in the market

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Frequently Asked Questions

Proleukin (Aldesleukin) and Ontak (Denileukin diftitox) are the approved IL-2 stimulators in the market.

Merck (MSD), Novartis, Eisai, Sanofi, Innovent Biologics, Amgen are some of the major players in the IL-2 stimulators market.

Major indications for IL-2 stimulators are malignant melanoma, renal cell carcinoma, cutaneous T-cell lymphoma, and peripheral T-cell lymphoma.

There are more than 50 molecules in the phase-I/II clinical development for IL-2 stimulators.

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Author

Muni Kumar Meravath

Muni Kumar Meravath is a seasoned Healthcare Market Research Analyst with over 6 years of experience in the healthc.....

Key Market Players

  • Merck
  • Novartis
  • Eisai
  • Sanofi
  • Innovent Biologics
  • Amgen
  • Apeiron Biologics
  • Roche
  • Beijing SL Pharma
  • Pfizer
  • Jiangsu Hengrui Pharma
  • Otsuka
  • Moderna

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