IL-2 Stimulators Market: Competitive Landscape, Pipeline, and Market 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.