{"id":30911,"date":"2025-01-31T17:52:00","date_gmt":"2025-01-31T12:22:00","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=30911"},"modified":"2025-01-31T12:52:43","modified_gmt":"2025-01-31T07:22:43","slug":"interleukin-2-targeting-therapies","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/interleukin-2-targeting-therapies","title":{"rendered":"Interleukin-2-targeting Therapies: Journey from Bench to Bedside"},"content":{"rendered":"\n

Expected data readouts in 2025, filling the unmet need, and estimated market opportunity in Oncology, Immunological and Neurodegenerative Diseases<\/em><\/strong><\/p>\n\n\n\n

In the evolving landscape of immunotherapy, Interleukin-2 (IL-2) therapies have carved a niche, particularly in the treatment of metastatic melanoma, metastatic renal cell carcinoma (mRCC), relapsed or refractory Peripheral T-cell Lymphoma (R\/R PTCL) and relapsed or refractory Cutaneous T-cell Lymphoma (R\/R CTCL). In addition to it, IL-2 therapies<\/a> are now being vigorously explored across a wide range of disease areas, spanning oncology, autoimmune disorders, and beyond. Ongoing investigations include indications such as non-segmental vitiligo (NSV), aplastic anemia, amyotrophic lateral sclerosis (ALS), PTCL, CTCL, platinum-resistant ovarian cancer (PROC), head and neck squamous cell carcinoma (HNSCC), melanoma, atopic dermatitis, alopecia areata, non-small cell lung cancer (NSCLC), mucosal melanoma, and others.<\/p>\n\n\n\n

The global IL-2 therapy market<\/a> is experiencing robust growth, fueled by biotechnological advancements and the increasing recognition of IL-2’s versatility across multiple therapeutic areas. With the emergence of novel therapies and expanded indications, the United States IL-2 market is projected to reach USD 3.2 billion<\/strong> by 2034. Key players driving this expansion include Iovance Biotherapeutics, Eisai, Citius Pharmaceuticals, Nektar Therapeutics, Mural Oncology, Corvus Pharmaceuticals, and Krystal Biotech<\/strong>, among others. These companies are investing heavily in R&D to develop next-generation IL-2-based therapies with enhanced efficacy and safety profiles.<\/p>\n\n\n\n

<\/span><\/p>\n

\n<\/colgroup>\n\n\n\n\n\n\n
\n

Addressable Patient Population for Approved IL-2 Therapies<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Indication<\/span><\/p>\n<\/td>\n

\n

Eligible Patient Pool in 2024<\/span><\/p>\n<\/td>\n

\n

Approved IL-2 Therapies<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Metastatic melanoma<\/span><\/p>\n<\/td>\n

\n

26,000 (US)<\/span><\/p>\n<\/td>\n

\n

PROLEUKIN<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

R\/R CTCL<\/span><\/p>\n<\/td>\n

\n

3,000 (US and JP)<\/span><\/p>\n<\/td>\n

\n

LYMPHIR\/REMITORO<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

R\/R PTCL<\/span><\/p>\n<\/td>\n

\n

4,000 (JP)<\/span><\/p>\n<\/td>\n

\n

REMITORO<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n\n\n\n

<\/div>\n\n\n\n

The first chapter in the IL-2 era was written in 1992 when PROLEUKIN<\/strong>, the first recombinant human IL-2, was approved for the treatment of mRCC<\/a>, and a few years later, in 1998, the therapy gained approval for metastatic melanoma treatment.<\/p>\n\n\n\n

The commercial success of PROLEUKIN<\/strong> has been turbulent, with flat sales<\/strong> since 2021 as reported by Clinigen Group. However, in 2023, PROLEUKIN\u2019s rights were transferred to Iovance Biotherapeutics, which has rejuvenated interest in the therapy by integrating it with AMTAGVI (Lifileucel), a tumor-derived autologous T-cell therapy, with an anticipated commercial opportunity of USD 300 million<\/strong> in the 7MM by 2034 in metastatic melanoma, offering hope for patients with tumors resistant to other therapies.<\/p>\n\n\n\n

A new dawn: From PROLEUKIN to LYMPHIR<\/strong><\/h2>\n\n\n\n

In a remarkable twist of fate, LYMPHIR<\/strong> (denileukin diftitox-cxdl) emerged as the next evolution of IL-2 therapy. Approved by the FDA in August 2024, LYMPHIR represents a significant leap forward. In 2021, it received regulatory approval in Japan for the treatment of relapsed or refractory PTCL<\/a> and CTCL under the brand name REMITORO<\/strong>. Unlike its predecessor, PROLEUKIN<\/strong>, LYMPHIR\u2019s unique targeted mechanism focuses on selectively depleting IL-2 receptors on malignant T cells and regulatory T cells (Tregs). This selective targeting allows LYMPHIR to treat CTCL with greater precision, fewer side effects, and more efficacy. LYMPHIR\u2019s approval not only opened a new chapter for adult patients with relapsed or refractory Stage I\u2013III CTCL but also set the stage for further exploration in solid tumors. <\/p>\n\n\n\n

From autoimmunity to immuno-oncology<\/strong><\/h2>\n\n\n\n

While IL-2\u2019s legacy in cancer treatment had been well established, its potential in autoimmune diseases was still relatively untapped. In recent years, however, this landscape has been changing rapidly, with new IL-2-based therapies showing promise in managing chronic conditions like atopic dermatitis, alopecia areata, and neurodegenerative diseases like amyotrophic lateral sclerosis.<\/p>\n\n\n\n

\"Emerging-IL-2-based-Therapies-in-Top-Oncology-Indications\"<\/figure>\n\n\n\n

The emergence of Rezpegaldesleukin (NKTR-358)<\/strong>, a recombinant protein developed by Nektar Therapeutics<\/strong>, marked a new frontier in autoimmunity treatment. This novel therapy selectively stimulates T-regulatory cells (Tregs)<\/a> via the IL-2 pathway, investigated for moderate-to-severe atopic dermatitis (Phase II) and severe alopecia areata (Phase II), Nektar<\/strong> expects topline data in H1 2025<\/strong> and H2 2025<\/strong>, respectively for both indications. Rezpegaldesleukin offers a more precise and less toxic approach to controlling inflammation. The ability to self-administer the drug through subcutaneous injections further enhances its appeal and is expected to reach a market of around USD 930 million<\/strong> by 2034.<\/p>\n\n\n\n

Simultaneously, Soquelitinib (CPI-818)<\/strong>, developed by Corvus Pharmaceuticals<\/strong>, takes a distinct approach by inhibiting ITK (IL-2-inducible T-cell kinase)<\/strong>, a protein critical for T-cell activation. This novel therapy is under investigation for moderate-to-severe atopic dermatitis (Phase I) and relapsed\/refractory peripheral T-cell lymphoma (PTCL) (Phase III). In August 2024, the US FDA granted Fast Track Designation (FTD)<\/strong> for R\/R PTCL after two prior systemic therapies, while in February 2024, Orphan Drug Designation (ODD)<\/strong> was granted for T-cell lymphoma. Early-stage data from December 2024 for atopic dermatitis were promising, with final results expected in H1 2025<\/strong>, <\/strong>whereas its first launch is <\/strong>expected in PTCL by 2027<\/strong> in the US. Combining both PTCL and atopic dermatitis, it is expected to reach a market of approximately USD 360 million<\/strong> by 2034.<\/p>\n\n\n\n

Meanwhile, in the field of neurodegenerative diseases, ILTOO pharma\u2019s<\/strong> ILT-101<\/strong>, an IL-2 replacement therapy, which is already available under an expanded access program in Europe for ALS, is expected to launch post-regulatory approval in European countries first. Within the ALS market landscape<\/a>, there remains a high trial failure rate of even late-stage pipeline therapies, with limited approved therapies such as Riluzole <\/strong>and Radicava<\/strong>, which are the basis of the standard of care in ALS.\u00a0<\/p>\n\n\n\n

\"Emerging-IL-2-based-Therapies-in-Top-Immunology-Indications\"<\/figure>\n\n\n\n

Anticipated data readouts in 2025 – Whether IL-2s can meet the safety and efficacy benchmark in respective indications?<\/strong><\/h2>\n\n\n\n

As the field of IL-2-targeting therapies<\/strong><\/a> continues to mature, the next generation of treatments is already on the horizon, promising to further refine and expand the reach of immunotherapy.<\/p>\n\n\n\n

One such promising therapy is ALKS 4230 (nemvaleukin alfa)<\/strong>, developed by Mural Oncology<\/strong>. This recombinant fusion protein is an IL-2 receptor agonist with platinum-resistant ovarian cancer (PROC) as its leading indication followed by mucosal melanoma. According to the latest presentation in November 2024, Mural Oncology<\/strong> anticipates the interim overall survival readout for the PROC cohort (ARTISTRY-7)<\/strong> to be available by late 1Q\/early 2Q 2025<\/strong>, with top-line data for mucosal melanoma (ARTISTRY-6, Cohort 2)<\/strong> expected in 2Q 2025<\/strong>. ALKS 4230<\/strong> has also garnered key regulatory designations that underscore its potential and expedite its path toward commercialization and reach a market of nearly USD 140 million<\/strong> by 2034. <\/p>\n\n\n\n

Another exciting innovation is KB707<\/strong>, developed by Krystal Biotech<\/strong>, which delivers IL-2 <\/strong>and IL-12<\/strong> directly to the tumor site through gene therapy. Krystal Biotech is the same company that received approval for the first topical gene therapy, VYJUVEK<\/strong><\/a>, <\/strong>for <\/strong>dystrophic epidermolysis bullosa in May 2023. The company is now developing two different routes of administration of intratumoral injection for metastatic melanoma and inhalation for advanced NSCLC. The product has already received FTD in both indications. Early-stage clinical trials have shown particularly promising results for NSCLC, preliminary clinical data in post-anti-PD-1 NSCLC patients demonstrated a 27% ORR and 73% DCR in monotherapy trials, reinforcing KB707\u2019s potential to reshape cancer treatment. KB707 exemplifies how targeted gene therapies could reshape the treatment of cancer, offering a more localized, potent immune response with fewer adverse effects.<\/p>\n\n\n\n

Additionally, CUE-101<\/strong> from Cue Biopharma<\/strong> represents a significant advancement in IL-2-based therapies, specifically targeting the HPV16 antigen in HNSCC. The US FDA granted FTD<\/strong> to CUE-101 in October 2022, recognizing its potential to treat HPV16+ refractory\/metastatic HNSCC both as a monotherapy and in combination with KEYTRUDA<\/strong>. By integrating IL-2 replacement<\/strong> with targeted antigen presentation<\/strong>, CUE-101 seeks to improve tumor targeting while simultaneously enhancing the anti-cancer immune response. Currently undergoing clinical trials, this innovative therapy is already showing promising results, particularly when used in combination with immune checkpoint inhibitors<\/a> such as KEYTRUDA<\/strong>, <\/strong>and is expected to reach a market value of approximately USD 370 million<\/strong> by 2034.<\/p>\n\n\n\n

Looking ahead, the IL-2 market is poised for a period of rapid transformation. Therapies like PROLEUKIN<\/strong> and LYMPHIR<\/strong> are already making significant impacts in oncology, while newer agents like ALKS 4230<\/strong>, Rezpegaldesleukin<\/strong>, and Soquelitinib<\/strong> are broadening the landscape for autoimmune diseases and immuno-oncology. By 2034, the market for IL-2-based\/targeting therapies is expected to reach an estimated USD 4 billion<\/strong>, reflecting the expanding role of IL-2 in treating both cancer and autoimmune diseases.\u00a0<\/p>\n\n\n\n

<\/span><\/p>\n

\n
\n<\/colgroup>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

Top IL-2 Therapies: Expected Launches, Eligible Patient Pool, and Market Potential<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Product<\/span><\/p>\n<\/td>\n

\n

Company<\/span><\/p>\n<\/td>\n

\n

Top Indications<\/span><\/p>\n<\/td>\n

\n

Molecule type<\/span><\/p>\n<\/td>\n

\n

Eligible Patient Pool (US 2024)<\/span><\/p>\n<\/td>\n

\n

Estimated Cost at Launch (in US) in USD<\/span><\/p>\n<\/td>\n

\n

Expected Launch Year (US)<\/span><\/p>\n<\/td>\n

\n

Market Potential (US 2034) in USD million<\/span><\/p>\n<\/td>\n

\n

Other Indications<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Nemvaleukin Alfa<\/span><\/p>\n

(ALKS 4230)<\/span><\/p>\n<\/td>\n

\n

Mural Oncology<\/span><\/p>\n<\/td>\n

\n

PROC (III)<\/span><\/p>\n<\/td>\n

\n

Fusion protein<\/span><\/p>\n<\/td>\n

\n

4,439 (~20% of ovarian cancer)<\/span><\/p>\n<\/td>\n

\n

16,000<\/span><\/p>\n<\/td>\n

\n

2027<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n

\n

Cutaneous Melanoma (II), Squamous Cell Carcinoma of Head and Neck<\/span><\/p>\n

(II), Advanced Solid Tumors<\/span><\/p>\n

(I)<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Mucosal Melanoma (II)<\/span><\/p>\n<\/td>\n

\n

1,420 (~1.4% of melanoma)<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n

\n

2027<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Soquelitinib<\/span><\/p>\n

(CPI-818)<\/span><\/p>\n<\/td>\n

\n

Corvus Pharmaceuticals<\/span><\/p>\n<\/td>\n

\n

Relapsed\/refractory PTCL (III)<\/span><\/p>\n<\/td>\n

\n

Small molecule<\/span><\/p>\n<\/td>\n

\n

6,320 (~50% of PTCL cases are expected to be relapsed\/refractory)<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n

\n

2027<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n

\n

Solid tumors (Ia)<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Moderate to severe atopic dermatitis<\/span><\/p>\n

(Ib)<\/span><\/p>\n<\/td>\n

\n

6,636,891 (~40% of atopic dermatitis are moderate to severe)<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n

\n

2031<\/span><\/p>\n<\/td>\n

\n

280<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Darleukin (L19IL2)<\/span><\/p>\n<\/td>\n

\n

Philogen<\/span><\/p>\n<\/td>\n

\n

Metastatic NSCLC Stage IV (II)<\/span><\/p>\n<\/td>\n

\n

Fusion protein<\/span><\/p>\n<\/td>\n

\n

136,262 (~57% NSCLC cases are Denovo Stage IIIB and Stage V + % progressed from Stage I,II,IIIA to Stage IIIB and V)<\/span><\/p>\n<\/td>\n

\n

~180,000<\/span><\/p>\n<\/td>\n

\n

2029<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n

\n

Anti-PD1 refractory unresectable stage III-IV melanoma (II), Advanced\/metastatic Fibroblast Activation Protein (FAP)-positive solid tumors (I)<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

MK-6194<\/span><\/p>\n<\/td>\n

\n

Merck<\/span><\/p>\n<\/td>\n

\n

NSV (II)<\/span><\/p>\n<\/td>\n

\n

Fc-fusion protein<\/span><\/p>\n<\/td>\n

\n

1,662,164  (~75% of Vitiligo)<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n

\n

2028<\/span><\/p>\n<\/td>\n

\n

300<\/span><\/p>\n<\/td>\n

\n

Systemic Lupus Erythematosus (SLE) (II),<\/span><\/p>\n

Ulcerative Colitis (I), Atopic Dermatitis (I)<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Rezpegaldesleukin (REZPEG\/NKTR-358)<\/span><\/p>\n<\/td>\n

\n

Nektar Therapeutics<\/span><\/p>\n<\/td>\n

\n

Moderate-to-Severe Atopic Dermatitis (II)<\/span><\/p>\n<\/td>\n

\n

Pegylated-recombinant-human interleukin-2<\/span><\/p>\n<\/td>\n

\n

6,636,891 (~40% of atopic dermatitis are moderate to severe)<\/span><\/p>\n<\/td>\n

\n

~78,000<\/span><\/p>\n<\/td>\n

\n

2029<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n

\n

SLE (II)<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Severe to Very Severe Alopecia Areata (II)<\/span><\/p>\n<\/td>\n

\n

246,761 (~40% of alopecia areata)<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n

\n

2029<\/span><\/p>\n<\/td>\n

\n

180<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

ILT-101<\/span><\/p>\n<\/td>\n

\n

ILTOO Pharma<\/span><\/p>\n<\/td>\n

\n

Newly diagnosed ALS (II)<\/span><\/p>\n<\/td>\n

\n

Recombinant proteins<\/span><\/p>\n<\/td>\n

\n

24,160<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n

\n

2029<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n

\n

Type 1 diabetes (II), Bipolar disorder (II), Moderate to severe SLE (II), Acute respiratory distress syndrome related to COVID-19 (II), Autoimmune and inflammatory diseases (II), Unexplained repeated spontaneous early miscarriages (I\/II)<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

CUE-101<\/span><\/p>\n<\/td>\n

\n

Cue Biopharma<\/span><\/p>\n<\/td>\n

\n

HPV16+ Recurrent\/Metastatic HNSCC (I)<\/span><\/p>\n<\/td>\n

\n

Fusion Protein<\/span><\/p>\n<\/td>\n

\n

17,263(~90% are HPV16+ and according to SEER ~27% of HNC cases are localized)<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n

\n

2028<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n

\n

Locally advanced HPV16+ oropharyngeal squamous-cell carcinoma (OPSCC)<\/span><\/p>\n

II<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

CUE-101 ±  KEYTRUDA<\/span><\/p>\n<\/td>\n

\n

First-line HPV+ R\/M HNSCC (I)<\/span><\/p>\n<\/td>\n

\n

17,263(~90% are HPV16+ and according to SEER ~27% of HNC cases are localized<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n

\n

2028<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

REGN7257<\/span><\/p>\n<\/td>\n

\n

Regeneron Pharmaceuticals<\/span><\/p>\n<\/td>\n

\n

Severe Aplastic Anemia (II)<\/span><\/p>\n<\/td>\n

\n

Monoclonal antibody<\/span><\/p>\n<\/td>\n

\n

320 (~40% of aplastic anemia cases are severe)<\/span><\/p>\n<\/td>\n

\n

~200,000<\/span><\/p>\n<\/td>\n

\n

2029<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n

 <\/td>\n<\/tr>\n
\n

IBI-363<\/span><\/p>\n<\/td>\n

\n

Innovent<\/span><\/p>\n<\/td>\n

\n

Advanced Melanoma (II)<\/span><\/p>\n<\/td>\n

\n

PD-1\/IL-2α-bias bispecific antibody fusion protein<\/span><\/p>\n<\/td>\n

\n

26,259  (~25% melanoma cases are advanced)<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n

\n

2030<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n

\n

Advanced solid malignancies (NSCLC, colorectal cancer, RCC) (II)<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

KB707<\/span><\/p>\n<\/td>\n

\n

Krystal Biotech<\/span><\/p>\n<\/td>\n

\n

Unresectable or metastatic melanoma (I\/II)<\/span><\/p>\n<\/td>\n

\n

Gene therapy<\/span><\/p>\n<\/td>\n

\n

26,259  (~25% melanoma cases are advanced)<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n

\n

2029<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n

 <\/td>\n<\/tr>\n
\n

Advanced solid tumor malignancies affecting the lungs (NSCLC) (I\/II)<\/span><\/p>\n<\/td>\n

\n

136,262 (~57% NSCLC cases are Denovo Stage IIIB and Stage V + % progressed from Stage I,II,IIIA to Stage IIIB and V)<\/span><\/p>\n<\/td>\n

\n

~300,000<\/span><\/p>\n<\/td>\n

\n

2030<\/span><\/p>\n<\/td>\n

\n

XX<\/span><\/p>\n<\/td>\n

 <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/span><\/div>\n\n\n\n
<\/div>\n\n\n\n

In addition to the aforementioned companies, several other organizations are actively evaluating their IL-2-based and targeting therapies across early and mid-stage phases of development.<\/p>\n\n\n\n

<\/span><\/p>\n

\n
\n<\/colgroup>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

Comparison of Mid- and Early-stage Emerging Drugs Under Development<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Product<\/span><\/p>\n<\/td>\n

\n

Company<\/span><\/p>\n<\/td>\n

\n

Indications<\/span><\/p>\n<\/td>\n

\n

Highest Phase<\/span><\/p>\n<\/td>\n

\n

Molecule type<\/span><\/p>\n<\/td>\n

\n

RoA<\/span><\/p>\n<\/td>\n

\n

MoA<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

BNZ132-1-40\/EQ 101<\/span><\/p>\n<\/td>\n

\n

Bioniz Therapeutics\/ Equillium<\/span><\/p>\n<\/td>\n

\n

LGL Leukemia or Refractory CTCL<\/span><\/p>\n<\/td>\n

\n

II<\/span><\/p>\n<\/td>\n

\n

Pegylated peptide<\/span><\/p>\n<\/td>\n

\n

IV<\/span><\/p>\n<\/td>\n

\n

Tri-specific inhibitor of IL-2, IL-9 and IL-15<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Moderate to Severe Alopecia Areata<\/span><\/p>\n<\/td>\n

\n

II<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Oncoquest-L vaccine<\/span><\/p>\n<\/td>\n

\n

XEME Biopharma<\/span><\/p>\n<\/td>\n

\n

Stage III or IV asymptomatic, non-bulky follicular lymphoma<\/span><\/p>\n<\/td>\n

\n

II<\/span><\/p>\n<\/td>\n

\n

Vaccine<\/span><\/p>\n<\/td>\n

\n

SC<\/span><\/p>\n<\/td>\n

\n

IL-2 replacements<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

CLL<\/span><\/p>\n<\/td>\n

\n

I<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

ANV419<\/span><\/p>\n<\/td>\n

\n

Anaveon<\/span><\/p>\n<\/td>\n

\n

Relapsed\/Refractory Advanced Solid Tumors<\/span><\/p>\n<\/td>\n

\n

II<\/span><\/p>\n<\/td>\n

\n

Antibody-cytokine fusion protein<\/span><\/p>\n<\/td>\n

\n

IV infusion<\/span><\/p>\n<\/td>\n

\n

IL-2 agonist<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

MDNA11<\/span><\/p>\n<\/td>\n

\n

Medicenna Therapeutics and Merck<\/span><\/p>\n<\/td>\n

\n

Advanced solid tumors<\/span><\/p>\n<\/td>\n

\n

I\/II<\/span><\/p>\n<\/td>\n

\n

Long-acting “beta-only” recombinant interleukin-2 (rIL-2) albumin fusion<\/span><\/p>\n<\/td>\n

\n

IV<\/span><\/p>\n<\/td>\n

\n

IL-2 Super Agonist<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Pegenzileukin\/THOR-707<\/span><\/p>\n<\/td>\n

\n

Sanofi<\/span><\/p>\n<\/td>\n

\n

Plasma Cell Myeloma Refractory<\/span><\/p>\n<\/td>\n

\n

I\/II<\/span><\/p>\n<\/td>\n

\n

Fusion protein<\/span><\/p>\n<\/td>\n

\n

IV<\/span><\/p>\n<\/td>\n

\n

IL-2 replacements<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

GI-101\/GI-101A<\/span><\/p>\n<\/td>\n

\n

GI Innovation<\/span><\/p>\n<\/td>\n

\n

Advanced Solid Tumors<\/span><\/p>\n<\/td>\n

\n

I\/II<\/span><\/p>\n<\/td>\n

\n

Bispecific Fc fusion protein<\/span><\/p>\n<\/td>\n

\n

IV infusion<\/span><\/p>\n<\/td>\n

\n

CD80-lgG4 Fc-IL-2v<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

GI-102<\/span><\/p>\n<\/td>\n

\n

GI Innovation<\/span><\/p>\n<\/td>\n

\n

Advanced Solid Tumors<\/span><\/p>\n<\/td>\n

\n

I\/II<\/span><\/p>\n<\/td>\n

\n

Bispecific fusion protein<\/span><\/p>\n<\/td>\n

\n

IV infusion or SC<\/span><\/p>\n<\/td>\n

\n

Inhibits CTLA-4 and PD-L1 via CD80 synergize with potent activity of IL-2v3<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

TransCon IL-2 β\/γ<\/span><\/p>\n<\/td>\n

\n

Ascendis Pharma<\/span><\/p>\n<\/td>\n

\n

Locally Advanced or Metastatic Solid Tumor Malignancies<\/span><\/p>\n<\/td>\n

\n

I\/II<\/span><\/p>\n<\/td>\n

\n

Cytokine protein<\/span><\/p>\n<\/td>\n

\n

IV Infusion<\/span><\/p>\n<\/td>\n

\n

IL-2 β receptor agonists<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

AU-007<\/span><\/p>\n<\/td>\n

\n

Aulos Bioscience<\/span><\/p>\n<\/td>\n

\n

Unresectable locally advanced or metastatic cancer conditions<\/span><\/p>\n<\/td>\n

\n

I\/II<\/span><\/p>\n<\/td>\n

\n

Monoclonal antibody<\/span><\/p>\n<\/td>\n

\n

IV<\/span><\/p>\n<\/td>\n

\n

IL-2 receptor alpha subunit CD25 antagonists<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

SLC-3010<\/span><\/p>\n<\/td>\n

\n

Selecxine<\/span><\/p>\n<\/td>\n

\n

Advanced Solid Tumor<\/span><\/p>\n<\/td>\n

\n

I\/II<\/span><\/p>\n<\/td>\n

\n

Humanized antibody<\/span><\/p>\n<\/td>\n

\n

IV<\/span><\/p>\n<\/td>\n

\n

CD8+ T-lymphocyte stimulants<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

XTX202<\/span><\/p>\n<\/td>\n

\n

Xilio Therapeutics<\/span><\/p>\n<\/td>\n

\n

Advanced solid tumors (metastatic RCC or unresectable or metastatic melanoma)<\/span><\/p>\n<\/td>\n

\n

I\/II<\/span><\/p>\n<\/td>\n

\n

Tumor-activated beta-gamma biased, engineered IL-2 molecule<\/span><\/p>\n<\/td>\n

\n

IV<\/span><\/p>\n<\/td>\n

\n

IL-2 replacements<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Eciskafusp alfa (PD1-IL2v)<\/span><\/p>\n<\/td>\n

\n

Hoffmann-La Roche<\/span><\/p>\n<\/td>\n

\n

Advanced and\/or metastatic solid tumors<\/span><\/p>\n<\/td>\n

\n

Ib<\/span><\/p>\n<\/td>\n

\n

Recombinant fusion protein<\/span><\/p>\n<\/td>\n

\n

IV or SC<\/span><\/p>\n<\/td>\n

\n

IL-2 receptor agonists\/PD1 receptor antagonists<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

STK-012<\/span><\/p>\n<\/td>\n

\n

Synthekine<\/span><\/p>\n<\/td>\n

\n

Solid tumors (with a focus on NSCLC and RCC)<\/span><\/p>\n<\/td>\n

\n

Ia\/Ib<\/span><\/p>\n<\/td>\n

\n

Recombinant fusion proteins<\/span><\/p>\n<\/td>\n

\n

SC<\/span><\/p>\n<\/td>\n

\n

α\/β-Biased IL-2 partial agonist, IL-2 replacements<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

AB248<\/span><\/p>\n<\/td>\n

\n

Asher Bio<\/span><\/p>\n<\/td>\n

\n

Locally advanced or metastatic solid tumors (melanoma, RCC, NSCLC, and SCCHN)<\/span><\/p>\n<\/td>\n

\n

Ia\/Ib<\/span><\/p>\n<\/td>\n

\n

Fusion protein<\/span><\/p>\n<\/td>\n

\n

IV infusion<\/span><\/p>\n<\/td>\n

\n

IL-2 replacements<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

WTX-124<\/span><\/p>\n<\/td>\n

\n

Werewolf Therapeutics<\/span><\/p>\n<\/td>\n

\n

Advanced or metastatic solid tumors (metastatic melanoma, RCC CSCC, NSCLC<\/span><\/p>\n<\/td>\n

\n

I<\/span><\/p>\n<\/td>\n

\n

INDUKINE molecule<\/span><\/p>\n<\/td>\n

\n

IV<\/span><\/p>\n<\/td>\n

\n

IL-2 replacements<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

SAR444336 (THOR809)<\/span><\/p>\n<\/td>\n

\n

Sanofi<\/span><\/p>\n<\/td>\n

\n

Inflammatory indications<\/span><\/p>\n<\/td>\n

\n

I<\/span><\/p>\n<\/td>\n

\n

Recombinant protein<\/span><\/p>\n<\/td>\n

\n

SC<\/span><\/p>\n<\/td>\n

\n

IL-2 replacements<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

SYNCAR-001 + STK-009<\/span><\/p>\n<\/td>\n

\n

Synthekine<\/span><\/p>\n<\/td>\n

\n

CD19+ hematologic malignancies with or without lymphodepletion<\/span><\/p>\n<\/td>\n

\n

I<\/span><\/p>\n<\/td>\n

\n

SYNCAR-001 (CAR-T cell therapy); STK-009 (cytokine)<\/span><\/p>\n<\/td>\n

\n

SYNCAR-001 (IV) + STK-009 (SC)<\/span><\/p>\n<\/td>\n

\n

SYNCAR-001 (CD19 orthoCAR-T) + STK-009 (orthoIL-2)<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Patients with severe, refractory SLE and Lupus nephritis<\/span><\/p>\n<\/td>\n

\n

I<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Hepatocellular carcinoma<\/span><\/p>\n<\/td>\n

\n

IND<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

BNT 153<\/span><\/p>\n<\/td>\n

\n

BioNtech<\/span><\/p>\n<\/td>\n

\n

Solid tumors<\/span><\/p>\n<\/td>\n

\n

I<\/span><\/p>\n<\/td>\n

\n

Nucleoside-modified mRNA (modRNA)<\/span><\/p>\n<\/td>\n

\n

IV<\/span><\/p>\n<\/td>\n

\n

IL-2 stimulants<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Igrelimogene litadenorepvec (TILT 123)<\/span><\/p>\n<\/td>\n

\n

TILT Biotherapeutics<\/span><\/p>\n<\/td>\n

\n

Solid tumor (melanoma and SCCHN) refractory to or progressing after anti-PD(L)1<\/span><\/p>\n<\/td>\n

\n

I<\/span><\/p>\n<\/td>\n

\n

Oncolytic adenovirus<\/span><\/p>\n<\/td>\n

\n

IV\/intratumoral\/intraperitoneal\/intrapleural injection<\/span><\/p>\n<\/td>\n

\n

IL-2 expression stimulants<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Immune checkpoint inhibitor refractory NSCLC<\/span><\/p>\n<\/td>\n

\n

I<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Platinum-resistant or refractory ovarian cancer<\/span><\/p>\n<\/td>\n

\n

I<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

CUG252<\/span><\/p>\n<\/td>\n

\n

Cugene\/AbbVie<\/span><\/p>\n<\/td>\n

\n

Mild-to-moderate SLE<\/span><\/p>\n<\/td>\n

\n

I<\/span><\/p>\n<\/td>\n

\n

Peptide<\/span><\/p>\n<\/td>\n

\n

SC<\/span><\/p>\n<\/td>\n

\n

IL-2 replacements<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Diakine-DK210 (EGFR)<\/span><\/p>\n<\/td>\n

\n

DEKA Biosciences<\/span><\/p>\n<\/td>\n

\n

Locally advanced and\/or metastatic EGFR+ tumors<\/span><\/p>\n<\/td>\n

\n

I<\/span><\/p>\n<\/td>\n

\n

Fusion protein<\/span><\/p>\n<\/td>\n

\n

SC<\/span><\/p>\n<\/td>\n

\n

IL-2 replacements<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

DF6215<\/span><\/p>\n<\/td>\n

\n

Dragonfly Therapeutics<\/span><\/p>\n<\/td>\n

\n

Advanced (unresectable, recurrent, or metastatic) solid tumors<\/span><\/p>\n<\/td>\n

\n

I<\/span><\/p>\n<\/td>\n

\n

Pleiotropic cytokine<\/span><\/p>\n<\/td>\n

\n

IV<\/span><\/p>\n<\/td>\n

\n

IL-2Rα-active agonist<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

mRNA-6231<\/span><\/p>\n<\/td>\n

\n

ModernaTX<\/span><\/p>\n<\/td>\n

\n

Autoimmune diseases<\/span><\/p>\n<\/td>\n

\n

I<\/span><\/p>\n<\/td>\n

\n

Lipid nanoparticle encapsulated, mRNA-based therapy<\/span><\/p>\n<\/td>\n

\n

SC<\/span><\/p>\n<\/td>\n

\n

interleukin 2 mutein<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/span><\/span><\/div>\n\n\n\n

<\/div>\n\n\n\n

Several companies are engaged in the development of IL-2-based or targeting therapies, currently in the very early stages of development, specifically in the preclinical phase. These include Medicenna Therapeutics<\/strong> (MDNA223, MDNA209, MDNA113), a collaboration between Medicenna Therapeutics and Merck<\/strong> (MDNA223), Xilio Therapeutics<\/strong> (XTX501), Shanghai Junshi Biosciences<\/strong> (JS206), Egle Therapeutics<\/strong> (EGL001, EGL002, EGL003), Cue Biopharma<\/strong> (CUE-401), Iovance Biotherapeutics<\/strong> (IOV3001), among others.<\/p>\n\n\n\n

As the pipeline of IL-2-based therapies<\/a> grows, the future holds immense promise. Next-generation therapies<\/strong> are designed not only to extend survival in cancer patients but also to address the unmet medical needs of those suffering from autoimmune disorders. The ability to precisely modulate the immune system, enhancing its ability to fight disease without causing undue harm, is the hallmark of this new era of immune-based treatments<\/strong>.<\/p>\n\n\n\n

\"Interleukin-2<\/a><\/figure>\n","protected":false},"excerpt":{"rendered":"

Expected data readouts in 2025, filling the unmet need, and estimated market opportunity in Oncology, Immunological and Neurodegenerative Diseases In the evolving landscape of immunotherapy, Interleukin-2 (IL-2) therapies have carved a niche, particularly in the treatment of metastatic melanoma, metastatic renal cell carcinoma (mRCC), relapsed or refractory Peripheral T-cell Lymphoma (R\/R PTCL) and relapsed or […]<\/p>\n","protected":false},"author":14,"featured_media":30913,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[17],"tags":[22432,22433,22434,22435,22430,22431,22436,22400],"industry":[17225],"therapeutic_areas":[17227,17228],"class_list":["post-30911","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","tag-il-2","tag-il-2-inhibitors","tag-il-2-therapies","tag-il-2-therapy-market","tag-interleukin-2","tag-interleukin-2-inhibitors","tag-t-regulatory-cells","tag-treg-cell-based-therapies","industry-pharmaceutical","therapeutic_areas-immunological-and-autoimmune-disorders","therapeutic_areas-oncology"],"acf":[],"yoast_head":"\nInterleukin-2 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class=\"advgb-post-tax-term\">Interleukin-2<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Interleukin-2 Inhibitors<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">T-Regulatory Cells<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Treg Cell-based Therapies<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">IL-2<\/span>","<span class=\"advgb-post-tax-term\">IL-2 Inhibitors<\/span>","<span class=\"advgb-post-tax-term\">IL-2 Therapies<\/span>","<span class=\"advgb-post-tax-term\">IL-2 Therapy Market<\/span>","<span class=\"advgb-post-tax-term\">Interleukin-2<\/span>","<span class=\"advgb-post-tax-term\">Interleukin-2 Inhibitors<\/span>","<span class=\"advgb-post-tax-term\">T-Regulatory Cells<\/span>","<span class=\"advgb-post-tax-term\">Treg Cell-based Therapies<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 1 year 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