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Last update 11 Oct 2025

Aldesleukin

Last update 11 Oct 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Interleukins

Synonyms

125-L-Serine-2-133-interleukin 2, IL-2 (Chiron), Interleukin-2 (Chiron)

+ [12]

Target

IL-2R

Action

agonists, stimulants

Mechanism

IL-2R agonists(Interleukin-2 receptor agonists), Immunostimulants

Therapeutic Areas

NeoplasmsUrogenital DiseasesSkin and Musculoskeletal Diseases+ [8]

Active Indication

Renal Cell CarcinomaNeuroblastoma recurrentHPV positive oropharyngeal squamous cell carcinoma+ [33]

Inactive Indication

Acquired Immunodeficiency SyndromeAcute Basophilic LeukemiaAcute Eosinophilic Leukemia+ [112]

Originator Organization

Chiron Corp.

Active Organization

National Cancer Institute

Prometheus Biosciences, Inc.

Iovance Biotherapeutics, Inc.

+ [8]

Inactive Organization

Roger Williams Realty Corp.

City of Hope National Medical CenterJonsson Comprehensive Cancer Center

+ [17]

License Organization

Clinigen Ltd.

Novartis AG

Prometheus Biosciences, Inc.

+ [1]

Drug Highest PhaseApproved

First Approval Date

United States (05 May 1992),

Renal Cell Carcinoma

RegulationOrphan Drug (United States), Orphan Drug (South Korea)

Structure/Sequence

Sequence Code 720

Source: *****

425

Clinical Trials associated with Aldesleukin

NCT05821686

/ Not yet recruitingPhase 1/2IIT

Efficacy of Intralesional IL-2 for Resectable Triple Negative Breast Cancer

This study is a single arm, phase II pilot design. The study will evaluate the safety and efficacy of intralesional immunotherapy (e.g. IL-2) in early stage TNBC. The overall objective of the research study is to advance our knowledge of novel immunotherapies and routes of administration for the treatment of TNBC
HYPOTHESES: Neoadjuvant treatment of TNBC with intralesional IL-2 is safe and well tolerated and can produce a pathological response.
Aim 1: Examine the safety and possible efficacy of a novel neoadjuvant intralesional intervention (IL-2) for patients with early-stage TNBC.

Start Date02 Jan 2026

Sponsor / Collaborator

Nova Scotia Health Authority

NCT06904066

/ RecruitingPhase 1IIT

A Phase I Study of Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Other Hematologic Malignancies

Background:
Blood cancers (such as leukemias) can be hard to treat, especially if they have mutations in the TP53 or RAS genes. These mutations can cause the cancer cells to create substances called neoepitopes. Researchers want to test a method of treating blood cancers by altering a person s T cells (a type of immune cell) to target neoepitopes.
Objective:
To test the use of neoepitope-specific T cells in people with blood cancers
Eligibility:
People aged 18 to 75 years with any of 9 blood cancers.
Design:
Participants will have a bone marrow biopsy: A sample of soft tissue will be removed from inside a pelvic bone. This is needed to confirm their diagnosis and the TP53 and RAS mutations in their cancer cells. They will also have a skin biopsy to look for these mutations in other tissue.
Participants will undergo apheresis: Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein.
The T cells will be grown to become neoepitope-specific T cells.
Participants receive drugs for 3 days to prepare their body for the treatment. The modified T cells will be given through a tube inserted into a vein. Participants will need to remain in the clinic at least 7 days after treatment.
Participants will have 8 follow-up visits in the first year after treatment. They will have 6 more visits over the next 4 years. Long-term follow-up will go on for 10 more years.

Start Date15 Oct 2025

Sponsor / Collaborator

National Cancer Institute

NCT06626256

/ Not yet recruitingPhase 1IIT

A Phase 1 Safety and Efficacy Study of STIL101 for Injection in Locally Advanced, Unresectable, or Metastatic Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Renal Cell Carcinoma, Cervical Cancer, and Melanoma

This phase I trial tests the safety and side effects of STIL101 for injection and how well it works in treating patients with pancreatic cancer, colorectal cancer (CRC), renal cell cancer (RCC), cervical cancer (CC) and melanoma that has spread to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). STIL101 for injection, an autologous (made from the patients own cells) cellular therapy, is made up of specialized white blood cells called lymphocytes or "T cells" collected from a piece of the patients tumor tissue. The T cells collected from the tumor are then grown in a laboratory to create STIL101 for injection. STIL101 for injection is then given to the patient where it may attack the tumor. Giving chemotherapy, such as cyclophosphamide and fludarabine, helps prepare the body to receive STIL101 for injection in a way that allows the T cells the best opportunity to attack the tumor. Aldesleukin is a form of interleukin-2, a cytokine made by leukocytes. Aldesleukin increases the activity and growth of white blood cells called T lymphocytes and B lymphocytes. Giving STIL101 for injection may be safe, tolerable and/or effective in treating patients with locally advanced, metastatic or unresectable pancreatic cancer, CRC, RCC, CC and melanoma.

Start Date05 Oct 2025

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

100 Clinical Results associated with Aldesleukin

100 Translational Medicine associated with Aldesleukin

100 Patents (Medical) associated with Aldesleukin

2,963

Literatures (Medical) associated with Aldesleukin

01 Dec 2025·PROTEIN EXPRESSION AND PURIFICATION

High-efficient refolding and purification of recombinant human interleukin-2 from inclusion bodies

Article

Author: Wang, Shanshan ; Zhang, Sheng ; Wang, Jiayu ; Fang, Yuming ; Zhao, Xinyi ; Wang, Shuo ; Wang, Fei ; Yu, Jiawei ; Jing, Xiaoran ; Jiang, Junjun ; Liu, Yuxiao

Human interleukin-2 (hIL-2) serves as a crucial cytokine in the treatment of cancer and autoimmune disorders. Nevertheless, the advancement of research and clinical applications involving this cytokine has been hindered by the constraints associated with the production of recombinant human interleukin-2 (rhIL-2). This study presents a scalable and robust purification protocol for rhIL-2 derived from inclusion bodies (IBs) in Escherichia coli. Our results indicate that microfiltration-based method could improve the purity of the denatured IBs effectively, and various refolding conditions were assessed to improve the recovery of refolded rhIL-2, resulting in an increase in the refolding yield from 15 % to 45 %. Subsequently, purification through three-column chromatography could refine the refolded rhIL-2 efficiently. Ultimately, the robustness of the purification process is substantiated by three consecutive scale-up experiments, achieving a productivity of 4 mg rhIL-2/g cell pellets, alongside high product purity and significant product activity.

01 Sep 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Receptor-based bioassay for functional IL-2 quantification

Article

Author: Wang, Shanshan ; Shan, Xuelian ; Wang, Jiayu ; Gong, Grace ; Hu, Xinyue ; Xu, Shuangshuang ; Lu, Chuanwei ; Fang, Yuming

IL-2 is a potent cytokine that promotes multiple immune cells proliferation and activation. Accordingly, IL-2 based immunotherapies are emerging to treat cancers or AIDS by enhancing T cell growth and function. Besides, IL-2 is indispensable in in vitro cultivation of immune cells which is a critical step of CAR-T or CAR-NK immunotherapies. In bulk manufacturing of recombinant IL-2, E. coli expression system has several advantages such as low cost and rapid growth. However, high level protein expression in prokaryotic organisms often results in inactive insoluble aggregates, also known as inclusion bodies. It is crucial and most challenging work to solubilize and refold the protein of interest from inclusion bodies to generate its bioactive form. While multiple spectrum method had been applied to monitor the refolding process, the question of how to measure the refolding efficiency from the perspective of its biological function remained unaddressed. Here we present a receptor-based sandwich ELISA method to evaluate the bioactive product in samples and provide a guidance for manufacturing bioactive rhIL-2 (recombinant human IL-2) with prokaryotic expression system. Compared to traditional antibody-based ELISA method, this novel approach truly measures the presence of functional rhIL-2 and also potentially allows the detection of rhIL-2 variants with modifications like PEGylation as it doesn't rely on the exact amino acid sequence.

01 Jul 2025·CYTOKINE

The role of interleukin (IL)-2 cytokine family in Parkinson's disease

Review

Author: Daglia, Maria ; Tabari, Mohammad Amin Khazeei ; Larsen, Danaé S ; Amini, Alireza ; Sanaye, Pantea Majma ; Khan, Haroon ; Alsharif, Khalaf F ; Hadipour, Mahboube ; Goleij, Pouya

Parkinson's disease (PD) is a neurodegenerative disorder, which primarily impacts the nervous system, marked by its immune and inflammatory characteristics. The interleukin-2 (IL-2) cytokine family has a crucial role in regulating both neuroinflammation and immune activity, positioning it as one of the critical immune pathways in PD. Balancing pro-inflammatory and anti-inflammatory signals in PD heavily depends on the IL-2 cytokine family, that includes IL-2, IL-4, IL-7, IL-9, IL-15 and IL-21. This balance is vital for neuron survival and resistance to degeneration. Disruptions in IL-2 signaling can upset the equilibrium among regulatory T cells (Tregs) and pro-inflammatory T cells, such as Th1 and Th17, further aggravating the chronic neuroinflammation typical of PD. In PD, a decline in IL-2 or receptor dysfunction can hinder Treg activity, leading to increased inflammation and neurodegeneration. Similarly, IL-15 and IL-21 supports cytotoxic immune cell function, including natural killer (NK) cells and CD8+ T cells, which may exacerbate neuronal damage by sustaining pro-inflammatory processes. Moreover, IL-4 and IL-7 have anti-inflammatory roles in maintaining T cell homeostasis, and their dysregulation can contribute to interruption of the blood-brain barrier and increased infiltration of immune cells into the central nervous system. Targeting the IL-2 cytokine family in Parkinson's disease has shown therapeutic potential by expanding Tregs, which reduce neuroinflammation and promote dopaminergic neuron survival. Recombinant IL-2 and IL-2/anti-IL-2 complexes have demonstrated efficacy in animal models, enhancing Treg function and leading to improved neuroprotection. Additionally, IL-4-based therapies have been explored for their ability to shift microglia toward a neuroprotective phenotype, further enhancing neuronal survival by modulating inflammatory responses and cellular metabolism. Current research is exploring how to optimize cytokine delivery while minimizing immune side effects, with the goal of developing more targeted therapies for PD.

136

News (Medical) associated with Aldesleukin

14 Aug 2025

·www.prnewswire.com

Cancer Treatment Stocks Surge as $866B Market Attracts Private Investment

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Aug. 14, 2025 /PRNewswire/ -- USA News Group News Commentary – Federal budget cuts have put pressure on cancer research efforts in the United States, but private investment is helping to fill the gap, with oncology ventures securing hundreds of millions in funding so far in 2025. The Senate's recent restoration of $15 million for the Pancreatic Cancer Research Program (PCARP) was a win, yet its earlier elimination underscored the fragility of public support. Against this backdrop, investors are zeroing in on companies with standout science, solid pipelines, and clear regulatory strategies, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), Fate Therapeutics, Inc. (NASDAQ: FATE), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), and Nektar Therapeutics (NASDAQ: NKTR). Global Market Insights estimates the global oncology market at US$345.1 billion in 2025 and forecasts it will climb to US$866.1 billion by 2034, growing at a robust 10.8% CAGR. The U.S. alone is expected to contribute $377.1 billion to that total. Vision Research Reports projects an even larger figure for the global cancer drug sector, predicting it will surpass US$900 billion in sales by 2034. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has officially entered the most critical phase of its development journey—pursuing a potential registration-enabling trial in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) for its flagship asset, pelareorep. In its latest Q2 2025 report, the company confirmed it has begun formal discussions with the U.S. Food and Drug Administration (FDA) aimed at finalizing a pivotal study design, with trial start-up activities expected to begin as early as Q4 2025. For investors and potential partners, this represents a clear transition from promising clinical data to potential regulatory approval in one of medicine's most challenging cancer types. "We have turned the corner from proof-of-concept studies and will be sprinting toward regulatory clarity for the remainder of the year," said Jared Kelly, CEO of Oncolytics. "As we shore up our intellectual property, get a clear registration path for pelareorep, and allow our GOBLET data to mature, we will establish our position as the only platform immunotherapy in gastrointestinal tumors." The strategic focus on mPDAC reflects both compelling clinical results and a significant market opportunity. Pelareorep is a systemically delivered oncolytic virus designed to convert immunologically "cold" tumors—those typically invisible to the immune system—into "hot" tumors that can respond to immunotherapy. In first-line pancreatic cancer studies, pelareorep-based regimens have demonstrated a notable 21.9% two-year overall survival rate, compared to a 9.2% historical benchmark for standard chemotherapy alone. Even more compelling, when pelareorep was combined with chemotherapy and a checkpoint inhibitor, researchers recorded a 62% objective response rate—particularly significant given that checkpoint inhibitors are not currently approved for use in this indication. These results stem from pelareorep's dual mechanism: it both replicates within cancer cells and activates the body's immune response against tumors. "This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME—all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep." Translational data from the GOBLET and AWARE-1 studies demonstrate how pelareorep transforms the tumor microenvironment, increasing PD-L1 expression, heightening interferon signaling, and mobilizing tumor-infiltrating lymphocytes in the blood—changes that correlate with tumor size reduction. This mechanistic validation, combined with survival data from over 1,100 patients across multiple studies, has solidified the company's decision to prioritize this indication. Oncolytics' execution-focused strategy is being led by Jared Kelly and Andrew Aromando, who both played key roles in Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Kelly was appointed CEO earlier this year, while Aromando recently joined as Chief Business Officer. In line with their focus on capital efficiency, the company has terminated its At-the-Market and Equity Line of Credit facilities, citing sufficient resources to advance key milestones without near-term shareholder dilution. Regulatory advantages are already in place to accelerate development. Pelareorep holds Fast Track and Orphan Drug designations for pancreatic cancer from the FDA, meaning the agency has already recognized both the drug's potential and the serious unmet need in this patient population. These statuses streamline review processes and enhance the program's attractiveness to potential pharmaceutical partners. The context underscores the opportunity: pancreatic cancer remains one of the deadliest common cancers, with a five-year survival rate of less than 14%. Unlike other cancers where immunotherapies have transformed treatment, mPDAC has largely resisted immunotherapeutic approaches—making pelareorep's immune-activating mechanism particularly promising for this underserved patient population. Back in July, Oncolytics hosted a key opinion leader event featuring gastrointestinal cancer experts who reviewed survival outcomes for patients and biomarker validation. The expert panel reinforced the view that pelareorep's mechanism of activating innate and adaptive immune responses is both biologically sound and commercially relevant for first-line mPDAC treatment. With this latest milestone, Oncolytics is entering a phase where FDA feedback will shape both clinical plans and potential commercial partnerships. If the agency accepts the company's proposed trial framework centered on an overall survival endpoint, the resulting study could provide definitive proof of pelareorep's market potential in mPDAC. The company expects to provide an updated clinical timeline in Q3 2025, with trial start-up activities potentially beginning as early as Q4 2025. With compelling survival data, regulatory designations in place, and an experienced leadership team driving execution, Oncolytics is positioning pelareorep for a pivotal test in one of oncology's most challenging and underserved markets. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) reported strong Q2 2025 results with $60 million in total product revenue, driven primarily by its breakthrough melanoma therapy Amtagvi, which treated over 100 patients in the second quarter. "Growth for Amtagvi and Proleukin will continue in the second half of 2025 as existing ATC growth continues and large community practices begin treating patients," said Frederick Vogt, Ph.D., J.D., Interim President and CEO of Iovance. "We expect our first ex-U.S. regulatory approval imminently and remain on track to provide updates on our clinical programs." The company's tumor-infiltrating lymphocyte (TIL) therapy—which uses a patient's own immune cells to fight cancer—generated $54.1 million in revenue and represents the first FDA-approved T-cell therapy for solid tumors, offering new hope for advanced melanoma patients who have tried other treatments without success. With expanded clinical trials planned for lung cancer and endometrial cancer, plus international approvals expected in Canada and other markets, Iovance is positioned to bring its innovative cancer treatment to patients worldwide. Fate Therapeutics, Inc. (NASDAQ: FATE) recently announced promising clinical progress for its off-the-shelf CAR T-cell therapy FT819, which showed lasting responses in lupus patients and received FDA clearance to begin trials for a solid tumor program targeting MICA/B proteins. While primarily focused on autoimmune diseases, the company's next-generation FT836 CAR T-cell therapy represents a significant advancement in cancer treatment as it's designed to target solid tumors without requiring harsh conditioning chemotherapy, potentially making the treatment safer and more accessible. "Building on this momentum, we are also working closely with the FDA under our RMAT designation with the goal of commencing our registrational study for FT819 in SLE and LN in 2026," said Bob Valamehr, Ph.D., MBA, President and CEO of Fate Therapeutics. "Additionally, we continue to strengthen our broader pipeline programs with an extended partnership with Ono Pharmaceuticals, and advancements in bringing our next-generation, off-the-shelf CAR T cells with Sword and Shield™ technology toward the clinic." The company's stem cell-based platform continues to advance multiple programs, including partnerships for HER2-positive solid tumors, positioning Fate as a leader in developing ready-made cancer cell therapies. Inovio Pharmaceuticals, Inc. (NASDAQ: INO) remains on track to submit its application for INO-3107 in the second half of 2025, targeting Recurrent Respiratory Papillomatosis (RRP), a rare cancer-related condition caused by HPV that affects the airways. The company's DNA medicine platform represents a novel approach to treating HPV-related diseases and cancers, with INO-3107 showing significant clinical benefit by reducing the need for repeated surgeries in RRP patients from an average of 4.1 procedures annually to just 0.9 procedures. "We believe that INO-3107 could become the preferred treatment option for Recurrent Respiratory Papillomatosis (RRP) patients and their physicians—a treatment option with the potential to change the trajectory of this disease," said Dr. Jacqueline Shea, President and CEO of INOVIO. "I look forward to building on the significant progress of this past quarter and providing updates as we work toward a potential approval date in mid-2026." Beyond RRP, Inovio's technology platform is designed to treat various HPV-related cancers and other tumors by teaching the body's immune system to recognize and fight cancer cells. With breakthrough therapy designation from the FDA and plans for a trial involving 100 patients, INO-3107 could become the first DNA-based therapy approved for treating this serious cancer-related condition. Nektar Therapeutics (NASDAQ: NKTR) reported impressive Phase 2b data for rezpegaldesleukin in treating moderate to severe atopic dermatitis, with the company positioning this immune system regulator as a first-in-class treatment for autoimmune diseases. While primarily focused on autoimmune conditions, Nektar's pipeline includes NKTR-255, a treatment designed to boost the immune system's ability to fight cancer, which is being tested in multiple ongoing clinical trials with various partners. "As a first-in-class, T regulatory cell biologic, rezpegaldesleukin is poised to become an important novel mechanism to treat millions of patients with autoimmune disorders," said Howard W. Robin, President and CEO of Nektar. "Finally, we are making significant progress on advancing preclinical studies with a new bispecific antibody, NKTR-0166, which combines the TNFR2 epitope with a validated antibody target." The company's technology platform creates novel treatments that could potentially address both autoimmune diseases and cancer by enhancing the immune system's cancer-fighting abilities. With additional data expected from hair loss trials in December 2025 and continued development of next-generation programs, Nektar is advancing a unique approach to immune system therapy that could benefit millions of patients with serious diseases. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. Logo - SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 2Orphan DrugClinical Result

16 Jul 2025

·pipelinereview.com

Genetic Leap receives FDA IND clearance for first-in-class, oral natural IL-2 modulator

– GL-IL2-138 is a small molecule RNA agent that modulates natural IL-2, allowing for downregulating or upregulating the immune system to fight devastating diseases – Potential to unite Humira-grade inflammation control and Keytruda-class anti-cancer power in a single pill, without the drawbacks NEW YORK, NY, USA I July 16, 2025 I Genetic Leap, a clinical stage, AI-native biotech pioneering RNA genetic therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for GL-IL2-138, the company’s small-molecule modulator of natural interleukin-2 (IL-2). IL-2 is a pleiotropic cytokine that regulates the careful homeostatic balance between immune tolerance and activation. The tremendous potential of IL-2 to address multiple major diseases is universally recognized. Recombinant IL-2 protein (rIL-2) was the first FDA-approved immunotherapy proven effective against cancer at high dose, though toxicity has historically limited its use. And low dose rIL-2 is clinically effective in autoimmune and neurodegeneration diseases. But numerous attempts by pharma companies to remove toxicity from rIL-2 muteins have flopped, earning IL-2 its reputation as an impossible target. Genetic Leap addressed this herculean challenge by developing a small molecule drug that binds endogenous IL-2 mRNA to drive controlled, systemic production of natural IL-2 protein by immune cells, which has many advantages over rIL-2 including: “We created the Genetic Leap AI platform to deliver breakthroughs like GL-IL2-138,” said Dr. Bertrand Adanve, Founder and CEO of Genetic Leap. “Innovative medicine that defies known scientific limitations, like a sci-fi drug made real. GL-IL2-138 is like combining Humira (leading autoimmune biologic) and Keytruda (leading cancer biologic) into one oral pill without the downsides and applicable to even more diseases. GL-IL2-138 is poised to be a giant leap for human health, and Genetic Leap is the company making it happen.” The drug will now be tested in a randomized, double-blind, placebo-controlled phase 1 clinical trial to evaluate its tolerability, pharmacokinetics and pharmacodynamics in humans. About Genetic Leap Genetic Leap is innovating at the cutting edge of AI and RNA genetic therapeutics to redefine drug development and more quickly address the health needs of millions of people. For more information, please visit www.genetic-leap.com or our LinkedIn . SOURCE: Genetic Leap

Phase 1INDImmunotherapy

14 Jul 2025

·www.globenewswire.com

Real-World Data Demonstrate a 49% Response Rate for Commercial Amtagvi® in Patients with Advanced Melanoma

61% Response Rate Observed in Third-Line or Earlier Patients SAN CARLOS, Calif., July 14, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that a real-world, retrospective study demonstrates the benefit of commercial Amtagvi® (lifileucel) in real-world clinical settings for patients with advanced (unresectable or metastatic) melanoma previously treated with immune checkpoint inhibitor (ICI) therapy and, if appropriate, targeted therapy. Among 41 evaluable patients treated at four authorized treatment centers, the physician-assessed objective response rate (ORR) was 48.8% (20/41). Response rates with Amtagvi were higher in third-line or earlier patients (two or fewer prior lines of therapy) with an ORR of 60.9% (14/23). An ORR of 33.3% (6/18) was observed in patients following three or more prior lines of therapy. All evaluable patients received commercial Amtagvi according to the U.S. prescribing information and completed at least one follow-up physician assessment. Additional results and follow-up from the real-world clinical study will be presented at an upcoming medical meeting this year. Lilit Karapetyan, MD, MS of H. Lee Moffitt Cancer Center & Research Institute stated, “Lifileucel demonstrates a robust response rate in real-world clinical settings. I am particularly encouraged by the higher response rate in less heavily treated patients. It is remarkable to observe a response in more than half of those patients, supporting consideration of lifileucel as soon as possible after ICI therapy. I am confident in the potential for positive outcomes in more patients as we continue to adopt lifileucel.” In February 2024, the U.S. Food and Drug Administration granted accelerated approval to Amtagvi for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. The approval was based on overall response rate and duration of response from the C-144-01 clinical trial. With this approval, Amtagvi became the first one-time T cell therapy for a solid tumor cancer as well as the first approved treatment option for patients with advanced melanoma after anti-PD-1 and targeted therapy. Iovance is also conducting TILVANCE-301, a Phase 3 trial in frontline advanced melanoma to confirm clinical benefit. About Amtagvi® Amtagvi is a prescription medicine used to treat adults with a type of skin cancer that cannot be removed surgically or has spread to other parts of the body called unresectable or metastatic melanoma. Amtagvi is used when your melanoma has not responded or stopped responding to a PD-1 blocking drug either by itself or in a combination, and if your cancer is BRAF mutation positive, a BRAF inhibitor drug with or without a MEK inhibitor drug that has also stopped working. The approval of Amtagvi is based on a study that measured response rate. Continued approval for this use may depend on the results of an ongoing study to confirm benefit. Important Safety Information What is the most important information that I should know about Amtagvi? You will likely be in a hospital prior to and after receiving Amtagvi. Before taking Amtagvi, tell your healthcare provider about all of your medical conditions, including if you: Have any lung, heart, liver or kidney problemsHave low blood pressureHave a recent or active infection or other inflammatory conditions including cytomegalovirus (CMV) infection, hepatitis B or C or human immunodeficiency virus (HIV) infectionAre pregnant, think you may be pregnant, or plan to become pregnantAre breastfeedingNotice the symptoms of your cancer are getting worseHave had a vaccination in the past 28 days or plan to have one in the next few monthsHave been taking a blood thinner Tell your doctor about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive Amtagvi? Amtagvi is made from your surgically removed tumor. Tumor derived T cells are grown in a manufacturing center at the end of which they number in the billions of cells.Your tumor tissue is sent to a manufacturing center to make Amtagvi. It takes about 34 days from the time your tumor tissue is received at the manufacturing center until Amtagvi is available to be shipped back to your healthcare provider, but the time may vary. Your Amtagvi will be provided in 1-4 patient-specific infusion bag(s) containing 100 mL to 125 mL of viable (alive) cells per bag.After your Amtagvi arrives at your treating institution, your healthcare provider will give you lymphodepleting chemotherapy to prepare your body.Approximately 30 to 60 minutes before you are given Amtagvi, you may be given other medicines including: Medicines for an allergic reaction (anti-histamines)Medicines for fever (such as acetaminophen) Your Amtagvi will be provided in 1 to 4 infusion bag(s) containing 100 mL to 125 mL of viable cells per bag. When your body is ready for Amtagvi infusion, your healthcare provider will give Amtagvi to you by intravenous infusion. This usually takes less than 90 minutes. After getting Amtagvi Beginning 3 to 24 hours after Amtagvi is given, you may be given up to 6 doses of IL-2 (aldesleukin) every 8 to 12 hours via intravenous infusion. Your doctor may discontinue IL-2 (aldesleukin) infusion any time if you have severe side effects. You will have to stay in the hospital until you have completed the IL-2 (aldesleukin) treatment and you have recovered from any serious side effects associated with the Amtagvi treatment. You should plan to stay within 2 hours of the location where you received your treatment for several weeks after getting Amtagvi. Your healthcare provider will check to see if your treatment is working and help you with any side effects that occur. What are the possible side effects of Amtagvi? The most common side effects of the Amtagvi treatment include chills, fever, low white blood cell count (may increase risk of infections), fatigue, low red blood cell count (may cause you to feel tired or weak), fast or irregular heartbeat, rash, low blood pressure, and diarrhea. These are not all the possible side effects of the Amtagvi treatment. Talk with your healthcare provider for more information about Amtagvi. You can ask your healthcare provider for information about Amtagvi that is written for healthcare professionals. You may report side effects to Iovance at 1-833-400-4682, or to the FDA, at 1-800-FDA-1088 or at www.fda.gov/medwatch. Please see Full Prescribing Information and Patient Information, including Boxed Warning, for additional Important Safety Information. About Iovance Biotherapeutics, Inc. Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit http://www.iovance.com/. Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners. Forward-Looking Statements Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products, including Amtagvi, for which we have obtained U.S. Food and Drug Administration (“FDA”) approval, and Proleukin, for which we have obtained FDA and European Medicines Agency (“EMA”) approval; the risk that the EMA or other ex-U.S. regulatory authorities may not approve or may delay approval for our marketing authorization application submission for lifileucel in metastatic melanoma; the acceptance by the market of our products, including Amtagvi and Proleukin, and their potential pricing and/or reimbursement by payors, if approved (in the case of our product candidates), in the U.S. and other international markets and whether such acceptance is sufficient to support continued commercialization or development of our products, including Amtagvi and Proleukin, or product candidates, respectively; future competitive or other market factors may adversely affect the commercial potential for Amtagvi or Proleukin; the risk regarding our ability or inability to manufacture our therapies using third party manufacturers or at our own facility, including our ability to increase manufacturing capacity at such third party manufacturers and our own facility, may adversely affect our commercial launch; the results of clinical trials with collaborators using different manufacturing processes may not be reflected in our sponsored trials; the risk regarding the successful integration of the recent Proleukin acquisition; the risk that the successful development or commercialization of our products, including Amtagvi and Proleukin, may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain FDA, EMA, or other regulatory authority approval of, or other action with respect to, our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with the FDA, EMA, or other regulatory authorities may support registrational studies and subsequent approvals by the FDA, EMA, or other regulatory authorities, including the risk that the planned single arm Phase 2 IOV-LUN-202 trial may not support registration; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that enrollment may need to be adjusted for our trials and cohorts within those trials based on FDA and other regulatory agency input; the risk that the changing landscape of care for cervical cancer patients may impact our clinical trials in this indication; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from the FDA, EMA, or other regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with the FDA, EMA, or other regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities (including from our prior meetings with the FDA regarding our non-small cell lung cancer clinical trials); the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues may not continue to serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global pandemic; the effects of global and domestic geopolitical factors; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates. CONTACTS InvestorsIR@iovance.com650-260-7120 ext. 150 MediaPR@iovance.com 650-260-7120 ext. 150

Phase 3ImmunotherapyClinical ResultAccelerated ApprovalCell Therapy

100 Deals associated with Aldesleukin

External Link

KEGG	Wiki	ATC	Drug Bank
D00748	-	L03AC01	DB00041

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Renal Cell Carcinoma	United States	Chiron Corp.	05 May 1992

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
High Risk Neuroblastoma	Phase 3	United States	National Cancer Institute	21 Dec 2009
Acute Myeloid Leukemia	Phase 3	France	Chiron Corp.	01 Mar 2005
Neuroblastoma recurrent	Phase 3	United States	National Cancer Institute	18 Oct 2001
Neuroblastoma recurrent	Phase 3	Australia	National Cancer Institute	18 Oct 2001
Neuroblastoma recurrent	Phase 3	Canada	National Cancer Institute	18 Oct 2001
Neuroblastoma recurrent	Phase 3	New Zealand	National Cancer Institute	18 Oct 2001
Acute Basophilic Leukemia	Phase 3	United States	National Cancer Institute	01 Nov 2000
Acute Eosinophilic Leukemia	Phase 3	United States	National Cancer Institute	01 Nov 2000
Adult Acute Monoblastic and Monocytic Leukemia	Phase 3	United States	National Cancer Institute	01 Nov 2000
Adult acute myeloid leukemia with del(5q)	Phase 3	United States	National Cancer Institute	01 Nov 2000

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AU-007 (AACR2025)	Phase 2	Advanced Malignant Solid Neoplasm	86	AU-007	wihhyjpvxd(tuuorehyxj) = no Grade 5 TRAE occurred dzbogvjgws (cqeofmvypn )	Positive	29 Apr 2025
NCT02500576 (CTgov)	Phase 2	Melanoma, Cutaneous Malignant \| Metastatic melanoma	18	I2+fludarabine+cyclophosphamide+MK-3475 (Arm 1)	ycdiutxwoe = oqqkfjvajv juplwqmfly (egtihxcswa, hnhocutzxc - lzmqxfqjai) View more	-	15 Jan 2025
				TIL+fludarabine+cyclophosphamide+MK-3475+IL-2 (Arm 2)	ycdiutxwoe = xfwujcezft juplwqmfly (egtihxcswa, trfpwgmxzi - nifkdzcrve) View more
NCT03318900 (CTgov)	Phase 1/2	Recurrent ovarian cancer \| Platinum-Resistant Ovarian Carcinoma	5	Cyclophosphamide+IL-2 (Dose Level 1)	imhvacwgzh(qfemxffzsx) = rieagymett hunihpugpx (dlijklgvrs, slqkltxbsm - fwcfoocjeq) View more	-	07 Nov 2024
				Cyclophosphamide+IL-2 (Dose Level 2)	imhvacwgzh(qfemxffzsx) = nitdsqsdsr hunihpugpx (dlijklgvrs, hpibiszoas - kwysmskpmv) View more
NCT05267626 (SITC2024) Manual	Phase 1/2	Advanced Malignant Solid Neoplasm	-	AU-007	gzyqdpadsx(tftbxknztf) = None xpitzaglwf (xcqobuhroz ) View more	Positive	05 Nov 2024
				AU-007 + aldesleukin
NCT03296137 (2017-002323-25 \| ###DELETE, CTgov)	Phase 1/2	Neoplasm Metastasis \| Neoplasms	25	infiltrating lymphocytes+ipilimumab+Fludara+Cyclophosphamide+Nivolumab+proleukin (All Participants)	tcqmctojon = naxyhweprk sjbsyvygae (pyzanazjyj, tieqlixkbr - vgbzxvztcd) View more	-	26 Oct 2024
				infiltrating lymphocytes+ipilimumab+Fludara+Cyclophosphamide+Nivolumab+proleukin (Treated Participants)	bxpkbnjkxj(tyzjbtfoys) = hqneuoliml pkcqukdqmn (fkcqdmrpcb, ejcdztwcdl - towpovjyhs) View more
NCT02027935 (CTgov)	Phase 2	Metastatic melanoma	16	Autologous CD8+ Melanoma Specific T Cells+Ipilimumab+Cyclophosphamide+Aldesleukin	fwbjpqenru(rmzhyjmceh) = wlfhfxqimn fnkiudeamk (pjauvupcvf, iikgmjiije - duznrmfjge) View more	-	08 Oct 2024
NCT03233828 (IL-2, CTgov)	Phase 3	Melanoma, Cutaneous Malignant \| Visible Lesion	1	Aldesleukin (Intralesional IL-2 Injection)	ipiycyozji(xebtkzpvzo) = xdyzqtfute aehepjqwsa (dsejbtyzuy, nbdaqjnnsl - clqlefprdg) View more	-	24 Jul 2024
				Saline (Saline Injection)	ipiycyozji(xebtkzpvzo) = eyxsykiftv aehepjqwsa (dsejbtyzuy, atucmpkdgs - umeqvobhnz) View more
NCT03007238 (CTgov)	Phase 2	Steroid Refractory Graft Versus Host Disease \| Chronic graft-versus-host disease	10	ECP (Treatment (ECP+IL-2))	uqcrzhpwgk = imerthoqgm yicvvuside (hbmvoryzot, lpczhrblvq - htuiukkudf) View more	-	08 Apr 2024
				ECP (Overall Study)	cruxtzvtcq = ytvhqonzoa cptzwdmjwn (opdftfrtqj, wvqikrqpve - skqtofbdfd) View more
NCT01856023 (PROCLIVITY02, CTgov)	Phase 4	Metastatic melanoma	29	Ipilimumab+High Dose Interleukin-2 (Treatment Arm 1)	svytndyhdj = qpbvnocxnu rxbpewveic (vrotmnsfkq, sqsrossymp - gwyppqiqmr)	-	05 Dec 2023
				Ipilimumab+High Dose Interleukin-2 (Treatment Arm 2)	svytndyhdj = ekdzofieab rxbpewveic (vrotmnsfkq, orjgitxjuh - wjzkwtrcfy)
NCT02620865 (CTgov)	Phase 1/2	Pancreatic adenocarcinoma metastatic	2	Laboratory Biomarker Analysis+Paclitaxel Albumin-Stabilized Nanoparticle Formulation+Leucovorin Calcium+Gemcitabine Hydrochloride+Sargramostim+Aldesleukin+oxaliplatin+Irinotecan Hydrochloride+Fluorouracil	jdwxndxovz(mfpndigywr) = zukzsdpgzp vfcatzaonl (ojwimxjcbs, geojnqudpu - ieelknsulr) View more	-	15 May 2023

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