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Last update 18 Apr 2025

Aldesleukin

Last update 18 Apr 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 recurrentMalignant melanoma, metastatic+ [32]

Inactive Indication

Acquired Immunodeficiency SyndromeAcute Basophilic LeukemiaAcute Eosinophilic Leukemia+ [113]

Originator Organization

Chiron Corp.

Active Organization

National Cancer Institute

Prometheus Biosciences, Inc.

Iovance Biotherapeutics, Inc.

+ [8]

Inactive Organization

Barbara Ann Karmanos Cancer InstituteNational Institutes of Health Clinical Center

National Institute on Aging

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: *****

412

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

NCT06204991

/ Not yet recruitingPhase 1IIT

Phase 1 Study to Evaluate the Safety and Efficacy of TILs Transduced With IL-7 (ADP-TILIL7) in Patients With Locally Advanced or Metastatic Melanoma

The primary objective of this Phase 1 clinical trial is to evaluate the feasibility and tolerability of a novel generation of gene-modified tumor infiltrating lymphocytes (TILs) in a cohort of 10 patients aged 18-75 diagnosed with unresectable or metastatic melanoma. TILs will undergo transduction with the Interleukin-7 (IL-7) gene, for IL-7 production upon antigen engagement.
Participants will undergo:
* screening
* tumor operation following autologous TIL production (incl. transduction) - takes approximately 4-6 weeks
* admission for lymphodepleting chemotherapy (Cyclophosphamide and Fludarabine phosphate), TIL infusion and high-dose IL-2 infusions for a maximum of 6 doses
* Following treatment, patients will undergo systematic and regularly planned assessments, encompassing clinical evaluation, biochemistry analyses, and PET/CT scans. This thorough follow-up regimen will be continued until any of the following events occur: progressive disease, withdrawal from study, or end of study, which spans a duration of 15 years for trials involving genetically modified organisms.

Start Date01 May 2025

Sponsor / Collaborator

Herlev Hospital

[+1]

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 Date30 Apr 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

2,983

Literatures (Medical) associated with Aldesleukin

01 Jul 2025·JOURNAL OF NEUROIMMUNOLOGY

Autoantigen and IL-2 activated CD4+CD25+T regulatory cells are induced to express CD8 and are autoantigen specific in inhibiting experimental autoimmune encephalomyelitis

Article

Author: Bedi, Sukhandep ; Tran, Giang T ; Hodgkinson, Suzanne J ; Robinson, Catherine M ; Al-Atiyah, Ranje ; Verma, Nirupama D ; Carter, Nicole ; Hall, Bruce M ; Rakesh, Prateek

Experimental autoimmune encephalomyelitis (EAE) induced by immunization with myelin basic protein (MBP) is a self-limiting disease model of multiple sclerosis. CD4⁺CD25⁺Foxp3⁺T cells play a role in limiting autoimmune disease but treatment with antigen naïve CD4⁺CD25⁺ cells does not reduce EAE. This study examined if in vitro activation by MBP and rIL-2 induced CD4⁺CD25⁺Foxp3⁺ cells that could inhibit EAE. Culture of CD4⁺CD8^-CD25⁺cells from naïve rats with MBP and rIL-2 induced activated Treg that reduced the severity of clinical EAE and infiltration of CD8⁺T cells and macrophage into brain stem. CD4⁺CD25⁺T cells activated by an irrelevant autoantigen and rIL-2 did not suppress EAE. Resting CD4⁺CD25⁺T cells activated by autoantigen and rIL-2 have mRNA for Infgr, Il12rb2, Il5 but not Tbet, Gata3, Ilr5ra or Ifng. These changes in mRNA expression are the markers of Ts1 cells. A proportion of CD4⁺CD8^-CD25⁺ cells activated by MBP/rIL-2 were induced to express CD8α, CD8β and CD62L. Depletion of CD4⁺CD8α⁺CD25⁺ cells removed the capacity of MBP and rIL-2 activated CD4⁺CD25⁺T cells to suppress EAE. This study demonstrated that in vitro activation of CD4⁺CD8^-CD25⁺ cells by MBP/rIL-2 induced relevant antigen-specific Treg within days, which expressed CD8α, CD8β and CD62L with a Ts1 phenotype and that had greater potency than freshly isolated antigen naive CD4⁺CD25⁺Treg in suppressing clinical severity of EAE and immune inflammation in CNS. These findings may guide development of antigen-specific Treg for therapy.

18 Apr 2025·Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences

[Biological activity and antitumor effect of long-acting recombinant human interleukin-2 drug].

Article

Author: Zhang, Fengxia ; Zhu, Jingjing ; Jin, Ting ; Liang, Xuejun

OBJECTIVE:

To investigate the biological activity and antitumor effect of pegylated recombinant human interleukin 2 (PEG-rhIL-2) obtained by site-specific conjugation of polyethylene glycol (PEG) with non-natural amino acids, and to explore its antitumor mechanism.

METHODS:

The binding activities of PEG-rhIL-2 at three different sites (T41, Y45, and V91) to human interleukin 2 receptors α (IL-2R_α) and β (IL-2R_β) and were detected by surface plasmon resonance (SPR) technology. Western blot was used to detect the levels of the Janus kinase-signal transducer and activator of transcription 5 (JAK-STAT5) signaling pathway activated by different doses of rhIL-2 and PEG-rhIL-2 in CTTL-2 and YT cells. Blood was collected after a single administration in mice to detect the drug concentration at different time points and evaluate the pharmacokinetic parameters of Y45-PEG-rhIL-2. Mouse hepatoma cell line Hepa1-6, pancreatic cancer cell line Pan-02, and colon cancer cell line MC-38 were selected. Tumor models were constructed in C57BL/6 mice. Different doses of Y45-PEG-rhIL-2 and excipient control were administrated respectively to evaluate the tumor suppression effect of the drug. In the MC-38 colon cancer model, the tumor suppression effect of Y45-PEG-rhIL-2 combined with anti-programmed death-1 (PD-1) monoclonal antibody was evaluated. Hepa1-6 mouse tumor models were constructed and rhIL-2, Y45-rhIL-2 and Y45-PEG-rhIL-2 were administrated respectively. The proportion of tumor-infiltrating lymphocytes was analyzed by flow cytometry.

RESULTS:

The SPR detection results showed that the binding activities of PEG-rhIL-2 to IL-2R_α/IL-2R_β were both reduced. The affinity of Y45-PEG-rhIL-2 to IL-2R_α was reduced to approximately 1/250, and its affinity to IL-2R_β was reduced to 1/3. Western blot results showed that the activity of Y45-PEG-rhIL-2 in stimulating JAK-STAT5 signaling in CTLL-2 cells expressing heterotrimeric IL-2 receptor complex IL-2R_αβγwas reduced to approximately 1/300, while its activity in YT cells expressing heterodimeric IL-2 receptor complex IL-2R_βγwas reduced to approximately 1/3. The pharmacokinetic evaluation after a single dose in the mice showed that the elimination half-life of Y45-PEG-rhIL-2 was 17.7 h. Y45-PEG-rhIL-2 has pharmacokinetic characteristics superior to those of rhIL-2. Y45-PEG-rhIL-2 showed dose-dependent tumor suppression activity, and the combination of Y45-PEG-rhIL-2 and anti-PD-1 antibody had a better tumor-inhibiting effect than the single use of Y45-PEG-rhIL-2 or anti-PD-1 antibody. Flow cytometry analysis demonstrated that 72 h after the administration of Y45-PEG-rhIL-2, the proportion of tumor-infiltrating cytotoxic T lymphocytes (CD8⁺T cells) increased by 86.84%. At 120 h after administration, the ratio of CD8⁺T cells to regulatory T cells (Treg) increased by 75.10%.

CONCLUSION:

Y45-PEG-rhIL-2 obtained by site-specific conjugation via non-natural amino acids changed its receptor binding activity and inhibited tumor growth in dose-dependent manner in multiple tumor models by regulating CD8⁺T cells.

04 Mar 2025·Expert Opinion On Drug Safety

Drug-induced noninfectious myocarditis: a disproportionality analysis of the FAERS database

Article

Author: Yan, Liyuan ; Zheng, Guanqun

BACKGROUND:

This investigation aims to identify and evaluate the most common and critical drugs associated with the risk of noninfectious myocarditis utilizing the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.

METHODS:

Data pertaining to noninfectious myocarditis from 2004 Q1 to 2024 Q2 were extracted. Following data standardization, multiple signal quantification techniques, including Reporting Odds Ratio (ROR) and Proportional Reporting Ratio, were employed for analysis.

RESULTS:

The study identified a total of 10,763 adverse event reports associated with noninfectious myocarditis. Disproportionality analysis revealed that the top 5 drugs by ROR were phendimetrazine tartrate (ROR 104.64), trimethoprim + sulfamethoxazole (ROR 67.65), aldesleukin (ROR 52.67), mesalazine (ROR 49.73), and balsalazide disodium (ROR 45.26). Notably, among the 30 drugs with the strongest ROR signals, 8 drugs lacked myocarditis risk information in their package inserts.

CONCLUSION:

Through comprehensive analysis of the FAERS database, our study identified drugs with a strong signal for myocarditis that are not currently indicated on their labels. The findings suggest that the potential risk of myocarditis associated with these medications is significant and warrants close monitoring in clinical practice.

124

News (Medical) associated with Aldesleukin

15 Apr 2025

·pipelinereview.com

Aulos Bioscience Doses First Patient in Phase 2 Cohort Evaluating AU-007 in Combination With Nivolumab for Second-Line Treatment of Melanoma

LARKSPUR, CA, USA I April 14, 2025 I Aulos™ Bioscience, an immuno-oncology company working to revolutionize cancer care through development of immune-activating antibody therapeutics, today announced dosing of its first patient with a combination of AU-007, the anti-PD-1 antibody nivolumab and low-dose, subcutaneous aldesleukin in a Phase 2 expansion cohort focused on second-line treatment of melanoma. This new cohort is part of Aulos’ Phase 1/2 clinical trial of AU-007 in patients with unresectable locally advanced or metastatic cancer. Preliminary Phase 2 data presented in November at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting showed that a combination of AU-007 and low-dose, subcutaneous aldesleukin is clinically active in patients with melanoma, with durable objective responses achieved. The additional Phase 2 cohort in melanoma now allows the nivolumab combination portion of this study to progress. “We are excited that the first patient is receiving treatment in this new Phase 2 cohort evaluating AU-007 in combination with nivolumab,” said Aron Knickerbocker, Aulos Bioscience’s president and chief executive officer . “Given its unique mechanism of action and the positive data presented to date on AU-007 and low-dose, subcutaneous aldesleukin, we believe that AU-007 holds real promise as a novel immuno-oncology treatment in combination with checkpoint inhibitors in multiple cancer types. These include non-small cell lung cancer, for which we initiated a Phase 2 cohort with the anti-PD-L1 antibody avelumab in November, and now melanoma.” AU-007 is the first human monoclonal antibody designed with the assistance of artificial intelligence to enter a human clinical trial. The antibody harnesses the power of interleukin-2 (IL-2) by binding precisely to the portion of IL-2 that binds to CD25, which prevents IL-2 from binding to high-affinity IL-2 receptors on Tregs, vasculature, pulmonary tissue and eosinophils. This redirects IL-2 to medium-affinity receptors on effector T cells (Teffs) and natural killer (NK) cells, which expand and kill tumor cells. Aulos anticipates presenting preliminary data from the Phase 2 cohort evaluating AU-007, nivolumab and low-dose, subcutaneous aldesleukin as a second-line treatment for melanoma in the second half of 2025. The company will present new Phase 2 data for AU-007 and low-dose, subcutaneous aldesleukin without a checkpoint inhibitor as a second-line treatment for melanoma at the American Association for Cancer Research (AACR) Annual Meeting later this month. To learn more about the AU-007 clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626 ). For patients and providers in the U.S., please visit www.solidtumorstudy.com . For patients and health professionals in Australia, please visit www.solidtumourstudy.com . About AU-007 AU-007 is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy. About Aulos Aulos Bioscience is an immuno-oncology company working to revolutionize cancer patient care through immune-activating antibody therapeutics that direct patients’ immune systems toward killing tumor cells. Matching world-class machine learning from co-founder Biolojic Design with an in-depth understanding of the immune system, Aulos’ initial clinical candidate, AU-007, is a human antibody designed by leveraging artificial intelligence that harnesses the power of IL-2 to induce tumor killing while limiting the immunosuppression and toxicities typically associated with this validated pathway. The company was founded by Biolojic Design and Apple Tree Partners ( ATP ) and is led by pioneers in the fields of artificial intelligence, antibody development and cancer immunotherapies. For more information, visit www.aulos.com , X ( @AulosBioscience ) and LinkedIn . SOURCE: Aulos Bioscience

Phase 2ImmunotherapyAACRClinical Result

27 Mar 2025

·www.globenewswire.com

Oncotelic Therapeutics Announces Successful Completion of Phase 1 Trial of OT-101 and IL-2, Highlights Findings at SWCR 2025 Conference

March 25, 2025 -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) ("Oncotelic", the "Company" or "We" or “Our”), ”), a leader in RNA-based therapeutics, announced today the successful completion of a Phase 1 clinical trial evaluating OT-101, in combination with IL-2 for advanced or metastatic solid tumors. These results set the stage for new studies that combine OT-101,an antisense therapeutic targeting Transforming Growth Factor Beta 2 (TGFβ2), with checkpoint inhibitors (“CKIs”) and recombinant IL-2 (aldesleukin) (“IL-2”). The announcement coincides with a presentation delivered by Vuong Trieu, Ph.D., Chairman & CEO of Oncotelic, at the 5th Symposium on World Cancer Research (SWCR) 2025. In his talk, titled “Transforming Growth Factor Beta 2 in Aging, Cancer, Lupus, and Immuno-Oncology: A Convergence of Disease Pathways and Therapeutic Potential,” Dr. Trieu described the central role of TGFβ2 in immune suppression across multiple diseases, and outlined the ongoing development of OT-101 in pancreatic cancer (Phase 3 STOP-PC study), gliomas, and combination regimens with immunotherapies. The Phase 1 trial (ClinicalTrials.gov ID: NCT04862767) investigated the safety and tolerability of OT-101 in combination with recombinant IL-2 in patients with advanced or metastatic solid tumors. The combination showed a tolerable safety profile at the planned dosing schedule, with no unexpected safety signals identified. Based on the favorable safety data, Oncotelic plans to advance OT-101 plus IL-2 into further clinical studies, exploring synergies with CKIs such as PD-1 blockers. TGFβ2’s Central Role in Cancer and Beyond: Dr. Trieu presented evidence that TGFβ2 is a critical driver of immunosuppression, fueling tumor progression by promoting an M2-like macrophage phenotype and blunting antitumor immunity. OT-101’s Clinical Progress and Versatility: In pancreatic ductal adenocarcinoma (PDAC), OT-101 is currently in a Phase 3 clinical trial (the STOP-PC study) combined with mFOLFIRINOX. OT-101 has shown encouraging activity in gliomas, where high intratumoral TGFβ2 expression correlates with poor prognosis. Combination regimens with CKIs and IL-2 address multiple pathways of immune evasion, potentially amplifying therapeutic benefits. Next Studies Targeting TGF β2 and Beyond: With the newly completed OT-101 and IL-2 Phase 1 trial, Oncotelic is poised to begin further combination trials to determine the added efficacy of OT-101, IL-2, and CKIs in solid tumors such as lung cancer, melanoma, and colorectal cancer. Next wave of clinical trials aiming to knock down TGF β 2 (e.g., with OT-101) paired with intervention with a complementary therapy, checkpoint blockade, IL-2, interferon-based regimens, or standard-of-care chemo, depending on the tumor indication “We are thrilled to announce the completion of our Phase 1 study evaluating OT-101 with IL-2, a key milestone that sets the stage for next-generation immunotherapy combinations,” said Dr. Vuong Trieu, Chairman & CEO of Oncotelic. Our findings reinforce that OT-101’s specific inhibition of TGFβ2 can significantly enhance the immune response, and we are eager to test these synergies with checkpoint inhibitors and IL-2 to maximize therapeutic potential for patients with hard-to-treat cancers.” The presentation, along with a chatbot powered by PDAOAI, can be accessed on our new PDAOAI public Discord: https://discord.gg/jz6Q7G2SBQ. Our PDAOAI Discord server allows members of the public to view and download the presentation. In addition, by using “/query”, they can utilize our proprietary chatbot technology to ask questions related to the presentation. We highly recommend joining Discord. If you need any help, members of the PDAOAI team can assist. In addition, you can use “/help”. We intend to use this server for our PDAOAI platform. For those who are interested in joining our investor Discord, can do so here: https://discord.gg/hMDV397832 "We are excited to bring PDAOAI to the public and are excited for the user feedback. This presentation is a beginning to bringing our AI technology to the masses and not just our internal team,” said Scott Myers, Product Manager. Oncotelic (f/k/a Mateon Therapeutics, Inc.), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic has rare pediatric designation for Diffuse Intrinsic Pontine Glioma (“DIPG” through OT-101) through its 45% joint venture, GMP Biotechnology Limited, melanoma (through CA4P), and Acute Myeloid Leukemia (“AML” through OXi 4503). Oncotelic also acquired PointR Data Inc. in November 2019 to build an AI driven biotechnology company. Further, Oncotelic acquired AL-101, during the 4th quarter of 2021, for the intranasal delivery of apomorphine. We intend to develop AL-101 for the treatment of Parkinson Disease, erectile dysfunction, female sexual disorder and hypoactive sexual desire disorder. All these ailments have a very large population suffering from them and there is a need for treatments for each. For more information on AL-101, refer to our 2023 Annual Report on form 10-K filed with the SEC on April 12, 2024. The content above comes from the network. if any infringement, please contact us to modify.

ImmunotherapyAcquisitionAACR

25 Mar 2025

·endpts.com

Cassava ends work on Alzheimer's drug; Alumis gets $40M upfront from Kaken

Plus, news about Relmada Therapeutics and Mural Oncology: Cassava Sciences finally stops work on Alzheimer’s drug: After a Phase 3 study of simufilam failed in November, Cassava said it was discontinuing a second Phase 3 trial. On Tuesday, the company said that trial failed, too, and it would stop work on simufilam in Alzheimer’s by the end of June. The drug did not meet primary, secondary or exploratory biomarker endpoints. “These results were unambiguous,” CEO Rick Barry said in a press statement. The SEC last year accused the drug’s co-developer Hoau-Yan Wang, a CUNY School of Medicine professor, of manipulating clinical trial results. Former CEO Remi Barbier and SVP of neuroscience Lindsay Burns paid more than $40 million to settle charges they made misleading statements about the Phase 2 studies. They allegedly told investors that the drug had significant therapeutic benefits when it did not. The company then continued studying the treatment. Cassava said Tuesday that it started preclinical studies of simufilam for epilepsy in people with tuberous sclerosis complex. Its stock $SAVA was down about 21% on Tuesday morning. — Lei Lei Wu Alumis inks deal in Japan: The California immunology biotech will get $40 million in upfront and near-term payments from Kaken Pharmaceutical as part of a licensing deal for rights to its oral TYK2 inhibitor in Japan. The Tokyo-based drugmaker also promised about $140 million in biobucks as part of the licensing deal for Alumis’ ESK-001 in dermatology indications. Alumis shares $ALMS were up about 22% on Tuesday morning. It is currently working on a merger with Acelyrin . — Kyle LaHucik Relmada Therapeutics’ bladder cancer deal: The Florida biotech will pay $3.5 million upfront and issue 3 million, or 10%, of its shares to Trigone Pharma for worldwide rights to an experimental bladder cancer drug. Called NDV-01, the drug is a sustained-release and intravesical formulation of gemcitabine and docetaxel. Relmada will take over development and other work for NDV-01 once an ongoing Phase 2 wraps up. Relmada gets rights to all regions except India, Israel and South Africa. Trigone could receive another $200 million in milestone payments and 3% royalties on net sales. The move comes a few months after Relmada’s depression drug failed another Phase 3 trial. — Kyle LaHucik Mural Oncology to stop a Phase 3 study in ovarian cancer: The biotech said an interim survival analysis showed that its IL-2 drug, called nemvaleukin alfa, plus Merck’s Keytruda was unlikely to succeed versus chemotherapy. Mural’s stock $MURA fell 60% on Tuesday morning. — Lei Lei Wu

Phase 3License out/inPhase 2Clinical Trial FailureClinical Trial Termination

100 Deals associated with Aldesleukin

External Link

KEGG	Wiki	ATC	Drug Bank
D00748	-	L03AC01	DB00041

R&D Status

Approved

10 top approved records.

to view more data

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

Developing

10 top R&D records.

to view more data

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
Refractory Hodgkin Lymphoma	Phase 3	United States	National Cancer Institute	01 Nov 2003
Refractory Hodgkin Lymphoma	Phase 3	Australia	National Cancer Institute	01 Nov 2003
Refractory Hodgkin Lymphoma	Phase 3	Canada	National Cancer Institute	01 Nov 2003
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
Neuroblastoma recurrent	Phase 3	Puerto Rico	National Cancer Institute	18 Oct 2001

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02500576 (CTgov)	Phase 2	Melanoma, Cutaneous Malignant \| Metastatic melanoma	18	I2+fludarabine+cyclophosphamide+MK-3475 (Arm 1)	oerlyozzlj = ultyjilvbp munzhdeokq (srqwpfajkk, hcebdbubts - yatlnnsalc) View more	-	15 Jan 2025
				TIL+fludarabine+cyclophosphamide+MK-3475+IL-2 (Arm 2)	oerlyozzlj = fbaqnijgya munzhdeokq (srqwpfajkk, vlvktxusyg - awgkbnblqy) View more
NCT03318900 (CTgov)	Phase 1/2	Recurrent ovarian cancer \| Platinum-Resistant Ovarian Carcinoma	5	IL-2+Cyclophosphamide (Dose Level 1)	whjfwhmwdu(wnlrkffunk) = cchhcvyccb zxkmyrbowq (bvposlkdow, ubwfzrhbbj - kqjyjahfmp) View more	-	07 Nov 2024
				IL-2+Cyclophosphamide (Dose Level 2)	whjfwhmwdu(wnlrkffunk) = zcawqwitas zxkmyrbowq (bvposlkdow, mepeyjtzpb - gnzcicbkzq) View more
NCT05267626 (SITC2024) Manual	Phase 1/2	Advanced Malignant Solid Neoplasm	-	AU-007	hjtsteqkrc(zhkukewuef) = None svzfhjkjpw (mbgraasehr ) View more	Positive	05 Nov 2024
				AU-007 + aldesleukin
NCT03296137 (2017-002323-25 \| ###DELETE, CTgov)	Phase 1/2	Neoplasms	25	infiltrating lymphocytes+Fludara+Cyclophosphamide+proleukin (All Participants)	uarbsntnna = umjcnvcbbj osaniynyjd (jhxxwvwdvj, omjtaemkfc - cbyuwcymbq) View more	-	26 Oct 2024
				infiltrating lymphocytes+Fludara+Cyclophosphamide+proleukin (Treated Participants)	byamxeebhu(fcixlwfzzp) = rjmkfeaxnr ukjzcsxlbx (jyaucpohze, lberscnwgb - dzccclhtno) View more
NCT02027935 (CTgov)	Phase 2	Metastatic melanoma	16	Autologous CD8+ Melanoma Specific T Cells+ipilimumab+Cyclophosphamide+Aldesleukin	qjvcmpqeqa(bsguduadgj) = axjcbjyumu zohktlouxk (ymqxmuhwuc, qzrebjpblk - gbgezxvcpp) View more	-	08 Oct 2024
NCT03233828 (IL-2, CTgov)	Phase 3	Melanoma, Cutaneous Malignant \| Visible Lesion	1	Aldesleukin (Intralesional IL-2 Injection)	hmdzwvyfrt(smpmifvfea) = pgrzrxhehg bpdxzefbha (xusqkyhuef, utpgqdwzir - uirsedzxry) View more	-	24 Jul 2024
				Saline (Saline Injection)	hmdzwvyfrt(smpmifvfea) = nzxlltifau bpdxzefbha (xusqkyhuef, aednariufq - omhtnittgc) View more
NCT03007238 (CTgov)	Phase 2	Chronic graft-versus-host disease \| Steroid Refractory Graft Versus Host Disease	10	ECP (Treatment (ECP+IL-2))	xzxzevmgfo = iegtkgryho ijphexmpbl (lqykzwazyz, jggpzwvdri - juexgnfmjq) View more	-	08 Apr 2024
				ECP (Overall Study)	ynnmjxirbx = iwthupfucy elkxhwfany (qaskpldeua, agpxbwmwib - ukaocdvbor) View more
NCT01856023 (PROCLIVITY02, CTgov)	Phase 4	Metastatic melanoma	29	ipilimumab+High Dose Interleukin-2 (Treatment Arm 1)	cwieahuoky = jzotcebolg mvmkewocfh (iapdrrpbvs, pfmvpyeyik - fpdrycolvt)	-	05 Dec 2023
				ipilimumab+High Dose Interleukin-2 (Treatment Arm 2)	cwieahuoky = jzvotdegox mvmkewocfh (iapdrrpbvs, nllnosntxq - tubxjwbjzk)
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	qutkifbhjw(hkfwmoabew) = zbshqwxrbt ixfnvypvof (eznkcjchpk, lxsyedlpwv - hsmxlnlogh) View more	-	15 May 2023
NCT02748564 (CTgov)	Phase 2	Melanoma, Cutaneous Malignant \| Mucosal Melanoma of the Head and Neck \| Metastatic melanoma ... View more	10	Laboratory Biomarker Analysis+pembrolizumab+Aldesleukin	agqoqjfand = lkfslywusd xybsypccov (syegznalve, bfeoborrah - ubtgogjzky) View more	-	09 Feb 2023

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Core Patent

Boost your research with our Core Patent data.

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Clinical Trial

Identify the latest clinical trials across global registries.

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Approval

Accelerate your research with the latest regulatory approval information.

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis