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Last update 03 Sep 2025

Ipilimumab

Last update 03 Sep 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti CTLA-4 monoclonal antibody, Anti-CTLA-4 Mab, Ipilimumab (Genetical Recombination)

+ [17]

Target

CTLA4

Action

inhibitors

Mechanism

CTLA4 inhibitors(Cytotoxic T-Lymphocyte-Associated Antigen 4 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases+ [12]

Active Indication

PD-L1 positive Non-Small Cell Lung CancerMetastatic hepatocellular carcinomaAdvanced Hepatocellular Carcinoma+ [288]

Inactive Indication

Acute lymphoblastic leukemia recurrentAcute Promyelocytic LeukemiaAdenocarcinoma, metastatic+ [128]

Originator Organization

Bristol Myers Squibb Co.

Active Organization

Bristol Myers Squibb Co.

The University of Texas MD Anderson Cancer Center

National Cancer Institute

+ [15]

Inactive Organization

Checkmate Pharmaceuticals, Inc.

University of Southern CaliforniaJonsson Comprehensive Cancer Center

+ [12]

License Organization

Nektar Therapeutics

Inspirna, Inc.

Gritstone bio, Inc.

+ [10]

Drug Highest PhaseApproved

First Approval Date

United States (25 Mar 2011),

Melanoma

RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (Australia), Priority Review (United States)

Structure/Sequence

Sequence Code 143797L

Source: *****

Sequence Code 9060585H

Source: *****

859

Clinical Trials associated with Ipilimumab

NCT07128680

/ Not yet recruitingPhase 1IIT

A Randomized Study of Nivolumab and Ipilimumab With and Without EXL01 in First-Line Treatment of Metastatic Renal Cell Carcinoma (mRCC)

This phase I trial tests the safety and effectiveness of nivolumab and ipilimumab with and without EXL01 for the treatment of renal cell cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. EXL01 is a live biotherapeutic product containing a strain of bacteria called Faecalibacterium prausnitzii. It may enhance a patient's response to treatment with immune checkpoint inhibitors like nivolumab and ipilimumab by altering the composition of the bacteria in the gut. Adding EXL01 to treatment with nivolumab and ipilimumab may be safe and more effective than giving nivolumab and ipilimumab alone.

Start Date05 Dec 2025

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT06968988

/ Not yet recruitingPhase 1IIT

Phase I Study With Expansion Cohort of Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue Sarcoma

The investigators hypothesize that zanzalintinib in combination with ipilimumab and nivolumab will be well tolerated and serve as a potential therapeutic strategy in metastatic soft tissue sarcoma (mSTS) including myxofibrosarcoma, undifferentiated pleomorphic sarcoma, dedifferentiated liposarcoma, cutaneous angiosarcoma, and undifferentiated sarcoma histologies.

Start Date30 Sep 2025

Sponsor / Collaborator

Washington University School of Medicine

[+1]

NCT07147101

/ Not yet recruitingNot ApplicableIIT

A Prospective, Non-interventional Study of Different First-line Immunotherapy in Advanced Hepatocellular Carcinoma Patients: Efficacy and Immune Microenvironment Dynamics

To evaluate the efficacy and immune microenvironment changes in advanced hepatocellular carcinoma (HCC) patients receiving different first-line immunotherapy.

Start Date01 Sep 2025

Sponsor / Collaborator

Fudan University

100 Clinical Results associated with Ipilimumab

100 Translational Medicine associated with Ipilimumab

100 Patents (Medical) associated with Ipilimumab

5,784

Literatures (Medical) associated with Ipilimumab

31 Dec 2025·OncoImmunology

Circulating cytokine associations with clinical outcomes in melanoma patients treated with combination nivolumab plus ipilimumab

Article

Author: Baginska, Joanna ; Rodig, Scott J. ; Severgnini, Mariano ; Hodi, F. Stephen ; Chen, Jiajia ; Manuszak, Claire ; Brennick, Ryan ; Weirather, Jason L. ; Manos, Michael ; Ranasinghe, Srinika ; Liu, David ; Huang, Amy Y. ; Holovatska, Marta ; Hathaway, Emma ; Nazzaro, Matthew ; Giobbie-Hurder, Anita ; Tarantino, Giuseppe ; Pfaff, Kathleen L. ; Russell, Janice D.

Nivolumab plus ipilimumab (aCTLA-4/aPD-1) combination therapy has significantly improved clinical outcomes in patients with metastatic melanoma, with 50%-60% of patients responding to treatment, but predictors of response are poorly characterized. We hypothesized that circulating cytokines and peripheral white blood cells may predict response to therapy and evaluated 15 cytokines and complete blood counts (CBC with differentials) from 89 patients with advanced melanoma treated with combination therapy from three points in time: pre-treatment, one month and approximately three months after starting therapy. Clinical endpoints evaluated included durable clinical benefit (DCB), progression-free survival (PFS), and overall survival (OS). A parsimonious predictive model was developed to identify cytokines predictors of response to combination therapy. In this study, we found that pre-treatment, patients with DCB had higher IL-23, lower CXCL6, and lower IL-10 levels. Lower NLR one month after starting therapy predicted better PFS and OS, primarily driven by an increase in absolute lymphocytes. A multivariate model demonstrated that baseline CXCL6, IL-10, IL-23 were independent predictors of therapy response, and the combined model has reached an area under the curve (AUC) of 0.79 in prediction of response to combination therapy. Our study identified baseline CXCL6, IL-23, and IL-10 as predictors of response to aCTLA4/aPD1 combination therapy among patients with metastatic melanoma. This study also provides a framework for identifying patients who are likely to respond to combination ICB, as well as a subset of patients with high risk of developing resistance and are thus in need of alternative therapeutic options, such as clinical trials.

31 Dec 2025·mAbs

Engineered ipilimumab variants that bind human and mouse CTLA-4

Article

Author: Barman, Ishita ; Diong, SJ ; Lee, Peter S. ; Bee, Christine ; Rajpal, Arvind ; Kumar, Anusha ; West, Sean M. ; Chau, Bryant ; Strop, Pavel ; Robison, Brett ; Chang, Olin ; Korman, Alan J. ; Moon, Thomas M.

Testing of candidate monoclonal antibody therapeutics in preclinical models is an essential step in drug development. Identification of antibody therapeutic candidates that bind their human targets and cross-react to mouse orthologs is often challenging, especially for targets with low sequence homology. In such cases, surrogate antibodies that bind mouse orthologs must be used. The antibody 9D9, which binds mouse CTLA-4, is a commonly used surrogate for CTLA-4 checkpoint blockade studies in mouse cancer models. In this work, we reveal that 9D9 has significant biophysical dissimilarities to therapeutic CTLA-4 antibodies. The 9D9-mCTLA4 complex crystal structure was determined and shows that the surrogate antibody binds an epitope distinct from ipilimumab and tremelimumab. In addition, while ipilimumab has pH-independent binding to hCTLA-4, 9D9 loses binding to mCTLA-4 at physiologically relevant acidic pH ranges. We used phage and yeast display to engineer ipilimumab to bind mouse CTLA-4 with single-digit nM affinity from an initial state with no apparent binding. The engineered variants showed pH-independent and cross-reactive binding to both mouse and human CTLA-4. Crystal structures of a variant in complex with both mouse and human CTLA-4 confirmed that it targets an equivalent epitope as ipilimumab. These cross-reactive ipilimumab variants may facilitate improved translatability and future mechanism-of-action studies for anti-CTLA-4 targeting in murine models.

31 Dec 2025·OncoImmunology

Impact of steroid dose and timing on efficacy of combination PD-1/CTLA-4 blockade

Article

Author: Burnette, Hannah R. ; Czapla, Juliane Andrade ; Cui, Can ; Lawless, Aleigha R. ; Curkovic, Nina B. ; Irlmeier, Rebecca ; Ye, Fei ; Sullivan, Ryan ; Johnson, Douglas B. ; Bai, Xue

With the increasing use of immune checkpoint inhibitors (ICIs) in combination regimens and in earlier stages of advanced melanoma, the effective management of immune-related adverse events (irAEs) is key to balancing immunotherapy efficacy and toxicity. Conflicting evidence exists on possible detrimental effects of immunosuppression with corticosteroids for irAEs on ICI effectiveness. We conducted a multicenter, retrospective cohort study of immunotherapy-naïve advanced melanoma patients undergoing treatment with ipilimumab and nivolumab and a small cohort treated with nivolumab/relatlimab. We utilized univariate tests to assess response, PFS, and OS based on presence of irAE, receipt of steroids for irAEs, peak dose, and time-to-steroid, as well as multivariable analysis for response, OS, and PFS in patients receiving steroids for irAEs. Among 226 total ipilimumab/nivolumab patients, those without irAEs had poorer PFS and OS compared to irAE groups regardless of steroid administration. In subgroup analysis of patients receiving steroids for an irAE, increased time-to-steroid was significantly associated with improved response (aOR, 1.026 p = 0.0005), PFS (aHR, 0.986 p = 0.001), and OS (aHR, 0.983 p = 0.0008). Higher peak steroid dose was significantly associated with poorer PFS (aHR, 1.002 p = 0.005), and OS (aHR, 1.002 p = 0.003). Use of additional immunosuppressants was associated with poorer OS (aHR, 1.941 p = 0.018). Cumulative dose was not significantly associated with outcomes. Among 42 additional patients treated with nivolumab/relatlimab, irAEs were significantly associated with improved PFS/OS, which appeared to be slightly mitigated by steroid administration; dosing relationships were limited by small numbers.

878

News (Medical) associated with Ipilimumab

29 Aug 2025

·www.einpresswire.com

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

29 Aug 2025

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April - June 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Adcetris (brentuximab vedotin) Guillain-Barre syndrome FDA determined that no action is necessary at the time based on available information. Arzerra (ofatumumab) Gazyva (obinutuzumab) Riabni (rituximab-arrx) Rituxan (rituximab) Rituxan Hycela (rituximab and hyaluronidase human) Ruxience (rituximab-pvvr) Truxima (rituximab-abbs) Colitis FDA determined that no action is necessary at the time based on available information. Balversa (erdafitinib) Calciphylaxis The "Warnings and Precautions", "Patient Counseling Information", and the "Patient Information" sections of the labeling were updated in April 2022 to include information about soft tissue mineralization, including calciphylaxis. Balversa labeling Bavencio (avelumab) Keytruda (pembrolizumab) Opdivo (nivolumab) Yervoy (ipilimumab) Imfinzi (durvalumab) * Necrotizing fasciitis FDA determined that no action is necessary at this time based on available information. *An administrative error resulted in the omission of Imfinzi (durvalumab) from the list of product names. Imfinzi was added after the initial quarterly report was posted. Beta-blockers Betapace (sotalol hydrochloride) Brevibloc (esmolol hydrochloride) Bystolic (nebivolol) Byvalson (nebivolol and valsartan) Coreg (carvedilol) Coreg CR (carvedilol) Corgard (nadolol) Corzide (nadolol and bendroflumethiazide) Dutoprol (metoprolol succinate and hydrochlorothiazide) Kapspargo Sprinkle (metoprolol succinate) Lopressor HCT (metoprolol tartrate and hydrochlorothiazide) Sectral (acebutolol hydrochloride) Sotylize (sotalol hydrochloride) Tenoretic (atenolol and chlorthalidone) Toprol XL (metoprolol succinate) Trandate (labetalol hydrochloride) Ziac (bisoprolol fumarate and hydrochlorothiazide) Generic products containing beta-blockers Hemangeol (Propranolol Hydrochloride)* Inderal LA (Propranolol Hydrochloride)* Innopran XL (Propranolol hydrochloride)* Lopressor (metoprolol tartrate)* Tenormin (Atenolol)* Hypoglycemia in pediatric patients The "Warnings and Precautions" and "Patient Counseling Information" sections of the labeling were updated between March 2023 and June 2024 to add additional information regarding hypoglycemia. Example: Coreg labeling An administrative error resulted in the inclusion of Betapace AF, Levatol, and Zebeta in the list of product names at the time of the initial quarterly posting. *An administrative error resulted in the omission of Hemangeol, Inderal LA, Innopran XL, Lopressor, and Tenormin from the list of product names and was added after the initial quarterly report was posted. Bosulif (bosutinib monohydrate) Gleevec (imatinib mesylate) Iclusig (ponatinib) Sprycel (dasatinib) Tasigna (nilotinib) Osteonecrosis The "Adverse Reactions" section of the Tasigna labeling was updated in February 2024 to include information about osteonecrosis. Tasigna labeling FDA determined that Gleevec and Sprycel are adequately labeled for osteonecrosis, and that no further regulatory action is needed at this time. FDA determined no action is necessary at this time for Iclusig and Bosulif based on available information. Cablivi (caplacizumab-yhdp) Hemorrhage The "Warnings and Precautions", "Drug Interactions", and "Patient Counseling Information" sections of the labeling were updated in February 2022 to include information about life-threatening and fatal bleeding. Cablivi labeling Cyramza (ramucirumab) Cardiac failure The "Adverse Reactions" section of the labeling was updated in March 2022 to include information about heart failure. Cyramza labeling Doxil (doxorubicin hydrochloride) Acute interstitial pneumonitis FDA determined that no action is necessary at the time based on available information. Gleevec (imatinib mesylate) Tasigna (nilotinib) Myasthenia gravis FDA determined that no action is necessary at the time based on available information. Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (ribociclib; letrozole) Verzenio (abemaciclib) Radiation recall phenomenon FDA determined that no action is necessary at the time based on available information. Lokelma (sodium zirconium cyclosilicate) Gastrointestinal disorders FDA determined that no action is necessary at the time based on available information. Padcev (enfortumab vedotin-ejfv) Pancreatitis FDA determined that no action is necessary at the time based on available information. Padcev (enfortumab vedotin-ejfv) Pneumonitis The "Adverse Reactions", "Warnings and Precautions", and "Patient Counseling Information" sections of the labeling were updated in July 2021 to include information about pneumonitis. Padcev labeling Poteligeo (mogamulizumab-kpkc) Cytomegalovirus viraemia The "Adverse Reactions" section of the labeling was updated in March 2022 to include cytomegalovirus infection. Poteligeo labeling Procysbi (cysteamine bitartrate) Generic products containing cysteamine bitartrate Fibrosing colonopathy The "Warnings and Precautions", "Adverse Reactions", "Patient Information", and "Patient Counseling Information" sections of the labeling were updated in February 2022 to include information about fibrosing colonopathy. Example: Procysbi labeling Sarclisa (isatuximab-irfc) Herpes zoster The "Dosage and Administration", "Adverse Reactions", and "Patient Information" sections of the labeling were updated in July 2022 to include information about herpes zoster. Sarclisa labeling Sprycel (dasatinib) Drug-induced liver injury The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information” and “Patient Information” sections of the labeling were updated in February 2023 to include information about hepatotoxicity. Sprycel labeling Taxotere (docetaxel) Rhabdomyolysis FDA determined that no action is necessary at the time based on available information. Veklury (remdesivir) Bradycardia FDA determined that no action is necessary at the time based on available information. Zepzelca (lurbinectedin) Extravasation The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in April 2022 to include information about extravasation. Zepzelca labeling Zepzelca (lurbinectedin) Tumor lysis syndrome The “Adverse Reactions” section of the labeling was updated in April 2022 to include tumor lysis syndrome. Zepzelca labeling Zepzelca (lurbinectedin) Rhabdomyolysis The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Information” sections of the labeling were updated in April 2022 to include rhabdomyolysis. Zepzelca labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

28 Aug 2025

·www.einpresswire.com

Seneca Therapeutics Announces the Closing of $3.9 million Series B Extension Round

Funding Provides 2+ Years Runway to Complete Phase I/II Trial of Seneca Vally Virus (SVV-001) Currently Underway in High-Grade Neuroendocrine Neoplasms PHILADELPHIA, PA, UNITED STATES, August 28, 2025 / EINPresswire.com / -- Seneca Therapeutics, Inc., announced today the closing of its $3.9 million Series B Extension Round. “We are excited about this raise, which provides the Company sufficient cash through 2027 and allows us to advance our goal of developing revolutionary treatments for solid tumors,” said Cuong Do, Executive Chairman at Seneca Therapeutics. “This will provide funding to complete our currently enrolling Phase I/II trial of SVV-001 in high-grade neuroendocrine neoplasms.” The currently underway Phase I/II trial of SVV-001 (NCT06889493) will assess the safety and preliminary efficacy of SVV-001 in combination with the checkpoint inhibitors nivolumab and ipilimumab for the treatment of high-grade neuroendocrine neoplasms. The trial will enroll 21-30 patients in three single-ascending dose cohorts and two multiple-ascending dose cohorts. A 15-patient expansion cohort is also planned. The trial is anticipated to take 12-18 months to complete. “Patients with high-grade neuroendocrine neoplasm don’t respond well to checkpoint inhibitor immunotherapies as these cancers are usually devoid of T-cells within the tumor environment – referred to as cold tumors – that are necessary for effective treatment,” said Dr. Paul Hallenbeck, President and Chief Scientific Officer at Seneca Therapeutics. “In pre-clinical studies, SVV-001 has shown the ability to draw in T-cells into the tumors thus making the cold tumors ‘hot’ and increase the response to checkpoint inhibitors and stimulating an anti-tumor immune response. We believe that by combining SVV-001 with dual checkpoint blockade of nivolumab and ipilimumab, we will enhance anti-tumor immunity and observe higher response rates.” The receptor of SVV-001, tumor endothelial marker 8 (TEM8), is a protein that is expressed by many solid tumors, and studies have shown that the high expression of TEM8 lowers survival rates across a number of solid tumor indications, including small cell lung cancer (a high-grade neuroendocrine neoplasm), bladder cancer, cervical cancer, breast cancer, and gastric cancer. High-grade neuroendocrine tumors and carcinomas are difficult-to-treat, and the objective response rates to treatment typically range from 5% to 20%. SVV-001 selectively binds to TEM8 expressed by tumor cells, infects and kills these cells, and elicits a systemic anti-tumor immune response. A wealth of pre-clinical data, epidemiology studies, and three prior clinical trials have shown that SVV-001 infection is highly specific to solid cancer cells. SVV-001 is being developed as a TEM8 therapeutic, with the aim of enhancing response rate and survival. In preclinical studies, SVV-001 administered in conjunction with nivolumab and ipilimumab eradicated tumors, induced a systemic anti-tumor immune response, and dramatically extended survival. This Phase I/II trial aims to replicate the preclinical data in patients with high-grade neuroendocrine tumors and carcinomas. About Seneca Therapeutics Seneca Therapeutics was founded to capitalize on the profound tumor specificity of SVV-001 and its binding specificity to TEM8, an important emerging cancer marker expressed in the majority of solid tumors. A SVV-001 Phase I/II trial recently started to further the clinical development of SVV-001. We anticipate initial data read out from this clinical trial in the second half of 2026 or first half of 2027. The Company has also developed an SVV-001 Companion Diagnostic that can identify patients whose tumor expresses TEM8 and may be susceptible to SVV-001 treatment. The Company is in the process of validating the diagnostic to be used in future clinical trials to identify patients that would benefit from SVV-001. Learn more at NULL www.senecatherapeutics.com . Forward-Looking Statements This press release contains “forward-looking statements” concerning the development of Seneca Therapeutics products, the potential benefits and attributes of those products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Seneca Therapeutics undertakes no obligation to update any forward-looking statements for any reason. Contact: Cuong Do Paul Hallenbeck, PhD Executive Chairman President and CSO cdo@senecatherapeutics.com paulhallenbeck@senecatherapeutics.com Franco et al. Front. Mol. Biosci. 11:1520223 Ilie et al. Neuroendocrinology (2023) 113 (2): 262–278 Al-Toubah et al. doi: 10.1016/j.esmoop.2024.102386. Bai et al. Cancer Biol Med. 2022 Oct 18;19(12):1649–1661 James Hussey Seneca Therapeutics +1 847-507-0033 email us here Visit us on social media: LinkedIn Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Clinical StudyImmunotherapy

100 Deals associated with Ipilimumab

External Link

KEGG	Wiki	ATC	Drug Bank
D04603	Ipilimumab	L01XC11	DB06186

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
PD-L1 positive Non-Small Cell Lung Cancer	China	Bristol-Myers Squibb Pharma EEIG	22 Jul 2025
Metastatic hepatocellular carcinoma	Australia	Bristol-Myers Squibb Australia Pty Ltd.	27 Jun 2025
Advanced Hepatocellular Carcinoma	European Union	Bristol Myers Squibb Co.	08 Mar 2025
Advanced Hepatocellular Carcinoma	Iceland	Bristol Myers Squibb Co.	08 Mar 2025
Advanced Hepatocellular Carcinoma	Liechtenstein	Bristol Myers Squibb Co.	08 Mar 2025
Advanced Hepatocellular Carcinoma	Norway	Bristol Myers Squibb Co.	08 Mar 2025
Unresectable Hepatocellular Carcinoma	European Union	Bristol Myers Squibb Co.	08 Mar 2025
Unresectable Hepatocellular Carcinoma	Iceland	Bristol Myers Squibb Co.	08 Mar 2025
Unresectable Hepatocellular Carcinoma	Liechtenstein	Bristol Myers Squibb Co.	08 Mar 2025
Unresectable Hepatocellular Carcinoma	Norway	Bristol Myers Squibb Co.	08 Mar 2025
Mismatch repair-deficient Colonic Cancer	European Union	Bristol-Myers Squibb Pharma EEIG	13 Jan 2025
Mismatch repair-deficient Colonic Cancer	Iceland	Bristol-Myers Squibb Pharma EEIG	13 Jan 2025
Mismatch repair-deficient Colonic Cancer	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	13 Jan 2025
Mismatch repair-deficient Colonic Cancer	Norway	Bristol-Myers Squibb Pharma EEIG	13 Jan 2025
Unresectable Esophageal Squamous Cell Carcinoma	United States	Bristol Myers Squibb Co.	27 May 2022
Esophageal Carcinoma	Japan	Bristol-Myers Squibb KK	26 May 2022
Hepatocellular Carcinoma	United States	Bristol Myers Squibb Co.	10 Mar 2020
Melanoma, Cutaneous Malignant	United States	Bristol Myers Squibb Co.	10 Jul 2018
Colorectal Cancer	United States	Bristol Myers Squibb Co.	16 Apr 2018
Metastatic Colorectal Carcinoma	European Union	Bristol-Myers Squibb Pharma EEIG	13 Jul 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bladder Cancer	Phase 3	United States	Ono Pharmaceutical Co., Ltd.	30 Jan 2022
Bladder Cancer	Phase 3	United States	Sino-American Shanghai Squibb Pharmaceuticals Ltd.	30 Jan 2022
HER2 negative Gastric Cancer	Phase 3	United States	Ono Pharmaceutical Co., Ltd.	05 Nov 2021
HER2 negative Gastric Cancer	Phase 3	Japan	Ono Pharmaceutical Co., Ltd.	05 Nov 2021
HER2 negative Gastric Cancer	Phase 3	Taiwan Province	Ono Pharmaceutical Co., Ltd.	05 Nov 2021
Glioblastoma	Phase 3	United States	National Cancer Institute	01 Sep 2020
Gliosarcoma	Phase 3	United States	National Cancer Institute	01 Sep 2020
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	United States	Bristol Myers Squibb Co.	08 Oct 2019
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	Bristol Myers Squibb Co.	08 Oct 2019
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Japan	Bristol Myers Squibb Co.	08 Oct 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05401786 (RAD-IO, WCLC2025)	Phase 2	Non-Small Cell Lung Cancer	54	IpilimumabCemiplimab + IpilimumabCemiplimab (SBRT)	cyvjtursrk(gmcycfcxgr) = qifnufnhcv nvxuluejaj (sngxhwtpoz, 1.5 - 4.2) View more	Positive	09 Sep 2025
NCT03918252 (WCLC2025)	Phase 2	Mesothelioma Neoadjuvant	30	Nivolumab	ehiobfqzuk(jkkuuptdnj) = zbeqzgqzgx wgsevfeiet (kixlsrhlbt, 47.8 - 83.4) View more	Positive	08 Sep 2025
				ipilimumab+Nivolumab	ehiobfqzuk(jkkuuptdnj) = qvwjiztmgi wgsevfeiet (kixlsrhlbt, 56.0 - 90.3) View more
NCT04026412 (CheckMate 73L \| CheckMate73L \| CheckMate -73L, CTgov)	Phase 3	Locally Advanced Lung Non-Small Cell Carcinoma	925	Ipilimumab+Nivolumab (Arm A:Nivo + CCRT/Nivo + Ipi)	exqlrqosug(eknugaiozj) = ycimeerumh lovestqneb (ofslnupeis, ghkjzmohiw - slnxplrbln) View more	-	24 Jul 2025
				Durvalumab (Arm C: CCRT/Durva)	exqlrqosug(eknugaiozj) = jtpledouql lovestqneb (ofslnupeis, eovrqpcqcr - zeaocoeplj) View more
NCT02553642 (CTgov)	Phase 2	Melanoma \| Bladder Cancer \| Locally Advanced Melanoma	81	Ipilimumab+Nivolumab (Melanoma Cancer Patients)	mfrpjtbqno(dkyksbrhpk) = xliyrxdfxj pfkfcivipp (apsoaguunc, qjkkcjnjon - fxnhfceyrl) View more	-	22 Jul 2025
				Nivolumab (Bladder Cancer Patients)	ocelnruijh = hnntqphghl iaapqormzr (ggtvxmqqoh, iowiwkfvxz - aaumzqcdks) View more
NCT04513522 (CheckMate 7C9, CTgov)	Phase 4	Advanced Renal Cell Carcinoma	101	Ipilimumab+Nivolumab	qckuuhancm = zwtcpgmpkk xgqddtjxmd (coiubljrya, puxutetmrw - jvpfbyqxpw) View more	-	11 Jul 2025
NCT03117309 (HCRN GU16-260 \| HCRN GU16-260-Cohort A, CTgov)	Phase 2	Advanced Renal Cell Carcinoma	164	Nivolumab (Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC)	rvfwpzmyic = ekvmghherg elvopkcbjt (uxffiefahv, bdghdfvfuq - ojilgkeelw) View more	-	10 Jul 2025
				Ipilimumab+Nivolumab (Cohort A Part B: Nivolumab and Ipilimumab in Clear Cell RCC)	cvtxqzsqce = qqdfacapky gzfhskneyt (qppuuexdgo, mdtxpafqwm - dqxksyumli) View more
NCT03298451 \| NCT04039607 \| NCT03434379 (IMbrave150, ESMO_GI2025) Manual	Not Applicable	Unresectable Hepatocellular Carcinoma First line	-	nivolumab + ipilimumab	kiosujvzxl(cwxpgwztps): OR = 2.35 (95% CI, 1.57 - 3.13) View more	Positive	03 Jul 2025
				durvalumab + tremelimumab
CheckMate 067/RELATIVITY-047 (ASCO2025)	Not Applicable	Metastatic melanoma PDL-1 status \| mutational profile \| extent of metastatic disease	288	Nivolumab/relatlimab	ctcnaukpbb(ijhghpgljr) = ninsrwqxpl qpfvsmtqld (ypxngywqce )	Positive	30 May 2025
				Nivolumab/ipilimumab	ctcnaukpbb(ijhghpgljr) = vsoipjjiho qpfvsmtqld (ypxngywqce )
ASCO2025	Not Applicable	Metastatic Merkel Cell Carcinoma	80	Ipilimumab plus Nivolumab	fgyckkkezu(butyodgguv) = pfrfsdsgpd cxfscukffm (yqkkcnzadh, 0.06 - 0.25) View more	Positive	30 May 2025
NCT04300244 (NIPU trial, ASCO2025)	Phase 2	Malignant Pleural Mesothelioma CD8+ \| CD20 \| CD66b+ ... View more	118	IPI/NIVO alone	mwedskwwku(ewrknhurcr): HR = 0.63 (95% CI, 0.42 - 0.97), P-Value = 0.04	Positive	30 May 2025
				IPI/NIVO + telomerase UV1 vaccine

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