Delving into the Latest Updates on Nadunolimab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Nidanilimab, CAN-04, CAN04

Target

IL1RAP

Action

inhibitors, stimulants

Mechanism

IL1RAP inhibitors(Interleukin-1 receptor accessory protein inhibitors), Natural killer cells stimulants(Natural killer cells stimulants)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [2]

Active Indication

Nodule of lungPancreatic CancerAdvanced Triple-Negative Breast Carcinoma

Inactive Indication

Advanced Malignant Solid NeoplasmColorectal CancerGallbladder Neoplasms+ [9]

Originator Organization

University of Lund

Active Organization

Cantargia AB

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

RegulationFast Track (United States)

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Structure/Sequence

Sequence Code 454033168L

Source: *****

Sequence Code 616720818H

Source: *****

Phase 1b/2 open-label study evaluates the safety, tolerability, and efficacy of combination immunotherapy with nadunolimab (anti-IL-1RAP) and toripalimab (anti-PD-1) in patients with chemotherapy-refractory metastatic microsatellite stable (MSS) colorectal cancer. Phase 1b will assess dose-limiting toxicity (DLT), while Phase 2 will evaluate objective response rate (ORR), including progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DOR). Exploratory analyses will investigate immunomodulatory effects through tumor and peripheral blood studies, and treatment will continue every 3 weeks for up to 1 year or until disease progression.

Start Date01 Dec 2025

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

[+2]

NCT06548230

/ RecruitingPhase 1/2

A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)

To evaluate safety and determine the recommended Phase II dose (RP2D). We hypothesize that targeting leukemia stem/progenitor cells (LSCs) with nadunolimab (IL1RAP antibody) alone or in combination with current therapies of azacitidine (HMA) and venetoclax (Bcl-2 inhibitor), is an effective treatment strategy for high-risk MDS and AML, and with a clinical trial we will establish the safety and the early efficacy of this approach.

Start Date05 Mar 2025

Sponsor / Collaborator-

100 Clinical Results associated with Nadunolimab

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100 Translational Medicine associated with Nadunolimab

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100 Patents (Medical) associated with Nadunolimab

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6

Literatures (Medical) associated with Nadunolimab

01 Sep 2025·LUNG CANCER

Letter to the editor: Critical analysis of the CANFOUR trial on nadunolimab in advanced NSCLC

Letter

Author: Yang, Zongyu ; Liao, Songjie

01 Aug 2025·LUNG CANCER

Safety, efficacy, and analysis of biomarkers in patients with advanced non-small cell lung cancer treated with the anti-IL1RAP antibody nadunolimab (CAN04) in combination with platinum doublet

Article

Author: Zvirbule, Zanete ; Magnusson, Susanne ; Thorsson, Lars ; Paz-Ares, Luis G ; Garcia-Ribas, Ignacio ; Paulus, Astrid ; Millrud, Camilla Rydberg ; Zemaitis, Marius ; Sanfridson, Annika ; Tersago, Dominique ; Losic, Nedjad ; Cicenas, Saulius

INTRODUCTION:

Interleukin-1 receptor accessory protein (IL1RAP), expressed in several tumors, is essential for IL-1α and IL-1β signaling which leads to tumor progression and treatment resistance. Nadunolimab, a fully humanized antibody-dependent cellular cytotoxicity-enhanced monoclonal antibody, targets IL1RAP and blocks IL-1α/IL-1β signaling. Efficacy and safety of nadunolimab plus platinum-based doublet chemotherapies were assessed in patients with non-small cell lung cancer (NSCLC) (NCT03267316).

METHODS:

Patients with advanced NSCLC received nadunolimab plus platinum-based doublet chemotherapies in first-line or second-line post-pembrolizumab. Study objectives included the anti-tumor response, progression-free survival (PFS), overall survival (OS), levels of biomarkers in serum, and immunohistochemistry of baseline and on-treatment tumor biopsies.

RESULTS:

43 patients were enrolled, median age 64 years, 38 % female, and 43 % were treated in second-line post-pembrolizumab. Median PFS was 7.2 months (95 % CI 5.6-9.2), median OS was 13.7 months (95 % CI 11.1-18.3), and 1-year survival was 54 %. The greatest benefits were observed in 11 patients with non-squamous histology treated in second-line post-pembrolizumab: median OS 26.7 months, ORR 91 % including two complete responders (with distinct biomarker profiles), and 1-year survival 82 %. Biomarker analyses showed that patients in second-line post-pembrolizumab had an enhanced level of tumor-infiltrating immune cells compared to treatment naïve patients. Rates of Grade 3+ neutropenia, anemia, and thrombocytopenia were higher than previous reports of platinum-based doublet chemotherapies alone.

CONCLUSIONS:

Nadunolimab plus platinum-based doublet chemotherapies showed promising efficacy in advanced NSCLC, with the greatest benefit in patients with non-squamous histology treated in second line after relapsing on pembrolizumab treatment.

01 Jun 2025·INVESTIGATIONAL NEW DRUGS

Safety, tolerability, and preliminary efficacy of nadunolimab, an anti-IL- 1 receptor accessory protein monoclonal antibody, in combination with pembrolizumab in patients with solid tumors

Article

Author: Jimeno, Antonio ; Cohen, Roger B ; Sanfridson, Annika ; Millrud, Camilla Rydberg ; Hreno, Jennifer ; Garcia-Ribas, Ignacio ; Wallén-Öhman, Marie ; Sun, Lova

Summary:

Interleukin (IL)-1 signaling has an essential role in tumor progression and immunosuppression and is linked to acquired resistance to anti-PD-1/PD-L1 treatment. Nadunolimab is an IL1RAP (IL-1 receptor accessory protein)-targeting antibody that blocks IL-1α/IL-1β signaling and has enhanced antibody-dependent cellular cytotoxicity. We investigated the safety and preliminary efficacy of nadunolimab with pembrolizumab in patients with metastatic solid tumors who had progressed on previous checkpoint inhibitor treatment, suggesting acquired checkpoint inhibitor resistance (NCT04452214). This phase 1b trial enrolled patients with metastatic disease who had exhausted or declined standard-of-care alternatives. Patients received nadunolimab (5 mg/kg) and standard-dose pembrolizumab. The primary objective was to assess safety. Secondary objectives were anti-tumor response as per iRECIST, pharmacokinetics, and changes in immune mediators. Fifteen patients with stage IV cancer (head and neck squamous cell carcinoma, non-small cell lung cancer, melanoma) entered the trial. Grade ≥ 3 adverse events were reported for 7 patients (47%). There was one dose-limiting toxicity of febrile neutropenia. The most frequent grade ≥ 3 adverse event was dysphagia (two patients). Seven patients (47%) had reductions in target lesion size. Median iPFS was 3.4 months (95% CI 1.4–8.6). Median OS was 19.7 months (95% CI 4.3–28.7) with 67% 1-year survival. Survival was significantly longer in patients with higher baseline tumor infiltration of CD163 + macrophages and natural killer cells and in patients with reduced on-treatment circulating IL-6 levels or neutrophil-to-lymphocyte ratio. Nadunolimab with pembrolizumab had an acceptable safety profile, and prolonged disease control was observed in a subset of patients. The results support further development of nadunolimab in combination with checkpoint inhibitors.

55

News (Medical) associated with Nadunolimab

29 May 2026

·www.biospace.com

Cantargia AB to Host Webcast Covering Rights Issue, Loan Agreement, and Strategic Priorities

LUND, SE / ACCESS Newswire / May 28, 2026 / Cantargia (STO:CANTA) - With reference to the Company's press release on May 28, 2026, regarding the decision to conduct a rights issue in combination with a loan, Cantargia AB (Publ) ("Cantargia" or the "Company") invites shareholders, analysts and the press to a live web cast on June 1, 2026, at 4 pm CEST with details below. "This rights issue strengthens our ability to deliver on nadunolimab's full potential," said Hilde Steineger, CEO of Cantargia. "We can now move beyond our current preclinical commitments to capture emerging opportunities in PDAC, including combination strategies with RAS inhibitors, while at the same time advancing promising early signals in high‑risk MDS and AML. With this added financial flexibility, we are better positioned to build nadunolimab as a backbone therapy across both solid tumors and hematological malignancies, and to create long‑term value for patients and shareholders." The proceeds from the rights issue and loan agreement will strengthen Cantargia's financial position and enable expansion of its clinical development strategy beyond current commitments of the Company's preclinical research, supporting new opportunities in the evolving PDAC treatment landscape. Preclinical data indicate that IL1RAP targeting with nadunolimab complements RAS inhibition and may enhance anti-tumor activity, supporting planned combination study. The increased financial flexibility allows Cantargia to advance these opportunities while progressing existing preclinical programs, reinforcing nadunolimab's potential as a backbone therapy. Continued development in combination with gemcitabine and nab-paclitaxel is supported by encouraging efficacy and manageable safety. Cantargia has also reported promising early clinical data from an ongoing investigator-initiated Phase 1b/2a study at MD Anderson Cancer Center in MDS and AML, where IL1RAP is overexpressed. In the high-risk MDS cohort, all five evaluable patients achieved complete remission in Phase 1b, based on early but notable data. The study is now advancing into Phase 2a, expected to enroll approximately 40 patients. These results expand nadunolimab's clinical potential into hematology and, supported by the strengthened financial position, enable further development planning in MDS as a significant long-term opportunity for the Company. Participants who wish to join the audio cast, please use the link below. Via the web session you will be able to ask written questions. Webcast: If you wish to participate via teleconference, please register on the link below. After registration you will be provided with phone numbers and a conference ID to access the conference. There will be an opportunity to ask questions verbally via the teleconference: For further information, please contact Hilde Steineger, CEO Telephone: +46 (0)46-275 62 60 E-mail: info@cantargia.com About Cantargia Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. Cantargia's oncology program, the antibody nadunolimab (CAN04), is being studied clinically, primarily in combination with chemotherapy with a focus on pancreatic cancer and non-small cell lung cancer. Positive data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases. In September 2025, the acquisition of CAN10 by Otsuka Pharmaceutical was completed. Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at . Attachments Cantargia AB to Host Webcast covering Rights Issue, Loan Agreement, and Strategic Priorities SOURCE: Cantargia View the original press release on ACCESS Newswire

19 May 2026

·www.biospace.com

Cantargia Publishes Interim Report for The First Quarter of 2026

LUND, SE / ACCESS Newswire / May 19, 2026 / Cantargia AB (publ); Nasdaq Stockholm:CANTA) today announced its interim report for the first quarter of 2026. "The first quarter of 2026 reflects both strong execution and important strategic progress for Cantargia. We have delivered promising early clinical data in MDS, advanced our pipeline, and taken decisive steps to position the Company for increased long-term value creation in a rapidly evolving treatment landscape.", said Hilde Steineger, CEO of Cantargia. Significant events in the first quarter New preclinical data on anti-tumor effects of nadunolimab in metastatic colorectal cancer were presented at the Keystone Cancer Immunotherapy conference. Significant events after the end of the period The study design and scientific rationale for the investigator-initiated Phase 1b/2a study of nadunolimab in combination with checkpoint inhibitors in microsatellite-stable (MSS) colorectal cancer were presented at AACR 2026. Early but highly encouraging data were presented from the ongoing investigator-initiated Phase 1b/2a study evaluating nadunolimab in higher-risk myelodysplastic syndrome (HR-MDS) and acute myeloid leukemia (AML), including complete remission in all HR-MDS patients evaluated to date, leading to initiation of a formal hematological malignancies program. In view of exciting new Phase 3 data in PDAC from Revolution Medicine's RAS inhibitor, we see a clear opportunity to enhance value by rethinking the timing and structure of the planned Phase 2b/3 PDAC study for nadunolimab so that a future pivotal program is taking full advantage of the new RAS inhibitor driven treatment landscape. Dr. Wolfram Dempke will transition from the role of Chief Medical Officer and continue to support Cantargia as Chair of our PDAC Scientific Advisory Board Financial information First Quarter 2026 Net sales: SEK 0.5 M (0.0) Operating results: SEK -36.9 M (-45.0) Results after tax: SEK -33.0 M (-46.9) Earnings per share: before and after dilution, SEK -0.13 (-0.19) Equity/assets ratio: 87 (59) per cent Cash and cash equivalents: SEK 246.0 M (103.9) Short-term investments: SEK 12 M (0.0) In conjunction to the report, Cantargia invites investors, analysts, and media to an audiocast with teleconference (in English) on May 19, at 3:00 p.m. CEST, where Cantargia's CEO, Hilde Steineger, and CFO, Patrik Renblad, will present Cantargia and comment on the report, followed by a Q&A-session. If you wish to participate via audiocast, please use the link below. Via the web session you will be able to ask written questions. Webcast: . If you wish to participate via teleconference, please register on the link below. After registration you will be provided phone numbers and a conference ID to access the conference. You can ask questions verbally via the teleconference: . The webcast will also be available on demand on Cantargia's corporate website: For further information, please contact Hilde Steineger, CEO Telephone: +46 (0)46-275 62 60 E-mail: info@cantargia.com This information is information that Cantargia is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-05-19 07:00 CEST. About Cantargia Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. Cantargia's oncology program, the antibody nadunolimab (CAN04), is being studied clinically, primarily in combination with chemotherapy with a focus on pancreatic cancer and non-small cell lung cancer. Positive data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases. In September 2025, the acquisition of CAN10 by Otsuka Pharmaceutical was completed. Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at . Attachments Interim Report Q1 2026 SOURCE: Cantargia View the original press release on ACCESS Newswire

AcquisitionAACRImmunotherapy

06 May 2026

·www.biospace.com

Invitation to the Presentation of Cantargia’s Interim Report for Q1 2026

LUND, SE / ACCESS Newswire / May 6, 2026 / Cantargia AB (publ) (Nasdaq Stockholm:CANTA) will publish the company's interim report for Q1 2026 on Tuesday, May 19, 2026, at 07:00 a.m. CEST. In conjunction to the report, investors, analysts, and media are invited to an audiocast with teleconference (in English) on May 19, at 3:00 p.m. CEST, where Cantargia's CEO Hilde Steineger, and CFO Patrik Renblad, will present Cantargia and comment on the report, followed by a Q&A-session. If you wish to participate via audiocast, please use the link below. Via the web session you will be able to ask written questions. Webcast: . If you wish to participate via teleconference, please register on the link below. After registration you will be provided with phone numbers and a conference ID to access the conference. You can ask questions verbally via the teleconference. . The webcast will also be available on demand on Cantargia's corporate website: For further information, please contact Hilde Steineger, CEO Telephone: +46 (0)46-275 62 60 E-mail: info@cantargia.com About Cantargia Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. Cantargia's oncology program, the antibody nadunolimab (CAN04), is being studied clinically, primarily in combination with chemotherapy with a focus on pancreatic cancer and non-small cell lung cancer. Positive data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases. In September 2025, the acquisition of CAN10 by Otsuka Pharmaceutical was completed. Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at . Attachments Invitation to the Presentation of Cantargia’s Interim Report for Q1 2026 SOURCE: Cantargia View the original press release on ACCESS Newswire

Acquisition

100 Deals associated with Nadunolimab

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nodule of lung	Phase 2	United States	Cantargia AB	21 May 2026
Pancreatic Cancer	Phase 2	United States	Cantargia AB	20 Feb 2024
Advanced Triple-Negative Breast Carcinoma	Phase 2	Spain	Cantargia AB	11 Jan 2022
Advanced Malignant Solid Neoplasm	Phase 2	France	Cantargia AB	22 Sep 2021
Advanced Malignant Solid Neoplasm	Phase 2	Spain	Cantargia AB	22 Sep 2021
Gallbladder Neoplasms	Phase 2	France	Cantargia AB	22 Sep 2021
Gallbladder Neoplasms	Phase 2	Spain	Cantargia AB	22 Sep 2021
Intrahepatic Cholangiocarcinoma	Phase 2	France	Cantargia AB	22 Sep 2021
Intrahepatic Cholangiocarcinoma	Phase 2	Spain	Cantargia AB	22 Sep 2021
Non-Small Cell Lung Cancer	Phase 2	France	Cantargia AB	22 Sep 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05181462 (TRIFOUR, PipelineReview) Manual	Phase 1/2	Advanced Triple-Negative Breast Carcinoma HER2 Negative \| PR Negative \| ER Negative	99	nadunolimab+Gemcitabine+Carboplatin	etyennyuxj(rvntwnglbn) = lgfiqhmihn rrrwkbjoux (xkksawqyjq )	Negative	18 Jul 2025
				Gemcitabine+Carboplatin	etyennyuxj(rvntwnglbn) = pduxeylhjh rrrwkbjoux (xkksawqyjq )
NCT05181462 (TRIFOUR, SABCS2024 \| Company_Website) Manual	Phase 1/2	Advanced Triple-Negative Breast Carcinoma	15	Nadunolimab gemcitabine+ carboplatin	oizyzboemd(errenrcdrw) = lfyrzagkln qpprerrlgi (bkqzkhhgck, 32 - 84) View more	Positive	10 Dec 2024
NCT05116891 (CESTAFOUR, Company_Website) Manual	Phase 1/2	Neoplasms \| Non-Small Cell Lung Cancer \| Biliary Tract Neoplasms	-	Nadunolimab in combination with gemcitabine/cisplatin (NSCLC + first arm)	rkmxrnipwl(lznfoxugxn) = flxbbhwaci zttqvgxcbp (sjmprbqenb ) View more	Positive	28 Oct 2024
				Nadunolimab in combination with gemcitabine/cisplatin (biliary tract cancer + first arm)	rkmxrnipwl(lznfoxugxn) = evnpiiiavv zttqvgxcbp (sjmprbqenb ) View more
NCT05116891 (CANFOUR, ESMO2024) Manual	Phase 1/2	Non-Small Cell Lung Cancer First line \| Second line	40	Nadunolimab cisplatingemcitabine	zfyqdzjzcg(wugpkuqkvs) = wkxoqcuqdn rffytpydeg (uwhihgtggf ) View more	Positive	14 Sep 2024
				Nadunolimab cisplatingemcitabine	zfyqdzjzcg(wugpkuqkvs) = ybvmigztdg rffytpydeg (uwhihgtggf ) View more
NCT04452214 (ESMO2024) Manual	Phase 1	Solid tumor \| Squamous Cell Carcinoma of Head and Neck \| Melanoma ... Second line View more	15	Nadunolimab 5 mg/kg + Pembrolizumab	aftwsmtypu(mlcoenyhso) = 1(G3 febrile neutropenia) eahtquyhed (ezkfvpulws ) View more	Positive	14 Sep 2024
NCT03267316 (CANFOUR, ASCO2024)	Phase 1/2	Pancreatic Cancer	73	Nadunolimab 1 mg/kg	nmcoxomyzx(uzrbofbrno) = orndntdzhv fhstvtwktu (jwgtylzuku ) View more	Positive	24 May 2024
				Nadunolimab 2.5 mg/kg	nmcoxomyzx(uzrbofbrno) = azameqiilw fhstvtwktu (jwgtylzuku ) View more
NCT05181462 (TRIFOUR, ESMO 12023 \| ESMO 22023) Manual	Phase 1/2	Triple Negative Breast Cancer HER2 Negative \| ER Negative \| PR Negative	13	nadunolimab++gemcitabine 1000 mg/m2+carboplatin 2 mg/mL/min (Nadunolimab 1 mg/kg)	jbolhyuivf(zattymmojy) = tzjfnypdjf nkiematzqx (tkuqbjkyff )	Positive	21 Oct 2023
				nadunolimab++gemcitabine 1000 mg/m2+carboplatin 2 mg/mL/min (Nadunolimab 2.5 mg/kg)	jbolhyuivf(zattymmojy) = cwnjmuzqwv nkiematzqx (tkuqbjkyff )
NCT03267316 (ASCO2023)	Phase 1/2	Non-Small Cell Lung Cancer	30	Nadunolimab 1 mg/kg + cisplatin/gemcitabine	nklcaamqlu(oxjyvhbwfy) = zjtmdwkram dbiddtzkwf (jpehsmbgno, 3.7 - 7.5) View more	Positive	31 May 2023
				Nadunolimab 2.5 mg/kg + cisplatin/gemcitabine	twuchfuycr(tdjiiihcvn) = uawgeubixv tkqgfckrhr (dtjwrhogzd )
NCT03267316 \| NCT05116891 (CANFOUR, AACR2023)	Phase 1/2	Pancreatic Ductal Adenocarcinoma	73	Nadunolimab	sonqnvgdup(oiepppzahm) = hlqbbhoqcc gdawjmobjj (vwlijlgrly, 10.0 - 19.1) View more	-	04 Apr 2023
NCT03267316 (CANFOUR, ASCO2022) Manual	Phase 1/2	Pancreatic adenocarcinoma	76	gemcitabine+nab-paclitaxel+nadunolimab	mgkoniubzs(knlunsvmwq) = Infusion-related reactions were reported in 29% (grade 3 in 3%). Peripheral sensory neuropathy was rare (only two grade 2 events). fsrpycbdta (mowwzuescs ) View more	Positive	02 Jun 2022

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