Drugs / Mitazalimab
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07319195 | Apr 2026 → Apr 2028 expected | breast cancer | Jennifer Zhang | Recruiting | No outcome recorded |
| Phase 14 trials | ||||||
| Phase 1 | NCT06205849 | Jul 2024 → Aug 2028 expected | malignant pancreatic neoplasm | University of California, San Diego | Recruiting | No outcome recorded |
| Phase 1 | NCT05650918 | Aug 2021 → May 2023 | malignant pancreatic neoplasm | Joachim Aerts, MD PhD | Completed | No outcome recorded |
| Phase 1 | NCT02829099 | Sep 2016 → Jul 2021 | high grade malignant neoplasm | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02379741 | Apr 2015 → Mar 2017 | neoplasm | Alligator Bioscience AB | Completed | No outcome recorded |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT04888312 | Sep 2021 → Jun 2026 overdue | pancreatic ductal adenocarcinoma | Alligator Bioscience AB | Active not recruiting | Met primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT07199764 | Nov 2025 → Oct 2027 expected | pancreatic ductal adenocarcinoma | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07437287 | Jul 2026 → Apr 2030 expected | biliary tract cancer | UNICANCER | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 50
| Date | Issuer | Release |
|---|---|---|
| 2026-04-20 | Alligator Bioscience AB | Results New data from investigator‑initiated study evaluating Alligator Bioscience’s mitazalimab to be presented at AACR Annual Meeting 2026 alligatorbioscience.se ↗
Overall, neoantigen reactivity increased significantly following treatment, indicating that mitazalimab + IRE results in an expansion of tumor specific T cells. |
| 2025-12-01 | Alligator Bioscience AB | Results Alligator Bioscience announces publication of REACtiVe-2 Phase 1 trial data in Nature Communications alligatorbioscience.se ↗
The combination therapy significantly decreased intratumoral collagen content, likely through mitazalimab-mediated macrophage activation and stromal degradation. |
| 2025-11-05 | Alligator Bioscience AB | Results Alligator Bioscience presents new data on mitazalimab and ATOR-4066 at SITC 40th Anniversary Annual Meeting alligatorbioscience.se ↗
The mitazalimab abstract presents new data from the OPTIMIZE-1 trial in metastatic pancreatic cancer, further characterizing efficacy, safety, and biomarker responses at two dose levels. |
| 2025-10-13 | Alligator Bioscience AB | Results REACtiVe-2 Phase 1 data featuring mitazalimab demonstrate immune activation in metastatic pancreatic cancer – to be presented at ESMO 2025 alligatorbioscience.se ↗
The investigator-sponsored trial, conducted at Erasmus MC Cancer Institute, demonstrated that the combination of mitazalimab and Amphera’s dendritic cell vaccine MesoPher was safe and well-tolerated, with enhanced systemic and local immune responses. |
| 2025-10-08 | Alligator Bioscience AB | Results Alligator announces publication of OPTIMIZE-1 biomarker analysis in Cell Reports Medicine supporting mitazalimab and mFOLFIRINOX in metastatic pancreatic cancer alligatorbioscience.se ↗
Baseline expression of a tumor-intrinsic fibrotic gene signature, directly linked to the mode of action of mitazalimab, was associated with improved overall survival. |
| 2025-09-22 | Alligator Bioscience AB | Results Alligator announces final 30-month OPTIMIZE-1 results highlighting the potential of mitazalimab in metastatic pancreatic cancer alligatorbioscience.se ↗
Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, today announced final results from the OPTIMIZE-1 trial evaluating its lead asset, mitazalimab, in combination with mFOLFIRINOX chemotherapy in patients with previously untreated metastatic pancreatic cancer. |
| 2025-08-20 | Alligator Bioscience AB | Results Alligator Bioscience provides highlights from R&D event 2025 alligatorbioscience.se ↗
Long-term follow-up data continue to demonstrate encouraging overall survival in metastatic pancreatic cancer, supporting the confirmed regulatory path and planned initiation of a Phase 3 trial. |
| 2025-07-01 | Alligator Bioscience AB | Results Alligator to present 24-month OPTIMIZE-1 data at ESMO GI 2025 alligatorbioscience.se ↗
Patients receiving 900 μg/kg mitazalimab showed a median overall survival of 14.9 months and a median progression-free survival of 7.8 months, supporting a sustained clinical benefit. |
| 2025-06-17 | Alligator Bioscience AB | Regulatory Alligator receives positive scientific advice from EMA on Phase 3 trial of mitazalimab alligatorbioscience.se ↗
The advice confirms that the proposed Phase 3 study of mitazalimab in combination with mFOLFIRINOX is appropriately designed to support future marketing authorization application. |
| 2025-06-13 | Alligator Bioscience AB | Regulatory Alligator Bioscience receives FDA endorsement of mitazalimab Phase 3 dose for pancreatic cancer alligatorbioscience.se ↗
This positive regulatory feedback confirms Alligator’s dose selection and represents a key milestone in the late-stage development of mitazalimab. |
| 2025-06-03 | Alligator Bioscience AB | Results Biomarker data from Alligator Bioscience’s OPTIMIZE-1 trial presented at ASCO 2025 Annual Meeting alligatorbioscience.se ↗
The biomarker analyses highlighted mitazalimab’s immunological mechanism of action, with immune activation in responding patients and gene signatures associated with clinical benefit and improved survival. |
| 2025-05-23 | Alligator Bioscience AB | Results Alligator Bioscience presents OPTIMIZE-1 biomarker data at ASCO 2025 Annual Meeting alligatorbioscience.se ↗
Mitazalimab-induced biomarkers were associated with clinical benefit supporting a significant contribution of mitazalimab to clinical efficacy, including the intratumoral immune activation in responding patients. |
| 2025-05-20 | Alligator Bioscience AB | Regulatory Alligator Bioscience announces paediatric study waiver for mitazalimab granted by the European Medicines Agency alligatorbioscience.se ↗
The waiver, issued as part of the Paediatric Investigation Plan (PIP) regulatory process, exempts Alligator from the obligation to conduct pediatric studies with mitazalimab in the treatment of pancreatic cancer. |
| 2025-04-24 | Alligator Bioscience AB | Results Alligator Bioscience AB reports financial results for Q1 2025 and provides a business update alligatorbioscience.se ↗
Announcement of encouraging overall survival benefit from the Phase 2 trial OPTIMIZE-1, with 24-month follow-up data showing a 29.4% survival rate for mitazalimab in combination with mFOLFIRINOX—three times higher than estimates for chemotherapy alone. |
| 2025-02-26 | Alligator Bioscience AB | Results Alligator Bioscience Announces Continued Encouraging Overall Survival Benefit for Mitazalimab alligatorbioscience.se ↗
The data demonstrated a 24-month survival rate of 29.4% in patients treated with mitazalimab in combination with mFOLFIRINOX. |
| 2025-01-27 | Alligator Bioscience AB | Results Alligator Bioscience Reports Incremental Overall Survival Benefit of mitazalimab combined with mFOLFIRINOX based on Literature-based Indirect Comparison of Outcomes alligatorbioscience.se ↗
The results demonstrated a significantly better Overall Survival (OS) potential for mitazalimab in combination with mFOLFIRINOX compared to FOLFIRINOX-based regimens (hazard ratio 0.64, 95% CI 0.46 – 0.87) and FOLFIRINOX-based plus NALIRIFOX regimens (hazard ratio 0.68, 95% CI 0.47 – 0.99). |
| 2024-11-06 | Alligator Bioscience AB | Results Alligator Bioscience Presents an Update with Clinical and Biomarker Results with Mitazalimab in Phase 2 Pancreatic Cancer at SITC 2024 alligatorbioscience.se ↗
The confirmed overall response rate (ORR) was 42.1%, with 23 partial responses (PR) and one complete response (CR). |
| 2024-06-26 | Alligator Bioscience AB | Results Alligator Bioscience Announces Substantial Overall Survival Benefit and Unprecedented Duration of Response in the 18-Month Analysis from Mitazalimab OPTIMIZE-1 Phase 2 Study in 1st Line Pancreatic Cancer alligatorbioscience.se ↗
The data demonstrated a near doubling of the 18-month survival rate to 36.2% in patients treated with mitazalimab in combination with mFOLFIRINOX, compared to 18.6% reported with FOLFIRINOX[1] alone. |
| 2024-06-20 | Alligator Bioscience AB | Results Alligator Bioscience to Present Positive Phase 2 Data on Mitazalimab in Pancreatic Cancer at ESMO GI 2024 alligatorbioscience.se ↗
The trial study met its primary endpoint, with mitazalimab showing a manageable safety profile and promising DoR associated with a clinically meaningful survival benefit. |
| 2024-06-03 | Alligator Bioscience AB | Results Alligator Bioscience’s Phase 2 mitazalimab Pancreatic Cancer Data Published in The Lancet Oncology alligatorbioscience.se ↗
Data presented in The Lancet Oncology, from the OPTIMIZE-1 trial of mitazalimab in combination with mFOLFIRINOX, showed a confirmed ORR of 40.4% in 57 evaluable patients (unconfirmed ORR was 50.9%). |
| 2024-05-23 | Alligator Bioscience AB | Results Alligator Bioscience to Present Positive Phase 2 Mitazalimab Data in Pancreatic Cancer at 2024 ASCO Annual Meeting alligatorbioscience.se ↗
OPTIMIZE-1 achieved its primary endpoint, demonstrating a confirmed Objective Response Rate (ORR) of 40.4%, an unconfirmed ORR of 50.9% and a disease control rate (DCR) of 79% in 57 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). |
| 2024-04-08 | Alligator Bioscience AB | Results Alligator Bioscience Announces Two Presentations on Mitazalimab and ATOR-4066 at the AACR Annual Meeting 2024 alligatorbioscience.se ↗
Moreover, the presentation underlines the synergistic potential of this combination for an improved antitumor response compared to FOLFIRINOX alone. |
| 2023-10-26 | Alligator Bioscience AB | Regulatory Alligator Bioscience AB reports financial results for the first 9 months of 2023 and for Q3 2023 and provides a business update alligatorbioscience.se ↗
During another busy and productive quarter for Alligator we achieved one more important milestone in the clinical and commercial development of our lead asset with the addition of orphan designation for mitazalimab in pancreatic cancer by the European regulator. |
| 2023-09-28 | Alligator Bioscience AB | Results Alligator Bioscience Presents New Data Demonstrating Durable Response and Encouraging Anti-Tumor Activity of Lead Asset Mitazalimab alligatorbioscience.se ↗ |
| 2023-09-27 | Alligator Bioscience AB | Results Alligator Bioscience Announces Publication Highlighting Pharmacodynamic Data from Mitazalimab Phase 1 Study in Scientific Journal “Cells” alligatorbioscience.se ↗
The analysis revealed that at the current Phase 2 dose 900 μg/kg mitazalimab induced peripheral transcriptomic alterations consistent with immune activation expected from a strong CD40 agonist. |
| 2023-08-21 | Alligator Bioscience AB | Regulatory Alligator Bioscience Receives European Medicine Agency Orphan Designation for Mitazalimab in Pancreatic Cancer alligatorbioscience.se ↗
Alligator Bioscience (Nasdaq Stockholm: ATORX) today announces that the European Medicines Agency (EMA) has granted Orphan Designation to its lead asset mitazalimab for the treatment of pancreatic cancer. |
| 2023-07-11 | Alligator Bioscience AB | Results Alligator Bioscience to Present its CD40 Program at the 3rd Annual Tumor Myeloid-Directed Therapies Summit in July 2023 alligatorbioscience.se ↗
Latest analysis shows increase in ORR and favorable DoR suggesting durable benefits of mitazalimab in combination with mFOLFIRINOX |
| 2023-06-26 | Alligator Bioscience AB | Results Alligator Bioscience Announces Positive Second Interim Efficacy Analysis from Mitazalimab OPTIMIZE-1 Phase 2 Study in 1st Line Pancreatic Cancer alligatorbioscience.se ↗
Lund, Sweden – Alligator Bioscience (Nasdaq Stockholm: ATORX) today announces positive second interim results from the ongoing OPTIMIZE-1 Phase 2 study of the company's lead asset mitazalimab in 1st line metastatic pancreatic cancer. |
| 2023-06-05 | Alligator Bioscience AB | Results Alligator Bioscience to Present Latest Clinical Data from Mitazalimab OPTIMIZE-1 Phase 2 Trial in Pancreatic Cancer at ASCO Annual Meeting 2023 alligatorbioscience.se ↗
The data presented at ASCO demonstrate that mitazalimab in combination with mFOLFIRINOX is a feasible treatment regimen for 1st line pancreatic cancer patients with encouraging interim efficacy and well-manageable safety profile, consistent with mFOLFIRINOX monotherapy. |
| 2023-05-18 | Alligator Bioscience AB | Regulatory Alligator Bioscience Receives FDA Orphan Drug Designation for Mitazalimab in Pancreatic Cancer alligatorbioscience.se ↗
the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead asset mitazalimab for the treatment of pancreatic cancer. |
| 2023-04-03 | Alligator Bioscience AB | Regulatory Alligator Bioscience Announces FDA Authorization to Initiate Mitazalimab OPTIMIZE-2 Phase 2 Trial in Urothelial Carcinoma alligatorbioscience.se ↗ |
| 2023-01-02 | Alligator Bioscience AB | Results Alligator Bioscience Announces Positive Interim Results from Mitazalimab OPTIMIZE-1 Phase 2 Trial in Pancreatic Cancer Exceeding 50% Objective Response Rate alligatorbioscience.se ↗
The interim results demonstrate an objective response rate (ORR) of 52% in 23 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). |
| 2022-12-22 | Alligator Bioscience AB | Results Alligator Bioscience Announces Publication Highlighting Phase 1 Mitazalimab Data in Solid Tumors in Peer-Reviewed Journal “Investigational New Drugs” alligatorbioscience.se ↗
Pharmacodynamic results demonstrated immune activation, as indicated by increased cytokines and chemokines, consistent with its proposed mechanism as a CD40 agonist. |
| 2022-11-10 | Alligator Bioscience AB | Results Data presented on mitazalimab and ATOR-1017 in Two Poster Presentations at SITC Annual Meeting 2022 – November 8-12, 2022 alligatorbioscience.se ↗
The analysis of the RNA sequencing data clearly demonstrates that mitazalimab induces strong immune responses in patients by activating myeloid cells and B cells. |
| 2022-09-14 | Alligator Bioscience AB | Results Alligator Bioscience Presents Additional Data from mitazalimab OPTIMIZE-1 Phase 1b/2 Trial at AACR Special Conference on Pancreatic Cancer 2022 alligatorbioscience.se ↗
Data from Phase 1b dose escalation part of the study shows that mitazalimab combined with mFOLFIRINOX is safe and well tolerated |
| 2022-03-23 | Alligator Bioscience AB | Results Alligator Bioscience Announces mitazalimab OPTIMIZE-1 Trial Update: Successful Completion of Phase Ib, Phase II enrolling at 900 µg/kg alligatorbioscience.se ↗
The Data Review Committee has declared the 900 µg/kg mitazalimab dose to be safe and recommended that the dosing level should be continued for the Phase II study. |
| 2022-01-18 | Alligator Bioscience AB | Results Alligator Bioscience Announces OPTIMIZE-1 Trial Update: Cohort Fully Dosed with No Adverse Effects Reported alligatorbioscience.se ↗
All patients in the 450 µg/kg cohort have been dosed and there have been no adverse effects related to study medication has been reported. |
| 2021-09-02 | Alligator Bioscience AB | Results Positive Results from the Scandion Oncology and Alligator Bioscience Collaboration Further Supports Efficacy of Mitazalimab in Combination Therapy alligatorbioscience.se ↗
We were pleased to see that the results strengthen and expand the preclinical efficacy data for mitazalimab by demonstrating synergy with FOLFIRINOX in tumors resistant to chemotherapy. |
| 2021-06-30 | Alligator Bioscience AB | Results Alligator Bioscience AB and Scandion Oncology A/S present promising preclinical data alligatorbioscience.se ↗
Importantly, the current data indicate that the anti-tumor effect of SCO-101, mitazalimab and FOLFIRINOX is even more potent than mitazalimab and FOLFIRINOX. |
| 2021-05-05 | Alligator Bioscience AB | Results Alligator’s mitazalimab shown to enhance cancer vaccine alligatorbioscience.se ↗
The published data show that mitazalimab activates dendritic cells and tumor-reactive T cells resulting in enhanced anti-tumor efficacy in combination with a model cancer vaccine. |
| 2021-03-11 | Alligator Bioscience AB | Results Mitazalimab synergizes with chemotherapy – Alligator Bioscience presents new preclinical data at AACR alligatorbioscience.se ↗
The abstract, titled ”Mitazalimab, a potent CD40 agonist with potential for combination with chemotherapy”, demonstrates that mitazalimab synergizes with chemotherapy, notably FOLFIRINOX, leading to improved long-term survival in a preclinical tumor model. |
| 2020-12-28 | Alligator Bioscience AB | Regulatory Alligator Bioscience submits CTA for the mitazalimab Phase II study OPTIMIZE-1 alligatorbioscience.se ↗
Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced that it has submitted a CTA (Clinical Trial Authorization) application to the relevant regulatory authorities to start a Phase II efficacy study of its wholly-owned CD40 targeting antibody mitazalimab. |
| 2020-12-04 | Alligator Bioscience AB | Regulatory Approved IND for Alligator Bioscience’s CD40-targeting antibody mitazalimab alligatorbioscience.se ↗
Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced an approved IND (Investigational new Drug) for the CD40 targeting antibody mitazalimab. |
| 2020-11-05 | Alligator Bioscience AB | Results Alligator Bioscience presents the CD40 antibody mitazalimab at the World Immunotherapy Congress 2020 alligatorbioscience.se ↗
The comparison demonstrates the potent immune-activating properties and anti-tumor effects of mitazalimab. |
| 2020-09-04 | Alligator Bioscience AB | Results Alligator Bioscience presents positive biomarker data demonstrating proof of mechanism in mitazalimab clinical Phase I study alligatorbioscience.se ↗
The study identified a large number of upregulated genes after treatment with mitazalimab, such as PD-L1, which supports a clinical development plan for mitazalimab in combination studies with PD-1 inhibition. |
| 2019-05-15 | Alligator Bioscience AB | Results Alligator Bioscience: ADC-1013 clinical Phase I data to be presented at ASCO alligatorbioscience.se ↗
Early evidence of clinical activity in this study included a partial response (PR) in a patient with renal cell cancer and 10 patients with prolonged stable disease (SD) ≥6 months. |
| 2019-01-29 | Alligator Bioscience AB | Results Alligator Bioscience publishes clinical phase I data for ADC-1013 in the International Journal of Cancer alligatorbioscience.se ↗
The results show that the agonistic anti-CD40 antibody ADC-1013 is safe and tolerated at clinically relevant dose levels. |
| 2018-11-01 | Janssen Research & Development, LLC | Results Janssen Shows Commitment to Advancing the Science and Treatment of Blood Cancers and Related Conditions With More Than 80 ASH 2018 Data Presentations From Differentiated Oncology and Cardiovascular Portfolios jnj.com ↗
JNJ-64457107, a CD40 Agonist, Induces Cell Death in BCL6hiIRF4neg GCB Subtype of DLBCL |
| 2017-11-07 | Alligator Bioscience AB | Results Results from Alligator Bioscience’s clinical phase I study support further clinical development of ADC-1013 alligatorbioscience.se ↗
The study results show that ADC-1013 is generally well tolerated and support further clinical development of ADC-1013 as a mono- or combination therapy. |
| 2017-05-04 | Alligator Bioscience AB | Results Alligator Bioscience presents promising immuno-oncology data at US conference; – Strong new preclinical findings for ADC-1013 and ATOR-1015 alligatorbioscience.se ↗
ADC-1013, licensed to Janssen Biotech Inc., was shown to induce synergistic anti-tumor effects in combination with PD-1 receptor blockade in a pre-clinical bladder cancer model. |
All press releases naming this drug 77 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Mitazalimab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07199764 ↗ |
| Known as | ADC-1013 | “The use of CD40 agonists (such as mitazalimab, also known as JNJ-64457107 and ADC-1013) may convert pancreatic adenocarcinomas into immunological hot tumors by T-cell-dependent...” NCT05650918 ↗ |
| Known as | JNJ-64457107 | “The use of CD40 agonists (such as mitazalimab, also known as JNJ-64457107 and ADC-1013) may convert pancreatic adenocarcinomas into immunological hot tumors by T-cell-dependent...” NCT05650918 ↗ |
| Known as | JNJ-7107 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297870 ↗ |
| Known as | Vanalimab | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297870 ↗ |
| Action | Activate | “agonistic human monoclonal IgG1 anti-CD40 antibody” NCT02379741 ↗ |
| Modality | Monoclonal antibody | “an agonistic human monoclonal IgG1 anti-CD40 antibody” NCT02379741 ↗ |
| Route | Other | “administered intratumorally (as repeated injections directly into the tumor tissue)” NCT02379741 ↗ |
| Target | CD40 | “anti-CD40 antibody” NCT02379741 ↗ |