This is a phase I study of an agonistic CD40 antibody (mitazalimab) injected intratumorally at the time of surgical IRE in patients with locally advanced pancreatic cancer. Intratumoral delivery has potential to be more effective than systemic (intravenous) delivery while decreasing the systemic side effects of immunotherapy. We hypothesize that local delivery of mitazalimab at the time of IRE in patients with locally advanced pancreatic cancer will be safe, augment the immune effects of IRE, and decrease the risk of recurrence.

Start Date25 Jun 2024

Sponsor / Collaborator

University of California San Diego

[+2]

NCT04888312 / Active, not recruitingPhase 1/2

An Open-label Phase 1b/2 Study Assessing the Safety and Efficacy of Mitazalimab in Combination With Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Phase 1b/2 study to assess the safety and efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma.

Start Date17 Sep 2021

Sponsor / Collaborator

Alligator Bioscience AB

[+2]

NL-OMON52234 / CompletedNot Applicable

Dendritic Cells loaded with allogeneic tumor lysate (MesoPher) in combination with a CD40 agonist (Mitazalimab) in metastatic pancreatic disease (REACtiVe-2 Trial) - REACtiVe-2

Start Date30 Aug 2021

Sponsor / Collaborator

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

100 Clinical Results associated with Mitazalimab

100 Translational Medicine associated with Mitazalimab

100 Patents (Medical) associated with Mitazalimab

Literatures (Medical) associated with Mitazalimab

01 Feb 2024·Cytokine & growth factor reviews

Harnessing the potential of CD40 agonism in cancer therapy

Review

Author: Richmond, Ann ; Zhou, Yang ; Yan, Chi

CD40 is a member of the tumor necrosis factor (TNF) receptor superfamily of receptors expressed on a variety of cell types. The CD40-CD40L interaction gives rise to many immune events, including the licensing of dendritic cells to activate CD8⁺ effector T cells, as well as the facilitation of B cell activation, proliferation, and differentiation. In malignant cells, the expression of CD40 varies among cancer types, mediating cellular proliferation, apoptosis, survival and the secretion of cytokines and chemokines. Agonistic human anti-CD40 antibodies are emerging as an option for cancer treatment, and early-phase clinical trials explored its monotherapy or combination with radiotherapy, chemotherapy, immune checkpoint blockade, and other immunomodulatory approaches. In this review, we present the current understanding of the mechanism of action for CD40, along with results from the clinical development of agonistic human CD40 antibodies in cancer treatment (selicrelumab, CDX-1140, APX005M, mitazalimab, 2141-V11, SEA-CD40, LVGN7409, and bispecific antibodies). This review also examines the safety profile of CD40 agonists in both preclinical and clinical settings, highlighting optimized dosage levels, potential adverse effects, and strategies to mitigate them.

01 Feb 2023·Investigational new drugs

A phase 1 study of intravenous mitazalimab, a CD40 agonistic monoclonal antibody, in patients with advanced solid tumors

Article

Author: Hellemans, Peter ; Peretz-Yablonski, Tamar ; Girgis, Suzette ; Xia, Qi ; Pendás, Natalia ; Calvo, Emiliano ; Guo, Yue ; Fourneau, Nele ; Perets, Ruth ; Verona, Raluca ; Geva, Ravit ; Moreno, Victor

Mitazalimab is an agonistic human monoclonal antibody targeting CD40, a target for anti-tumor immunotherapy. This phase 1, dose-escalation study evaluated the safety, dose-limiting toxicities (DLTs), pharmacokinetic and pharmacodynamic profile of mitazalimab. Adults with advanced solid malignancies received mitazalimab intravenously once every-2-weeks. Dose-escalation was pursued with and without pre-infusion corticosteroids for mitigation of infusion-related reactions (IRRs). In all, 95 patients were enrolled in 7 cohorts (n = 50, 75-2000 µg/kg) with corticosteroids and in 5 cohorts (n = 45, 75-1200 µg/kg) without corticosteroids. Two patients experienced DLTs (transient Grade-3 headache; Grade-3 drug-induced liver injury [Hy's law]). The most frequently reported (≥ 25%) treatment-emergent adverse events were fatigue (44.2%), pyrexia (38.9%), pruritus (38.9%), chills (27.4%), and headache (26.3%). IRRs were reported in 51.6% of patients; pruritus (30.5%; with corticosteroids [36.0%], without corticosteroids [24.4%]) was the most frequent. Following the first infusions of 600 μg/kg and 2000 μg/kg, mitazalimab was rapidly cleared from the systemic circulation with mean terminal half-life of 11.9 and 24.1 h, respectively. Pharmacokinetics appeared to exhibit target-mediated drug disposition at the tested doses. Mitazalimab treatment induced higher levels of selected chemokines and transient reduction of B-cells, T-cells, and NK cells. One patient (renal cell carcinoma) displayed partial response lasting 5.6 months. Stable disease was reported by 35 (36.8%) patients, persisting for ≥ 6 months in 9 patients. Mitazalimab has a manageable safety profile with acceptable pharmacokinetic and pharmacodynamic properties. Future clinical development will evaluate combination with existing treatment options. Trial registration NCT02829099 (ClinicalTrials.gov; July 7, 2016).

01 Dec 2021·Cancer immunology, immunotherapy : CIIQ2 · MEDICINE

The human anti-CD40 agonist antibody mitazalimab (ADC-1013; JNJ-64457107) activates antigen-presenting cells, improves expansion of antigen-specific T cells, and enhances anti-tumor efficacy of a model cancer vaccine in vivo

Q2 · MEDICINE

Article

Author: Enell Smith, Karin ; Thagesson, Mia ; Deronic, Adnan ; Ellmark, Peter ; Werchau, Doreen ; Nilsson, Anneli

Abstract:

Non-responders to checkpoint inhibitors generally have low tumor T cell infiltration and could benefit from immunotherapy that activates dendritic cells, with priming of tumor-reactive T cells as a result. Such therapies may be augmented by providing tumor antigen in the form of cancer vaccines. Our aim was to study the effects of mitazalimab (ADC-1013; JNJ-64457107), a human anti-CD40 agonist IgG1 antibody, on activation of antigen-presenting cells, and how this influences the priming and anti-tumor potential of antigen-specific T cells, in mice transgenic for human CD40. Mitazalimab activated splenic CD11c+ MHCII+ dendritic cells and CD19+ MHCII+ B cells within 6 h, with a return to baseline within 1 week. This was associated with a dose-dependent release of proinflammatory cytokines in the blood, including IP-10, MIP-1α and TNF-α. Mitazalimab administered at different dose regimens with ovalbumin protein showed that repeated dosing expanded ovalbumin peptide (SIINFEKL)-specific CD8+ T cells and increased the frequency of activated ICOS+ T cells and CD44hi CD62L− effector memory T cells in the spleen. Mitazalimab prolonged survival of mice bearing MB49 bladder carcinoma tumors and increased the frequency of activated granzyme B+ CD8+ T cells in the tumor. In the ovalbumin-transfected tumor E.G7-OVA lymphoma, mitazalimab administered with either ovalbumin protein or SIINFEKL peptide prolonged the survival of E.G7-OVA tumor-bearing mice, as prophylactic and therapeutic treatment. Thus, mitazalimab activates antigen-presenting cells, which improves expansion and activation of antigen-specific T cells and enhances the anti-tumor efficacy of a model cancer vaccine.

News (Medical) associated with Mitazalimab

04 Jun 2024

·www.pharmaceutical-technology.com

ASCO 2024: Alligator shares positive data for pancreatic cancer drug

Alligator Bioscience’s pancreatic cancer therapy compared favourably with standard of care chemotherapies in a recent data readout. Credit: peakSTOCK via Getty Images. Alligator Bioscience released positive data from its Phase Ib/II OPTIMIZE-1 study (NCT04888312) investigating its pancreatic cancer monoclonal antibody therapy, mitazalimab. Recommended Buyer's Guides Buyer's Guide Leading Guide to Packaging Materials, Containers and Containment Services for the Pharmaceutical Industry Buyer's Guide Top Guide for Drug Delivery Systems The Sweden-headquartered company presented the Phase II readout at the American Society of Clinical Oncology Annual Meeting (ASCO 2024), publishing the data in the Lancet Oncology on 3 June. Patients who took mitazalimab in combination with mFOLFIRINOX, demonstrated a confirmed objective response rate (ORR) of 40.4% with a median overall survival (mOS) of 14.3 months. This was an improvement compared to historical data from treatment with mFOLFIRINOX where patients typically achieve a 31.6% ORR and a mOS of 11.1 months. In an exclusive interview with Pharmaceutical Technology , Alligator CEO Dr Søren Bregenholt says: “We believe that adding three months to the overall survival is clinically meaningful. It is definitely meaningful for the patients, and it is also a differential that is approvable in almost all major territories.” Bregenholt explains that for 80% of pancreatic cancer patients, the only option available for frontline and second-line treatment is chemotherapy. He adds that approved therapies are quite “mediocre” in terms of response rate and clinical benefit. The US Food and Drug Administration (FDA) recently approved Ipsen Biopharmaceuticals’ chemotherapy combination, NALIRIFOX, for the first-line treatment of pancreatic cancer in February 2024. NALIRIFOX uses Onivyde (irinotecan liposome) with oxaliplatin, fluorouracil, and leucovorin to treat the diseases The regimen is the second US-approved Onivyde regimen for metastatic pancreatic adenocarcimoma with FOLFIRINOX receiving an approval over a decade ago. Bregenholt adds that treatment with mitazalimab has very few adverse reactions and side effects compared to the many commonly associated with the marketed chemotherapy combinations. See Also: J&J seeks expanded approvals for paediatric HIV-1 therapy FDA fast tracks Quince Therapeutics’ rare ataxia drug EryDex Mitazalimab is a CD40 agonist that treats pancreatic cancer by activating and proliferating memory T cells and enhancing the immune response. Bregenholt says that the company has begun to plan its Phase III trial for mitazalimab. “We expect to start the Phase III trial in the first half of next year,” he says.

Phase 3Clinical ResultASCODrug ApprovalPhase 2

03 Jun 2024

·www.biospace.com

Alligator Bioscience's Phase 2 mitazalimab Pancreatic Cancer Data Published in The Lancet Oncology

LUND, SE / ACCESSWIRE / June 03, 2024 / Alligator Bioscience (STO:ATORX) Publication in world-leading clinical oncology journal validates the quality and potential implications of Phase 2 OPTIMIZE-1 results The study reported Objective Response Rate (ORR) of 40.4% in 57 evaluable patients, primary endpoint was met. The novel combination of mitazalimab and mFOLFIRINOX and the unique dosing schedule resulted in an unprecedented Duration of Response (DoR, median 12.5 months) together with a prolonged Overall Survival (OS, median 14.3 months). These results compare favorably to the historically reported outcomes for FOLFIRINOX alone and most other standard of care or investigational therapies. These data were also presented at the ASCO annual meeting on June 1; updated data with longer follow-up are expected end of June 2024. Lund, Sweden - Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced the publication of positive Phase 2 data on its lead drug candidate mitazalimab in first line metastatic pancreatic cancer in The Lancet Oncology . The journal is an internationally trusted source of clinical, and global health knowledge. With an Impact Factor of 51.1, it is the world-leading clinical oncology research journal. With a 5-year overall survival rate of less than 5%, current systemic therapies for metastatic pancreatic ductal adenocarcinoma (mPDAC) are associated with poor outcomes. 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%). Median DoR was 12.5 months and the median OS was 14.3 months. Median Progression Free Survival (PFS) was 7.7 months. These data compare favorably to the historically reported outcomes with FOLFIRINOX (ORR 31.6%, mDoR 5.9 months, mOS 11.1 months and mPFS 6.4 months) [1] . The recently approved new treatment regimen of NALIRIFOX was associated with an ORR of 42%, mDoR of 7.3 months, mPFS 7.4 months and a mOS of 11.1 months. [2] "The long-lasting responses and related biomarker associations reported in OPTIMIZE-1 are highly encouraging, demonstrating a critical immunomodulatory contribution of mitazalimab. The increase in ORR and PFS, compared to FOLFIRINOX alone, are superior outcomes and we believe that the reported depth and duration of response are strong indicators that the observed increases in survival will remain evident," said Prof. Jean-Luc van Laethem, Head of the Digestive Oncology Department of Erasme Hospital (ULB) Brussels, Principal Investigator of the OPTIMIZE-1 trial and lead author of the article in The Lancet Oncology. "Furthermore, mitazalimab showed a favorable safety pro it could offer better quality of life for pancreatic patients who currently have few treatment options. The data from OPTIMIZE-1 are very promising and are strongly supportive of the continued development of mitazalimab and mFOLFIRINOX in mPDAC, in a confirmatory trial." OPTIMIZE-1 , an open-label, single-arm, multicenter, Phase 1b/2 study, assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX. The DoR and OS are expected to improve further, as a majority of the patients were still alive at the time of the analysis (cut-off date November 2023). The OPTIMIZE-1 results compare favorably to the previously reported outcomes with FOLFIRINOX[1] as well as more recently reported data of the NALIRIFOX regimen in the NAPOLI 3 Phase 3 trial[2]. The OS at 12 months in OPTIMIZE-1 was 59.3%, compared to 48.1% for FOLFIRINOX[1] and 45.6% for NALIRIFOX[2]. "This publication in The Lancet Oncology is an important validation of the highly promising results of our OPTIMIZE-1 mitazalimab study. A substantial number of patients were either in the treatment or in the follow-up at the time of the primary analysis . Consequently, the 18-month survival follow-up data, which we expect at the end of June 2024, should provide further important insights into the potential of mitazalimab," said Søren Bregenholt, CEO of Alligator Bioscience. Click here for the full article in The Lancet Oncology . Title: Combining CD40 agonist mitazalimab with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (OPTIMIZE-1): a single-arm, multicentre phase 1b/2 study. Provisional Publication Date: June 1st, 2024 Article Number: 24TLO0432 Two posters (abstracts 2569 and 4133) detailing the positive OPTIMIZE-1 data were presented on June 1 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. [1] Conroy et al., N Engl J Med 2011; 364:1817-1825; DOI: 10.1056/NEJMoa1011923 [2] Wainberg et al., Lancet 2023; 402(10409):1272-1281; DOI: 10.1016/S0140-6736(23)01366-1 About pancreatic cancer Pancreatic cancer is the 12th largest cancer by number of patients. It is expected to become the second leading cause of cancer death in the western world by 2030. There are about 200,000 annual cases in the U.S. and the EU, with very poor prognosis: five-year survival is about 10% and median survival about 6 months. For 80% of patients, the only option is chemotherapy that offers only marginal benefit. FOLFIRINOX is expected to be the preferred first line regimen in the U.S. and the EU for patients with good performance status. Sources: POLARIS Market Research, KOL event Alligator Bioscience Søren Bregenholt, CEO E-mail: soren.bregenholt@alligatorbioscience.com Phone: +46 (0) 46 540 82 00 Cohesion Bureau Investors Frank Hoerning Andersen E-mail: frank.hoerning@cohesionbureau.com Phone: +45 25 66 86 02 Media Sam Cage E-mail: sam.cage@cohesionbureau.com Phone: +45 24 37 63 42 About Alligator Bioscience Alligator Bioscience AB is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs. Alligator's portfolio includes several promising drug candidates, with the CD40 agonist mitazalimab as its key asset. Furthermore, Alligator is co-developing ALG.APV-527 with Aptevo Therapeutics Inc., several undisclosed molecules based on its proprietary technology platform, Neo-X-Prime™, and novel drug candidates based on the RUBY™ bispecific platform with Orion Corporation. Out-licensed programs include AC101/HLX22, in Phase 2 development, by Shanghai Henlius Biotech Inc. and an undisclosed target to Biotheus Inc. Alligator Bioscience's shares are listed on Nasdaq Stockholm (ATORX) and is headquartered in Lund, Sweden. For more information, please visit alligatorbioscience.com . Attachments Alligator Bioscience's Phase 2 mitazalimab Pancreatic Cancer Data Published in The Lancet Oncology SOURCE: Alligator Bioscience View the original press release on accesswire.com

Clinical ResultASCOPhase 2Phase 3Immunotherapy

24 May 2024

·www.pharmaceutical-technology.com

ASCO 2024: Verastem’s combo therapy for pancreatic cancer hits early trial success

Verastem will present the results at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting on 1 June 2024. Image credit: Shutterstock/CI Photos. Verastem Oncology has reported positive initial results from an ongoing Phase I/II trial investigating kinase inhibitor avutometinib for the treatment of pancreatic cancer. The US biopharma company announced the initial interim safety and efficacy results as it gears up for a presentation at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting on 1 June 2024. Verastem’s trial, named RAMP 205, is a single-arm study evaluating avutometinib plus defactinib in combination with gemcitabine and nab-paclitaxel, the latter two being standard-of-care chemotherapy, in patients with previously untreated metastatic pancreatic ductal adenocarcinoma. Out of the six patients receiving 2.4mg avutometinib, five achieved a confirmed overall response rate (ORR). The 83% ORR exceeds other promising treatments in the space, including Jacobio Pharmaceutical’s glecirasib and Alligator Bioscience’s mitazalimab , amongst others. Shares in the company rose 40% in premarket trading. See Also: ASCO 2024: MediLink’s NSCLC and breast cancer ADC shows early safety success ASCO 2024: MSD’s ADC shows efficacy in lung and breast tumours Patients in the dose level I cohort received 2.4mg of avutometinib twice a week and 200mg of defactinib twice a day for three weeks out of every four. Patients also were administered with 800mg/m² of gemcitabine and 125mg/m² of nab-paclitaxel on days one, eight and 15. Avutometinib works by blocking both mitogen-activated protein kinase (MEK) kinase activity and rapidly accelerated fibrosarcoma’s (RAF) ability to phosphorylate MEK. The RAF/MEK clamp drug creates an anti-tumour response by inhibiting the RAS/MAPK pathway. Verastem says that its mechanism has an advantage over MEK-only inhibitors, as MEK signalling can be blocked without the compensatory activation of MEK, which can limit efficacy. Defactinib reduces tumour growth by blocking focal adhesion kinase (FAK). Verastem’s chief medical officer John Hayslip said the trial results “are encouraging” and “demonstrate the importance of targeting the RAS/MAPK pathway, as more than 90% of pancreatic tumours have a KRAS mutation”. Hayslip added: “We continue to progress the study evaluating other dose and schedule regimens to determine the recommended Phase II dose in the trial.” Verastem gained an exclusive wordwide licence for avutometinib from Chugai Pharmaceuticals in January 2020. Defactinib was meanwhile licensed from Pfizer back in 2012. Whilst Verastem touted positive efficacy results, the biopharma did report 19 treatment-emergent serious adverse events (SAEs) from 12 patients in the trial. 11 patients had Grade 3 or higher SAEs, including biliary obstruction, febrile neutropenia, and pulmonary embolism, amongst others. Two participants left the trial due to adverse events. From the dose level 1 cohort, there was one case of dose-limiting toxicity of febrile neutropenia. Verastem stated the dose cohort was cleared after additional patients were evaluated. Avutometinib won orphan drug designation from the US Food and Drug Administration (FDA) in March 2024. The agency designated the award for the treatment of recurrent low-grade serous ovarian cancer alone or with defactinib. Verastem’s has Phase II (NCT04625270) and Phase III (NCT06072781) trials ongoing for ovarian cancer treatment .

Clinical ResultASCOOrphan DrugPhase 1Phase 2

100 Deals associated with Mitazalimab

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 2	BE	Alligator Bioscience AB	17 Sep 2021
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 2	FR	Alligator Bioscience AB	17 Sep 2021
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 2	ES	Alligator Bioscience AB	17 Sep 2021
Advanced Malignant Solid Neoplasm	Phase 1	DK	Alligator Bioscience AB	01 Apr 2015
Advanced Malignant Solid Neoplasm	Phase 1	SE	Alligator Bioscience AB	01 Apr 2015
Advanced Malignant Solid Neoplasm	Phase 1	GB	Alligator Bioscience AB	01 Apr 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04888312 (OPTIMIZE-1, Pubmed)	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma	70	Mitazalimab 900 μg/kg	nknqqulytl(dojrctncsx) = eight patients [11%] wmfoaxgppk (wwdcuiefld ) View more	Positive	01 Jul 2024
NCT04888312 (OPTIMIZE-1, ASCO2024) Manual	Phase 2	Metastatic Pancreatic Ductal Adenocarcinoma First line	-	mitazalimab+FOLFIRINOX	ueihmddaca(qrwcxykddd) = associated with an expansion in the frequency of effector CD4 T cells (p < 0.0001) at day 8 after receiving mitazalimab. wdwhlopnbk (roolymwqcd )	Positive	24 May 2024
NCT04888312 (OPTIMIZE-1, ASCO2024) Manual	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma First line KRAS G12D \| KRAS G12R \| KRAS G12V	57	Mitazalimab + mFOLFIRINOX	dbnqwsbpny(flnllrncjj) = inqimuytto ionlmwvtzg (ueasviqlid, 29.4 - 52.1) View more	Positive	24 May 2024
OPTIMIZE-1 (PRNewswire) Manual	Phase 2	Pancreatic Cancer First line	57	Mitazalimab	obtsxgxjae(ckwouluult) = caoqndshbs mlvegepyxs (jvufblszna ) View more	Positive	01 Jul 2023
NCT04888312 (OPTIMIZE-1, ASCO2023) Manual	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma	43	Mitazalimab + mFOLFIRINOX	wzeyfbsniq(wlbosilklx) = tyuavdtxow yrloyntswu (eaxoqoxhxp ) View more	Positive	31 May 2023
NCT04888312 (OPTIMIZE-1, PipelineReview) Manual	Phase 2	Secondary malignant neoplasm of pancreas First line	23	mFOLFIRINOX+Mitazalimab	yuamginvwu(jnzdasorup) = kehrxuiphk ljsmgcajrk (mfugibeguf ) View more	Positive	02 Jan 2023
NCT02829099 (Pubmed)	Phase 1	HR-positive/HER2-low Solid Tumors	95	Mitazalimab	uhygkfyoxk(hstkeljefl) = fiplrlkgve jztnwptsuj (eysmwhupsi ) View more	-	20 Dec 2022
NCT04888312 (OPTIMIZE-1, AACR2022) Manual	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma First line	11	Mitazalimab+mFOLFIRINOX	wzquqqxbof(wappfidkdo) = sfwrtklfsa psgijfokcl (tyaottphmk ) View more	Positive	15 Nov 2022
NCT04888312 (OPTIMIZE-1, ASCO2022) Manual	Phase 1	Metastatic Pancreatic Ductal Adenocarcinoma	5	mFOLFIRINOX+Mitazalimab	iuugiuxgtt(uqfpqdosjj) = lutvhilhbd tuovoiykxo (ffxbowaupj ) View more	Positive	02 Jun 2022
SITC2015	Phase 1	-	-	ADC-1013	iectyzgrbz(jgarwoslyn) = jgorlmjfrn alsdocouyg (rjwnkktaah ) View more	-	04 Nov 2015

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