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-OMON27591

/ RecruitingNot ApplicableIIT

Dendritic Cells loaded with allogeneic tumor lysate (MesoPher) in combination with a CD40 agonist (Mitazalimab) for metastatic pancreatic disease

Start Date20 Jul 2021

Sponsor / Collaborator-

100 Clinical Results associated with Mitazalimab

100 Translational Medicine associated with Mitazalimab

100 Patents (Medical) associated with Mitazalimab

Literatures (Medical) associated with Mitazalimab

01 Jul 2024·LANCET ONCOLOGY

Combining CD40 agonist mitazalimab with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (OPTIMIZE-1): a single-arm, multicentre phase 1b/2 study

Article

Author: Batlle, Jaime Feliu ; Prenen, Hans ; Cassier, Philippe Alexandre ; Pilla, Lorenzo ; Gallego, Inmaculada ; Pazo-Cid, Roberto Antonio ; Blanc, Jean-Frédéric ; Garrote, Mercedes Rodriguez ; Van Laethem, Jean-Luc ; Borbath, Ivan ; Pico de Coaña, Yago ; Ellmark, Peter ; Smith, Karin Enell ; Ambarkhane, Sumeet Vijay ; Mitry, Emmanuel ; Macarulla, Teresa ; Geboes, Karen Paula ; Lambert, Aurélien

BACKGROUND:

Current systemic therapies for metastatic pancreatic ductal adenocarcinoma are associated with poor outcomes with a 5-year overall survival rate under 5%. We aimed to assess the safety and antitumour activity of mitazalimab, a human CD40 agonistic IgG1 antibody, with modified FOLFIRINOX (mFOLFIRINOX; fluorouracil, leucovorin, oxaliplatin, and irinotecan), in chemotherapy-naive patients with metastatic pancreatic ductal adenocarcinoma.

METHODS:

OPTIMIZE-1 was a single-arm, multicentre, phase 1b/2 study which enrolled adults with histologically-confirmed metastatic pancreatic ductal adenocarcinoma and European Cooperative Oncology Group performance status 0 or 1 in 14 university hospitals in Belgium, France, and Spain. The primary endpoint of phase 1b was to determine the recommended phase 2 dose of intravenous mitazalimab (450 μg/kg or 900 μg/kg) when combined with intravenous mFOLFIRINOX (oxaliplatin 85 mg/m², leucovorin 400 mg/m², irinotecan 150 mg/m², fluorouracil 2400 mg/m²). In the first 21-day treatment cycle, mitazalimab was administered on days 1 and 10, and mFOLFIRINOX on day 8. In subsequent 14-day cycles mitazalimab was administered 2 days after mFOLFIRINOX. The phase 2 primary endpoint was objective response rate. Activity and safety analyses were conducted on the full analysis set (all patients who received the combination of mitazalimab at the recommended phase 2 dose and mFOLFIRINOX for at least two treatment cycles) and safety set (all patients who received any study treatment), respectively. Enrolment is complete, and data represents a primary analysis of the ongoing trial. The trial is registered at Clinicaltrials.gov (NCT04888312).

FINDINGS:

Between Sept 29, 2021, and March 28, 2023, 88 patients were screened and 70 patients were enrolled (40 [57%] were female and 30 [43%] were male). In phase 1b, 900 μg/kg mitazalimab was determined as the recommended phase 2 dose. Overall, five patients received 450 μg/kg mitazalimab; 65 received 900 μg/kg mitazalimab. No dose-limiting toxicities were observed at 450 μg/kg, and one dose-limiting toxicity was observed at 900 μg/kg. 57 patients were evaluated for activity, and all 70 patients were included in the safety set. At data cutoff on Nov 14, 2023, median follow-up was 12·7 months (95% CI 11·1-15·7). Of the 57 patients, 29 (51%) remained on study and 18 (32%) remained on treatment. The primary endpoint (objective response rate >30%) was met (objective response rates in 23 [40%]; one-sided 90% CI ≥32 of 57 patients). The most common grade 3 or worse adverse events were neutropenia (18 [26%] of 70 patients), hypokalaemia (11 patients [16%]), and anaemia and thrombocytopenia (eight patients [11%]). Serious adverse events were reported in 29 (41%) of 70 patients, the most common being vomiting (five [7%] of 70 patients), decreased appetite (four [6%]), and diarrhoea and cholangitis (three [4%] of 70 patients for each), none considered related to mitazalimab. No treatment-related deaths were reported.

INTERPRETATION:

Mitazalimab with mFOLFIRINOX demonstrated manageable safety and encouraging activity, warranting continued development in a phase 3, randomised, controlled trial. The results from OPTIMIZE-1 pave the way for further exploration and confirmation of a novel immunotherapy treatment regimen for metastatic pancreatic ductal adenocarcinoma, which is a complex and aggressive cancer with very low survival rates and restricted treatment options.

FUNDING:

Alligator Bioscience.

01 Feb 2024·Cytokine & growth factor reviews

Harnessing the potential of CD40 agonism in cancer therapy

Review

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

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 ; Perets, Ruth ; Fourneau, Nele ; Verona, Raluca ; Moreno, Victor ; Geva, Ravit

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).

News (Medical) associated with Mitazalimab

17 Dec 2024

·www.businesswire.com

CD40 Targeted Therapies Clinical Trials, Therapeutic Approaches & Market Opportunity Insight Report 2025 - First CD40 Targeted Therapy Approval Expected By 2027 - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "CD40 Targeted Therapies Clinical Trials, Therapeutic Approaches & Market Opportunity Insight 2025" report has been added to ResearchAndMarkets.com's offering. CD40 targeted therapies have become a focal point in immunotherapy research, with growing attention on harnessing the potential of the CD40 receptor to treat a variety of diseases. While no CD40 targeted therapies have yet been approved for clinical use, some promising candidates are currently undergoing late stage clinical development. Moreover, additional candidates are slated to enter late-stage trials within the next year, expanding the pool of CD40 targeted therapies in clinical development. These ongoing research and clinical trials suggest that CD40 targeted therapies could become a vital treatment option for patients with prevalent diseases in the coming years. Global CD40 Targeted Therapies Clinical Trials, Therapeutic Approaches & Market Opportunity Insight 2025 Report Highlights: First CD40 Targeted Therapy Approval Expected By 2027 CD40 Targeted Therapies In Clinical Trials: > 20 Therapies CD40 Inhibitors Clinical Trials Insight By Company, Country, Indication & Phase CD40 Targeted Therapy Research & Development Trends By Indication CD40 Targeted Therapy Market Trend Analysis By Region CD40 Targeted Therapies Proprietary Technologies By Company Historically, the primary focus of CD40 targeted therapies has been on autoimmune and inflammatory diseases. However, there is an increasing interest in exploring their potential for treating cancer and other conditions. More recent studies have expanded the scope of CD40 targeting to include infectious diseases, such as HIV and COVID-19, as well as neurodegenerative diseases like Alzheimer's and Parkinson's disease. Some research has also suggested that CD40 targeted therapies might be beneficial for diseases like cardiovascular conditions, where CD40's signaling pathway, although not directly involved in disease initiation, plays a role in disease progression and inflammation. Over the years, various strategies have been employed to target the CD40 receptor and its ligand. These include traditional monoclonal antibodies as well as next-generation molecular therapeutics such as small interfering RNA (siRNA). While antibodies are developed either as CD40 agonists or as antagonists, CD40 targeted siRNAs aim to reduce CD40 protein expression by degrading CD40 mRNA. Several other conventional and next-generation approaches are undergoing active research and clinical trials to assess their safety and efficacy. Nonetheless, antibody therapies remain the dominant approach in CD40 targeted research. Among the most advanced CD40/CD40L targeted antibodies are those for autoimmune and inflammatory diseases, with some entering phase 3 clinical trials. For example, Sanofi's Frexalimab, a promising anti CD40 antibody, is currently in phase 3 trials for autoimmune conditions. In the cancer domain, CD40 targeted antibodies are also making significant strides, with companies like Alligator Bioscience preparing to initiate phase 3 clinical trials for its lead candidate, mitazalimab, an anti-CD40 antibody for pancreatic ductal adenocarcinoma (PDA) and pancreatic cancer. The development of CD40 targeted therapies has been greatly facilitated by the advent of proprietary technologies and platforms. One notable example is GenMab's DuoBody platform, which enables the creation of bispecific antibodies that can target two different antigens simultaneously. This technology has been leveraged to develop several promising immunotherapies, including its CD40 targeted therapy, GEN1042/BNT312, currently in phase 2 trial for malignant solid tumors. As the field of CD40 targeted therapies evolves, the competitive landscape is becoming increasingly crowded, with many major pharmaceutical companies entering the arena. Notable players include Amgen, Sanofi, GenMab, BioNTech, and Biogen, all of which are investing heavily in this space. Collaborations between pharmaceutical companies and academic institutions have been essential in advancing the scientific understanding of CD40 targeted therapies, combining cutting edge research with clinical expertise to bring these therapies closer to market. In conclusion, while CD40 targeted therapies have not yet been approved for clinical use, they represent a promising and rapidly developing area of research across a wide range of diseases. As more therapies enter clinical trials and the competitive landscape intensifies, it is clear that CD40 targeted therapies could become a cornerstone of treatment for cancer, autoimmune diseases, infectious diseases, and beyond in the near future. Key Topics Covered: Introduction To CD40 Targeted Therapies Considering CD40 As Drug Target Over Other CD Markers History & Evolution Of CD40 Targeting Therapies CD40 Targeted Therapies - Mechanism Of Action Agonist Mediated Activation Of CD40 Signaling Antagonist-Mediated Inhibition Of CD40 Signaling CD40 Targeted Therapeutic Approaches Antibody Formats Fusion Proteins Peptides Nucleic Acids CD40 Targeted Therapy Research & Development Trends By Indication Cancer Neurological Diseases Autoimmune & Inflammatory Disorders Transplant Rejection Microbial Infections Global CD40 Targeted Therapy Market Outlook Current Market Trends & Developments Future Market Opportunities CD40 Targeted Therapy Market Trend Analysis By Region US Europe China Japan Australia CD40 Targeted Therapies Clinical Trials Insight By Company, Country, Indication & Phase Research Preclinical Phase I Phase I/II Phase II Phase III CD40 Targeted Therapies - Proprietary Technologies By Company Alligator Bioscience - FIND Technology & Neo-X-Prime Aprilbio - SAFA Platform Biocytogen - RenMice EnnoDC - Unnamed Platform Genmab - DuoBody Harbour BioMed - Harbour Mice & HBICE Kyowa Kirin - REGULGENT Strike Pharma - ADAC Technology Platform Global CD40 Targeted Therapy Market Dynamics Competitive Landscape Alligator Bioscience Amgen Biogen BioNTech Eledon Pharmaceuticals EnnoDC Genmab Innovent Bio Novartis Sanofi Tonix Pharmaceuticals UCB For more information about this report visit https://www.researchandmarkets.com/r/46sm5e About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

ImmunotherapyPhase 3Phase 2

13 Dec 2024

·www.accesswire.com

Last Day of Trading in Warrants Series TO 9 in Alligator Bioscience AB is 13 December 2024

LUND, SE / ACCESSWIRE / December 13, 2024 / Alligator Bioscience (STO:ATORX) 13 December 2024 is the last day of trading in warrants series TO 9 in Alligator Bioscience AB ("Alligator Bioscience" or the "Company"). Subscription of ordinary shares by exercise of warrants series TO 9 is ongoing until 18 December 2024. One (1) warrant series TO 9 entitles the holder to subscribe for one (1) new ordinary share in the Company at a subscription price of SEK 0.55 per share.During March - April 2024, Alligator Bioscience carried out a rights issue of units (the " Rights Issue "). Each unit issued in the Rights Issue consisted of one (1) ordinary share and one (1) warrant series TO 9. One (1) warrant series TO 9 entitles the holder to subscribe for one (1) new ordinary share in the Company. Upon full exercise of all warrants, Alligator Bioscience will receive approximately SEK 55.0 million before issue costs. 13 December 2024 is the last day of trading in warrants series TO 9.Complete terms and conditions for the warrants are available on the Company's website, www.alligatorbioscience.com .Summarized terms for warrants series TO 9Exercise period : 4 December 2024 - 18 December 2024.Subscription price : SEK 0.55 per share. The subscription price corresponds to 90 per cent of the volume-weighted average price of the Company's ordinary share on Nasdaq Stockholm during the period 4 - 29 November 2024.Issue volume : 100,084,946 warrants series TO 9. For each warrant series TO 9, the holder can subscribe for one (1) new ordinary share in the Company. If all warrants are exercised, 100,084,946 ordinary shares will be issued, which will provide the Company with approximately SEK 55.0 million before issue costs.Last day of trading in warrants series TO 9 : 13 December 2024.Share capital and dilution : Upon full exercise of all 100,084,946 warrants series TO 9, the share capital will increase by a maximum of SEK 80,067.9568 to SEK 687,259.2256 through the issuance of a maximum of 100,084,946 new ordinary shares, resulting in that the total number of outstanding shares in the Company will increase from 758,989,086 to 859,074,032, whereof 858,294,863 are ordinary shares and 779,169 are series C shares. Upon full exercise of all warrants series TO 9, the dilution of the ordinary shares amounts to approximately 11.7 per cent. The total number of votes in the Company will, following full exercise of all warrants TO 9, amount to 858,372,779.9.Please note that the warrants series TO 9 that are not exercised by 18 December 2024, or sold by 13 December 2024, will expire without value. In order for the warrants not to lose their value, active subscription of shares or sale of warrants is required. Please note that some nominees may close their application earlier than 18 December 2024.AdvisersVator Securities AB acts as Sole Global Coordinator and bookrunner in connection with the Rights Issue and Van Lanschot Kempen N.V. acts as financial adviser to Alligator Bioscience in connection with the Rights Issue. Setterwalls Advokatbyrå AB is legal adviser to Alligator Bioscience in connection with the Rights Issue. Vator Securities AB acts as the issuing agent in connection with the Rights Issue.For further information, please contact:Søren Bregenholt, CEOE-mail: [email protected]Phone: +46 (0) 46 540 82 00The information was submitted for publication, through the agency of the contact person set out above, at 08:00 a.m. CET on December 13, 2024.About Alligator BioscienceAlligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. Its portfolio includes lead drug candidate mitazalimab, for which the company reported unprecedented survival data at 18-months follow up in first-line metastatic pancreatic cancer patients in Phase 2 testing and is in preparation for Phase 3 development. The follow-on bispecific antibody ATOR-4066 is in preclinical testing. Alligator has a proprietary technology platform, comprised of two antibody libraries, ALLIGATOR-GOLD® and ALLIGATOR-FAB™, the powerful protein optimization strategy FIND® and the bispecific antibody format RUBY™, which drives rapid design and development of innovative drugs.Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden.For more information, please visit alligatorbioscience.com .IMPORTANT INFORMATIONThe information in this press release does not contain or constitute an offer to acquire, subscribe for or otherwise trade in shares, warrants or other securities in Alligator. The invitation to the persons concerned to subscribe for units consisting of shares and warrants in Alligator has only been made through the prospectus published by Alligator on 15 March 2024, and through the supplement prospectus published by Alligator on 22 March 2024. The prospectuses have been approved and registered by the Swedish Financial Supervisory Authority and have been published on the Company's website, www.alligatorbioscience.com .Since Alligator Bioscience conducts essential services according to the Swedish Screening of Foreign Direct Investments Act ( Sw. lag (2023:560) om granskning av utländska direktinvesteringar), the exercise of warrants for subscription of ordinary shares may require review by the Inspectorate of Strategic Products (ISP). The Company will, no later than in connection with the commencement of the exercise period for the warrants, publish more information about this on the Company's website, www.alligatorbioscience.com .AttachmentsLast day of trading in warrants series TO 9 in Alligator Bioscience AB is 13 December 2024SOURCE: Alligator Bioscience

Phase 2

04 Dec 2024

·www.accesswire.com

Alligator Bioscience Publishes Financial Calendar for 2025

LUND, SE / ACCESSWIRE / December 04, 2024 / Alligator Bioscience (STO:ATORX) Lund, Sweden - Alligator Bioscience (Nasdaq Stockholm: ATORX), hereby publishes its financial calendar for 2025:Extraordinary General Meeting13 January 2025Deadline for Alligator Bioscience's shareholders to submit resolutions to be considered by the Annual General Meeting31 January 2025Year-end report 202422 January 2025Annual report 2024March 2025Interim report Q1 202524 April 2025Annual General Meeting7 May 2025Interim report H1 202510 July 2025Interim report Q3 202523 October 2025Year-end report 202512 February 2026For further information, please contact:Søren Bregenholt, CEOE-mail: [email protected]Phone: +46 (0) 46 540 82 00Johan Giléus, CFOE-mail: [email protected]Phone: +46 (0) 46 540 82 00The information was submitted for publication, through the agency of the contact person set out above, at 08:45 a.m. CET on December 4, 2024.About Alligator BioscienceAlligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. Its portfolio includes lead drug candidate mitazalimab, for which the company reported unprecedented survival data at 18-months follow up in first-line metastatic pancreatic cancer patients in Phase 2 testing and is in preparation for Phase 3 development. The follow-on bispecific antibody ATOR-4066 is in preclinical testing. Alligator has a proprietary technology platform, comprised of two antibody libraries, ALLIGATOR-GOLD® and ALLIGATOR-FAB™, the powerful protein optimization strategy FIND® and the bispecific antibody format RUBY™, which drives rapid design and development of innovative drugs.Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden.For more information, please visit alligatorbioscience.com .AttachmentsAlligator Bioscience publishes financial calendar for 2025SOURCE: Alligator Bioscience

Clinical ResultPhase 3Financial StatementPhase 1Phase 2

100 Deals associated with Mitazalimab

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 2	Belgium	Alligator Bioscience AB	17 Sep 2021
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 2	France	Alligator Bioscience AB	17 Sep 2021
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 2	Spain	Alligator Bioscience AB	17 Sep 2021
Advanced Malignant Solid Neoplasm	Phase 1	Denmark	Alligator Bioscience AB	01 Apr 2015
Advanced Malignant Solid Neoplasm	Phase 1	Sweden	Alligator Bioscience AB	01 Apr 2015
Advanced Malignant Solid Neoplasm	Phase 1	United Kingdom	Alligator Bioscience AB	01 Apr 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04888312 (OPTIMIZE-1, NEWS) Manual	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma First line	-	MITAZALIMAB + mFOLFIRINOX	embivlsdeq(lxoqcjypmb) = vdvicmbeyr gsamycsago (yxfwnvqzmb ) View more	Positive	26 Feb 2025
NCT04888312 (OPTIMIZE-1, NEWS) Manual	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma First line	-	mFOLFIRINOX	embivlsdeq(lxoqcjypmb) = wfvjgxgarl gsamycsago (yxfwnvqzmb ) View more	Positive	26 Feb 2025
NCT04888312 (OPTIMIZE-1, Pubmed)	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma	70	Mitazalimab 900 μg/kg	dodkdppuys(wsfovnjjrn) = eight patients [11%] vmghamwuiu (ybwvtmfdid ) View more	Positive	01 Jul 2024
NCT04888312 (OPTIMIZE-1, ASCO2024) Manual	Phase 2	Metastatic Pancreatic Ductal Adenocarcinoma First line	-	mitazalimab+FOLFIRINOX	snkovlxsvt(yptrdjdijt) = associated with an expansion in the frequency of effector CD4 T cells (p < 0.0001) at day 8 after receiving mitazalimab. uaggoakkiz (vtjidjbfcp )	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	ohkibovqah(hczbkgswgz) = cjsbkjekmb xwtxiwfxgf (cdldlsqyff, 29.4 - 52.1) View more	Positive	24 May 2024
NCT04888312 (OPTIMIZE-1, PRNewswire) Manual	Phase 2	Pancreatic Cancer First line	57	Mitazalimab	fyiobvbgmm(tfmtbroqvd) = gpkhcgzyxz brziunhycw (ofihzdikmr ) View more	Positive	01 Jul 2023
NCT04888312 (OPTIMIZE-1, ASCO2023) Manual	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma	43	Mitazalimab + mFOLFIRINOX	nlrnvsdijn(weypxygyte) = ocoxwxwlgq njwqjjzjrp (josanlssrs ) View more	Positive	31 May 2023
NCT04888312 (OPTIMIZE-1, PipelineReview) Manual	Phase 2	Metastatic Pancreatic Cancer First line	23	mFOLFIRINOX+Mitazalimab	xumqgwcwsd(arzwkikarh) = mbmljbymao lmzubsptbw (avrsbhjfbe ) View more	Positive	02 Jan 2023
NCT02829099 (Pubmed)	Phase 1	Advanced Malignant Solid Neoplasm	95	Mitazalimab	vrgyukyuls(bpzfgfvicg) = vnaycmgnuw ylltpxtgfr (dyudjszxjc ) View more	-	20 Dec 2022
NCT04888312 (OPTIMIZE-1, AACR2022) Manual	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma First line	11	Mitazalimab+mFOLFIRINOX	ywnoxrzuii(quduhgxuok) = zboydyeefx rcvnhwekis (gefitnxafi ) View more	Positive	15 Nov 2022
NCT04888312 (OPTIMIZE-1, ASCO2022) Manual	Phase 1	Metastatic Pancreatic Ductal Adenocarcinoma	5	mFOLFIRINOX+Mitazalimab	zmxaoksvnv(dkocsorihi) = bysozbzojb clxmmzoykx (hkhqkleexo ) View more	Positive	02 Jun 2022

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