This study investigates whether a single subcutaneous administration of anti-PD-1 antibody can induce CD8+ T-cell tumor-infiltration that can be non-invasively monitored with [89Zr]crefmirlimab berdoxam PET imaging as an imaging biomarker.

Start Date01 Aug 2024

Sponsor / Collaborator

Radboud University Medical Center

[+3]

NL-OMON53860 / SuspendedPhase 2

CD8 T cell imaging by positron emission tomography with 89Zr-Df-IAB22M2C in giant cell arteritis and rheumatoid arthritis: a pilot study - CD8 T cell PET in GCA and RA

Start Date01 Dec 2023

Sponsor / Collaborator

Universitair Medisch Centrum Groningen

NCT05849467 / RecruitingPhase 1IIT

Central Nervous System Uptake of Anti-CD8+ T Cell Minibodies in Multiple Sclerosis and Progressive Multifocal Leukoencephalopathy: A Pilot Study

Background:
Multiple sclerosis (MS) and progressive multifocal leukoencephalopathy (PML) are disorders that affect the central nervous system (CNS). The CNS includes the brain, spinal cord, and optic nerves. Both diseases can cause muscle weakness and impair vision, speech, and coordination. Researchers are working to better understand how MS and PML affect the CNS.
Objective: To test whether an experimental radioactive tracer (minibody) can help positron emission tomography (PET) scans detect certain immune cells in the CNS of people with MS and PML.
Eligibility:
People aged 18 years and older with MS or PML.
Design:
Participants will come to the clinic for at least 3 visits over 4 to 6 weeks.
Participants will undergo testing. They will have a physical and neurological exam. They will have blood tests and tests of their heart function. They will have a magnetic resonance imaging (MRI) scan of the brain. They may have a spinal tap: Their lower back will be numbed, and a needle will be inserted between the bones of the spine to withdraw fluid from around the spinal cord.
Minibody is given through a tube with a needle placed in a vein in the arm. This takes 5 to 10 minutes. Participants will have heart function tests before and after receiving the minibody.
Participants will return the next day for the PET scan. They will lie on a table that moves through a doughnut-shaped machine. This scan will take about 1 hour.
Participants with PML may opt to repeat the minibody infusion and the PET scan within 6 months.

Start Date19 Oct 2023

Sponsor / Collaborator

National Institute of Neurological Disorders & Stroke

100 Clinical Results associated with Zirconium (89Zr) crefmirlimab berdoxam

100 Translational Medicine associated with Zirconium (89Zr) crefmirlimab berdoxam

100 Patents (Medical) associated with Zirconium (89Zr) crefmirlimab berdoxam

Literatures (Medical) associated with Zirconium (89Zr) crefmirlimab berdoxam

01 Jan 2024·Immune Network

Influenza Virus-Derived CD8 T Cell Epitopes: Implications for the Development of Universal Influenza Vaccines

Review

Author: Kim, Sang-Hyun ; Oh, Jihee ; Kim, Jeong-Ki ; Padasas, Bill Thaddeus ; Son, Ju-Ho ; Webby, Richard J ; Españo, Erica ; Park, Chan-Su ; Lee, Young-Ran

The influenza virus poses a global health burden. Currently, an annual vaccine is used to reduce influenza virus-associated morbidity and mortality. Most influenza vaccines have been developed to elicit neutralizing Abs against influenza virus. These Abs primarily target immunodominant epitopes derived from hemagglutinin (HA) or neuraminidase (NA) of the influenza virus incorporated in vaccines. However, HA and NA are highly variable proteins that are prone to antigenic changes, which can reduce vaccine efficacy. Therefore, it is essential to develop universal vaccines that target immunodominant epitopes derived from conserved regions of the influenza virus, enabling cross-protection among different virus variants. The internal proteins of the influenza virus serve as ideal targets for universal vaccines. These internal proteins are presented by MHC class I molecules on Ag-presenting cells, such as dendritic cells, and recognized by CD8 T cells, which elicit CD8 T cell responses, reducing the likelihood of disease and influenza viral spread by inducing virus-infected cell apoptosis. In this review, we highlight the importance of CD8 T cell-mediated immunity against influenza viruses and that of viral epitopes for developing CD8 T cell-based influenza vaccines.

01 Jan 2023·Frontiers in immunology

Case Report: Imaging immune checkpoint inhibitor-induced yin-yang effects in the brain.

Author: Aarntzen, E H J G ; Bol, K F ; Westdorp, H ; Peeters, E ; van Herpen, C M L

Background:

Treatment with immune checkpoint inhibitors (ICI) can induce durable responses in cancer patients, but it is commonly associated with serious immune-related side effects. Both effects are suggested to be mediated by CD8+ T-cell infiltration. Whole body CD8+ T-cell distribution can be visualized by PET imaging of a 89Zr-labeled anti-humanCD8a minibody, currently investigated in a phase 2b trial.

Main body:

An adult patient diagnosed with metastatic melanoma developed ICI-related hypophysitis after two courses of combined immunotherapy (ipilimumab (3 mg/kg) and nivolumab (1 mg/kg) at 3 weeks interval). On a [⁸⁹Zr]Zr-crefmirlimab berdoxam PET/CT scan, made 8 days before clinical symptoms occurred, increased CD8+ T-cell infiltration in the pituitary gland was detected. Simultaneously, tracer uptake in a cerebral metastasis was increased, indicating ICI-induced tumor infiltration by CD8+ T-cells.

Conclusions:

The observations in this case report underscore the role of CD8+ T-cell in non-tumor tissues in ICI-related toxicity. In addition, it illustrates a potential role for molecular imaging by PET/CT for investigation and monitoring of ICI-induced effects.

News (Medical) associated with Zirconium (89Zr) crefmirlimab berdoxam

02 May 2023

·www.prnewswire.com

ImaginAb and Quibim partner to revolutionize immune status diagnosis and immunotherapy prediction

This ground-breaking collaboration will enhance accuracy and efficiency of immunotherapy response for improved patient outcomes LOS ANGELES and VALENCIA, Spain, May 2, 2023 /PRNewswire/ -- ImaginAb Inc., a global biotechnology company developing 89Zr crefmirlimab berdoxam (CD8 ImmunoPET™) imaging agent and radiopharmaceutical therapies (RPT), and Quibim, a global company born with the ambition of transforming imaging data into actionable predictions, are pleased to announce their new collaboration. Together, the two partners aim to revolutionize immunotherapy treatment planning by combining ImaginAb's investigational CD8 ImmunoPET technology with Quibim's cutting-edge image processing technology. Immunotherapy has shown remarkable promise in treating cancer and other diseases, but accurately predicting the efficacy of these treatments remains a challenge. CD8 ImmunoPET™ is an 89Zr-labeled minibody that has been designed to bind to the CD8 receptor on human T cells for quantitative, non-invasive PET imaging. This method is currently being researched to determine whether it may be used to assess the immune status of a patient, to measure the efficacy of immunotherapies, and to predict patient outcomes. As part of this collaboration, Quibim will develop an imaging-based algorithm to interpret CD8 ImmunoPET™ PET/CT exams, with the aim of quantitatively assessing the efficacy of the 89Zr-labeled minibody in targeting the CD8 receptor in the tumor microenvironment. The algorithm will use advanced image processing techniques to extract quantitative measures of tracer uptake in the tumor and surrounding tissues, enabling accurate assessment of the binding efficacy of the minibody to CD8 receptors. The resulting quantitative data will provide valuable insights into the minibody's biodistribution and targeting specificity to inform future clinical development of the imaging agent and its potential therapeutic application. Ian Wilson, Chief Executive Officer of ImaginAb, said: "This partnership presents a unique opportunity to broaden the potential applicability of CD8 ImmunoPET by incorporating advanced image processing techniques into image interpretation. We look forward to working together with Quibim to deepen our understanding of immune imaging with the aim of ultimately improving patient care." Dr. Ángel Alberich, CEO of Quibim, said: "We are thrilled to partner with ImaginAb in this ground-breaking effort to advance in the quantitative assessment of novel radiotracers' efficacy in PET/CT exams. Together, we aim to make a real difference in the lives of patients by improving the accuracy and efficiency of immunotherapy prediction through imaging-based models." Through this collaboration, ImaginAb and Quibim are poised to make significant contributions to the field of immunotherapy with the goal of improving the lives of countless patients. Stay tuned for updates on our progress and breakthroughs. About ImaginAb A clinical stage, revenue-generating global biotechnology company developing next-generation imaging agents and radiopharmaceutical therapy products through its proprietary minibody and cys-diabody platforms. The lead candidate, CD8 ImmunoPET™, is currently in Phase II clinical trials and has been licensed by pharmaceutical and biotech companies for use in immunotherapy clinical trials. For more information, visit About Quibim Quibim, with offices in New York (United States), Cambridge (UK) and Valencia, Madrid and Barcelona (Spain), was born from the ambition of transforming imaging into a catalyst for precision health. This is done designing pioneering tools that unlock imaging data to improve patient outcomes. The company is specialized in the development of AI models created by the use of real-world evidence (RWE) projects and biopharma partners to extract new insights from images; thereby developing novel quantitative imaging biomarkers to deeply analyze disease mechanisms, advance drug development, and monitor treatment progress using a whole-body approach. Quibim leads RWE studies with 10M+ de-identified research imaging registries from 50.000+ oncology patients. For more information, visit SOURCE ImaginAb, Inc.

ImmunotherapyPhase 2

18 Apr 2023

·www.pharmaceutical-technology.com

ImaginAb licenses CD8 ImmunoPET tracer to Leucid Bio

Leucid Bio will use ImaginAb’s CD8 ImmunoPET tracer along with LEU011 in its basket study to treat solid tumours. Credit: National Cancer Institute on Unsplash. Biotechnology company ImaginAb has entered into a new non-exclusive licence and supply agreement with Leucid Bio for CD8 ImmunoPET technology. ImaginAb will be responsible for licensing and supplying the clinical doses of 89Zr crefmirlimab berdoxam, its investigational CD8 ImmunoPET tracer, to Leucid Bio. Leucid Bio will use the CD8 ImmunoPET tracer along with LEU011 targeting NKG2DL, autologous CAR T-cells, in its basket study to treat solid tumours. ImaginAb CEO Ian Wilson stated: “We are delighted that Leucid Bio will use our investigational CD8 ImmunoPET for the first time in conjunction with CAR-T therapies. “This agreement with Leucid Bio is an opportunity for ImaginAb to continue expanding our partnerships, and showcases the increasing adoption of our CD8 ImmunoPET technology.” CD8 ImmunoPET (89Zr crefmirlimab berdoxam) is an 89Zr-labeled mini body, designed to bind to CD8 receptors on human T cells for non-invasive, quantitative PET imaging. The technique is currently being investigated for diagnosing the immune status of a patient, measuring the efficacy of immunotherapies and predicting patients’ outcomes. Leucid Bio chief business officer Artin Moussavi said: “This is an exciting partnership for Leucid as this cutting-edge technology will provide evidence of the biodistribution of LEU011 CAR T-cells. “This will be the first time this technology will be used in a solid tumour CAR-T clinical setting, allowing Leucid to generate data that demonstrate the tracking of LEU011 to tumour sites in the first phase of the trial. “This data would validate in humans the significant improvements already demonstrated with LEU011 in preclinical studies.” Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.

License out/inImmunotherapy

12 Apr 2023

·www.biospace.com

ImaginAb Executes New License and Supply Agreement for CD8 ImmunoPET Technology with Leucid Bio

LOS ANGELES and LONDON, April 12, 2023 /PRNewswire/ -- ImaginAb Inc., a global biotechnology company developing 89Zr crefmirlimab berdoxam (CD8 ImmunoPET™) imaging agent and radiopharmaceutical therapies (RPT), is pleased to announce the execution of a new non-exclusive License and Supply Agreement with Leucid Bio (Leucid), a biotech company pursuing a differentiated approach to develop next generation Chimeric Antigen Receptor T-cell (CAR-T) therapies using the Company's proprietary Lateral CAR Platform. Under the terms of the agreement, ImaginAb will license and supply clinical doses of ImaginAb's investigational CD8 ImmunoPET tracer, 89Zr crefmirlimab berdoxam, to Leucid for use in its basket study in solid tumors, with LEU011 targeting NKG2DL, Autologous CAR T-cells. Ian Wilson, Chief Executive Officer of ImaginAb, said: "We are delighted that Leucid Bio will use our investigational CD8 ImmunoPET for the first time in conjunction with CAR-T therapies. This agreement with Leucid Bio is an opportunity for ImaginAb to continue expanding our partnerships and showcases the increasing adoption of our CD8 ImmunoPET technology." Artin Moussavi, Chief Business Officer of Leucid Bio, commented: "This is an exciting partnership for Leucid as this cutting edge technology will provide evidence of the biodistribution of LEU011 CAR T-cells. This will be the first time this technology will be used in a solid tumor CAR-T clinical setting allowing Leucid to generate data that demonstrates the tracking of LEU011 to tumor sites in the first phase of the trial. This data would validate, in humans, the significant improvements already demonstrated with LEU011 in preclinical studies." About ImaginAb A clinical stage, revenue-generating global biotechnology company developing next-generation imaging agents and radiopharmaceutical therapy products through its proprietary minibody and cys-diabody platforms. The lead candidate, CD8 ImmunoPET™, is currently in Phase II clinical trials and has been licensed by pharmaceutical and biotech companies for use in immunotherapy clinical trials. For more information, visit About CD8 ImmunoPET™ (89Zr crefmirlimab berdoxam) An 89Zr-labeled minibody that has been designed to bind to the CD8 receptor on human T cells for quantitative, non-invasive PET imaging. This method is currently being researched to determine whether it may be used to diagnose the immune status of a patient, to measure the efficacy of immunotherapies, and to predict patient outcomes. About Leucid Bio Leucid Bio is a pioneering biotech company developing cell therapies for refractory cancers, especially solid tumours. Leucid was founded to translate 20 years of King's College London (King's) research in the CAR-T field and is led by a highly experienced management team with both scientific and commercial expertise. As part of Leucid's ongoing relationship with King's, it benefits from exclusive access to and resources from the deep scientific, clinical, and manufacturing expertise of John Maher and his academic team of immuno-oncology experts. Leucid is headquartered in London, UK, with operations based at Guy's Hospital with its own R&D and process development laboratories, enabling it to maintain its patient-centric focus on developing better cell therapies for the benefit of individuals with hard-to-treat solid tumours. View original content to download multimedia: SOURCE ImaginAb, Inc.

ImmunotherapyLicense out/inPhase 2Cell Therapy

100 Deals associated with Zirconium (89Zr) crefmirlimab berdoxam

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Melanoma	Phase 2	US	ImaginAb, Inc.	09 Dec 2021
Melanoma	Phase 2	AU	ImaginAb, Inc.	09 Dec 2021
Melanoma	Phase 2	BE	ImaginAb, Inc.	09 Dec 2021
Melanoma	Phase 2	NL	ImaginAb, Inc.	09 Dec 2021
Melanoma	Phase 2	CH	ImaginAb, Inc.	09 Dec 2021
Melanoma	Phase 2	GB	ImaginAb, Inc.	09 Dec 2021
Merkel Cell Carcinoma	Phase 2	US	ImaginAb, Inc.	09 Dec 2021
Merkel Cell Carcinoma	Phase 2	AU	ImaginAb, Inc.	09 Dec 2021
Merkel Cell Carcinoma	Phase 2	BE	ImaginAb, Inc.	09 Dec 2021
Merkel Cell Carcinoma	Phase 2	NL	ImaginAb, Inc.	09 Dec 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03802123 (1472, SITC2022)	Phase 2	Advanced cancer	52	89-Zr-Crefmirlimab Berdoxam (CD8 cell immunohistochemistry)	cxhiuwiwje(lqwuitzojv) = levakefjiy jmlveudgmg (nwizpvgbot, 114 - 461)	Positive	07 Nov 2022
NCT03107663 (Pubmed) Manual	Phase 1	Solid tumor	15	89Zr-Df-IAB22M2C	magryhghdl(plbalzqwde) = No drug-related adverse events or abnormal laboratory results were noted except for a transient increase in anti-drug antibodies in 1 subject wqmmqkgrvj (gmotkcoxhp )	Positive	19 Aug 2021
NCT03107663 (ASCO2018)	Phase 1	HR-positive/HER2-low Solid Tumors	3	anti-CD8 minibody (Mb) 89Zr-IAB22M2C (<sup>89</sup>Zr-IAB22M2C)	aedlbwyzii(ptonepeycb) = No immediate or delayed side effects were seen with ⁸⁹Zr-IAB22M2C wescfkdosw (movzfkmftb )	-	01 Jun 2018
SITC2016	Not Applicable	-	-	89Zr-Df-IAB22M2C	scbzdsstip(fgkuorihjq) = omwjrkjbeo vrfbghgwzk (nlclpzbote ) View more	-	08 Dec 2016

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