A Reduced Intensity Conditioning Regimen With CD3-Depleted Hematopoietic Stem Cells to Improve Survival for Patients With Hematologic Malignancies Undergoing Haploidentical Stem Cell Transplantation

Blood and marrow stem cell transplant has improved the outcome for patients with high-risk hematologic malignancies. However, most patients do not have an appropriate HLA (immune type) matched sibling donor available and/or are unable to identify an acceptable unrelated HLA matched donor through the registries in a timely manner. Another option is haploidentical transplant using a partially matched family member donor.
Although haploidentical transplant has proven curative in many patients, this procedure has been hindered by significant complications, primarily regimen-related toxicity including GVHD and infection due to delayed immune reconstitution. These can, in part, be due to certain white blood cells in the graft called T cells. GVHD happens when the donor T cells recognize the body tissues of the patient (the host) are different and attack these cells. Although too many T cells increase the possibility of GVHD, too few may cause the recipient's immune system to reconstitute slowly or the graft to fail to grow, leaving the patient at high-risk for significant infection.
For these reasons, a primary focus for researchers is to engineer the graft to provide a T cell dose that will reduce the risk for GVHD, yet provide a sufficient number of cells to facilitate immune reconstitution and graft integrity. Building on prior institutional trials, this study will provide patients with a haploidentical (HAPLO) graft engineered to specific T cell target values using the CliniMACS system. A reduced intensity, preparative regimen will be used in an effort to reduce regimen-related toxicity and mortality.
The primary aim of the study is to help improve overall survival with haploidentical stem cell transplant in this high risk patient population by 1) limiting the complication of graft versus host disease (GVHD), 2) enhancing post-transplant immune reconstitution, and 3) reducing non-relapse mortality.

Start Date14 Dec 2007

Sponsor / Collaborator

St. Jude Children's Research Hospital, Inc.

NCT00924001 / TerminatedPhase 1/2IIT

Phase I/II Study Using a Non-Myeloablative Lymphocyte Depleting Regimen of Chemotherapy Followed by Infusion of Allogeneic Tumor-Reactive Lymphocyte Cell Line DMF5 in Metastatic Melanoma

Background:
This study will use cells called DMF5 to treat patients with metastatic melanoma (melanoma that has spread beyond the primary tumor site).
The DMF5 cells were first obtained from a tumor of a patient with melanoma with HLA-A201 tissue type. The tumor cells were grown in the laboratory, and when the laboratory-grown cells were given back to the patient, the patient's tumors shrank dramatically. In laboratory tests, DMF5 cells were also shown to shrink mouse melanoma tumors.
Objectives:
-To determine whether preparatory chemotherapy followed by infusion of DMF5 cells is a safe and effective for shrinking melanoma tumors.
Eligibility:
-Patients with metastatic melanoma and tissue type HLA-A201 who are 18 years of age or older.
Design:
Patients have a preparatory regimen of chemotherapy with cyclophosphamide and fludarabine followed by infusion of DMF5 cells and then high-dose interleukin. The chemotherapy, interleukin and cells are given intravenously (through a vein).
Patients have frequent blood tests to look for the side effects and response to treatment.
Patients may be asked to have a tumor biopsy (surgical removal of a small piece of tumor tissue) to examine the effects of treatment on the immune cells in the tumor.
Patients have a physical examination, computed tomography (CT) of the chest, abdomen and pelvis and laboratory tests 4 to 6 weeks after treatment and then monthly to evaluate the tumor.
The first group of patients participates in the Phase I portion of the study, called the dose escalation phase. This phase will determine the highest safe dose of DMF5 cells. There will be three dose levels of DMF5 cells, with the first patients enrolled getting the smallest dose and then increasing the dose when the preceding level has been shown to be safe.
Patients in the Phase II portion of the study receive DMF5 cells at the highest dose found to be safe in Phase I, to test the effectiveness of the treatment.

Start Date01 Aug 2007

Sponsor / Collaborator

National Cancer Institute

NCT00152113 / CompletedPhase 1IIT

Hematopoietic Stem Cell Transplantation for Patients With Sickle Cell Disease and Prior Stroke or Abnormal Transcranial Doppler Ultrasound Using Reduced-Intensity Conditioning and T-Cell Depleted HSC From Partially Matched Family Donors

Sickle cell disease is a life-long blood condition that can cause damage to the brain and other organs of the body. Children may develop severe, debilitating clinical states, with stroke or abnormal blood flow to the brain. Treatment generally includes chronic blood transfusions which may cause iron overload, potentially leading to severe and sometimes fatal complications.
Hematopoietic stem cell transplant using cells obtained from a sibling or an unrelated volunteer donor who is a perfect HLA "match" (same tissue type) for the recipient has shown to help, and possibly cure, sickle cell disease. Unfortunately, only about 10-20% of sickle cell patients have a HLA matched sibling donor, and the likelihood of locating an appropriate HLA matched unrelated donor through the various donor registries is limited.
Stem cells from partially HLA matched family members (also called haploidentical transplant) is an option currently being explored for this patient population. This type of transplant has been used and found to be successful in some patients, mostly those with cancers of the blood. However, there can be significant complications with haploidentical transplant, primarily infection, failure of the graft to grow (graft failure), and a disorder called graft-versus-host disease. In addition, few patients with sickle cell disease have undergone this procedure. Therefore, the risks and benefits of haploidentical transplants for patients with sickle cell disorder are not as well established as those using an HLA identical sibling or unrelated donor.
The primary objective of this study is to assess the safety of haploidentical stem cell transplantation for children and adolescents with severe sickle cell disease and stroke or abnormal transcranial Doppler ultrasound requiring chronic transfusion therapy. The treatment plan will be considered safe if there is not excessive toxicity. Toxicity for this protocol is defined as graft failure/graft rejection, severe acute GVHD, or regimen related death within 100 days after the last cellular product administered.
Of note, the protocol was closed to accrual in September 2007 as we had met the stopping rules related to graft integrity (graft failure and graft rejection). Participants currently enrolled continue to be followed per protocol.

Start Date01 Apr 2005

Sponsor / Collaborator

St. Jude Children's Research Hospital, Inc.

100 Clinical Results associated with MUROMONAB-CD3

100 Translational Medicine associated with MUROMONAB-CD3

100 Patents (Medical) associated with MUROMONAB-CD3

2,714

Literatures (Medical) associated with MUROMONAB-CD3

01 Feb 2025·COMPUTERS IN BIOLOGY AND MEDICINE

Structural insight into CD20/CD3-bispecific antibodies by molecular modeling

Article

Author: Hou, Jing-Zhou ; Chu, Xiaojie ; Feng, Zhiwei ; Sun, Ze-Yu ; Xie, Xiang-Qun ; Hou, GanQian ; Liang, Tianjian ; Li, Wei ; Zhang, Yiyang

Non-Hodgkin's Lymphoma (NHL) remains a significant challenge in hematology, with chemotherapy and radiation therapy as conventional treatment options, albeit with limitations such as adverse effects. Immunotherapy, particularly bispecific antibodies (BsAbs) T cell engagers (TCEs), has emerged as a promising approach. Despite their potential, TCEs pose challenges, including adverse events like cytokine release syndrome. Understanding the structural details of TCEs and their interactions with target proteins is crucial for optimizing their therapeutic efficacy and toxicity. In this study, we further developed our protocol MCCS-Docker for protein-protein interactions and applied it to investigate the structural intricacies of CD3 interactions with therapeutic antibodies such as OKT3, UCHT1, Mosunetuzumab, Odronextumab, Glofitamab, and Epcoritamab using computational modeling techniques. Our analysis not only approved the effectiveness of our updated MCCS-Docker protocol but also revealed detailed binding interactions between the BsAbs and CD3, elucidating key residues of Tyrosine and Asparagine in the antibodies involved in the binding interface. Molecular dynamics simulations validated the stability of these interactions over time, confirming the reliability of the binding poses generated from docking studies. Overall, our study offered a novel method to predict critical residues in protein-protein interactions and enhanced the understanding of the structural determinants governing BsAb interactions with target proteins, offering valuable insights for designing and optimizing immunotherapeutic agents for NHL and related hematologic malignancies.

01 Aug 2024·VETERINARY IMMUNOLOGY AND IMMUNOPATHOLOGY

Development of an in vitro assay for screening programmed death receptor-1/programmed cell death ligand 1 monoclonal antibody therapy in dogs

Article

Author: Kato, Masahiro ; Tsukui, Toshihiro ; Mizuno, Takuya ; Igase, Masaya

Immunomodulatory antibody drugs that modulate the function of immune checkpoint molecules, such as programmed death receptor-1 (PD-1) and programmed cell death ligand 1 (PD-L1), have been established as new cancer treatments in human medicine. In recent years, there have also been reports on antibodies that inhibit immune checkpoint molecules in dogs, and clinical trials using such antibodies for canine cancer have been gradually increasing in number. Because inhibitory antibodies restore T-cell function by inhibiting the binding of PD-1 on T cells and its ligand PD-L1, the quality of antibody function has been evaluated using activated T cells or peripheral blood mononuclear cells isolated from healthy dogs; however, the assays and dogs used significantly vary. Therefore, in the present study, we developed a reporter gene assay using reporter cells (Jurkat/NFATluc/cPD1) and effector cells (CTAC/OKT3/cPDL1). Jurkat/NFATluc/cPD1 were generated by introducing both of the NFAT-responsive luciferase gene as a marker of T-cell signaling and canine PD-1, into a human T lymphoid cell line, Jurkat. CTAC/OKT3/cPDL1 were generated by introducing single-chain FV (scFV) of anti-human CD3 antibody (OKT3) and canine PD-L1 into a canine thyroid carcinoma cell line, CTAC. Ligation of PD-1 on Jurkat/NFATluc/cPD1 via binding of PD-L1 on CTAC/OKT3/cPDL1 suppressed NFAT luciferase activity induced by CD3 ligation by scFV of OKT3. The addition of anti-canine PD-1 and PD-L1 antibodies, both of which were previously developed in our laboratory, restored this suppression with high sensitivity, although the anti-human PD-L1 antibody atezolizumab induced a very weak restoration. This assay is an useful method for functionally evaluating the inhibition of canine PD-1 and PD-L1 binding.

01 May 2024·Journal for ImmunoTherapy of Cancer

Neoantigen-specific stimulation of tumor-infiltrating lymphocytes enables effective TCR isolation and expansion while preserving stem-like memory phenotypes

Article

Author: Parkhurst, Maria ; Levy, Lior ; Zacharakis, Nikolaos ; Vale, Nolan R ; Marquardt, Charles A ; Islam, Rafiqul ; Rosenberg, Steven A ; Ray, Satyajit ; Yu, Zhiya ; Prickett, Todd D ; Masi, Robert V ; Kim, Sanghyun P ; Li, Yong ; Benzine, Tiffany ; Gartner, Jared J ; Bera, Alakesh ; Lowery, Frank J ; Goff, Stephanie L ; Krishna, Sri ; Gasmi, Billel ; Sindiri, Sivasish ; Levin, Noam ; Robbins, Paul F

Background:

Tumor-infiltrating lymphocytes (TILs) targeting neoantigens can effectively treat a selected set of metastatic solid cancers. However, harnessing TILs for cancer treatments remains challenging because neoantigen-reactive T cells are often rare and exhausted, and ex vivo expansion can further reduce their frequencies. This complicates the identification of neoantigen-reactive T-cell receptors (TCRs) and the development of TIL products with high reactivity for patient treatment.

Methods:

We tested whether TILs could be in vitro stimulated against neoantigens to achieve selective expansion of neoantigen-reactive TILs. Given their prevalence, mutant p53 or RAS were studied as models of human neoantigens. An in vitro stimulation method, termed “NeoExpand”, was developed to provide neoantigen-specific stimulation to TILs. 25 consecutive patient TILs from tumors harboring p53 or RAS mutations were subjected to NeoExpand.

Results:

We show that neoantigenic stimulation achieved selective expansion of neoantigen-reactive TILs and broadened the neoantigen-reactive CD4+and CD8+TIL clonal repertoire. This allowed the effective isolation of novel neoantigen-reactive TCRs. Out of the 25 consecutive TIL samples, neoantigenic stimulation enabled the identification of 16 unique reactivities and 42 TCRs, while conventional TIL expansion identified 9 reactivities and 14 TCRs. Single-cell transcriptome analysis revealed that neoantigenic stimulation increased neoantigen-reactive TILs with stem-like memory phenotypes expressing IL-7R, CD62L, and KLF2. Furthermore, neoantigenic stimulation improved the in vivo antitumor efficacy of TILs relative to the conventional OKT3-induced rapid TIL expansion in p53-mutated or KRAS-mutated xenograft mouse models.

Conclusions:

Taken together, neoantigenic stimulation of TILs selectively expands neoantigen-reactive TILs by frequencies and by their clonal repertoire. NeoExpand led to improved phenotypes and functions of neoantigen-reactive TILs. Our data warrant its clinical evaluation.

Trial registration number:

NCT00068003,NCT01174121, andNCT03412877.

News (Medical) associated with MUROMONAB-CD3

19 Oct 2023

·www.prnewswire.com

Monoclonal Antibodies: A Transformative Force in Biopharmaceuticals, Driving Growth in Antibody Discovery Services and Platforms

DUBLIN, Oct. 19, 2023 /PRNewswire/ -- The "Antibody Discovery Market: Focus on Services and Platforms - Distribution by Type of Service Offered, Antibody Discovery Method, Type of Antibody Generated, Nature of Antibody Generated, Therapeutic Areas and Key Geographies: Industry Trends and Global Forecasts, 2023-2035" report has been added to ResearchAndMarkets.com's offering. The global antibody discovery services and platforms market is poised for significant growth, with a projected value of over $1.6 billion in 2023 and a forecasted Compound Annual Growth Rate (CAGR) of 12.0% during the coming years. The market is driven by pharmaceutical companies' increasing reliance on outsourcing antibody discovery processes and the growing demand for targeted therapies. Streamlining Drug Development with Outsourcing The traditional drug development process is lengthy, spanning 10-15 years and involving investments of over $2 billion. Despite these efforts and investments, more than 90% of drug candidates fail in clinical trials. To streamline drug development, reduce timelines, and mitigate financial risks associated with failed trials, pharmaceutical companies are increasingly outsourcing their discovery-stage operations to specialized contract research organizations (CROs). Outsourcing allows companies to optimize resource utilization, save costs, and tap into a global network of scientific talent, ultimately enhancing the efficiency and success rate of bringing novel antibody-based therapeutics to market. Evolution of Monoclonal Antibodies Since the approval of the first monoclonal antibody-based therapy, Orthoclone OKT3, in 1986, monoclonal antibodies have become a versatile class of biopharmaceuticals. These antibodies have seen significant advancements in engineering, format diversification, and discovery methods. Over 160 monoclonal antibodies have been approved worldwide for the treatment of diseases such as cancer, chronic inflammatory diseases, infectious diseases, and cardiovascular diseases. Recent approvals include ELREXFIOT, TALVEYT, Rystiggo, COLUMVI, and EPKINLYT. Due to the complexities associated with discovering such antibodies, many firms are licensing and utilizing specialized antibody discovery platforms and technologies, driving the growth of the antibody discovery services and platforms market. Market Drivers: Biotech Advancements and Increasing Demand Key drivers of the global antibody discovery services and platforms market include recent advancements in biotechnology, a growing demand for targeted therapies, rising prevalence of chronic diseases, increased R&D expenditure in the pharmaceutical industry, and a growing trend of outsourcing antibody discovery. Collaborations between academic institutions and antibody discovery companies further contribute to market growth. Market Size and Segments The global market size for antibody discovery services and platforms is projected to grow at an annualized CAGR of 11.0% during the forecast period. The hit generation segment holds the largest market share, driven by its significance in R&D expenditure. In terms of the antibody discovery method, the hybridoma method is dominant, thanks to its capability to create immortalized cell lines for continuous antibody manufacturing. Regional Analysis: North America Leads North America currently captures nearly 40% of the market, driven by a rising interest in advanced antibody discovery platforms and increased outsourcing in the pharmaceutical industry. North America is anticipated to grow at a CAGR of 12% during the forecast period. Key Players and Recent Developments Key players in the antibody discovery services and platforms market include Ablexis, Antibody Solutions, ChemPartner, GenScript, Genmab, Harbour BioMed, ImmunoPrecise, Mabsilico, and more. Recent developments in the field include the launch of transgenic mouse-based antibody discovery platforms and initiatives to support the discovery of bispecific antibody formats. Recent Developments: In June 2023, AbTherx announced the launch of its transgenic mouse-based antibody discovery platform, AtlasT Mice. In June 2023, Sanyou Biopharmaceuticals, a China-based company, launched its Sanyou Super Trillion Common Light Chain Antibody Discovery Platform, which supports the discovery of bispecific antibody formats. In January 2023, IASO Biotherapeutics raised USD 75 million in a venture series C round, highlighting the increasing funding activity in the antibody drug discovery service and platform domain. In March 2023, Twist Bioscience announced the launch of its antibody discovery services under the Twist Biopharma Solutions subsidiary after acquiring Abveris, an antibody discovery CRO, in 2022. Key Topics Covered: 1. PREFACE 2. RESEARCH METHODOLOGY 3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS 4. EXECUTIVE SUMMARY 5. INTRODUCTION 6. ANTIBODY DISCOVERY: PROCESS AND METHODS 7. ANTIBODY DISCOVERY SERVICE PROVIDERS: MARKET LANDSCAPE 8. COMPANY COMPETITIVENESS ANALYSIS 9. COMPANY PROFILES: ANTIBODY DISCOVERY SERVICE PROVIDERS 10. ANTIBODY DISCOVERY TECHNOLOGIES: MARKET LANDSCAPE 11. TECHNOLOGY COMPETITIVENESS ANALYSIS 12. COMPANY PROFILES: ANTIBODY DISCOVERY PLATFORM PROVIDERS 13. PARTNERSHIPS AND COLLABORATIONS 14. FUNDING AND INVESTMENT ANALYSIS 15. MARKET IMPACT ANALYSIS: DRIVERS, RESTRAINTS, OPPORTUNITIES AND CHALLENGES 16. GLOBAL ANTIBODY DISCOVERY SERVICES MARKET 17. ANTIBODY DISCOVERY SERVICES MARKET, BY TYPE OF SERVICE OFFERED 18. ANTIBODY DISCOVERY SERVICES MARKET, BY TYPE OF ANTIBODY DISCOVERY METHOD 19. ANTIBODY DISCOVERY SERVICES MARKET, BY NATURE OF ANTIBODY DISCOVERED 20. ANTIBODY DISCOVERY SERVICES MARKET, BY TYPE OF THERAPEUTIC AREAS 21. ANTIBODY DISCOVERY SERVICES MARKET, BY KEY GEOGRAPHIES 22. GLOBAL ANTIBODY DISCOVERY TECHNOLOGIES MARKET 23. ANTIBODY DISCOVERY TECHNOLOGIES MARKET, BY TYPE OF ANTIBODY DISCOVERED 24. ANTIBODY DISCOVERY TECHNOLOGIES MARKET, BY KEY GEOGRAPHIES 25. LICENSING DEAL STRUCTURE 26. SWOT ANALYSIS: ANTIBODY HUMANIZATION SERVICE PROVIDERS 27. CASE IN POINT: DRUG DISCOVERY PROCESSES OF TOP SELLING ANTIBODIES 28. FUTURE GROWTH OPPORTUNITIES IN ANTIBODY DISCOVERY 29. CONCLUSION 30. EXECUTIVE INSIGHTS 31. APPENDIX 1: TABULATED DATA 32. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATION Companies Mentioned 2BScientific 3SBio AAT Bioquest Ab Initio Biotherapeutics Ab Studio ABBA Therapeutics AbBioSci Abbiotec AbbVie Abcalis Abcam AbCellera Abcentra (formerly CardioVax) Abcepta AbCheck Abclonal Abcore ABDYS Abeome Abexxa Biologics ABGENEX AbGenics Life Sciences Abilita Bio ABL Bio Ablexis Ablynx Abnova Abpro AbSano Absci Absea Biotechnology Absolute Antibody Abterra Biosciences AbTherx AbTis Abveris (Acquired by Twist Bioscience) AbVision Abwiz Bio Abzena Abzyme Therapeutics AC Immune Acceleron Pharma Accurus Biosciences AceMab Achaogen Aclys Bio ACROBiosystems ACYTE Biotech Adagene Adaptate Biotherapeutics ADC Therapeutics Adcentrx Therapeutics Adimab AdipoGen Life Sciences Administration for Strategic Preparedness and Response (ASPR) Aduro Biotech AffinityImmuno AFSBio Aganitha Agency for Science, Technology and Research Agenus Agro-Bio AIMM Therapeutics Aimmune Therapeutics Akeagen Akeso Akeso Biopharma Alacrita Alamar Biosciences Aldevron Alector Alexion AlivaMab Discovery Services Alligator Bioscience Allogene Therapeutics Alloy Therapeutics Almirall AlpalifeBio ALSA Ventures Alvaxa Biosciences (Acquired by Sensei Biotherapeutics) ALX Oncology Alytas Therapeutics Amerigo Scientific Amgen AMSBIO Analytics Engine AnaptysBio Angios Annoron Biotechnology Antengene Antibodies Incorporated Antibodies-online Antibody Analytics Antibody Design Labs Antibody Production Services (A division of Life Science Group) Antibody Solutions Antiverse AP Biosciences Apexigen APITBIO Applied Biological Materials Applied StemCell AprilBio Aptevo Therapeutics Aragen Life Sciences Aravive Arctoris Arcus Biosciences argenx Aridis Pharmaceuticals aRNAy Sciences Aro Biotherapeutics Aronora Arsanis Artizan Biosciences Arvinas ARVYS Proteins AskGene Pharma Astellas AstraZeneca aTen Therapeutics Atlantis Bioscience Atlas Venture Atreca ATUM Aureka Aurigene Pharmaceutical Services Autolus Therapeutics Automated Lab Solutions AvantGen Aviva Systems Biology AxioMx Axxora Bayer BBI Group BBI Solutions Beckman Coulter BeiGene BenevolentAI Berkeley Lights Betta Pharmaceuticals Bhami's Research Laboratories Bhat Bio-tech India Big Cypress Acquisition BigHat Biosciences Bill & Melinda Gates Foundation Bill & Melinda Gates Medical Research Institute Bio Bench BioArctic BioAtla BioBench Solutions Biochem Pharma BioClue (Acquired by ImmunoPrecise Antibodies) Bio-Connect Biocure Technology Biocytogen BioD BioDuro-Sundia Biogen BioHub International Trade Bioinborn Scientific Biointron BioInvent BioKey (Acquired by ImmunoPrecise Antibodies) Biologics International Biomolecular Discovery Services BioNTech Bioqube Ventures Bio-Rad Laboratories Biosion BioStrand (Acquired by ImmunoPrecise Antibodies) Biosynth Biotalys Bio-Techne Biotecnol BIOTEM BioTeZ Biotheus BioTickle BioVision BioXpress Therapeutics Bird Rock Bio Blue Sky BioServices (Acquired by LakePharma) BlueBird Bio Bluejay Therapeutics Boan Biotech Boehringer Ingelheim Bolt Biotherapeutics Boster Biological Technology Bristol Myers Squibb Broteio Pharma CALIXAR Cambridge Research Biochemicals CANbridge Pharmaceuticals Cancer Research UK Cantargia Capra Science Capralogics Caris Life Sciences Carterra CASI Pharmaceuticals Catalent Biologics Cayman Chemical CD ComputaBio CDI Laboratories Celexion Celgene Cell Signaling Technology Celltrion Celros Biotech Celsius Therapeutics Centre for Applied Medical Research Centers for Disease Control and Prevention Charles River ChemBio Discovery Solutions ChemPartner Cherry Biolabs Chia Tai Tianqing Pharmaceutical Chiome Bioscience Chipscreen Biosciences ChromoTek Chugai Pharmabody Research Chugai Pharmaceutical Cidara Therapeutics Cilag Citryll City of Hope Cizzle Biotechnology Clayton Biotechnologies Click Chemistry Tools Clinica Universidad de Navarra CliniSciences Columbia University Irving Medical Center Compass Therapeutics Context Therapeutics Coronavirus Immunotherapy Consortium Corvidia Therapeutics Cosmo Bio CP Qingdao Creative Bioarray Creative Biolabs Creative Biostructure Creative Diagnostics Crescendo Biologics Crystal Bioscience CSL Behring Cstone Pharmaceuticals CureVac Curia CUSABIO Cyclogenix Cygnus Technologies DAAN Biotherapeutics Daiichi Sankyo Dako Dana-Farber Cancer Institute Danaher DaTaMabs DBA Italia Deerfield Discovery and Development Denali Therapeutics DetaiBio Diagnostic BioSystems Diatheva Digital Proteomics Dingkang Biology discoveric bio Distributed Bio DJS Antibodies Dragonfly Therapeutics E2DG Eisai Elabscience Eli Lilly and Company Elpis Biopharmaceuticals Emergent BioSolutions Empirico e-nnovation Life Sciences ENPICOM Enthera Entos Pharmaceuticals Envigo EpimAb Biotherapeutics EQRx Erasmus MC Ethris Eureka Therapeutics Eurofins Discovery Everest Medicines Evitria Evotec EVQLV Exelixis ExeVir Bio Exiris exonbio Exscientia Faculta (Acquired by Prosci) FairJourney Biologics Faron Pharmaceuticals Ferring Pharmaceuticals FibroGen Five Prime Therapeutics Fluoroprobes Forty Seven Foundery Innovations Fred Hutchinson Cancer Center Frederick National Laboratory for Cancer Research French Institute of Health and Medical Research Frugi Biotechnology Funakoshi Fusion Antibodies Fusion Pharmaceuticals G&P Biosciences G.CLIPS BIOTECH Gator Bio Genagon Therapeutics Gene Techno Science GeneBeyond Genedata GeneFrontier GENEWIZ (Acquired by Azenta Life Sciences) GeneX India Bioscience Genmab Genome Institute of Singapore Genor Biopharma GenoSafe Genovac GenScript Genuv Gen-Y Biologics GigaGen Gilead Sciences Gladstone Institutes Glenmark Pharmaceuticals Glythera Gmax Biopharm Government of British Columbia Government of Canada Green Mountain Antibodies Grenoble Hospital GSK Gustave Roussy GV20 Therapeutics HaemaLogiX Hangzhou Qiantang River Electric Harbour Antibodies Harbour BioMed Harpoon Therapeutics HD Biosciences Helix BioPharma Jiangsu Hengrui Pharmaceuticals Henlix Biotech Heptares Therapeutics HI-Bio HiFiBiO Therapeutics Himalaya Therapeutics H-Immune Therapeutics (Acquired by HiFiBiO Therapeutics) HJB Holzel Diagnostika Handels Horizon Discovery Hualan Genetic Engineering Hubrecht Institute Humanigen Hummingbird Bioscience I&L Biosystems i2 Pharmaceuticals IAMA France IASO Biotherapeutics Ibex Biosciences iBio Icagen Icosagen IGEM Therapeutics IgGenix IGM Biosciences I-Mab Biopharma iMetabolic Biopharma Immatics Biotechnologies Immorna Immune Biosolutions Immune Pharmaceuticals Immunitas Therapeutics immunitoAI Immunochem ImmunoChina Pharmaceuticals ImmunoGenes Immunome Immunomic Therapeutics ImmunoPrecise Antibodies ImmunoQure Immusmol Immutep In-Cell-Art Incyte Indivumed InflaRx Inhibrx Innate Pharma InnoBation Bio Innovagen Innovative Targeting Solutions Innovent Inotiv InstaDeep Institute for Research in Biomedicine Intarcia Therapeutics (Acquired by i2o Therapeutics) Integral Molecular Integrated DNA Technologies International Livestock Research Institute Invenra Invetx IONTAS IRBM Isogenica Italian National Institute of Health ITBMed iTeos Therapeutics Janssen Jazz Pharmaceuticals Johnson & Johnson Innovation Jotbody Jounce Therapeutics Juno Therapeutics Junshi Biosciences Just Biotherapeutics JW Pharmaceuticals Kadmon Kairos Therapeutics KAKEN PHARMACEUTICAL Kanwhish Biotechnology KareBay Biochem Karolinska University Hospital Kemp Proteins KGbio Kite Pharma KMD Bioscience Kodiak Sciences KYinno Kymab Kyoritsuseiyaku Kyowa Kirin La Jolla Institute for Immunology LabGenius Labtoo LakePharma LamKap Bio LAMPIRE Biological Labs Lanier Biotherapeutics Lava Therapeutics Leadgene Biomedical Leading Biology Leads Biolabs LegoChem Biosciences Leica Microsystems LEO Pharma LG Chem LifeArc LifeTein Ligand Pharmaceuticals Light Chain Bioscience Lineage Cell Therapeutics Lonza Loxo Oncology Lunaphore Lundbeck Luye Pharma MAB Discovery MabGenesis Mablytics Mabpharm MAbSilico mAbsolve MabSpace Biosciences Mabtech MabVax Mabworks MacroGenics Magenta Therapeutics Maine Biotechnology Services Maravai LifeSciences Masaachusetts General Hospital Mass Biologics Maverick Therapeutics Beijing Mede Taikang Biotechnology MedAbome MedGenome Medicilon MedImmune Medix Biochemica MEDx MEMO Therapeutics Memorial Sloan Kettering Cancer Center Merck Merus Mila MI-mAbs Mithra Pharmaceuticals Mitsubishi Tanabe Pharma Corporation Moderna ModeX Therapeutics ModiQuest Molcure Molecular Devices Molecular Templates MolMed Mologic Moradec MorphoSys Mount Sinai MSD MSM Protein Technologies Mycenax Biotech Myrio Therapeutics Mythic Therapeutics Nanjing Chia-Tai Tianqing Pharmaceutical Company Nanocarry Therapeutics NanoCellect Biomedical NanoString Technologies National Cancer Institute National Research Council of Canada's Human Health Therapeutics Research Centre National, Heart, Lung, and Blood Institute NaturalAntibody Nautilus Systems NB Health Laboratory NBE Therapeutics Nelum NeoBiotechnologies NeoClone Neon Therapeutics neoX Biotech Neurimmune Nexum Nidus MB Technologies Nidus BioSciences Nkarta Nona BioSciences Nordic Society of Gynaecological Oncology Normunity North Dakota State University Northway Biotech NovaRock Biotherapeutics Novartis Novo Holdings Novo Nordisk Numab Therapeutics NYU Langone Health Oak BioSciences Oblique Therapeutics Olympic Protein Technologies OmniAb OncoC4 OncoOne OncoResponse Oncothyreon Onena Medicines Ono Pharmaceuticals Open Monoclonal Technology Optimeos Life Sciences OREGA Biotech OriCell OriGene Technologies OriMAbs Orion OSE Immunotherapeutics Ossianix Oxford Biomedica OXGENE Pandion Therapeutics Panoply Bio Paragon Therapeutics Pascal Biosciences Pediatric Brain Tumor Consortium Penn Medicine PerkinElmer Perseus Proteomics Pfizer pH Pharma Phanes Therapeutics PharmAbcine PharmAbs PharmaEssentia Innovation Research Center PharmaLegacy Pharmsynthez Pierre Fabre Pinteon Therapeutics Pioneering Medicines Pionyr Immunotherapeutics Potenza Therapeutics Precision Antibody Prellis Biologics ProMab Biotechnologies Prometheus Authors Prosci Protein Alternatives Proteogenix ProteoNic ProtTech Purdue Pharma Pure Biologics PX'Therapeutics QIMR Berghofer Medical Research Institute QoolAbs Quadira Biosciences Queen's University Rallybio Rapid Novor RayBiotech RD Biotech ReCentrics Biotechnology Regeneron Pharmaceuticals Resonant Therapeutics Retrogenix RevMab Biosciences Revolve Biotechnologies Rezolute Roche Rockland Immunochemicals RubrYc Therapeutics Rx Biosciences RxBiologics SAb Biotherapeutics Saccharo Salipro Biotech San Diego Biomedical Research Institute Sanders Tri-Institutional Therapeutics Discovery Institute Sanofi Sanyou Biopharmaceuticals Sartorius SBH Sciences Scandion Oncology Scotia Biologics Sea Lane Biotechnologies Selecxine Sema4 Sensei Biotherapeutics Serum Institute of India Servier Severance Hospital Sevion Therapeutics Shanghai Henlius Biotech Shanghai KangaBio Shanghai Pidu Biotechnology Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry RAS Shire Sichuan Kelun-Biotech Biopharmaceutical Siegfried Holding Simcere Simon Fraser University Single Cell Technology Sino Biological Sinobioway Sinopharm SmartPharm Therapeutics Sorrento Therapeutics SOTIO SouthernBiotech Specialised Therapeutics Specifica Sphere Fluidics Stanford University Straterx Summit Therapeutics Sunshine Guojian Surface Oncology Surrozen Sutro Biopharma Suzhou Bright Scistar Biotechnology Company Syd Labs Symphogen Synaffix Synbio Technologies Syngene Synthelis Tachyon Therapeutics Takeda Tanabe Research Laboratories Tasgen Biotech (Acquried by I-Mab Biopharma) Tasly Biopharmaceuticals Taurus Biosciences TC BioPharm Technical University of Denmark Telesis Bio Telix Pharmaceuticals Tempus Labs TeneoBio TESARO Tetra Partner Network Tetragenetics Teva Pharmaceuticals TG Therapeutics The Antibody Company The Wistar Institute Theraclone Sciences Theranyx ThermoFisher Scientific Third Venture Biopharma ThromboGenics Tizona Therapeutics Tmunity Therapeutics Torch Biosciences TRACON Pharmaceuticals TRANSCENTA Transgene TRIANNI Tsinghua University Tubulis Twist Bioscience U.S. Naval Medical Research Unit No. 3 UCLA Technology Development Group Universiti Sains Malaysia University College London University of Manchester University of Oxford University of Pennsylvania University of Southampton University of Surrey University of Texas MD Anderson Cancer Center University of Tokyo University of Zurich U-Protein (Acquired by ImmunoPrecise Antibodies) Utrecht University Vaccinex ValenzaBio (Acquired by ACELYRIN) Vall d'Hebron Institute of Oncology Valneva VBI Vaccines VectorB2B venBio Partners VERAXA Biotech Vir Biotechnology ViralClear Pharmaceuticals Visterra Viva Biotech Voyager Therapeutics Washington University Washington University School of Medicine Westlake Pharmaceuticals Services Westlake Therapeutics Wisconsin Alumni Research Foundation Worg Pharmaceuticals WuXi AppTec WuXi Biologics WuXi STA Wyss Institute XBiotech xCella Biosciences X-Chem Xencor XOMA Y- Biologics Yale Cancer Center Yangyang YenZym Antibodies Yinuoke Ymmunobio YUMAB Yurogen Biosystems Zai Lab Zebra Biologics Zhejiang Doer Biologics Zhejiang Teruisi Biopharmaceuticals Zoetis ZoonBio Biotechnology Zumutor Biologics Zydus Zymeworks For more information about this report visit 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. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

AcquisitionImmunotherapy

06 Sep 2023

·www.globenewswire.com

Study Validating MoA of Intranasal Foralumab in Alzheimer’s Disease Published in the Prestigious Journal PNAS, Following FDA IND Clearance

The authors conclude that “nasal anti-CD3 has the potential to be a non-toxic novel immunotherapeutic approach for the treatment of Alzheimer’s disease (AD)”FDA has cleared the IND for intranasal foralumab, a fully human anti-CD3 monoclonal antibody, for human study in mild to moderate Alzheimer’s DiseaseThe publication shows anti-CD3 monoclonal antibody (mAb) administered intranasally, ameliorates disease in a 3xTg model of Alzheimer’s disease by targeting microglial activation in the brain, while expanding regulatory T cells in the peripheryRemarkably, this reduced microglial activation and improved cognition occurs independent of amyloid beta disposition. NEW YORK, Sept. 06, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced acceptance of a publication, “Nasal Administration of anti-CD3 monoclonal antibody (mAb) ameliorates disease in a mouse model of Alzheimer’s disease”, in the preeminent1 journal, Proceedings of the National Academy of Sciences (PNAS), that supports foralumab’s mechanism as a potential treatment for Alzheimer’s disease (AD), a difficult-to-treat neuroinflammatory disease.2 This is the second publication pertaining to intranasal administration of anti-CD3 monoclonal antibody this year to be published in PNAS.3 This study shows that intranasal anti-CD3 ameliorates disease in a rodent model of AD by targeting microglial activation in the brain and brain gene expression independent of affecting amyloid beta deposition. These studies identify a novel approach to treat Alzheimer's disease. The publication can be found at : https://www-pnas-org.libproxy1.nus.edu.sg/doi/10.1073/pnas.2309221120 Howard L. Weiner, M.D., a Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis Center and Co-Director of the Center for Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System and Chairman of Tiziana's Scientific Advisory Board, stated, “I am proud to be the senior author on this seminal publication showing that anti-CD3 mAb mitigates Alzheimer’s disease in a rodent model. Remarkably, we found this benefit occurred independent of reduction of amyloid beta plaque in the brain. This finding demonstrates a unique mechanism of action that can now be tested in humans using foralumab, a fully human anti-CD3 mAb, foralumab, in which we modulate microglia by inducing T cells in the periphery that migrate to the brain. This represents a unique approach to treating Alzheimer’s disease that could also potentially be employed in combination with anti-amyloid therapy. The neuromodulation of the T cell inflammatory response we observed in the brains of Alzheimer’s mice is consistent with multiple sclerosis research we have conducted at the Ann Romney Center and validates our scientific rationale for testing foralumab in Alzheimer’s patients after the recent IND clearance by the United States Food and Drug Administration.” “We’ve now have had two seminal publications in the esteemed journal PNAS related to novel and significant research on intranasal anti-CD3. It has been established through both publications that intranasal anti-CD3 positively modulates the immune system allowing Tiziana to explore foralumab in multiple neuro-inflammatory disease indications in addition to our ongoing research in non-active secondary progressive multiple sclerosis. We believe this scientific publication, along with the groundbreaking research continuously being conducted by our partners at Brigham and Women’s Hospital led by Dr. Weiner, greatly increases the utilization potential of our foralumab portfolio,” commented Gabriele Cerrone, Executive Chairman, founder and acting Chief Executive Officer of Tiziana. Study Rationale Alzheimer's disease is a neurodegenerative disease characterized by amyloid beta (Aβ) plaques, neurofibrillary tangles, and microglial activation. Neuroinflammation is a major component of AD. Microglia are the primary immune cells of the brain that help both maintain homeostasis and react to injury. Studies showing activated microglia and astrocytes surrounding Aβ plaques suggest significant involvement of inflammatory pathways in Alzheimer’s disease. Therapies targeting Aβ have shown positive effects in subjects with AD. Nasal anti-CD3 has been shown to treat animals with a progressive form of experimental autoimmune encephalomyelitis (EAE), a model for multiple sclerosis, by inducing regulatory T cells that dampen microglial inflammation in the brain. Study Design In this study, mice were treated three times a week with intranasal anti-CD3 for five months and compared against isotype control or saline. In the treated mice, the study found modulation of the activated microglia phenotype, changes in gene expression patterns in the brain and improved cognition, which all occurred independent of affecting amyloid beta deposition. Modulation of activated microglia was measured in treated mice by sorting the microglia using microglia-specific markers and performing a gene expression analysis using the Nanostring mouse myeloid panel and comparing treated mice versus control. Changes in gene expression were measured in the cortex and hippocampus. Cognition was measured including spatial learning and long- and short- term memories as assessed by the Morris water maze and the novel arm Y-maze behavioral test. Amyloid beta accumulation was measured by immunofluorescence in the hippocampus and prefrontal cortex areas of the brain. About Foralumab Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets, an effect demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. Intranasal foralumab Phase 2 trials are expected to start in Q3 2023 in patients with non-active SPMS immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of inflammatory human diseases that affects the brain and other organs.2,3 About Tiziana Life Sciences Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal, oral and inhalation approaches in development have the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, the only fully human anti-CD3 mAb, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. For further inquiries: Tiziana Life Sciences Ltd Paul Spencer, Business Development and Investor Relations +44 (0) 207 495 2379info@tizianalifesciences.com Investors:Irina KofflerLifeSci Advisors, LLC646.970.4681ikoffler@lifesciadvisors.com 1 https://www-pnas-org.libproxy1.nus.edu.sg/about/article-journal-metrics 2 https://www-pnas-org.libproxy1.nus.edu.sg/doi/10.1073/pnas.2309221120 3 https://www-pnas-org.libproxy1.nus.edu.sg/doi/10.1073/pnas.2220272120

ImmunotherapyINDPhase 2

04 Feb 2022

·www.biospace.com

Tiziana Announces Submission of Amendment to Investigational New Drug Application to Advance Oral Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, in Patients with Crohn’s Disease

Tiziana Life Sciences Plc (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company enabling breakthrough immunotherapies via novel routes of drug delivery, today announced submission of an amendment to an Investigational New Drug (IND) application for evaluation of orally administered capsules of foralumab, which it believes would be the first “take home” immunotherapy, in patients with mild-to-moderately active Crohn’s Disease. If accepted by the U.S. Food and Drug Administration (FDA), the amendment is expected to expedite patient enrollment and completion of the foralumab Phase 1b study by the fourth quarter of 2022. The currently planned Phase 1b study with an amended protocol is designed as a placebo-controlled, randomized and dose-escalating trial, in mild-to-moderate patients with Crohn’s Disease. The patients will be dosed up to 5 mg once daily for five consecutive days and safety of patients will be monitored throughout the treatment period in the hospital or clinical research unit (CRU). The primary objective of this study is to determine safety and tolerability. The study will also evaluate the pharmacodynamic (PD) effects on modulation of immunobiomarkers, including calprotectin, a widely used biomarker for gut inflammation, in stools, as a secondary endpoint. Data from an earlier Phase 1a, single-ascending dose (SAD) study with orally administered foralumab in healthy volunteers determined that the treatment was well-tolerated up to 5 mg, which was the highest dose tested. This amendment would allow for the investigation of a broader patient population as well as a shorter dosing period. Previously, Tiziana had submitted an IND to conduct a Phase 1b study in moderate-to-severe active Crohn’s Disease patients to evaluate safety of enteric-coated foralumab capsules administered orally once daily for 14 days as an inpatient study in the hospital or CRU with safety monitoring, for which the FDA issued a ‘Study May Proceed letter’. However, initial feasibility findings indicated that enrollment of patients in this initial safety study, requiring 14-day hospitalization, was highly challenging due to the COVID-19 pandemic. Thus, the clinical protocol has been amended to expedite patient enrollment and study completion. The clinical findings from this Phase 1b study could support moving foralumab into a Phase 2 clinical trial in patients with mild-to-moderate Crohn’s Disease. Tiziana is awaiting FDA’s comments on the amended TILS-014 protocol and, with clearance of the amendment, anticipates completing the Phase 1b study by the fourth quarter of 2022. Dr. Kunwar Shailubhai, Chief Executive Officer of Tiziana noted, “Current immunotherapies for treatment of Crohn’s disease, including ulcerative colitis, are administered either intravenously or subcutaneously. In this clinical study, foralumab would be formulated as a novel, convenient, ‘take home’ immunotherapy in an oral capsule form. Thus, submission of this IND amendment marks an important step towards advancing our novel approach as well as validating the local mode of action of foralumab to potentially treat Crohn’s Disease and other inflammatory bowel diseases”. About Foralumab Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in healthy volunteers and in patients with Crohn's disease. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that whilst targeting the T cell receptor, orally administered foralumab modulates immune responses of the T-cells and enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017. Clin Immunol.183:240-246). Once a day treatment for 10 consecutive days with intranasal foralumab was not only well tolerated but it also produced strong clinical responses in COVID-19 patients (Moreira et al., 2021. Front Immunol. 2021; 12: 709861). Based on these studies, the intranasal and oral administration of Foralumab offers the potential to become a well-tolerated immunotherapy for autoimmune and inflammatory diseases by the induction of Tregs. About Tiziana Life Sciences Ltd Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal, oral and inhalation approaches in development have the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s two lead candidates, intranasal foralumab, the only fully human anti-CD3 mAb, and milciclib, a pan-CDK inhibitor, have both demonstrated a favorable safety pro clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.

CollaborateAntibodyImmunotherapy

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KEGG	Wiki	ATC	Drug Bank
D05092	MUROMONAB-CD3	L04AA02	DB00075

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Allograft Rejection	US	Ortho Pharmaceutical Corp.	19 Jun 1986
Renal transplant rejection	US	Ortho Biotech Products LP	19 Jun 1986

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Hepatitis C, Chronic	Phase 2	AT	InSpira Medical AB	01 Nov 2011
Hepatitis C, Chronic	Phase 2	PL	InSpira Medical AB	01 Nov 2011
Neoplasms	Phase 1	IT	-	-

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NCT00566696 (CTgov)	Phase 2	Acute Myeloid Leukemia \| Hodgkin's Lymphoma \| Chronic phase chronic myeloid leukemia ... View more	73	CliniMACS+Fludarabine+cyclophosphamide+Muromonab+Anti-thymocyte globulin (Rabbit)+G-CSF+Mycophenolate mofetil+L-phenylalanine mustard+Rituxan™+Thioplex®+Alemtuzumab	dhwuciunhg(jtyqrvjiwo) = ahyxznblwg crendwexoh (jtjovblvnv, npgwluqkaj - mqbziituiu) View more	-	03 May 2016
NCT00924001 (CTgov)	Phase 1/2	Metastatic melanoma	1	Fludarabine+Cyclophosphamide+OKT-3+Aldesleukin	iwkacqeikw(znejomjzat) = tctticqodo rmlzbbokja (ggqxcblaal, ldctlacnew - movczbwfmc) View more	-	07 Jun 2012

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