A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS014, a HER2-Targeting Antibody Drug Conjugate (ADC), in Participants With Advanced HER2+ Solid Tumors

This study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS014, a HER2 targeting antibody-drug conjugate, in patients with advanced solid tumors.

Start Date14 Sep 2023

Sponsor / Collaborator

Iksuda Therapeutics Ltd.

NCT05365659 / RecruitingPhase 1

A Phase 1 Cohort Dose Escalation and Expansion Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS03 in Patients with Advanced B Cell Non-Hodgkin Lymphomas (NHL)

This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, antineoplastic activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS03, a CD19 targeting antibody-drug conjugate, in patients with advanced B cell non-Hodgkin lymphoma (NHL).

Start Date05 Sep 2023

Sponsor / Collaborator

Iksuda Therapeutics Ltd.

100 Clinical Results associated with Iksuda Therapeutics Ltd.

0 Patents (Medical) associated with Iksuda Therapeutics Ltd.

Literatures (Medical) associated with Iksuda Therapeutics Ltd.

02 Nov 2023·Blood

Author: Nadler, Paul I. ; Deckert, Jutta ; Harrup, Rosemary Anne ; Lutz, Robert J ; Thirlway, Jenny ; Assouline, Sarit ; Browning, David M ; Lee, Seung Tae ; Lewis, Katharine L. ; Wood, Debra L

Background: IKS03 is an antibody-drug conjugate (ADC) comprising an anti-CD19 antibody conjugated with novel ConjuALL technology to a highly potent proprietary DNA-crosslinking pyrrolobenzodiazepine (PBD) prodrug payload for the treatment of CD19-positive hematologic malignancies. Both the payload and the linker of IKS03 incorporate an innovative tumor-selective chemistry that takes advantage of the overexpression of beta glucuronidase in cancer cells compared to most normal tissues. Payload release and activation require cleavage of glucuronide moieties that are incorporated into the linker payload structure providing improvements in both efficacy and safety compared to traditional ADC formats. This “glucuronide trigger” is stable while in circulation with minimal to no systemic payload release from the ADC. Following binding and internalization of IKS03 into a CD19-positive cancer cell, beta glucuronidase can release the active PBD payload leading to cell death. Normal tissues without CD19 expression and/or with low levels of the beta glucuronidase enzyme have limited ADC uptake, are less able to process IKS03 and are differentially spared.In preclinical studies, IKS03 demonstrated significant in vivo efficacy with complete tumor regressions in CD19-positive diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL) xenograft models at single doses of 0.1 to 1 mg/kg. IKS03 demonstrated greater activity than the clinical benchmark ADC loncastuximab tesirine. IKS03 is also highly effective in patient-derived xenograft models that contain some of the genetic alterations commonly found in relapsed/refractory NHL patients. Results from toxicology studies in cynomologus monkey suggest a manageable safety profile at single doses, well above those required for in vivo activity. Pharmacokinetics are favorable with a mean total ADC half-life of 8 days and undetectable levels of the active PBD payload in circulation confirming targeted delivery of the payload.Study Design and Methods: This Phase 1 multicenter, open label, non-randomized study of IKS03 will consist of two parts: dose-escalation (Part I) and dose-expansion (Part II) together enrolling approximately 140 adult patients with relapsed or refractory B-cell NHL after at least two prior lines of systemic therapy. Patients will receive repeat doses of study drug by IV infusion on Day 1 of each 21-day cycle, until disease progression, unacceptable toxicity, or another withdrawal criterion is met. Key exclusion criteria include: active central nervous system involvement with NHL; clinically significant cardiovascular, pulmonary or hepatic disease; or receipt of other CD19-directed therapy within 3 months.Part I dose escalation will enroll patients with confirmed CD19-positive, measurable or non-measurable advanced B-cell NHL. Eligible subtypes include DLBCL, MCL, FL, high-grade B-cell, and marginal zone lymphoma as per WHO 2016 classification. Patients with Burkitt's lymphoma, Waldenström macroglobulinemia, and chronic lymphocytic leukemia are excluded. In Part 1, the primary objective is establishment of the recommended Phase 2 dose (RP2D) by evaluation of safety, tolerability and the maximum tolerated dose (MTD) of IKS03. Dose escalation will follow a 3+3 design. A two cycle Dose-Limiting Toxicity (DLT) assessment period will be observed, and dose-escalation decisions will be guided by a study safety committee. Dose escalation increments will be adjusted based on occurrence of protocol-specified DLTs as well as overall tolerability. Secondary objectives include characterization of immunogenicity and pharmacokinetic (PK) profile of IKS03. Exploratory objectives include preliminary antineoplastic activity per Lugano criteria (Cheson et al, JCO 2014) and evaluation of pharmacodynamic markers.Part II will further evaluate the antineoplastic activity of IKS03 at the RP2D in expansion cohorts of patients with selected NHL subtypes and with measurable disease. Sample size will be determined for each subtype using a Simon Two-Stage design. Secondary objectives include further evaluation of safety, tolerability, immunogenicity and PK profile of IKS03 as well as confirmation of the RP2D. Clinical trial information: NCT05365659.

02 Nov 2023·Blood

IKS03, a Novel CD19-Targeted Antibody Drug Conjugate, Induces Target Dependent In Vivo Cell Killing of B-Cell Lymphoma Xenografts By DNA Crosslinking

Author: Deckert, Jutta ; Lodge, Adam ; Mysliwy, Justyna ; Lutz, Robert J ; Thirlway, Jenny

CD19 is widely expressed in B-cell non-Hodgkin lymphoma including diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). IKS03 is a CD19-targeting antibody drug conjugate (ADC) with a novel linker payload design for tumor-selective payload release. Site-specific conjugation using farnesyltransferase-catalysed ConjuALL technology to a DNA crosslinking agent yields a homogenous ADC with drug-to-antibody ratio (DAR) of 2. To minimize systemic release of the highly potent payload in human plasma, IKS03 incorporates a linker specifically cleavable by the lysosomal enzyme beta-glucuronidase. In addition, the payload is a pro-drug with a protecting moiety cleavable by the same enzyme. Therefore, following CD19-dependent binding and uptake, IKS03 requires intracellular lysosomal processing in the target cell to both release and fully activate the free pyrrolobenzodiazepine (PBD) dimer payload which induces DNA crosslinking, blocks DNA replication and ultimately leads to tumor selective cell death.In vivo efficacy was evaluated in CD19-expressing preclinical human xenograft models representing different subtypes of B-NHL. IKS03 was highly active against Farage and OCI-LY10 DLBCL xenografts as well as Granta-519 MCL xenografts in SCID mice with durable tumor regressions observed following treatment with a single dose of 0.1 to 0.3 mg/kg. Likewise, in a Ramos lymphoma model a single IKS03 dose of 0.3 mg/kg significantly inhibited tumor growth. IKS03 demonstrated greater in vivo efficacy than the clinical benchmark ADCs polatuzumab vedotin and loncastuximab tesirine approved for the treatment of patients with B-cell non-Hodgkin lymphomas.PBD cytotoxic agents have been described to induce DNA crosslinking leading to DNA damage. To demonstrate that IKS03 in vivo activity is the result of targeted payload release, Ramos xenografts were established in immunodeficient mice and treated with up to 1 mg/kg of IKS03 in comparison with a non-targeted ADC utilizing the same linker payload format. Tumors were excised at 1 day and 3 days post-treatment and assessed for the presence of phospho-H2AX positive foci, a marker of DNA damage, by immunohistochemistry. IKS03 treatment increased both frequency and staining intensity of nuclear phospho-H2AX foci in Ramos xenografts in a dose- and time-dependent manner. In contrast, the non-targeted control ADC did not result in any changes as compared to a vehicle control. This confirms the specific induction of DNA damage in CD19 positive lymphomas as a pharmacodynamic response to IKS03 treatment in vivo.In conclusion, IKS03 is highly effective in an array of preclinical MCL and DLBCL xenograft models at doses that are well tolerated. In vivo, IKS03 treatment increased the level of phospho-H2AX indicative of irreversible DNA damage in a target-dependent manner. This is consistent with the proposed mechanism of action of CD19-mediated delivery of a PBD payload specifically to B-cell tumors. Clinical investigation in patients with advanced B-Cell Non-Hodgkin Lymphomas is being initiated (NCT05365659).

15 Nov 2022·Blood

IKS03, a Next Generation CD19-Targeted Antibody Drug Conjugate, Shows Potent Activity in Preclinical Models of Aggressive B-Cell Lymphomas

Author: Deckert, Jutta ; Han, Na Ra ; Park, Yun-Hee ; Mysliwy, Justyna ; Ryu, Hyun-Min ; Chung, Chul-Woong ; Song, Ho Young ; Lutz, Robert J ; Lodge, Adam ; Thirlway, Jenny

News (Medical) associated with Iksuda Therapeutics Ltd.

23 Oct 2023

·www.biospace.com

Iksuda Therapeutics announces first patient dosed in Phase 1 trial of IKS014 in patients with advanced solid tumours that express HER2

Study is designed to evaluate the safety and tolerability of increasing dose levels of the antibody drug conjugate, IKS014, to establish a recommended Phase 2 dose IKS014 is the first of Iksuda’s ADCs to enter clinical trials NEWCASTLE, England--(BUSINESS WIRE)-- Iksuda Therapeutics (Iksuda), the developer of class leading antibody drug conjugates (ADCs) with enhanced tumour specificity, today announces that the first patient has completed a first cycle of therapy with IKS014, a human epidermal growth factor receptor 2 (HER2) ADC targeting patients with advanced HER2+ solid tumours. This follows positive data from Phase 1 clinical trials through Fosun Pharma, which is now progressing FS-1502 (IKS014) through Phase 2 and Phase 3 trials in China. The open-label, interventional study ( ) is designed to evaluate the safety and tolerability of increasing dose levels of IKS014 to establish a recommended Phase 2 dose. The second, dose-expansion, phase of the study (Phase 1b) is to further evaluate the safety, pharmacokinetics / pharmacodynamics, and efficacy of IKS014 at the recommended Phase 2 dose. The study is currently enrolling patients at five planned locations in Australia. The Phase 1b trial is expected to read out in 2H 2025. Dr Dave Simpson, Chief Executive Officer, Iksuda Therapeutics, said: “The dosing of the first patient in our Phase 1 trial of IKS014 marks a significant milestone for Iksuda: our transition to being a clinical-stage company. We hope that this trial of IKS014 could lead to improved treatment options for patients with HER2+ solid tumours.” About IKS014 IKS014 is a potential best-in-class antibody drug conjugate, benefiting from tumour selective activation and release of the cytotoxic agent monomethyl auristatin F (MMAF). In preclinical trials, it displayed impressive activity in high- and low-HER2 expressing tumours with significantly higher non-severely toxic dose (HNSTD) vs other HER2-directed drugs. Iksuda gained exclusive world-wide rights (excluding Greater China and South Korea) to IKS014 from LegoChem Biosciences. ( ) Fosun Pharma holds the licence to the ADC in Greater China where it is designated FS-1502. Fosun is currently conducting a Phase 2 clinical trial in China in patients with a range of solid tumours and has also initiated a Phase 3 trial in patients with advanced breast cancer. About Iksuda Therapeutics: Iksuda Therapeutics is a UK-based clinical stage biotechnology company focused on the development of class leading Antibody Drug Conjugates (ADCs) with enhanced tumour specificity, targeting difficult-to-treat cancers. Iksuda’s ADC design and pipeline is enabled by a broad armoury of payload mechanisms, tumour selective activation platforms and stable conjugation chemistries. The Company’s ADC portfolio is designed to significantly improve the therapeutic index of this important modality and improve the outcomes for patients living with cancer. View source version on businesswire.com: Contacts Iksuda Therapeutics Dave Simpson, Chief Executive Officer Tel: +44 (0) 191 6031680 Email info@iksuda.com FTI Consulting (Financial Media and IR) Simon Conway / Rob Winder Tel: +44 (0) 20 3727 1000 Iksuda@fticonsulting.com Source: Iksuda Therapeutics View this news release online at:

Phase 1ADCPhase 3Phase 2License out/in

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

16 Jun 2023

·www.prnewswire.com

Cancer Antibody Drug Conjugates Global Market to 2029: Look at more than 550 Drugs in Clinical Trial

DUBLIN, June 16, 2023 /PRNewswire/ -- The "Global Cancer Antibody Drug Conjugates Market Size, Drug Sales, Drug Dosage, Price, & Clinical Trials Outlook 2029" report has been added to ResearchAndMarkets.com's offering. Global Cancer Antibody Drug Conjugates Market Size, Drug Sales, Drug Dosage, Price, & Clinical Trials Outlook 2029 Report Highlights: Global Antibody Drug Conjugates Market Opportunity: > 40 Billion By 2029 Global & Regional Antibody Drug Conjugate Market Insight Approved Drugs Sales Insight Global & Regional, Yearly & Quarterly, 2019 -2023 Approved Antibody Drug Conjugates - Availability, Dosage & Price Insight Insight On Antibody Drug Conjugates In Clinical Trials: > 550 Drugs Insight On Commercially Approved Antibody Drug Conjugates: > 15 Drugs Cancer Antibody Drug Conjugates Clinical Pipeline By Company, Indication & Phase Global Cancer Antibody Drug Conjugate Market Trends by Indication The realm of cancer treatment is experiencing a surge of innovation that may greatly change how we currently diagnose as well as treat cancer. Clinical researchers and pharmaceutical companies continue to seek innovative solutions that offer enhanced efficacy and reduced side effects. Among the ongoing significant advancements, antibody drug conjugates (ADCs) have emerged as a groundbreaker in cancer therapeutics. This rapidly expanding market is transforming the treatment landscape, offering a new therapeutic option for patients globally. Antibody drug conjugates harness the synergistic potential of monoclonal antibodies and potent cytotoxic drugs, delivering a strong strike against cancer cells. By exploiting the specificity of monoclonal antibodies, antibody drug conjugates can selectively bind to cancer antigens, increasing drug delivery directly to tumor sites. This targeted approach enables higher drug concentrations at the desired location while minimizing harm to healthy, normal tissues. The antibody drug conjugate market is experiencing remarkable growth, driven by several key factors including the increasing cancer incidence rates, rowing demand for effective and personalized treatment options and advancements in antibody engineering and drug delivery technologies are propelling the market forward. Moreover, regulatory approvals have opened the way for the commercial success of antibody drug conjugates which has further encouraged investments in the field. For instance, Adcetris and Kadcyla have been in the market for a long time and their commercial sales hold a significant share of the current antibody drug conjugate market. The growth of these antibody drug conjugates represents the significant need for this therapeutic modality. Enhertu, another antibody drug conjugate which is relatively new to the market compared to Kadcyla and Adcetris, has shown immense success commercially. With its recent approval for breast cancer indication, the sales for Enhertu have escalated rapidly. Antibody drug conjugates have welcomed a new age of targeted cancer therapy and this novel class of cancer treatment can be evaluated to have an exponential increase in terms of both commercial success as well as expansion of the global portfolio. However, the development of antibody drug conjugates has been associated with significant challenges with difficulties in manufacturing, bioconjugation and their overall development. Nevertheless, collaboration between pharmaceutical companies and academic institutions has been an important factor that has helped in overcoming these limitations, resulting in such success of antibody drug conjugates. For instance, Lantern Pharma collaborating with Germany's Bielefeld University will leverage its proprietary Artificial Intelligence platform RADR for the rapid development of novel cryptophycin antibody drug conjugates, representing an exciting new class of strong and highly directed drug candidates. It is expected that outcomes from this collaborative arrangement will pave the way for next generation antibody drug conjugated designed using AI with high efficacy, swift development with sibilant cost reduction. The future of antibody drug conjugates is expected to be closely tangled with technological innovations. Novel conjugation strategies such as site specific conjugation are also being explored to enhance stability of antibody drug conjugates, resulting in improved therapeutic outcomes. Additionally, advancements in bioconjugation techniques, payload release mechanism and drug delivery systems offer opportunities to optimize the pharmacokinetics and bio distribution of antibody drug conjugates potentially increasing their effectiveness. Antibody drug conjugates have targeted a new level of efficacy, surpassing the capabilities of traditional monoclonal antibodies and opening opportunities for market expansion. While monoclonal antibodies are highly specific in their binding to cancer cell antigens, their therapeutic impact often relies on the activation of immune responses or blocking signaling pathways. In contrast, antibody drug conjugates offer a multifaceted approach by directly delivering a potent cytotoxic payload to cancer cells, exerting a direct cell killing effect. Overall, the antibody drug conjugates market represents a groundbreaking approach to cancer treatment. As market continues to expand, patients and healthcare professionals are witnessing significant advancements. With ongoing research, technological innovations and strategic collaborations, the future of antibody drug conjugates is set to transform the global cancer therapy market. This report provides a comprehensive analysis about the currently approved antibody drug conjugates in terms of their patent, price, dosage as well as their sales and treatment cost. Furthermore, the report also provides information about the regional impact of approved antibody drug conjugates while also providing information about the possible future opportunities in the global antibody drug conjugates market. Key Topics Covered: 1. Introduction to Antibody Drug Conjugates 1.1 Overview 1.2 Historical Development of ADCs 1.3 Evolution of Antibody Drug Conjugates 2. Need of Antibody Drug Conjugates 3. Global Antibody Drug Conjugate Market Insight 3.1 Current Market Scenario (2019 -2023) 3.2 Future Market Opportunity Assessment 2029 4. Antibody Drug Conjugate Market Regional Analysis 4.1 US 4.2 China 4.3 South Korea 4.4 India 4.5 Australia 4.6 Europe 4.7 Canada 4.8 Japan 4.9 Taiwan 5. Global Cancer Antibody Drug Conjugate Market Trends by Indication 5.1 Breast Cancer 5.2 Lung Cancer 5.3 Lymphoma 5.4 Leukemia 5.5 Cervical Cancer 5.6 Urothelial Cancer 5.7 Gastric Cancer 5.8 Other Cancers 6. Approved Antibody Drug Conjugates - Availability, Dosage & Price Insight 2023 6.1 Mylotarg 6.2 Adcetris 6.3 Kadcyla 6.4 Besponsa 6.5 Lumoxiti 6.6 Polivy 6.7 Padcev 6.8 Enhertu 6.9 Trodelvy 6.10 Blenrep 6.11 Zynlonta 6.12 Tivdak 6.13 Elahere 6.14 Aidixi 6.15 Ujvira 6.16 Akalux 7. Approved Antibody Drug Conjugate Sales Insights (Global & Regional, Yearly & Quarterly, 2019 -2023) 7.1 Adcetris 7.2 Padcev 7.3 Tivdak 7.4 Polivy 7.5 Kadcyla 7.6 Besponsa 7.7 Enhertu 7.8 Trodelvy 7.9 Zynlonta 7.10 Elahere 7.11 Blenrep 8. Global Antibody Drug Conjugates Clinical Trials Insight 2023 8.1 By Phase 8.2 By Indication 8.3 By Company 8.4 By Patient Segment 8.5 By Country 9. Global Cancer Antibody Drug Conjugates Clinical Pipeline By Company, Indication & Phase 9.1 Research 9.2 Preclinical 9.3 Phase-I 9.4 Phase-I/II 9.5 Phase-II 9.6 Phase-II/III 9.7 Phase-III 9.8 Preregistration 10. Marketed Cancer Antibody Drug Conjugates Clinical Insight 11. Global Cancer an Antibody Drug Conjugates Market Dynamics 11.1 Favorable Parameters 11.2 Challenges for Antibody Drug conjugates Market 12. Competitive Landscape 12.1 AbbVie 12.2 ADC Therapeutics 12.3 AstraZeneca 12.4 Bayer 12.5 BiOneCure Therapeutics 12.6 Biosion 12.7 Bio-Thera Solutions 12.8 Boehringer Ingelheim 12.9 Daiichi Sankyo Company 12.10 Duality Biologics 12.11 Exelixis 12.12 Genmab 12.13 Hangzhou DAC Biotech 12.14 Heidelberg Pharma AG 12.15 Iksuda Therapeutics 12.16 ImmunoGen 12.17 LaNova Medicines Limited 12.18 LegoChem Biosciences 12.19 Lepu Biopharma 12.20 Mersana Therapeutics 12.21 Molecular Templates 12.22 Multitude Therapeutics 12.23 NanoValent Pharmaceuticals 12.24 NewBio Therapeutics 12.25 Orum Therapeutics 12.26 ProfoundBio 12.27 Radiopharm Theranostics 12.28 Seagen 12.29 Sorrento Therapeutics 12.30 Sutro Biopharma 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: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

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