the official website of the antibody society
For World Cancer Day 2024, The Antibody Society has prepared a snapshot of the clinical development of therapeutic antibodies for cancer indication.
The infographic gives an overview on the trends in first in human studies and approvals, as well as on the active early and late stage pipelines (as of January 2024).
In this 15th installment of the annual ‘Antibodies to Watch’ article series, we review commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those granted a first approval in any country in 2023. We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14–32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.
The complete abstract is here: The ‘Antibodies to Watch’ article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody–drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14–32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.
Need insights into the early-stage antibody therapeutics pipeline? We’ve got you covered! Join us Tuesday Oct 24th for an in-depth analysis of the early-stage pipeline stratified by cancer and non-cancer indications, revealing trends in the molecular formats, targets, and mechanism of action.
Abstract: Since 2014, the number of antibody therapeutics entering clinical development annually has increased steadily, from 71 in 2014 to 286 in 2022. This has resulted in a clinical pipeline currently composed of ~1250 molecules, of which ~1100 and ~150 molecules are in early- and late-stage development, respectively. Despite the great interest in trends in early-stage clinical development, due to the difference in scale and difficulty in tracking molecules newly entered in clinical studies, analyses of trends in the global commercial development of antibody therapeutics are often limited to the late-stage clinical pipeline only. Luckily, The Antibody Society meticulously collects data for antibody therapeutics at all stages of clinical development. This webinar will provide an exhaustive analysis of the early-stage pipeline stratified by cancer and non-cancer indications, revealing trends in the molecular formats, targets, and mechanism of action.
Hoffmann-La Roche Limited (Roche Canada) announced that on March 24, 2023 Health Canada authorized COLUMVI® (glofitamab for injection) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from follicular lymphoma (trFL), or primary mediastinal B-cell lymphoma (PMBCL), who have received two or more lines of systemic therapy and are ineligible to receive or cannot receive CAR-T cell therapy or have previously received CAR-T cell therapy. COLUMVI has been issued marketing authorization with conditions, pending the results of trials to verify its clinical benefit. The authorization of COLUMVI® is the first in Canada and globally.
Glofitamab (RO7082859) is a full-length IgG1λ/ҡ bispecific T cell redirecting antibody targeting CD20 on malignant B cells and CD3 on T cells. This bispecific antibody was developed by Roche using the 2:1 CrossMab technology, characterized by 3 antigen-binding fragment (Fab) arms enabling monovalent binding to CD3ɛ and bivalent binding to CD20, with the second CD20 arm fused to the CD3ɛ-binding arms via a flexible linker. Glofitamab also features a heterodimeric Fc region engineered with PG LALA mutations to abolish binding to FcɣRs and C1q.
The Health Canada authorization is based on data from the open-label, phase I/II, multicenter, multi-cohort trial (NP30179) conducted to evaluate COLUMVI as monotherapy in patients with relapsed or refractory B-cell lymphoma. In the single-arm DLBCL cohort (n=108), 84.3% of patients were refractory to their most recent therapy and about one-third (34.3%) had received prior CAR T-cell therapy. The primary efficacy outcome measure was complete response (CR) rate as assessed by the IRC using 2014 Lugano response criteria. Results showed that 35.2% of patients (n=38/108) achieved a complete response (CR; a disappearance of all signs of cancer), and 50.0% (n=54/108) achieved an objective response (OR; the combination of CR or partial response, a decrease in the amount of cancer in their body).
An marketing authorization application containing data from the Phase 1/2 NP30179 study (NCT03075696) evaluating glofitamab for NHL was submitted to the European Medicines Agency. A biologics license application for glofitamab undergoing review by the Food and Drug Administration has a first action date of July 1, 2023.
Need data for other antibody therapeutics that have received marketing authorizations? Go to our searchable table of approved antibody therapeutics and those in regulatory review for more information.
Antibodies and antibody-derived bispecifics are one of the most successful therapeutic classes due to their excellent target specificity and tunable drug-like properties. The ability to tailor antibody functions using modern engineering approaches has ushered in a new wave of bi- and multi-specific antibody therapeutics that unlock novel target classes, biology, and mechanisms of action for the treatment of human diseases. In this collection of reviews, we invite The Antibody Society members, mAbs readers, and the broader scientific community to contribute review articles focused on bispecific and multispecific antibody-based molecules. The reviews should narrate the current state of the art in bi- and multi-specific antibody therapeutics, challenges and opportunities, and speculate on new vistas for the field.
We are particularly interested in reviews in the following topics:
• Overview of bispecific and multispecific antibody platforms (includes but not limited to Fc engineering, heavy and light chain pairing methodologies, high throughput production methods, geometrical and valency considerations etc.).
• Reviews on multispecific antibodies (beyond bispecifics i.e., more than two binding epitopes) and their applications.
• Reviews on bispecifics and multispecific antibodies beyond oncology (i.e., neurology, infectious disease, ophthalmology, rare diseases etc.).
• Reviews on various cell engagers (T cells, NK cells, macrophages etc.), overview of their design strategies, formats, applications and considerations for safety and tolerability in multiple disease areas.
• Bispecific/Biparatopic and multispecific/multiparatopic targeting beyond antibodies (Antibody drug conjugates, antibody cytokine fusions, CAR-T/NK/M therapies, ProTACs etc) in various therapeutic areas.
• Clinical development experience with bispecific and multispecific molecules with a focus on any or all of these areas: safety and tolerability, immunogenicity, biomarkers and/or bioanalytical assay development.
• Reviews on tissue targeting via bispecific and multispecific antibodies, important considerations for safety, tolerability and preclinical and clinical development.
• Focused review on developability of bispecific and multispecific molecules, CMC and manufacturing considerations. Bispecifics design and challenges in cell line development, upstream and downstream process development, analytical method development, product quality control strategy, process design and scale up, material demand and commercial manufacturing, regulatory guidance, etc.
Although these topics are especially of interest, we welcome well-written reviews in related areas as well. We intend to waive publication charges for up to 8 of the best review articles selected from pre-submission inquiries, which should consist of the title, abstract and general outline of the intended review article.
Please send pre-submission inquiries to Editor-in-Chief Dr. Janice Reichert (reichert.biotechconsulting@gmail.com), and Assistant Editors Drs. Nimish Gera (ngera@mythictx.com), Li Zhou (li.zhou@abbvie.com) and Jonathan Sockolosky (jonathan@curie.bio). Please feel free to contact us if you have any questions.
For examples of other mAbs Collections, please visit the journal website.
