The COVID-19 pandemic has presented many challenges to the biopharmaceutical industry. Initiating programs to discover and develop new antibodies that targeted SARS-CoV-2 was critical, but at the same time, programs bringing existing investigational therapies through late-stage clinical studies and regulatory review also needed to be maintained.

Dr. Janice Reichert (The Antibody Society) provides an update on antibody therapeutics approved in the US and European Union during 2020, those that may be approved by the end of 2021, and those that might enter regulatory review in the US or EU soon. She will also discuss current and potential emergency use authorizations for anti-SARS-CoV-2 antibodies.

Dr. Nick Hutchinson (FUJIFILM Diosynth Biotechnologies) discusses how the pandemic has driven scientists and engineers to find new ways to leverage antibody production capacity most effectively in order to meet the need for rapid early phase development, as well as high-demand commercial manufacturing and what this may mean for antibody manufacturing strategies in the future.

Drs. Janice Reichert (The Antibody Society), Alicia Chenoweth (King'sCollege London) and Silvia Crescioli (King'sCollege London) will discuss key events in antibody therapeutics development that occurred in 2021 and forecast events that might occur in 2022. They will provide an update on antibody therapeutics first approved in the US and European Union, as well as the rest of the world, during 2021, and those in regulatory review. Current and potential emergency use authorizations and approvals for anti-SARS-CoV-2 antibodies will also be discussed.

“Antibodies to Watch in 2023” highlights key events in commercial monoclonal antibody therapeutics development that occurred in 2022 and forecasts events that might occur in 2023. In this presentation, we will discuss the antibody therapeutics granted first approvals in either the United States or European Union in 2022, which include 4 bispecific antibodies ((tebentafusp, faricimab, mosunetuzumab and teclistamab) and 1 ADC (mirvetuximab soravtansine). We will also discuss approvals for antibody therapeutics that were first granted in China or Japan in 2022, which include 2 bispecific antibodies (cadonilimab and ozoralizumab). Globally, at least 24 investigational antibody therapeutics are undergoing review by regulatory agencies. Our data show that, with antibodies for COVID-19 excluded, the late-stage commercial clinical pipeline grew by ~20% in the past year to include nearly 140 investigational antibody therapeutics that were designed using a wide variety of formats and engineering techniques. Of those in late-stage development, marketing application submissions for at least 23 may occur by the end of 2023, of which 5 are bispecific (odronextamab, erfonrilimab, linvoseltamab, zanidatamab, and talquetamab) and 2 are ADCs (datopotamab deruxtecan, and tusamitamab ravtansine).

The ‘Antibodies to Watch’ 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 webinar, we discuss key details for antibody therapeutics granted a first approval in 2023. We briefly review 27 product candidates for which marketing applications are under consideration in at least one country or region, and 22 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 and antibody-drug conjugates. 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 therapeutics development efforts by the biopharmaceutical industry are robust and increasingly successful.

The extraordinary scope and scale of the COVID-19 pandemic has elicited extraordinary responses world-wide. Organizations located across the globe have mobilized teams to research the SARS-CoV-2 virus and COVID-19, conduct clinical studies of repurposed biologics, and research and develop anti-SARS-CoV-2 biologics. Disruptions at companies and regulatory agencies, however, have raised concerns about the effects of the pandemic on possible approvals of non-COVID-19 antibody therapeutics. In a series of webinars, The Antibody Society will report on important developments in the commercial pipeline of antibody therapeutics for COVID-19, as well as other indications.

In “Antibodies to Watch in a Pandemic”, Dr. Janice Reichert (The Antibody Society) provides an update on non-COVID-19 antibody therapeutics approved in the first half of 2020, and those that might be approved by the end of the year. She also discusses the ~ 130 biologics currently in development for COVID-19, which includes over 50 repurposed biologics and over 80 anti-SARS-CoV-2 biologics. Additionally, Dr. Thomas Schirrmann (Yumab) presents a case study of how to develop anti-SARS-CoV-2 antibodies in both academic and industrial settings.

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.