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the official website of the antibody society

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Learn how to harness the power of ADCs in our next webinar!

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Join us for our next webinar!

Antibody-drug conjugates (ADCs) have emerged as an important class of targeted therapeutics, combining the targeting specificity of antibodies with the potency of cytotoxic drugs. Recent advances in ADC research have led to improved stability, efficacy, and safety. There is a clear trend within Antibody therapeutics towards ADCs with the improvement of novel technologies to address a growing cancer population worldwide.

However, developing effective ADCs is expensive and poses unique informatics challenges. Researchers must integrate data across multiple modalities – from antibody discovery and engineering to small molecule payload development and optimization. Seamless collaboration between immunologists, protein engineers, chemists, and pharmacologists are essential.

The Signals™ Research Suite is the first integrated informatics platform purpose-built to accelerate multi-modal drug development like ADCs and is composed of a trio of scientific software applications:

  • Signals™ Notebook: The premier cloud-based electronic lab notebook that facilitates creation and communication about molecules of interest via hierarchical editing language for macromolecules (HELM), powered Chemdraw®.
  • Signals™ VitroVivo: For data analysis, visualization, and curve fitting bioassay results for standardized and consistent results, powered by Spotfire®.
  • Signals™ Inventa: Enabling multi-assay or multi-study comparison, powered by Spotfire, with the ability to find the best candidate to move forward, accelerating decision making. Researchers gain better visibility into ADC candidate profiling and can quickly determine structure-activity and structure-property relationships across modalities to select optimal conjugation sites and pairings.

Attendees will gain insights into the latest trends and challenges in ADC development, informed by recent research and advancements in the field. The presentation will also emphasize the importance of integrating various data types and sources in the ADC development process, showcasing how the Signals Research Suite facilitates this integration, thereby driving more efficient, safer drug development.

About the speaker:

Dr. Wisotsky attended the University of California, Santa Cruz with a focus on molecular and cellular biology. He obtained his Ph.D. at the University of California, Riverside for Neuroscience where he worked on taste detection from molecular mechanism to behavioral outcomes in fruit flies. Subsequently Zev joined startup companies with the focus to support scientists getting their science done more efficiently. He has worked within pre-sales teams to discover, consult, and deliver software solutions that meet customer needs both scientifically and technically. Today he is a Revvity Senior Principle Marketing Manager for Biologics in the Signals Suite.

Registration is open!

 

Reconnect with the AIRR Data Commons: Your Gateway to Immunology Discoveries

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The AIRR Community continues to spearhead innovation in immunology research with the ever-expanding AIRR Data Commons (ADC). For those unfamiliar, the ADC is a pioneering initiative that enables the sharing of standardized Adaptive Immune Receptor Repertoire (AIRR) data. This resource hosts a wealth of information about the diverse array of antibody/B-cell and T-cell receptors that govern immune responses, obtained from bulk and single-cell sequencing technologies. By facilitating the exchange of this valuable data, the ADC enables researchers to gain deeper insights into immunity, disease progression, and therapeutic interventions.

From its inception in 2018 with under 400 million sequence annotations, the ADC has expanded into nine distributed repositories housing 89 studies, over 9800 sample repertoires, and an astonishing 5.2 billion sequence annotations. But this growth is not just about numbers – it’s about fostering collaboration and igniting discoveries. Scientists around the world can access a unified platform to discover, compare, and analyze immunological data, transcending the limitations of individual labs. This interconnectedness not only drives innovation but also eliminates redundancy, saving precious time and resources.

As we look to the future, the ADC is poised to play an even more pivotal role. Its flexible, collaborative framework and continued growth in data will likely attract interdisciplinary partnerships that foster a holistic understanding of the immune system’s complexities. Moreover, the integration of technologies such as machine learning and AI promise to extract deeper insights from the wealth of data, unraveling intricate mechanisms of the immune response.

The AIRR Community’s effort to build and maintain the ADC transcends geographical boundaries and institutional affiliations, exemplifying the spirit of scientific inquiry. As we celebrate the achievements thus far, we eagerly anticipate the advancements that this collaborative endeavor will bring to immunology research in the years to come.

The ADC can be searched interactively using a web user interface at the iReceptor Gateway or VDJServer Community Data Portal. To contribute to the ADC, consider setting up a local repository via the iReceptor Turnkey or submitting data through the VDJServer Community Data Portal.

FDA approves sacituzumab govitecan (Trodelvy®) for triple-negative breast cancer

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On April 22, 2020, the US Food and Drug Administration (FDA) granted an accelerated approval to Trodelvy® (sacituzumab govitecan-hziy) for the treatment of patients with metastatic triple-negative breast cancer who received at least two prior treatments for metastatic disease. Sacituzumab govitecan is composed of an anti-TROP-2 humanized IgG1 antibody conjugated to the topoisomerase inhibitor SN38, which is the active metabolite of irinotecan.

The approval was based on the results of a clinical trial of 108 patients with metastatic triple-negative breast cancer who had received at least two prior treatments for metastatic disease. In this study, the overall response rate was 33.3%, with a median duration of response of 7.7 months. Of the patients who responded to treatment, 55.6% maintained their response for 6 or more months and 16.7% maintained their response for 12 or more months.

The accelerated approval program allows FDA to approve drugs for serious conditions to fill an unmet medical need based on a surrogate endpoint, i.e., a result that is reasonably likely to predict a clinical benefit to patients. Additional clinical trials are required to confirm Trodelvy’s clinical benefit, and the FDA can remove the drug from the market if the confirmatory trial does not show that the drug provides clinical benefit.

World ADC Award Winners Announced

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The Antibody Society congratulates the winners of World ADC Awards!

World ADC Awards showcases the innovation, leadership and devotion shown by the best companies, teams and individuals in the industry. Across 9 categories, the Awards recognized the extraordinary endeavours, teamwork and commercial acumen that has propelled the antibody-drug conjugate field to the forefront of cancer research today. The 6th Annual World ADC Awards Ceremony took place on the evening of Thursday October 10, 2019 at the Manchester Grand Hyatt, San Diego. The finalists and winners were shortlisted from over 1,147 votes cast, and scientific proposals from each submission were evaluated by the Judging panel.

The 2019 winners are:

Best ADC Platform Technology

Zymeworks (ZymeLink) – Winner
LegoChem Bio (Scaffold Based Approach) – Runner Up

Best New Drug Developer

ADC Therapeutics – Winner
Zymeworks – Runner Up

Most Promising Clinical Candidate

Trastuzumab Deruxtecan (DS-8201a) – Winner
Enfortumab Vedotin (Seattle Genetics/Astella) – Runner Up

Best Contract Manufacturing Provider

BSP Pharmaceuticals – Winner
Millipore Sigma – Runner Up

Best Contract Research Provider

PPD – Winner
Abzena – Runner Up

Best Pre-Clinical Publication

Winner: Chemically triggered drug release from an antibody-drug conjugate leads to potent antitumour activity in mice. Rossin R, Versteegen RM, Wu J, Khasanov A, Wessels HJ, Steenbergen EJ, Ten Hoeve W, Janssen HM, van Onzen AHAM, Hudson PJ, Robillard MS. Nat Commun. 2018 May 4;9(1):1484.

Runner Up: Chemically Defined Antibody- and Small Molecule-Drug Conjugates for in Vivo Tumor Targeting Applications: A Comparative Analysis. Cazzamalli S, Dal Corso A, Widmayer F, Neri D. J Am Chem Soc. 2018 Feb 7;140(5):1617-1621.

Best Clinical Publication

Winner: Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin’s Lymphoma. Connors JM, Jurczak W, Straus DJ, Ansell SM, Kim WS, Gallamini A, Younes A, Alekseev S, Illés Á, Picardi M, Lech-Maranda E, Oki Y, Feldman T, Smolewski P, Savage KJ, Bartlett NL, Walewski J, Chen R, Ramchandren R, Zinzani PL, Cunningham D, Rosta A, Josephson NC, Song E, Sachs J, Liu R, Jolin HA, Huebner D, Radford J; ECHELON-1 Study Group. N Engl J Med. 2018 Jan 25;378(4):331-344. doi: 10.1056/NEJMoa1708984.

Individual Input to the Field 2018

Prof. Dario Neri  (ETH Zurich)

Long-Standing Contribution to the Field

Dr. Alain Beck (Pierre Fabre)

For more information about the World ADC Awards, visit http://worldadc-awards.com/

For more information about the World ADC San Diego conference, visit https://worldadc-usa.com/

Four new antibody therapeutics enter regulatory review

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Marketing applications for four antibody therapeutics (crizanlizumab, enfortumab vedotin, teprotumumab, isatuximab) were recently submitted to the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA).

On July 16, 2019, Novartis announced the FDA accepted the company’s Biologics License Application (BLA) and has granted Priority Review for crizanlizumab (SEG101). Novartis submitted the application for crizanlizumab for the prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD). The FDA submission is supported by results from the Phase 2 SUSTAIN study, which showed that crizanlizumab (5 mg/kg) reduced the median annual rate of VOCs leading to health care visits by 45.3% compared with placebo (1.63 vs 2.98, P=0.010) in patients with or without hydroxyurea. Clinically significant reductions in the frequency of VOCs were observed among patients regardless of sickle cell disease genotype or hydroxyurea use. A marketing authorization application for crizanlizumab is undergoing evaluation by EMA.

  • Crizanlizumab, humanized IgG2 targeting P-selectin, was granted Breakthrough Therapy designation in December 2018

On July 16, 2019, Seattle Genetics, Inc. and Astellas Pharma Inc. announced submission of a BLA for accelerated approval to the FDA for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have received a PD-1/L1 inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. The submission is based on results from the first cohort of patients in the EV-201 pivotal Phase 2 clinical trial that were presented as a late-breaking abstract at the annual meeting of the American Society of Clinical Oncology (ASCO) in June.

  • Enfortumab vedotin is a human IgG1 antibody-drug conjugate that targets Nectin-4, a protein that is highly expressed in urothelial cancers.

On July 10, 2019, Horizon Therapeutics plc announced that it has submitted a BLA to FDA for teprotumumab for the treatment of active thyroid eye disease. Teprotumumab has Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA. Horizon requested priority review for the application, which, if granted, could result in a six-month review process. The FDA has a 60-day filing review period to determine whether the BLA is complete and acceptable for filing.

  • Teprotumumab is a human IgG1 antibody that targets insulin-like growth factor 1 receptor.

On July 10, 2019, Sanofi announced that the FDA has accepted for review the BLA for isatuximab (SAR650984) for the treatment of patients with relapsed/refractory multiple myeloma (RRMM). The target action date for the FDA decision is April 30, 2020. Isatuximab received orphan designation for relapsed/refractory multiple myeloma from both the FDA and the EMA, and in the second quarter of 2019 the EMA accepted a marketing authorization application for evaluation.

  • Isatuximab is a novel IgG1 antibody that binds selectively to a specific epitope on CD38.

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The Antibody Society maintains a comprehensive table of approved mAb therapeutics and those in regulatory review in the EU or US. Located in the ‘Web Resources’ section of our website, the list is updated regularly and can be downloaded in Excel format. Information about antibody therapeutics that may enter regulatory review in 2019 can be found in ‘Antibodies to watch in 2019’.