The Antibody Society

the official website of the antibody society

An international non-profit supporting antibody-related research and development.

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Phase I Data for Enfortumab Vedotin and the World ADC Awards

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During the annual congress of the European Society of Medical Oncology (ESMO) in Copenhagen, interim clinical data for enfortumab vedotin (ASG-22ME) and ASG-15ME (Seattle Genetics and Agensys/Astellas) in patients with metastatic urothelial cancer were presented. Both enfortumab vedotin and ASG-15ME are investigational ADCs making use of the microtubule-disrupting toxin MMAE conjugated to anti-Nectin-4 and a SLITRK6-targeting antibody respectively. Nectin-4 and SLITRK6 are highly expressed in urothelial cancers, particularly bladder cancer but also include carcinomas of the ureter and renal pelvis.

There is a high unmet need for patients with metastatic urothelial cancer. In 2016 approximately 77,000 people will be diagnosed and more than 16,000 will die from urothelial bladder cancer. For patients diagnosed with locally advanced or metastatic the average five-year survival is only approximately 15%.

The clinical trial data showed that each agent demonstrated anti-tumor activity in patients previously treated with platinum-based chemotherapy, checkpoint inhibitors, taxanes and those with liver metastases and were generally well-tolerated.

Of the 49 patients evaluable for response to enfortumab vedotin treatment, 18 patients (37%) had an objective response, including one patient (2%) achieving a complete response and 17 patients (35%) who achieved a partial response. The preliminary estimate of median progression-free survival is 16.6 weeks. The recommended phase II dose is 1.25 mg/kg.

Of the 48 patients evaluable for response upon ASG-15ME treatment, 18 patients (38%) showed an objective response, including one patient (2%) who achieved a complete response and 17 patients (35%) achieving a partial response. The preliminary estimate of median progression-free survival is 16.1 weeks.

Both agents demonstrated encouraging anti-tumor activity and safety in these patient groups, and these data support the scheduled advancement to later stage development.

 

In other ADC-related news this month, during the 7th World ADC conference in San Diego the winners of the 3rd World ADC Awards were announced. The World ADC Awards showcase excellence within antibody drug conjugate research and reward the innovation, leadership, and devotion shown by the best companies, teams, and individuals in the industry. Across eight categories winners were awarded which in full can be viewed here (http://worldadc-awards.com/awards-2016/winners/).

The award for Best ADC Platform Technology was won by the Fleximer platform developed by Mersana Therapeutics. Winner of the Most Promising Clinical Candidate
was the ADC Rovalpituzumab tesirine (developed by Abbvie-Stemcentrx). BSP Pharmaceuticals took the prize for Best Contract Manufacturing Provider and ADC Therapeutics won Best New Drug Developer. John Lambert was awarded for his Long Standing Contribution to the field.

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Antibody Engineering & Therapeutics

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Antibody Engineering & Therapeutics, the largest meeting devoted to antibody science and technology and the annual meeting of The Antibody Society, will be held in San Diego, CA on December 11-15, 2016. Each of 14 sessions will include presentations by leading industry and academic experts. In the meeting preview found here, the session chairs discuss the relevance of their topics to current and future antibody therapeutics development. Session topics include bispecifics and designer polyclonal antibodies; antibodies for neurodegenerative diseases; the interface between passive and active immunotherapy; antibodies for non-cancer indications; novel antibody display, selection and screening technologies; novel checkpoint modulators / immuno-oncology; engineering antibodies for T-cell therapy; novel engineering strategies to enhance antibody functions; and the biological impact of Fc receptor engagement. The meeting will open with keynote speakers Dennis R. Burton (The Scripps Research Institute), who will review progress toward a neutralizing antibody-based HIV vaccine; Olivera J. Finn, (University of Pittsburgh School of Medicine), who will discuss prophylactic cancer vaccines as a source of therapeutic antibodies; and Paul Richardson (Dana-Farber Cancer Institute), who will provide a clinical update on daratumumab for multiple myeloma. In a featured presentation, a representative of the World Health Organization’s INN expert group will provide a perspective on antibody naming. In addition, two pre-conference workshops covering ways to accelerate antibody drugs to the clinic and the applications of next-generation sequencing in antibody discovery and engineering will be held on Sunday December 11, 2016.

“Antibodies to watch in 2017” and progress on The Antibody Society’s 2016 initiatives will be presented during the Society’s special session on Wednesday, December 14, 2016. Janice Reichert, Executive Director of The Antibody Society, will recapitulate the approvals granted for antibody therapeutics in 2016 in the United States or European Union, and summarize the “Antibodies to watch” in 2017, i.e., monoclonal antibodies in regulatory review and those with Phase 3 clinical studies due for completion in 2017. She will also briefly discuss the Society’s initiative to address questions surrounding the World Health Organization’s international non-proprietary naming system.
Andrew Bradbury (Los Alamos National Laboratory), a member of the Society’s Board of Directors, will then review progress made during 2016 on the Society’s initiative to address issues related to antibody reagent reproducibility. In collaboration with the Global Biological Standards Institute, the Society organized the workshop “Research Antibodies: Solutions for Today and Tomorrow”, held at Asilomar in September 2016, with the goals to: 1) identify a set of standards to validate research antibodies, including recommendations for adoption by academia, industry, funders, and journals; 2) develop recommendations for an independent proficiency certification system or open access user ratings service; and 3) develop recommendations, timeline, and follow-up plan for the introduction of sequenced recombinant antibodies as research reagents. Dr. Bradbury will discuss the recommendations and conclusions that resulted from the Asilomar meeting and future plans for this initiative.
The Society supports the Adaptive Immune-Receptor Repertoire (AIRR) Community in developing recommendations for: 1) a common repository for AIRR sequence data, 2) minimal standards for publishing and depositing AIRR sequence data, and 3) resources and guidelines for the evaluation of molecular and statistical methods for AIRR sequence data, which were discussed at a workshop held at the National Institutes of Health’s Fishers Lane Facility in Rockville, MD in June 2016. Jamie K. Scott (Simon Fraser University),  a member of the Society’s Board of Directors, will provide an update on progress in these areas, and she will discuss future plans for this initiative.

Members of The Antibody Society receive a 15% discount on registration for this meeting! Contact us at membership@antibodysociety.org for the code. We look forward to seeing you in San Diego in December.

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WHO’s Open Session on INN to be held on April 12, 2016

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The World Health Organization (WHO) recently introduced new definitions for the assignment of antibody international nonproprietary names (INN). Linear protein sequence is now used to define humanness, which is a substantial change in the method by which therapeutic antibodies were previously classified as chimeric, humanized or human. The new definitions are scientifically flawed, provide results that are inconsistent with names of many existing antibody therapeutics, and do not consider advances in antibody technology and antibody development experience.

The Antibody Society will represent the Antibody Community at large at the WHO’s Open Session at the 62nd consultation on INN for pharmaceutical substances in Geneva on April 12, 2016, and we will request modifications that address the problems with the new system.
To be able to influence the WHO, we need your support. Please support our effort by agreeing to the statement here, and provide your name and contact information.

The Antibody Society’s presentation at the WHO’s Open Session on April 12, 2016 is available to Society members. Please log in to access the presentation, located on the Presentations page in the Members Only section.

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Comprehensive meeting report now available to members!

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20150625-example-imageThe 26th Antibody Engineering & Therapeutics meeting, the annual meeting of The Antibody Society, united over 800 participants from all over the world in San Diego from 6-10 December 2015. The latest innovations and advances in antibody research and development were discussed, covering a myriad of antibody-related topics by more than 100 speakers, who were carefully selected by The Antibody Society. As a prelude, attendees could join the pre-conference training course focusing, amongst others, on the engineering and enhancement of antibodies and antibody-like scaffolds, bispecific antibody engineering and adaptation to generate chimeric antigen receptor constructs. The main event covered four days of scientific sessions that included antibody effector functions, reproducibility of research and diagnostic antibodies, new developments in antibody-drug conjugates (ADCs), preclinical and clinical ADC data, new technologies and applications for bispecific antibodies, antibody therapeutics for non-cancer and orphan indications, antibodies to harness the cellular immune system, building comprehensive IgVH-gene repertoires through discovering, confirming and cataloging new germline IgVH genes, and overcoming resistance to clinical immunotherapy. The Antibody Society’s special session focused on “Antibodies to watch” in 2016. Another special session put the spotlight on the limitations of the new definitions for the assignment of antibody international nonproprietary names introduced by the World Health Organization. The convention concluded with workshops on computational antibody design and on the promise and challenges of using next-generation sequencing for antibody discovery and engineering from synthetic and in vivo libraries.

Find the full meeting report in the Members Only section.