The Antibody Society

the official website of the antibody society

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

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The Antibody Society announces the election of new Directors and Officers

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The Antibody Society, Inc., an international non-profit trade association focused on the advancement of antibody research and development, is pleased to announce the election of Drs. Alexey Lugovskoy and John Desjarlais to the Board of Directors, the election of Peter Ros as the Society’s Treasurer, and the promotion of Janice Reichert to Chief Operating Officer. They assumed these roles on January 1, 2023.

These Directors and Officers bring substantial experience and expertise to their new roles. Drs. Lugovskoy and Desjarlais have each made seminal contributions to the field of antibody discovery and development and have critical experience with building successful collaborations, partnerships and alliances. Peter Ros brings finance and accounting expertise and over twenty years of financial experience within biotech business operations, while Dr. Reichert brings expertise in business intelligence and seven years of experience as the Society’s Executive Director to her new role as COO.

Prof. Paul Parren, Chair of the Society’s Board of Directors remarked “I look forward to working with Alex, John, Peter, and Janice in their new roles. Their valued contributions and expertise will enable us to further professionalize the Society and increase its ability to support the field of therapeutic antibody drug development by stimulating the interchange of ideas with opinion leaders and policy makers.”

Alexey Lugovskoy, Ph.D., President and CEO of Diagonal Therapeutics and Entrepreneur in Residence at Atlas Venture.

During his 20+ year career in biotechnology, Dr. Lugovskoy guided multiple oncology, autoimmunity, and rare disease programs into the clinic serving as COO of Dragonfly Therapeutics, CDO of Morphic Therapeutic, Vice President of Therapeutics at Merrimack Pharmaceuticals, and Associate Director of Drug Discovery at Biogen. He is an author of over 100 patents and manuscripts, and an Associate Editor of mAbs. He received an Advanced Certificate for Executives in Management, Innovation and Technology from MIT Sloan School of Management, a Ph.D. in Biophysics from Harvard University, an M.Sc. in Molecular Biophysics, and a B.Sc. in Mathematics and Physics from the Moscow Institute of Physics and Technology.

John Desjarlais, Ph.D., Chief Scientific Officer, Xencor

Dr. Desjarlais is an internationally recognized leader in the field of antibody and protein engineering for the creation of novel therapeutic modalities to treat a variety of diseases, including autoimmune diseases and cancer. Dr. Desjarlais oversees all of Xencor’s discovery research and preclinical activities, from project conception and candidate generation through preclinical proof-of-concept and early development.  Prior to Xencor, Dr. Desjarlais was an Assistant Professor of Chemistry at Penn State University (1997-2001), where he developed and tested computational methods for the de novo design of proteins.  He began his work in the field of protein design as a Jane Coffin Childs Fellow at U.C. Berkeley.  Dr. Desjarlais holds a Ph.D. in Biophysics from the Johns Hopkins University and a B.S. degree in Physics from the University of Massachusetts, Amherst.

Peter Ros, RA, Vice President of Finance at Lava Therapeutics

Mr. Ros serves as Vice President of Finance at Lava Therapeutics, a biotechnology company focused on developing bispecific gamma-delta T cell engagers to transform cancer therapy, since January 2020. Prior to joining Lava Therapeutics, he served in various roles at Genmab, including as Senior Director of Accounting and Finance from October 2018 to December 2019, Senior Director of Finance and Accounting, R&D Operations from July 2015 to September 2018 and (Senior) Director of Finance from November 2001 to June 2015. Mr. Ros also served as an Accountant at PricewaterhouseCoopers from September 1993 to April 1999. He received a RA title in accountancy from VU Amsterdam (1998) and his HEAO RA degree in accountancy from Windesheim University (1993).

Janice Reichert, Ph.D., Chief Operating Officer of The Antibody Society

Dr. Reichert is an internationally-recognized expert in the development of antibody therapeutics. She served as the Executive Director of The Antibody Society from 2016 to 2022. Dr. Reichert is Founder and Editor-in-Chief of mAbs, a Society-affiliated journal that focuses on topics relevant to antibody research and development. Dr. Reichert has published extensively on development trends for antibody therapeutics, and she has presented her research results as an invited speaker at conferences held worldwide. Dr. Reichert received her PhD in Chemistry from the University of Pennsylvania and did her post-doctoral training at Harvard Medical School.

About The Antibody Society

The Antibody Society, Inc. is an international non-profit trade association representing individuals and organizations involved in antibody research and development. The Society is an authoritative source of information about antibody therapeutics development, which is disseminated via our website, presentations and publications. In addition, the Society organizes conferences and webinars on antibody research and development and related topics. The Society also serves as the home for the Adaptive Immune Receptor Repertoire Community, which focuses on developing standards and protocols for curating, analyzing and sharing antibody B and T cell receptors. As a business association, the Society can engage with government and international agencies such as the World Health Organization to discuss topics that are important to the antibody community, such as international naming conventions. To keep up to date with antibody-related news, follow us on LinkedIn and Twitter.

FDA approves Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease

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On January 6, 2023, the U.S. Food and Drug Administration approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer’s disease. The labeling states that treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in clinical trials. The approved dose of lecanemab is 10 milligram/kilogram every two weeks.

Lecanemab (BAN2401) is a humanized anti-amyloid beta protofibril IgG1k antibody initially developed by BioArctic Neuroscience. BAN2401 was licensed to Eisai in a collaboration agreement, allowing the jointly development of lecanemab as a treatment for Alzheimer disease (AD). Under an agreement with Biogen, Eisai and Biogen co-commercialize and co-promote lecanemab.

The accelerated approval was supported by data from Study 201 (NCT01767311), which assessed the clinical efficacy of lecanemab at multiple doses (2.5 mg/kg biweekly, 5 mg/kg monthly, 5 mg/kg biweekly, 10 mg/kg monthly, 10 mg/kg biweekly) or placebo and explored the dose response of lecanemab using a composite clinical score (ADCOMS) in 856 patients with mild cognitive impairment due to AD and mild AD with confirmed presence of amyloid pathology. Patients receiving the treatment had significant dose- and time-dependent reduction of amyloid beta plaque, with patients receiving the approved dose of lecanemab, 10 milligram/kilogram every two weeks, having a statistically significant reduction in brain amyloid plaque from baseline to Week 79 compared to the placebo arm, which had no reduction of amyloid beta plaque.

Lecanemab is also being evaluated in the Clarity AD Phase 3 study (NCT03887455), which is designed to evaluate the efficacy, long-term safety, and tolerability of 10 mg/kg IV lecanemab administered every 2 weeks in 1795 patients with early AD. The primary outcome measurement was the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment. In September 2022, Eisai Co and Biogen Inc announced positive topline results from Clarity AD Phase 3 trial where lecanemab met the primary endpoint by reducing by 27% the clinical decline on the CDR-SB compared with placebo at 18 months. All key secondary endpoints were also met. Based on results of the study, Eisai may file for traditional approval in the US and for marketing authorization applications in Japan and Europe.

Therapeutic Opportunities in Glycoscience: Bioorthogonal chemistry in translation

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Lecture summary written by Czeslaw Radziejewski, PhD.

Antibody Engineering & Therapeutics, held in December 2022, offered many opportunities to hear exciting and informative presentations by experts in the field, including Carolyn Bertozzi, Professor of Chemistry at Stanford University and 2022 Nobel prize laureate in Chemistry.

In her plenary lecture, Therapeutic Opportunities in Glycoscience: Bioorthogonal chemistry in translation, Prof. Bertozzi presented a retrospective of her remarkable contributions to chemical biology. She almost singlehandedly created the field of bioorthogonal chemistry, which is now used in the development of human biotherapeutics. Since its inception, bioorthogonal chemistry has had enormous scientific impact by enabling mechanisms to address a wide variety of biological questions.

Prof. Bertozzi was trained in traditional synthetic organic chemistry, but rapid advancements in biology inspired her to consider how chemical reactions might be reliably controlled within organisms. She started with the idea of performing chemical reactions in live cells. In contrast to organic synthesis, which is generally executed in organic solvents, often at high temperatures, chemistry done in live cells must occur in water at a pH close to physiological, at temperatures close to 37oC, and generally away from equilibrium. Carrying out reactions in living organisms is additionally complicated because the molecules used in-vivo cannot be toxic and cannot be metabolized faster than the reaction rate with a biological target. For such chemistry, Bertozzi coined the name and formulated the concept of bioorthogonal chemistry, which is chemistry that does not interact or interfere with a biological system. Bioorthogonal reagents and reactions must not have counterparts in biological systems. [1]

Prof. Bertozzi’s research focused on glycans, which are complex polysaccharides that decorate the surface of every mammalian cell. Notably, the structure and composition of glycans displayed on the cell surface undergo alterations in response to the physiological state of an organism. In normal cells, oligosaccharide structures terminate with the sialic acid, but it has been known since the 1960s that the glycosylation pattern on cancer cells is dramatically different from normal cells. Cancer cells tend to have a much higher abundance of sialic acids, which are attached to different sugars and in different linkages than in healthy cells. This difference in glycosylation architecture could potentially be exploited for imaging glycosylation using bioorthogonal chemistry. To begin with, the oligosaccharides would have to be labeled with a bioorthogonal sugar derivative bearing a functional group. In the next step, the functional group on the incorporated unnatural sugar would react with a bioorthogonal, detectable probe molecule. The early idea for a molecule that could be metabolically incorporated in place of sialic acid came from the work of a German carbohydrate chemist, Werner Reutter, who reported that N-acetyl-modified mannosamine could be used by cells as a precursor of side-chain modified sialic acid. Based on this observation, Bertozzi’s conceived the idea that the methyl group in the N-acetyl group could be appended with azide functionality. Then, a reactive, abiotic molecule could serve as the probe. Nucleophilic azide can enter a reaction called Staudinger reduction with triphenylphosphine, but this reaction results in azide reduction to a primary amine. However, when one of the phenyl rings was modified with an ester leaving group, hydrolysis of the transition product (azo-ylide) resulted in a stable linkage of the phosphine to sialic acid. The stable coupling of phosphine to azide group on a sugar moiety is known as Staudinger ligation.

[Read more…]

Ublituximab approved by FDA for multiple sclerosis

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On December 28, 2022, the U.S. Food and Drug Administration approved BRIUMVI™ (ublituximab-xiiy), for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. [1]

Ublituximab (TG-1101) is a chimeric anti-CD20 IgG1k antibody glycoengineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) that was originally developed by LFB Biotechnology and licensed to TG Therapeutics as a treatment for CLL and multiple sclerosis (MS).

The approval was based on results of the randomized, double-blinded, active-controlled Phase 3 trials ULTIMATE I (NCT03277261) and ULTIMATE II (NCT03277248) evaluating ublituximab (450 mg dose IV every 6 months, following a Day 1 infusion of 150 mg over four hours and a Day 15 infusion over one hour) compared to teriflunomide (14 mg oral tablets taken once daily) in a total of 1,094 patients with relapsing MS for both studies. The primary endpoint was the annualized relapse rate (ARR). Results from the ULTIMATE I and II Phase 3 trials showed that the primary endpoint was met, with a significant reduction of the ARR for ublituximab vs. teriflunomide over a period of 96 weeks. [2]

1.       TG Therapeutics, Inc. TG Therapeutics Announces FDA Approval of BRIUMVI™ (ublituximab-xiiy). Dec 28, 2022 press release

2.       Steinman L, Fox E, Hartung HP, Alvarez E, Qian P, Wray S, Robertson D, Huang D, Selmaj K, Wynn D, et al. Ublituximab versus teriflunomide in relapsing multiple sclerosis. N Engl J Med. 2022;387(8):704-714. doi:10.1056/NEJMoa2201904.

Wondering which Antibodies to Watch in 2023?

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Join us for our next webinar to learn which late-stage antibodies you should watch next year!

Registration is open!

Antibodies to Watch in 2023

 

Thursday January 12, 2023, 11am ET / 4pm CET

Speakers: Drs. Janice Reichert, Silvia Crescioli, Alicia Chenoweth & Jyothsna Visweswaraiah

“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).

Everyone who registers will receive 3 reminders before the event, as well as the link to the On Demand version when it is available.

Registration is open!