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the official website of the antibody society

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Call for papers: Attention Society members who are also authors!

July 3, 2023 by Janice Reichert

mAbs is the official journal of The Antibody Society. Each year, the journal’s publisher, Taylor & Francis, provides several article publishing charge (APC) waivers, with a value of up to $4000 USD / £3200 / €3840 / $5570 AUD each, that we may distribute to members. To be considered for an APC waiver, please submit pre-submission inquiries, which should include the authors, title, abstract, and general outline of the intended article, to membership@antibodysociety.org.

mAbs publishes high quality reports, reviews, and perspective articles covering a range of antibody R&D topics, including:

  • Design, engineering, and selection of antibody therapeutics, including antibody-drug conjugates, multispecific antibodies, and single-domain antibodies
  • Machine learning and artificial intelligence applications
  • Non-clinical studies of antibodies, such as mechanism of action studies, safety, and efficacy studies in animals
  • Manufacturing and formulation
  • Regulatory review and approval of antibody therapeutics

The deadline for submission of the APC waiver request is July 31, 2023.

The deadline for submission of the manuscript to the journal is January 31, 2024.

The selected recipients will be notified as soon as possible after the request submission deadline.

Please contact Janice Reichert (janice.reichert@antibodysociety.org) if you have questions.

Further information:

mAbs is a multidisciplinary, open access journal dedicated to the art and science of antibody research and development. The journal has a strong scientific and medical focus but serves a broad readership, including specialists in technology transfer, legal issues, investment, and the regulation of therapeutics.

The journal’s 2021 Impact Factor is 6.440 and, in total, articles are downloaded at a rate of over 1 million per year.

Members of The Antibody Society receive a 10% discount on article publication charges using their member code.

Filed Under: mAbs Tagged With: antibody discovery, antibody therapeutics, mAbs

Computational Antibody Discovery Symposium now On Demand

June 28, 2023 by Janice Reichert

Did you miss the Computational Antibody Discovery Symposium held on June 22?

On Demand videos are now available on YouTube!

  1. Introduction by Janice Reichert (The Antibody Society); Konrad Krawczyk (Natural Antibody); Andrew Buchanan (AstraZeneca), and
    the first speaker: Pietro Sormanni (University of Cambridge). Third-generation approaches of antibody discovery and optimization
  2. Tzvika Hartman (Biolojic Design). AI-driven design of smart therapeutics
  3. Sandeep Kumar (Boehringer Ingelheim). Biopharmaceutical Informatics: Syncretic use of computation and experimentation in discovery and development of biotherapeutics
  4. Ben Holland (Antiverse). Machine learning-based design of antibodies against difficult targets
  5. Panel discussion summary: Panelists provided their opinions and insights on these questions:
    What properties are more urgent to be able to design in silico – binding specificity, developability or something else?
    What performance should computational antibody design achieve to improve upon established protocols?
    What are the biggest hurdles for computational antibody discovery to achieve its full potential (models, data or something else)?
    How could industry and academia complement each other to solve the problem of computationally designing antibodies?
    What role does big tech/biopharma have to play in development and adoption of computational antibody design paradigms?
  6. Concluding remarks (Andrew Buchanan, AstraZeneca)

The complete playlist is here.

Please note: Victor Greiff presented unpublished material; posting of the video of his talk will be delayed. Please subscribe to our YouTube channel to receive an alert when new videos are added.

Thank you for your interest in the Symposium. We hope the videos inspire useful discussions in the future.

Filed Under: Antibody discovery, The Antibody Society Tagged With: antibody discovery, computation, in silico design, machine learning

RYSTIGGO® (rozanolixizumab-noli) approved by FDA

June 27, 2023 by Janice Reichert

On June 27, 2023, the US Food and Drug Administration approved RYSTIGGO® (rozanolixizumab-noli) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. Rozanolixizumab-noli is a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor, resulting in the reduction of circulating IgG. The drug is administered by subcutaneous infusion. UCB has indicated that rozanolixizumab-noli will be commercially available in the US during the 3rd quarter of 2023.

FDA’s approval is supported by safety and efficacy data from the pivotal Phase 3 MycarinG study (NCT03971422), published in The Lancet Neurology in May 2023. The primary efficacy endpoint was the comparison of the change from baseline between treatment groups in the MG-ADL total score at day 43. MG-ADL is a measurement tool which assesses the impact of gMG on daily functions of 8 signs or symptoms that are typically affected in gMG, such as breathing, talking, swallowing, and being able to rise from a chair. Each item is assessed on a 4-point scale where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. A total score ranges from 0 to 24, with the higher scores indicating more impairment. A statistically significant difference favoring rozanolixizumab-noli was observed in the MG-ADL total score change from baseline [-3.4 points in rozanolixizumab-noli-treated group at either dose vs -0.8 points in the placebo-treated group (p<0.001)].

Interested in 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.

Filed Under: Antibody therapeutic, Food and Drug Administration Tagged With: generalized myasthenia gravis, rozanolixizumab

Columvi® (glofitamab-gxbm) approved by FDA

June 16, 2023 by Janice Reichert

On June 15, 2023, the U.S. Food and Drug Administration (FDA) approved Columvi® (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response in the Phase 1/2 NP30179 study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Glofitamab (RO7082859, CD20-TCB, RG6026) 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 FDA accelerated approval is based on positive results from the Phase 1/2 NP30179 study of Columvi given as a fixed course for 8.5 months in 132 patients with DLBCL who had relapsed or were refractory to prior therapies, including 30% who had received prior CAR T-cell therapy. Additionally, 83% were refractory to their most recent therapy. Results showed patients treated with fixed-duration Columvi achieved durable remission, with 56% of patients achieving an overall response (OR; 74/132 [95% confidence interval (CI): 47-65]) and 43% of patients achieving a complete response (CR; 57/132 [95% CI: 35-52]). Over two-thirds of those who responded continued to respond for at least nine months (68.5% [95% CI: 56.7-80.3]). The median duration of response was 1.5 years (18.4 months [95% CI: 11.4-not estimable]). Data from the NP30179 study were recently published in the New England Journal of Medicine.

Columvi received its first worldwide approval in Canada in March 2023, and the European Medicines Agency’s Committee for Medicinal Products for Human Use recently granted a positive opinion recommending its approval in the European Union.

Glofitamab is under investigation in a randomized, open-label, multicenter Phase 3 study (STARGLO, NCT04408638) where patients with relapsed or refractory DLBCL receive glofitamab or rituximab in combination with gemcitabine + oxaliplatin (GemOx). Patients will receive up to 8 cycles of glofitamab IV or rituximab IV in combination with GemOx IV followed by up to 4 cycles of glofitamab monotherapy. The primary outcome measure is overall survival. The estimated study primary completion date is in April 2025.

Interested in 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.

Filed Under: Antibody therapeutic, Approvals, Food and Drug Administration Tagged With: Columvi, glofitamab, lymphoma

Enter soon – the James S. Huston Antibody Science Talent Award Competition deadline is Sep 15th!

June 1, 2023 by Janice Reichert

The Huston Award is given by The Antibody Society to recognize and encourage upcoming scientists in the field of antibody engineering and therapeutics. Early-career research scientists who have received an advanced degree (Ph.D., M.D., or equivalent) within the past 10 years are eligible for the Award. The scientist is recognized for making important contributions to the antibody field and/or the dissemination of antibody knowledge. The recipient will be invited to give a live webinar on their work, which will also be made available on demand on The Antibody Society’s Learning Center and YouTube channel, and to give a lecture at the Antibody Engineering & Therapeutics conference.

The application submission deadline is September 15, 2023.

The Award includes:

  • International recognition of the scientist’s accomplishments,
  • $1500 USD, and
  • Travel expenses and registration fee to attend the Antibody Engineering & Therapeutics conference, to be held December 14-16, 2023 in San Diego, California.

The award criteria and application details are here. Please note: Applicants must be nominated by a Member of the The Antibody Society.

What is it like to win? Our 2022 Huston Award recipient, Prof. Brandon DeKosky, describes his experience in this 2-min video.

Filed Under: Antibody engineering, Huston Award Tagged With: antibody engineering, Huston Award

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