The Antibody Society

the official website of the antibody society

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

Emerging Immunotherapeutics for Ovarian Cancer

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Join us on September 23rd!

The Antibody Society, in collaboration with the Ovarian Cancer Research Alliance (OCRA), is pleased to present the Emerging Immunotherapeutics for Ovarian Cancer Symposium. The mission of OCRA is to cure ovarian cancer, advocate for patients, and support survivors. The aim of this event is to spread knowledge and awareness around current and up-and-coming basic and clinical research on the use of antibody and immune therapeutics for the treatment of ovarian cancer.

View the expert speaker line-up and agenda.

During the event, visit the exhibition booths for information on products, services and available jobs, and enter the Society’s raffle. Ten lucky winners will receive a free Society T-shirt!

Register Now

Registration is free for The Antibody Society Members and Corporate Sponsors. Contact us at membership@antibodysociety.org for the 100% discount code, which is also found on the Discount Codes page of the Members Only section.

 

 

FDA issues Complete Response Letter for oportuzumab monatox BLA

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Oportuzumab monatox (Vysyneum™, Vicineum®, VB4-845) is a humanized single-chain variable fragment (scFv) targeting epithelial cell adhesion molecule fused to Pseudomonas aeruginosa exotoxin A (ETA(252-608). Sesen Bio is developing the drug, administered intravesically or intratumorally, as a treatment of high-risk non-muscle invasive bladder cancer (NMIBC) that is unresponsive to treatment with bacillus Calmette-Guérin (BCG). Oportuzumab monatox was granted FDA’s Fast Track designation for the treatment of NMIBC.

Sesen Bio’s rolling BLA submission for oportuzumab monatox for the treatment of BCG-unresponsive NMIBC was completed in December 2020, and accepted by FDA and granted Priority Review in February 2021. On August 13, 2021, the company announced that it received a Complete Response letter from the FDA in which the agency provided recommendations specific to additional clinical and statistical data and analyses, as well as Chemistry, Manufacturing and Controls (CMC) issues. Sesen Bio plans to work with FDA to address the concerns expressed in the letter. If another clinical trial is required, the company projects resubmitting the BLA in 2023. [1]

Sesen Bio submitted an MAA to the EMA for oportuzumab monatox for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) in March 2021, but withdrew the application in August 2021. [2]

Bimekizumab authorized for marketing in the EU

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On August 20, 2021, the European Commission authorized marketing of Bimzelx (bimekizumab) in the EU for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Bimekizumab is a humanized IgG1 kappa antibody that selectively inhibits IL-17A and IL-17F by binding regions that are common to these pro-inflammatory cytokines, which share ~50% sequence identity and are expressed as homodimers and IL-17A/F heterodimers. Bimekizumab is approved at a recommended dose of 320 mg, administered by two subcutaneous injections every four weeks to week 16 and every eight weeks thereafter. [1]

The decision to grant a marketing approval was supported by results from 3 Phase 3 studies that included an active comparator arm, ustekinumab (Stellara®; BE VIVID study; NCT03370133), adalimumab (Humira®; BE SURE study; NCT03412747), or secukinumab (Cosentyx®; BE RADIANT study; NCT03536884). All three pivotal studies met their co-primary endpoints at Week 16, demonstrating superiority of bimekizumab over the active comparator in certain defined measures (e.g., Psoriasis Area and Severity Index). Clinical responses achieved with bimekizumab at Week 16 were maintained up to one year. [2-4] Coprimary endpoints were also met in the Phase 3 BE READY study (NCT03410992), which investigated the efficacy and safety of bimekizumab in patients with moderate to severe plaque psoriasis compared to placebo. [5]

Bimzelx is the 8th antibody therapeutic to be first approved for marketing in the EU or US in 2021.

  1. European Medicines Agency. Bimzelx public assessment report.
  2. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo-controlled phase 3 trial. Lancet. 2021;397(10273):487-498.
  3. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141.
  4. Reich K, Warren RB, Lebwohl M, Gooderham M, Strober B, Langley RG, Paul C, De Cuyper D, Vanvoorden V, Madden C, Cioffi C, Peterson L, Blauvelt A. Bimekizumab versus Secukinumab in Plaque Psoriasis. N Engl J Med. 2021 Jul 8;385(2):142-152.
  5. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486.

FDA approves anifrolumab for systemic lupus erythematosus

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On July 30, 2021, the US Food and Drug Administration approved AstraZeneca’s Saphnelo (anifrolumab-fnia) for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. The recommended dosage is 300 mg administered as an intravenous infusion over a 30-minute period every 4 weeks. Saphnelo is undergoing regulatory review for SLE in the EU and Japan.

Anifrolumab (MEDI-546) is an interferon (IFN) alpha receptor 1 (IFNAR1)-specific human IgG1κ antibody. It binds to subunit 1 of IFNAR1, thereby blocking the action of different type I IFNs (IFN-α, IFN-β and IFN-ω). The heavy chain of the antibody incorporates 3 mutations, L234F, L235E, and P331S, to decrease effector functions. Type I IFNs are involved in the pathogenesis of SLE, and ~ 60-80% of adult patients with active SLE express elevated levels of type I IFN-inducible genes.

FDA’s approval was based in part on efficacy and safety data from two TULIP Phase 3 trials and the MUSE Phase 2 trial. In these trials, more patients treated with Saphnelo experienced a reduction in overall disease activity across organ systems, including skin and joints, and achieved sustained reduction in oral corticosteroid use compared to placebo, with both groups receiving standard therapy. Clinical study results from the Phase 3 TULIP-2 and TULIP-1 trials were published in The New England Journal of Medicine and in The Lancet Rheumatology, respectively,  while results from the MUSE Phase 2 trial were published in Arthritis & Rheumatology.

Need help keeping up to date on US and EU approvals?

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US in the Web Resources section of our website.

Needs and challenges of biological controls for AIRR-sequencing standardization: an AIRR-C review published in eLife

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Announcing the latest AIRR Community publication!

Adaptive Immune Receptor Repertoire (AIRR) can be deeply analyzed to study its complexity thanks to AIRR-sequencing (AIRR-seq) based on high throughput sequencing. However, like many high-throughput technologies, AIRR-seq comes with several technical challenges, notably the lack of established controls and standards, a necessity when considering current available and envisioned AIRR-seq applications. The Biological Resources Working Group within the AIRR Community, established in 2017, aims at studying, prioritizing and developing biological controls and standardization reagents for AIRR-seq studies. In this article, they review current practices, resources and considerations for using and developing AIRR-seq standards and controls.