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the official website of the antibody society

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Antibody Engineering & Therapeutics Europe Poster Competition Winners Announced!

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Congratulations to our winners!

To recognize the research activities of promising student and postdoctoral attendees of Antibody Engineering & Therapeutics Europe, The Antibody Society sponsors a competition for members who submit posters for display at the meeting. Our judges select the best work based on originality, relevance and perceived impact on the field of antibody research and development.

This year, our judges selected one student and one postdoc winners who receive: 1) complimentary registration to all conference sessions; 2) an opportunity to give a short oral presentation of their work in one of the conference sessions; and 3) a lovely crystal award.

The winners of the contest are:

Ms. Monica Fernandez-Quintero (University of Innsbruck)
Poster title: Antibodies exhibit multiple paratope states that can differ in VH-VL domain orientations

Dr. Christian Fercher (University of Queensland)
Poster title: Development of Reagentless Fluorescence Immunosensors for Continuous Analyte Monitoring

Please join us for the virtual Antibody Engineering & Therapeutics Europe conference on August 24-27, 2020.

Society members receive a 15% discount on the registration fee. Contact us at membership@antibodysociety.org for the code.

FDA grants first approval to belantamab mafodotin-blmf

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On August 5, 2020, the U.S. Food and Drug Administration (FDA) approved belantamab mafodotin-blmf (BLENREP) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. BLENREP was granted an accelerated approval for this indication based on response rate. Further adequate and well-controlled studies/clinical trials must be done to verify and describe clinical benefit.

Belantamab mafodotin-blmf is an antibody-drug conjugate (ADC) composed of a humanized IgG1 monoclonal antibody and the cytotoxic agent maleimidocaproyl monomethyl auristatin F. The ADC binds to B-cell maturation antigen found on myeloma cell surfaces and is internalized. In the cell, the cytotoxic agent is released and kills the cells.

Belantamab mafodotin-blmf was evaluated in the Phase 2 DREAMM-2 (NCT03525678), an open-label, multicenter trial. Efficacy was based on overall response rate (ORR) and response duration. In patients receiving the recommended dose of 2.5 mg/kg, the ORR was 31% (97.5% CI: 21%, 43%) 73% of responders had response durations ≥6 months. Detailed results of the study were published in The Lancet Oncology in February 2020.

On July 24, 2020, the European Medicines Agency’s (EMA) human medicines committee recommended granting a conditional marketing authorization in the European Union for Blenrep (belantamab mafodotin) to treat adult patients with relapsed and refractory multiple myeloma who no longer respond to treatment with an immunomodulatory agent, a proteasome inhibitor and a CD-38 monoclonal antibody. Blenrep was accepted in EMA’s PRIME scheme, and it was designated as an orphan medicinal product. EMA recommended a conditional marketing authorization, and this opinion was sent to the European Commission for the adoption of a decision on an EU-wide marketing authorization.

Antibodies to watch

Belantamab mafodotin-blmf is the 7th antibody therapeutic to be granted a first approval in the US or EU in 2020. The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. The table, which is located in the Web Resources section of the Society’s website, can be downloaded in Excel format. Information about antibody therapeutics approved outside the US or EU can be found in the table notes.

Information about other antibody therapeutics that may enter regulatory review in 2020 can be found in ‘Antibodies to watch in 2020’.

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FDA grants first approval to tafasitamab-cxix

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On July 31, 2020, the FDA approved Monjuvi® (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant. FDA had granted Monjuvi® an orphan drug designation for this indication, as well as Fast Track and Breakthrough Therapy designations, and the biologics license application was given a Priority Review. Monjuvi® was approved under FDA’s accelerated approval regulations, which require that further adequate and well-controlled studies/clinical trials be done to verify and describe clinical benefit. A marketing application for tafasitamab is undergoing evaluation by the European Medicines Agency.

Tafasitamab-cxix is a humanized cytolytic CD19-targeting monoclonal antibody that contains a IgG1/2 hybrid Fc-domain with 2 amino acid substitutions to modify the Fc-mediated functions of the antibody. Upon binding to CD19, tafasitamab-cxix mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cell-mediated cytotoxicity and antibody-dependent cellular phagocytosis.

FDA’s approval was based on the efficacy of Monjuvi® in combination with lenalidomide followed by Monjuvi® as monotherapy demonstrated in L-MIND (NCT02399085), an open label, multicenter single arm trial. Results from the study showed an overall response rate of 55% (primary endpoint), including a complete response rate of 37% and a partial response rate of 18%. The median duration of response was 21.7 months. The approval was granted to MorphoSys US Inc. MorphoSys and Incyte will co-commercialize the product in the United States. Incyte has exclusive commercialization rights outside the United States.

Antibodies to watch

Tafasitamab-cxix is the 6th antibody therapeutic to be granted a first approval in the US in 2020. Marketing applications for a substantial number of investigational antibody therapeutics are currently undergoing either FDA or EMA review, including:

  • Ansuvimab, a human IgG1 targeting Ebola virus glycoprotein for Ebola virus infection
  • Inolimomab, a mouse IgG1 targeting CD25 for host vs. graft disease
  • Bimekizumab, a humanized IgG1 targeting IL-17A, F for psoriasis
  • Omburtamab, a murine IgG1 targeting B7-H3 for CNS/leptomeningeal metastases from neuroblastoma
  • Tralokinumab, a human IgG4 targeting IL-13 for atopic dermatitis
  • Evinacumab, a human IgG4 targeting angiopoietin-like 3 for homozygous familial hypercholesterolemia
  • Sutimlimab, a humanized IgG4 targeting C1s for cold agglutinin disease
  • Aducanumab, a human IgG1 targeting amyloid beta for Alzheimer’s disease
  • Teplizumab, a humanized IgG1 targeting CD3 for Type 1 diabetes
  • Dostarlimab, a humanized IgG4 targeting PD-1 for endometrial cancer
  • Tanezumab, a humanized IgG2 targeting nerve growth factor for osteoarthritis pain
  • Margetuximab, a chimeric IgG1 targeting HER2 for HER2+ breast cancer
  • Naxitamab, a humanized IgG1 targeting GD2 for high-risk neuroblastoma and refractory osteomedullary disease
  • Belantamab mafodotin, a humanized IgG1 antibody-drug conjugate targeting BCMA for multiple myeloma
  • Oportuzumab monatox, a humanized scFv immunotoxin targeting EpCAM for bladder cancer
  • REGNEB3 (odesivimab, maftivimab, atoltivimab), a mixture of 3 human IgG1 targeting Ebola virus for Ebola virus infection
  • Narsoplimab, a human IgG4 targeting MASP-2 for hematopoietic stem cell transplant-associated thrombotic microangiopathies
  • Satralizumab, a humanized IgG2 targeting IL-6R  for neuromyelitis optica and neuromyelitis optica spectrum disorders

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. The table, which is located in the Web Resources section of the Society’s website, can be downloaded in Excel format. Information about other antibody therapeutics that may enter regulatory review in 2020 can be found in ‘Antibodies to watch in 2020’.

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COVID-19 data repository now available

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Interested in antibody/B-cell and T-cell receptor sequences derived from COVID-19 patients?

The iReceptor Project’s COVID-19 specific data repository has > 180 million sequences of AIRR-seq data (massive repertoires of antibody/B-cell and T-cell receptor sequences) from 5 studies of COVID-19 patients.

The data are available for download in a standard AIRR.tsv format, which makes it easy to import the data into many AIRR.seq analysis programs, and more COVID-19 studies will be available soon.

The iReceptor Gateway allows researchers to compare the COVID-19 data to ~2.5 billion immune receptor sequences from other infectious diseases, cancer studies, autoimmune patients and healthy control individuals. The Gateway can be used, for example, to determine whether antibodies discovered in COVID-19 patients are “public” (appearing in many individuals from many conditions including healthy controls) or “private” (only appearing in patients exhibiting severe COVID-19 reactions). This information and other repertoire comparisons should greatly accelerate the development of anti-COVID therapeutics and vaccines.

Present functionalities include:

  • Search for repertoires satisfying certain metadata (e.g. find all AIRR-seq repertoires from ovarian cancer studies)
  • Search for all repertoires that contain specific CDR3 sequences
  • Search identified repertoires for sequences derived from particular V, D, and J genes and alleles
  • Download sequences from these repertoires in AIRR.tsv format, easily importable to other AIRR-seq analysis tools

The iReceptor Gateway follows the protocols and standards developed by the AIRR-Community to facilitate sharing and analysis of AIRR-seq data. The AIRR Community, part of The Antibody Society, is a grassroots group of immunologists, immunogeneticists and computer scientists dedicated to sharing data through the AIRR Data Commons.  The iReceptor Project implements this Data Commons, and the development of the COVID-specific repository on the iReceptor Gateway follows the call from the AIRR Community for increased sharing of data during the coronavirus crisis.

Researchers interested in sharing data or exploring the AIRR Data Commons through the open iReceptor Gateway should visit www.ireceptor.org and contact support@ireceptor.org for an account.

iReceptor is a member of the iReceptor Plus Consortium.

Anti-IL-6R levilimab registered as COVID-19 treatment in Russia

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On June 11, 2020, Biocad announced that the Ministry of Health of the Russian Federation registered levilimab (trade name Ilsira) for patients with severe COVID-19. Developed by Biocad, levilimab is a human monoclonal antibody targeting membrane-bound and soluble forms of the interleukin 6 receptor. It was originally developed for treatment of rheumatoid arthritis. Levilimab received state approval for COVID-19 on June 5, 2020 through a fast-track mechanism according to Decree No. 441 of the Government of the Russian Federation, effective as of April 4, 2020.

The efficacy and safety of levilimab (BCD-089) in patients with severe COVID-19 is being evaluated in a Phase 3 multicenter, randomized, double-blind, placebo-controlled, adaptively designed clinical trial (NCT04397562). Initiated on April 24, 2020, the study includes 204 participants who received a single subcutaneous administration of levilimab at a dose of 324 mg in combination with standard therapy. According to Biocad, the results of a clinical trial of the drug demonstrate that levilimab therapy can significantly reduce mortality among patients with COVID-19.