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the official website of the antibody society

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Vabysmo™ (faricimab) approved in the European Union for ophthalmic disorders

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On September 15, 2022, the European Commission approved Vabysmo ™ (faricimab) for the treatment of wet, or neovascular, age-related macular degeneration (AMD) and visual impairment due to diabetic macular edema (DME). Faricimab (RO6867461, RG7716) is an anti-vascular endothelial growth factor-A (VEGF-A) and anti-angiopoietin-2 (Ang-2) bispecific antibody derived from Roche’s CrossMab technology.

The approval in the European Union was based in part on results from four Phase 3 studies in wet AMD and DME. The TENAYA (NCT03823287) and LUCERNE (NCT03823300) studies evaluated the effects of faricimab (6.0 mg administered at fixed intervals of every two, three, or four months) and aflibercept (Eylea®) (2.0 mg administered at fixed two-month intervals) in wet AMD patients. The YOSEMITE (NCT03622580) and RHINE studies (NCT03622593) compared the effects of faricimab (6.0 mg administered at personalized treatment intervals (PTI) of up to four months or 6.0 mg administered at fixed two-month intervals) to those of aflibercept (2.0 mg administered at fixed two-month intervals) in DME patients. Results of the TENAYA and LUCERNE and YOSEMITE and RHINE studies were published in The Lancet.

Interested in more information? Explore our searchable table of antibody therapeutics approved in the EU or US for details.

TECVAYLI® (teclistamab) approved in the European Union

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On August 24, 2022, The Janssen Pharmaceutical Companies of Johnson & Johnson announced the first approval worldwide for TECVAYLI® (teclistamab) by the European Commission, which granted conditional marketing authorization (CMA) of TECVAYLI® as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

Teclistamab (JNJ-64007957) is an IgG4l T-cell redirecting antibody derived from Ligand’s transgenic mouse (OmniAb) and Genmab’s DuoBody technology. The antibody selectively targets BCMA and CD3. Teclistamab was granted the European Medicines Agency’s PRIME designation for treatment of adult patients with relapsed or refractory MM who previously received ≥3 prior lines of therapy in 2021. Teclistamab had previously been granted Orphan Drug designations for MM in both the US and EU, and FDA granted Breakthrough Therapy designation to teclistamab for the treatment of relapsed or refractory MM.

The CMA was supported by positive results from the multicohort, open-label Phase 1/2 MajesTEC-1 study (NCT03145181 and NCT04557098), evaluating the safety and efficacy of teclistamab in adults with RRMM (n =165). In the MajesTEC-1 study, treatment with teclistamab resulted in deep and durable responses. The median duration of progression-free survival and the median duration of overall survival were 11.3 months (95 percent CI; range, 8.8–17.1) and 18.3 months (95 percent CI; range, 15.1–not estimable), respectively.

Janssen submitted a biologics license application to the US Food and Drug Administration seeking approval of teclistamab for the treatment of patients with relapsed or refractory multiple myeloma in December 2021.

Data for all approved antibody therapeutics can be found here.

Thanks to all who participated in Antibody Engineering & Therapeutics Europe!

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Another very successful Antibody Engineering & Therapeutics Europe has concluded!

The Antibody Society thanks all the volunteers who helped at the booth:

 

  • Demelza Willemsz (Genmab)
  • Thomas Wesselink (Genmab)
  • Chalana Zilvold – van den Oever (Genmab)
  • Charlotte Berendsen (Genmab)
  • Lisa King (Amsterdam UMC)
  • Milon de Jong (Amsterdam UMC)

In addition to Thomas, Milon and Lisa, Kerry Chester (Board of Directors member), Janine Schuurman (Society Vice President) and Sally Ward (Society President) appear in the image above.

We hope to see you in Amsterdam in June 2023 for the next Antibody Engineering & Therapeutics Europe.

Biologics Developability: Call for Papers

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Developability of biologics refers to their likelihood of success in progressing through manufacturing and clinical trials toward approval by regulatory authorities to be marketed as a drug for use in humans. A highly developable biologic should not only maintain high titer, good chemical and structural stability, resistance to various manufacturing stresses, such as low pH, shear stress, light, heat, for ease of manufacturing, but also possess target specificity, durable pharmacokinetics (PK) and low immunogenicity for assurance of safety and efficacy. Thus, developability is an umbrella concept under which manufacturability and other drug-like properties reside. Developability assessment via experimental assays or in silico analyses conducted during early-phase research can be crucial in (1) shaping lead molecule optimization strategy, (2) supporting selection of a final drug candidate molecule for progression into manufacturing, GLP toxicity studies, and other preparations for human clinical trials, and (3) reducing attrition and failure of therapeutic molecules in clinical trials. During the development stage, developability evaluation focuses more on assessment of critical quality attributes (CQAs) and quality control of product and manufacturing process-related impurities to ensure safety and efficacy.

Since the concept was introduced over a decade ago, developability is now a fast-changing field. mAbs thus aims to assemble a collection of articles reflecting the latest thinking across the industry in this area of drug research and development. As such, we invite The Antibody Society members, mAbs readers and the broader scientific community to contribute review articles focused on early stage developability assessment, and practical considerations, new technologies and strategies for CQAs assessment and control system at later stages of drug development. The reviews should narrate the state of the art and speculate on new vistas for the field.

mAbs will waive publication charges for up to 8 of the best review articles selected from pre-submission inquiries, which should consist of the title, abstract and general outline of the intended review article.

We are particularly interested in reviews in the following topics:

Early-Stage Drug Research

●        Review of the latest assays being used for assessment of developability. Include practical considerations of workflows, prioritization of assays given limited amounts of protein early on and based on known redundancies, and interpretations of assay results for decision making

●        Review of the latest in silico tools for stage appropriate risk assessment. For example, using machine learning-based data analysis and prediction for lead optimization and creating more manufacturable biologics

●        Commonalities and idiosyncrasies of manufacturability/developability assessment across non-traditional formats – ADCs vs bispecifics vs mAbs vs fragments vs Fc fusions

●        Translatability of manufacturability/developability risk assessment assays to preclinical and clinical readouts

Drug Development / CMC

●        Considerations on how product and process-related quality attributes impact PK/PD, biodistribution/retention at subcutaneous dosing sites, immunogenicity, such as host cell protein analysis and strategies used in CQA assessments

●        Practical considerations, novel strategies, and new technologies such as mass spectrometry used in generating evidence for CQAs assessment and process and product quality control

Although these topics are especially of interest, we welcome well-written reviews in related areas as well.

The deadline for the pre-submission enquiries is June 15, 2022, and the deadline for submission of the completed review articles is November 15, 2022.

Please send pre-submission inquiries to Editor-in-Chief Dr. Janice Reichert (reichert.biotechconsulting@gmail.com), and feel free to contact Assistant Editors Drs. Nathan Higginson-Scott (nathan.higginson-scott@seismictx.com), Feng Yang (yang.feng@gene.com) and Li Zhou (li.zhou@abbvie.com) if you have any questions.

Join us on April 28th for our webinar on Fc silencing techniques!

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Registration is open!

Thursday April 28, 2022, 11am ET

Speaker: Ian Wilkinson, PhD

Antibodies are nature’s pro-drugs, wonderfully evolved to target pathogens and activate immune systems. For certain indications where ADCC or CDC are required this is ideal, but for many other applications activation of inflammatory responses is unnecessary and potentially highly undesirable. In these situations silenced antibodies with either naturally low effector function or engineered Fc domains are the preferred option. However, many of the commonly used options in the clinic, such as IgG4, LALA or aglycosylation, are widely reported to still have residual Fc receptor binding and cytokine activation in patients.

This presentation will describe the first thorough comparison of most of the generic and proprietary Fc silencing mutations, demonstrating that all previously reported variants show residual binding to Fc receptors. It will also describe the discovery of a novel set of mutations, known as STR, that show no detectable binding to Fcγ receptors and do not elicit inflammatory cytokine responses. Meanwhile, immunogenicity, stability and PK are unaffected. This totally silenced variant has the potential to improve the safety and efficacy of therapeutic antibodies and Fc fusion proteins.