The Antibody Society

the official website of the antibody society

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

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.

AIRR Community Standards v1.4 Now Available

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The AIRR Community is pleased to announce the release of v1.4 of the AIRR Standards, including v1.2 of the AIRR Data Commons API (ADC API) to query AIRR compliant data repositories. This release enables additional compatibility with single-cell and emerging technologies, supports extended data/metadata capture, and improves data standardization and integration. Major changes include updated quantification fields and conversion of several fields to ontology references to provide consistency across studies.

Several exciting experimental releases are included in this update: new Germline and Genotype schemas for documenting VDJ germline reference sequences and subject VDJ and MHC genotypes, extensions to the Cell schema for storing single-cell gene expression and receptor reactivity, and data aggregation schemas to facilitate more complex and reproducible analyses.

The ADC API specification included in this release contains new capabilities for querying AIRR v1.4 Schema objects including Clone, Cell, CellExpression, and Receptor objects.

Check out these key links:

Python Package

R Package

Release Notes

Github

Check out the On AIRR – An AIRR-C Podcast series!

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If you haven’t already done so check out the On AIRR – An AIRR-C Podcast series.

The series aims to disseminate the goals and values of the Community, with a focus on their application to diagnostics and other clinical applications. Organizers are committed to presenting conversations with a diverse group of experts, and gathering the attention of a broad audience, including students, and researchers from both industry and academia.

There are seven podcasts available so far through Google, Spotify, Apple and Amazon with another four scheduled this Fall.

If you share podcast-related content in social media, please remember to use the hashtag #onairr!

Spesolimab (SPEVIGO®) approved by FDA

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Spesolimab (SPEVIGO®), a humanized anti-IL-36 IgG1k antibody developed by Boehringer Ingelheim, was approved by the FDA as a treatment option for generalized pustular psoriasis (GPP) flares in adults, as announced by BI on September 1, 2022. GPP is a rare and potentially life-threatening neutrophilic skin disease characterized by episodes of widespread eruptions of painful, sterile pustules. The FDA had previously granted spesolimab Breakthrough Therapy and Orphan Drug designations for the treatment of GPP, and the BLA for spesolimab received a Priority review. In addition, spesolimab has received Breakthrough Therapy Designation in China and Taiwan, Priority Review in the China, Orphan Drug Designation in Korea, Switzerland and Australia, and Rare Disease designation and fast track in Taiwan for the treatment of GPP flares. An MAA for use of spesolimab as a treatment of flares in GPP is undergoing evaluation by the EMA.

The approval by FDA was based in part on results from the 12-week pivotal Phase 2 Effisayil™ 1 clinical trial (NCT03782792), which evaluated the efficacy, safety, and tolerability of a single 900 mg dose of IV administered spesolimab, with the option of a second dose if symptoms persisted on Day 8, vs placebo in 53 patients experiencing a GPP flare. After one week, 54% of patients treated with SPEVIGO showed no visible pustules compared to 6% of those who received placebo. A 3-arm, 5-year Phase 2 study (NCT03886246) to evaluate spesolimab in GPP patients who took part in previous studies with spesolimab is currently recruiting an estimated 155 participants. Patients will be administered SPEVIGO® at 4-, 6- or 12-week intervals. The primary outcome measure of the study is the occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment; secondary outcome measures relate to the efficacy of the drug.

Curious about other approved antibody therapeutics? Summary data can be found here and more extensive data can be found here.

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.