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Tezspire (tezepelumab) approved in the European Union for severe asthma

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On September 19, 2022, the European Commission (EC) approved AstraZeneca’s Tezspire (tezepelumab) as an add-on maintenance treatment in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product in the European Union.

The EC’s approval was based on results from the PATHFINDER clinical trial program, which included the placebo-controlled NAVIGATOR Phase 3 trial (NCT03347279), which evaluated the effects of tezepelumab in adults and adolescents with severe uncontrolled asthma. In this study, patients received tezepelumab (210 mg; n=529) or placebo (n=532) SC every 4 weeks for 52 weeks. Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy in this study. For the tezepelumab group, the annualized rate of asthma exacerbations was 0.93 (95% CI, 0.80 to 1.07), while the rate was 2.10 (95% CI, 1.84 to 2.39) with placebo (rate ratio, 0.44; 95% CI, 0.37 to 0.53; P<0.001). Overall, data from the study indicated that, compared to those administered placebo, patients who received tezepelumab had fewer exacerbations and better lung function, asthma control, and health-related quality of life. Full results of the NAVIGATOR trial were published in The New England Journal of Medicine in May 2021.

Tezspire has been approved in the US and other countries for the treatment of severe asthma.

Interested in more information about approved antibody therapeutics? Explore our searchable table of antibody therapeutic products for details.

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.

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.

UK-based Senior Molecular Biologist position open

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This senior level position will be held in the Centre for Cancer Immunology at Southampton General Hospital. This is a newly constructed, dedicated research building that is the result of a significant fund-raising campaign. It builds on a 40 year history of pioneering immunology and cancer research at Southampton, and represents the first dedicated cancer immunology centre in the UK. The activities in this centre span from pioneering discovery science to applied research and preclinical modelling and, crucially, onto first-in-human clinical trials and beyond. The centre houses world-class research facilities, including state-of-the-art scientific laboratories and a clinical trials unit.

The position is associated with the laboratory of Professors Ward and Ober. Their interdisciplinary research program is dedicated to the use of protein engineering to develop novel antibody-based therapeutics that in the past has led to several therapeutics that are approved for clinical use. The group is also actively involved in the development of advanced microscopy techniques for the evaluation of novel therapeutics in cellular environments. Their interdisciplinary research is funded by major grants from the Wellcome Trust, Cancer Research UK and support from collaborating biopharma companies.

More information on the role, responsibilities and requirements can be found here.

Application can be made online here.

The Huston Antibody Science Talent Award competition is open!

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The James S. Huston Antibody Science Talent Award is sponsored 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 ten (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 lecture on their work, which will be made available on-line on The Antibody Society’s website, and to give a lecture at the Antibody Engineering & Therapeutics conference in December 2022.

The award includes: international recognition of the scientist’s accomplishments, a $1500 USD prize, and travel costs and registration fees to attend the annual Antibody Engineering & Therapeutics conference in San Diego, California.

The nomination process details are here. The deadline for submission is September 15, 2022.