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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.

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.

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The University of Houston is now accepting applications for an Assistant or Associate Professor position in Chemical & Biomolecular Engineering.

The William A. Brookshire Department of Chemical & Biomolecular Engineering at the University of Houston (UH) seeks to hire a tenure-track or tenured faculty member at the rank of Assistant or Associate Professor under the Presidential Frontier Faculty Program with research interests in the field of Biomolecular Engineering, with Immunoengineering being the preferred focus area.

The Presidential Frontier Faculty Program is a university-wide integrated interdisciplinary hiring campaign that is overseen by central University leadership and encompasses hiring a large cohort of convergence research faculty to work on health, energy, sustainability, and security. Competitive candidates are expected to have a Ph.D. degree or equivalent when they start their position and show potential for exceptional research and excellence in teaching and service. The successful candidate will be appointed at a rank commensurate with accomplishments and expertise.

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

A link for uploading application materials will be posted here: http://www.chee.uh.edu/about/open-positions

https://www.antibodysociety.org/jobs/uk-based-senior-molecular-biologist-position-open/

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.

Register for our upcoming webinar on BLI and its use in anti-snake venom antibody discovery

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Biolayer interferometry (BLI) is gaining popularity for protein and small molecule quantitation and kinetics research. The new advancements in biosensors, ease of use, reproducibility and low cost is driving its adoption. Even though BLI is one of the easiest of the tools, as with many other techniques, getting the best data depends on optimization of some key experimental factors. This webinar will discuss the best practices in BLI and result of such implementation by way of an example of screening of a broadly neutralizing antibody of snake venoms.

Snake envenomation results in over 100,000 deaths and 300,000 permanent disabilities in humans annually. Contemporary antivenoms are produced from the polyclonal serum of venom-immunized livestock and are specific to a single or narrow genetic range of related snakes. Could a broadly neutralizing monoclonal antibody, or a cocktail of a few broad components, provide protection from diverse snake venoms? Centi-3FTX-D09, originating from the B-cell memory of a human subject with an extensive history of diverse snake venom exposure, recognized a conserved neutralizing epitope of 3-finger toxins (3FTXs), a dominant snake neurotoxin. Four crystal structures of Centi-3FTX-D09 in complex with 3FTXs from mamba, taipan, krait, and cobra revealed the mechanism of broad neutralization to be epitope mimicry of the interface between these neurotoxins and their native host target, the nicotinic acetylcholine receptor. Centi-3FTX-D09 provided in-vivo protection against diverse 3FTXs and, in combination with the phospholipase inhibitor varespladib, protection against whole venom challenge for diverse, genetically distinct, elapid species.

About the Speakers

Register here!