Reducing immunogenicity by design: approaches to minimize immunogenicity of monoclonal antibodies

CT Harris, S Cohen - BioDrugs, 2024 - Springer
Monoclonal antibodies (mAbs) have transformed therapeutic strategies for various diseases.
Their high specificity to target antigens makes them ideal therapeutic agents for certain …

Immunogenicity risk assessment and mitigation for engineered antibody and protein therapeutics

PJ Carter, V Quarmby - Nature Reviews Drug Discovery, 2024 - nature.com
Remarkable progress has been made in recent decades in engineering antibodies and
other protein therapeutics, including enhancements to existing functions as well as the …

Anti-brolucizumab immune response as one prerequisite for rare retinal vasculitis/retinal vascular occlusion adverse events

AC Karle, MB Wrobel, S Koepke, M Gutknecht… - Science Translational …, 2023 - science.org
In October 2019, Novartis launched brolucizumab, a single-chain variable fragment
molecule targeting vascular endothelial growth factor A, for the treatment of neovascular age …

[HTML][HTML] KESTREL and KITE Phase 3 studies: 100-week results with brolucizumab in patients with diabetic macular edema

CC Wykoff, JG Garweg, C Regillo, E Souied… - American journal of …, 2024 - Elsevier
PURPOSE To report the 100-week outcomes from the KESTREL and KITE trials. DESIGN
Two phase 3, double-masked, active-controlled, randomized trials. METHODS Patients with …

Layer-by-layer microneedle-mediated rhEGF transdermal delivery for enhanced wound epidermal regeneration and angiogenesis

R Yuan, N Yang, Y Huang, W Li, Y Zeng… - … Applied Materials & …, 2023 - ACS Publications
Appropriate treatments for acute traumas tend to avoid hemorrhages, vascular damage, and
infections. However, in the homeostasis-imbalanced wound microenvironment, currently …

2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors …

L Pan, J Mora, K Walravens, L Wagner, S Hopper… - Bioanalysis, 2023 - Taylor & Francis
Abstract The 2022 16th Workshop on Recent Issues in Bioanalysis (WRIB) took place in
Atlanta, GA, USA on September 26–30, 2022. Over 1000 professionals representing …

Characterization and root cause analysis of immunogenicity to pasotuxizumab (AMG 212), a prostate-specific membrane antigen-targeting bispecific T-cell engager …

HL Penny, K Hainline, N Theoharis, B Wu… - Frontiers in …, 2023 - frontiersin.org
Introduction In oncology, anti-drug antibody (ADA) development that significantly curtails
response durability has not historically risen to a level of concern. The relevance and …

[HTML][HTML] Detection and management of intraocular inflammation after brolucizumab treatment for neovascular age-related macular degeneration

B Bodaghi, EH Souied, R Tadayoni, M Weber… - Ophthalmology …, 2023 - Elsevier
Purpose To present interim descriptive insights from the OCTOPUS and SWIFT studies on
incidence, clinical features, management, and outcomes of intraocular inflammation (IOI) …

Gains in the current understanding of managing neovascular AMD with brolucizumab

B Bodaghi, AM Khanani, R Khoramnia… - Journal of ophthalmic …, 2023 - Springer
Background Unresolved retinal fluid and high injection burden are major challenges for
patients with neovascular age-related macular degeneration. Brolucizumab addresses …

[HTML][HTML] Factors associated with intraocular inflammation in neovascular age-related macular Degeneration patients treated with brolucizumab

Y Hashimoto, S Inoda, H Takahashi… - … & Visual Science, 2024 - tvst.arvojournals.org
Purpose: To identify factors associated with intraocular inflammation (IOI) in patients with
neovascular age-related macular degeneration (nAMD) treated with brolucizumab. Methods …