Immunogenicity of Immunotoxins Containing Pseudomonas Exotoxin A: Causes, Consequences, and Mitigation

R Mazor, I Pastan - Frontiers in immunology, 2020 - frontiersin.org
Immunotoxins are cytolytic fusion proteins developed for cancer therapy, composed of an
antibody fragment that binds to a cancer cell and a protein toxin fragment that kills the cell …

Prevalence of pre-existing antibodies to CRISPR-associated nuclease Cas9 in the USA population

VL Simhadri, J McGill, S McMahon, J Wang… - … therapy Methods & …, 2018 - cell.com
The repurposing of the CRISPR/Cas microbial adaptive immune system for gene editing has
resulted in an exponential rise in new technologies and promising approaches for treating …

Do bacteria provide an alternative to cancer treatment and what role does lactic acid bacteria play?

LMT Dicks, W Vermeulen - Microorganisms, 2022 - mdpi.com
Cancer is one of the leading causes of mortality and morbidity worldwide. According to 2022
statistics from the World Health Organization (WHO), close to 10 million deaths have been …

2019 white paper on recent issues in bioanalysis: FDA immunogenicity guidance, gene therapy, critical reagents, biomarkers and flow cytometry validation (part 3 …

S Piccoli, D Mehta, A Vitaliti, J Allinson, S Amur… - Bioanalysis, 2019 - Taylor & Francis
Abstract The 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) took place in
New Orleans, LA, USA on April 1–5, 2019 with an attendance of over 1000 representatives …

Neutralizing Antibody Validation Testing and Reporting Harmonization

H Myler, J Pedras-Vasconcelos, T Lester, F Civoli… - The AAPS journal, 2023 - Springer
Evolving immunogenicity assay performance expectations and a lack of harmonized
neutralizing antibody validation testing and reporting tools have resulted in significant time …

Results from an international phase 2 study of the anti‐CD22 immunotoxin moxetumomab pasudotox in relapsed or refractory childhood B‐lineage acute …

NN Shah, D Bhojwani, K August… - Pediatric blood & …, 2020 - Wiley Online Library
Background In a multicenter phase 1 study of children with relapsed/refractory acute
lymphoblastic leukemia (ALL), moxetumomab pasudotox, an anti‐CD22 immunotoxin …

Investigation of pre-existing reactivity to biotherapeutics can uncover potential immunogenic epitopes and predict immunogenicity risk

N Bivi, T Moore, G Rodgers, H Denning, T Shockley… - MAbs, 2019 - Taylor & Francis
Despite recent advances in the development of tools to predict immunogenicity risk of
biotherapeutic molecules, the ability of a protein to elicit the formation of anti-drug antibodies …

Recommendations for the assessment and management of pre-existing drug-reactive antibodies during biotherapeutic development

L Xue, A Clements-Egan, L Amaravadi, M Birchler… - The AAPS Journal, 2017 - Springer
Anti-drug antibodies (ADA) pose a potential risk to patient safety and efficacy and are
routinely monitored during clinical trials. Pre-existing drug-reactive antibodies are present in …

Design of antibody variable fragments with reduced reactivity to preexisting anti-drug antibodies

MU Johansson, C Weinert, DA Reichardt, D Mahler… - MAbs, 2023 - Taylor & Francis
Upon reformatting of an antibody to single-chain variable fragment format, a region in the
former variable/constant domain interface of the heavy chain becomes accessible for …

Let's talk about BiTEs and other drugs in the real-life setting for B-cell acute lymphoblastic leukemia

D Deak, C Pop, AA Zimta, A Jurj, A Ghiaur… - Frontiers in …, 2019 - frontiersin.org
Background: Therapy for acute lymphoblastic leukemia (ALL) are currently initially efficient,
but even if a high percentage of patients have an initial complete remission (CR), most of …