AAPS Immunogenicity Discussion Group
Meeting Notes: 11 January 2024
Attendees: 25
Topics discussed at the meeting:
Immunogenicity assessment in rare diseases:
John Pirro was interested in how members were approaching immunogenicity assessment in rare diseases. Extent and types of assessment driven by risk assessment. People involved in this space are developing and validating ADA assays and where appropriate NAb. Often using healthy matrix with some assessments (e.g. selectivity) in small number of disease individuals. When preparing ISI, often looking at impact of ADA/Nab on PK/efficacy on an individual basis, numbers often too limited for population assessments.
Long term stability of ADA:
Bonnie Wu and Mohsen Rajabi ran a survey within AAPS to evaluate current approaches taken across industry to assessing (or not) LTS of ADA. Bonnie is going to lead a group to publish this and additional supportive data to the LTS of ADA in various matrices. For further information on the group, please contact Bonnie ([email protected]). Limiting to one representative per company.
Recent publication from Novo was highlighted (https://www.sciencedirect.com/science/article/pii/S0022175924000012).
Utility of the Confirmatory Assay for Determining ADA Status:
Michael Partridge, Dan Baltukonis, Marta Starcevic Manning, Ching-Ha (Vicky) Lai, Rob Nelson have formulated initial ideas on an AAPS group to discuss the topic. The aim would share (de-identified) data and evaluate whether the same conclusions would have been made with a single tier screening assay with lower false-positive rate. More details will be shared with the IDG and on the AAPS communities forum in the coming weeks.
Coming up:
At the February meeting, Dr. Sojin Bing and her team from FDA take us through their recent publication 'Rational immunosilencing of a promiscuous T-cell epitope in the capsid of an adeno-associated virus'. Date: Thursday 8 February 2024. Time 12:00-13:00 Eastern US, 18:00-19:00 CET. More details will be posted in a separate thread on the AAPS Communities.
Mark O'Dell and the team at B2S would like to share some data on Viral Interference with Immunogenicity Testing, Likely during the March meeting.
Want to know more:
If you'd like more information about getting involved with the AAPS-IDG, please contact:
Todd Lester ([email protected])
Rob Nelson ([email protected])
------------------------------
Robert Nelson
Scientific Officer, Senior Director
BioAgilytix Europe GmbH
Hamburg Germany
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer or other entities to which I am affiliated.
------------------------------