FDA Request for “Integrated Summary of Immunogenicity”
So much news to share!
EpiVax Delivers! As promised, EpiVax 2.0 will be arriving in 2024, our 26th year, along with new team members and new plans to expand the range of services offered.
Here are some previews:
MaGIC – An expedited report for biotech start-ups that have a need for speed – pre-formatted for rapid access to an immunogenicity risk assessment for one candidate.
Interoperability – Connectivity with tools used by protein engineering experts. Want us to connect to your 3D modeling tool? Send us your preferred tool name here!
Digital Master Files – Formal validation of our bioinformatics tools, for reference in your IND / BLA applications.
And BEST WISHES for a lovely holiday from the Epi-Team!!
FDA Request for “Integrated Summary of Immunogenicity”
The Integrated Summary of Immunogenicity (ISI) plays a crucial role in the FDA’s evaluation of IND applications for biologics and therapeutic protein products. The 2019 guidance emphasizes the importance of a clear and delineated ISI within the IND application.
Currently, FDA immunogenicity team members (see my LinkedIn post) are recommending that drug developers provide a comprehensive ISI as a chapter in their IND filing. EpiVax has over 25 years of experience in immunogenicity risk assessments. We’ll be rolling out ISI compatible reports in 2024! As Joao Pedras-Vasconcelos of the FDA’s CDER office says, “it’s never too early or too late to integrate!”
OmniAb cites EpiVax!
Check it out! : Complementary epitopes and favorable developability of monoclonal anti-LAMP1 antibodies generated using two transgenic animal platforms | PLOS ONE.
Eisai joins ISPRI Aficionados
We’re excited to announce that Eisai Co. Ltd. has just officially licensed the ISPRI toolkit, which will be a significant advantage for their pipeline. With a focus on therapeutic areas like tropical diseases, oncology, and neurology, Eisai plans to use ISPRI to screen a wide range of therapeutic modalities.
Eisai’s CSCO, Dr. Takashi Owa, said, “We look forward to having an advanced in silico toolkit such as ISPRI at our disposal to better understand and mitigate the immunogenicity of our early-stage biologic drug candidates.” Check out the press release for the full scoop!
Be Well! Stay Happy! And get your new COVID vaccine … I did! #VaccinesWork!
-Annie
