Cell Therapy Webinar

Assessing off-target liabilities and generating tox data for INDs

The adverse effects of off-target mediated CAR T activation in healthy tissues could be catastrophic for patients who receive novel cell therapies. As such, ensuring that cell therapies are specific to their intended targets is vital, particularly when assessing potential safety implications prior to clinical studies.

Specificity screening using the Human Cell Microarray platform allows any potential off-target liabilities to be monitored and managed throughout discovery and development. Cell Microarray data confirming protein and cell therapy specificity have been included in IND and BLA submissions to several major regulatory agencies, including the FDA (US), EMA (Europe), NMPA (China) and PMDA (Japan), either as a replacement to, or in conjunction with tissue cross reactivity (TCR) studies.

This webinar provides an overview of the Cell Microarray technology, with a particular focus on de-risking of cell therapy programs, particularly in the CAR T sphere. Industry case examples will show the utility of the platform from early lead candidate selection through to pre-IND safety, and clinical trial stages.

Featured presentations:

“Novartis experience with the Retrogenix platform to assess the specificity of biologics and cell therapies.” 

Dr Axel Vicart, Senior Principal Scientist (Research), Novartis

“Use of cell based off-target screening in CAR T-cell programs.” 

Yen Ho, Associate Scientist, Bristol Myers Squibb

“Specificity screening of mAbs, scFvs & CAR Ts against expressed receptors, heterodimers & secreted protein targets.”

Diogo Rodrigues Ferreirinha, European Business Development Manager, Retrogenix

Why use Retrogenix?

Ensuring that a novel biotherapeutic is specific to its intended target is undoubtedly advantageous when selecting promising lead candidates, however, it becomes vital when assessing potential safety implications prior to clinical studies.

Retrogenix specificity screening data has been readily accepted in applications for clinical trials and marketing approval in the US, Europe, China & Japan. Further details can be found in our case study using the link below. Or, to find out more, please get in touch with a member of our team.

 

Retrogenix data in regulatory submissions

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    I would like to thank you very much for the great and very timely work including this report which will be key data for our submission to the regulatory authorities.
    Marcel Walser, PhD, Senior Director Research, Molecular Partners
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