Therapeutic Product Immunogenicity Community

Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .

Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .

Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .

Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .

Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .

I think Eric is really hitting the nail on the head. Although animal studies have limited translational immunogenicity value, when referring to anti-drug antibody formation, there are still extremely valuable to define monitoring strategies for potential immune toxicities that could translate into humans.  This is specially relevant for peptides and gene therapy products.  It would be really useful to discuss what in vitro assays, besides PBMc and DC:T cell assays, could be qualified to de-risk candidates from an immune toxicity perspective.

Best,

Laura

Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .

I think Eric is really hitting the nail on the head. Although animal studies have limited translational immunogenicity value, when referring to anti-drug antibody formation, there are still extremely valuable to define monitoring strategies for potential immune toxicities that could translate into humans.  This is specially relevant for peptides and gene therapy products.  It would be really useful to discuss what in vitro assays, besides PBMc and DC:T cell assays, could be qualified to de-risk candidates from an immune toxicity perspective.

Best,

Laura

Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .

Vibha,

Fantastic! Then, happy to be part of the working group.

Best,

Laura

I think Eric is really hitting the nail on the head. Although animal studies have limited translational immunogenicity value, when referring to anti-drug antibody formation, there are still extremely valuable to define monitoring strategies for potential immune toxicities that could translate into humans.  This is specially relevant for peptides and gene therapy products.  It would be really useful to discuss what in vitro assays, besides PBMc and DC:T cell assays, could be qualified to de-risk candidates from an immune toxicity perspective.

Best,

Laura

Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .

Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .

Eric

Thanks for helping to move this discussion forward

Sorry for the vagueness of the message.  My intent is to engage drug development scientists who have expertise working with these in silico and in vitro models and the recent in vitro readouts that have helped with TCEs and immune modulatory biologics that could not be tested in animal species and relied on in vitro readouts.  

Regarding the tools, I would like to highlight the in silico and in vitro tools currently being used preclinically to understand not only immunogenicity risk but also immune toxicity for which animals were being used  conventionally   This would include  the human derived cell based and cell line based assays to understand target engagements, safety outcomes that are dose dependent based on varying levels of receptors or targets on in vitro models and their translation into dosing strategies based on immunotoxicity.  

Overall, a discussion on where it makes sense to use the NAM approach vs where the animal derived data may still be needed could be a good discussion to have in a group with discovery, DMPK and investigative toxicology scientists. As a community , the preclinical immunogenicity risk assessments have relied on similar assays and readouts so a discussion on which of these assays can be applied to understand the safety signals in absence of animal data would be good to brainstorm on.

Hope you would be open to joining the kickoff to bring forth your view point

As the immunogenicity risk assessment field has spent a lot of time discussing these in silico and human in vitro assays and their qualification, these assays could be used to support immuno-toxicity due to target engagement.  Some of the typical end points in animal testing to test for immune suppression or exacerbation include evaluation of cellular immunity (proliferation, ELISpot, flow-based assessments), humoral immunity (antibody titers), inflammation (cytokine secretions and related panels) and histopathology of LNs, and related lymphoid organs.  

Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .

Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .

Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .

Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .

Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .

Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .

Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .

Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .

Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .

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Vibha Jawa
Chief Scientific Officer
Epivax
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .

Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .

Recent guidance from FDA asks for reduced, refined or potential replacement of animal testing requirement using a range of approaches, including AI -based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (also referred to as New Approach Methodologies or NAMs data;).

The inclusion and implementation of such data is encouraged for investigational new drug (IND) applications. The risk assessment tools for immunogenicity have been employed during preclinical development for reduction of liabilities due to intrinsic and extrinsic risks and bringing the least risky candidate forward for clinical trials.  These qualified tools can act as surrogate for understanding potential immunotoxicity and immunogenicity in humans as the animal studies are reduced.  

I would like to invite members who would be interested in joining me in discussing this topic as part of the TPI and IRAM community .