Therapeutic Product Immunogenicity Community

Hi all,

The Immunogenicity Discussion Group (IDG) has proposed setting up an industry consortium to evaluate the utility of confirmatory assay, similar to the titer vs S/N consortium. We aim to compare ADA categorization with and without the confirmatory tier using de-identified datasets. Publications and conference presentations suggest a high correlation between tier 1 and tier 2 results, questioning the value of tier 2. We want to analyze datasets from various therapeutics where ADA assays are implemented (e.g., protein therapeutics, oligos, etc., and different assay formats) to understand where the confirmatory assay is useful and where it adds little value in reporting ADA results in clinical studies.

The primary objective is to assess ADA status differences (% positive, % treatment-emergent, % treatment-boosted, etc.) using a standard 2-tiered approach (5% tier 1 cut point followed by a 1% tier 2 cut point) versus a single tier with a 1% cut point.

We are looking for sponsors to contribute the following:

- De-identified datasets, including:

  - Raw clinical study data for screening and confirmation results (including baseline)

  - Where possible, validation data, including cut point data and assay performance metrics, and also the cut point statistics performed and recalculate the 1% screening CP

  - Where possible, drug concentration profiles, PD, and/or efficacy data

  - 1-2 people/sponsor to participate in the team and contribute to the manuscript

We aim to collect datasets by the end of Q4 2024. Please contact the IDG leaders if you are interested in joining this consortium. A kick-off meeting will be held in Dec 2024.

Contact information of IDG leaders:

Todd Lester: [email protected]

Robert Nelson: [email protected]

Best regards,

Michael, Rob, Dan, Marta, Vicky and Todd

To indicate your interest in participating, please use the link below to submit your contact information:

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Thanks!

Hi all,

The Immunogenicity Discussion Group (IDG) has proposed setting up an industry consortium to evaluate the utility of confirmatory assay, similar to the titer vs S/N consortium. We aim to compare ADA categorization with and without the confirmatory tier using de-identified datasets. Publications and conference presentations suggest a high correlation between tier 1 and tier 2 results, questioning the value of tier 2. We want to analyze datasets from various therapeutics where ADA assays are implemented (e.g., protein therapeutics, oligos, etc., and different assay formats) to understand where the confirmatory assay is useful and where it adds little value in reporting ADA results in clinical studies.

The primary objective is to assess ADA status differences (% positive, % treatment-emergent, % treatment-boosted, etc.) using a standard 2-tiered approach (5% tier 1 cut point followed by a 1% tier 2 cut point) versus a single tier with a 1% cut point.

We are looking for sponsors to contribute the following:

- De-identified datasets, including:

  - Raw clinical study data for screening and confirmation results (including baseline)

  - Where possible, validation data, including cut point data and assay performance metrics, and also the cut point statistics performed and recalculate the 1% screening CP

  - Where possible, drug concentration profiles, PD, and/or efficacy data

  - 1-2 people/sponsor to participate in the team and contribute to the manuscript

We aim to collect datasets by the end of Q4 2024. Please contact the IDG leaders if you are interested in joining this consortium. A kick-off meeting will be held in Dec 2024.

Contact information of IDG leaders:

Todd Lester: [email protected]

Robert Nelson: [email protected]

Best regards,

Michael, Rob, Dan, Marta, Vicky and Todd

Hi all,

The Immunogenicity Discussion Group (IDG) has proposed setting up an industry consortium to evaluate the utility of confirmatory assay, similar to the titer vs S/N consortium. We aim to compare ADA categorization with and without the confirmatory tier using de-identified datasets. Publications and conference presentations suggest a high correlation between tier 1 and tier 2 results, questioning the value of tier 2. We want to analyze datasets from various therapeutics where ADA assays are implemented (e.g., protein therapeutics, oligos, etc., and different assay formats) to understand where the confirmatory assay is useful and where it adds little value in reporting ADA results in clinical studies.

The primary objective is to assess ADA status differences (% positive, % treatment-emergent, % treatment-boosted, etc.) using a standard 2-tiered approach (5% tier 1 cut point followed by a 1% tier 2 cut point) versus a single tier with a 1% cut point.

We are looking for sponsors to contribute the following:

- De-identified datasets, including:

  - Raw clinical study data for screening and confirmation results (including baseline)

  - Where possible, validation data, including cut point data and assay performance metrics, and also the cut point statistics performed and recalculate the 1% screening CP

  - Where possible, drug concentration profiles, PD, and/or efficacy data

  - 1-2 people/sponsor to participate in the team and contribute to the manuscript

We aim to collect datasets by the end of Q4 2024. Please contact the IDG leaders if you are interested in joining this consortium. A kick-off meeting will be held in Dec 2024.

Contact information of IDG leaders:

Todd Lester: [email protected]

Robert Nelson: [email protected]

Best regards,

Michael, Rob, Dan, Marta, Vicky and Todd