Applied BioMath supporting Ph I trial of Northern Biologics’ lead antibody therapeutic

By Maggie Lynch contact

- Last updated on GMT


Related tags: Clinical trial, Clinical trial data, data model, Pharmacokinetics

Applied BioMath is providing clinical pharmacology and semi-mechanistic PK/PD modeling support for Northern Biologics Phase I clinical trial.

The extension of the previous collaboration will focus on clinical pharmacology, traditional and mechanistic pharmacokinetic and pharmacodynamics modeling of Phase I clinical analyses of MSC-I. MSC-I is an antibody therapeutic treatment targeting the cytokine LIF used for the treatment of cancer.

John Burke, CEO of Applied BioMath told us, “This is now a collaboration we supported pre-clinically and now that they’re [Northern Biologics] in the clinic they’re going to share the real clinical data. So, now we have more confidence in what individual patients and average patient dynamics might be.”

Applied BioMath previously worked with the Northern Biologics to create a human semi-mechanistic PK/PD model to support investigational new drug (IND) filing.

The goal of the collaboration is to continue building the model Applied BioMath created for preclinical development, a model that Burke said will get better with clinical data, thus enabling better predictions.

Burke said the company is looking at this from an engineering approach. “So, at a very, very high dimensional non-linear space we can start to de-risk this project or identify what experiments to do and what experiments not to do, so they [clients] can get to the clinic faster and with a better drug,”​ he explained.

Applied BioMath will update a human semi-mechanistic model from the previous portion of their collaboration.

The “fit-for-purpose” model examines timelines and how the drug works, and how the disease works in context with the mechanism of the drug, said Burke. “So, we really try to build the model to answer their questions, with the data they have, the data they will have,”​ he continued.

Northern Biologics could not provide a comment at this time. 

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