On September 29, 2020 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported a collaboration with Cullinan Oncology (Press release, Applied BioMath, SEP 29, 2020, View Source [SID1234567769]). Applied BioMath will develop a systems pharmacology model for CLN-049, a novel FLT3XCD3 bispecific antibody for Acute Myeloid Leukemia, being developed by Cullinan Florentine, a Cullinan Oncology company. This model will be used to determine first in human starting dose and to predict efficacious dose range in the clinic. "We look forward to leveraging the proven modeling approaches of Applied BioMath in our development project," said Jennifer Michaelson, Chief Development Officer, Biologics at Cullinan Oncology. "We see significant potential for Applied BioMath’s modeling efforts to augment our program, from predicting starting dose and efficacious dose ranges and informing optimal dose regimens in the clinic, to helping us design efficacy studies in mice and tolerability studies in non-human primates."
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Applied BioMath employs a rigorous fit-for-purpose model development process which aims to quantitatively integrate knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis. "Our mechanistic approach to systems pharmacology modeling is the most accurate way to translate across species and prepare for first in human doses," said Dr. John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "We look forward to leveraging our modeling expertise to help Cullinan Oncology advance their therapeutic to the clinic."