Applied BioMath (www.appliedbiomath.com), the industry-leader in applying mechanistic mathematical modeling, simulation, and analysis to de-risk therapeutic research and development, today announced a collaboration with Checkpoint Therapeutics, Inc., for semi-mechanistic pharmacokinetic and pharmacodynamic (PK/PD) modeling in advanced metastatic solid tumors.
"Applied BioMath's modeling approach will be an important predictor of optimal dosing regimens to support potential future registration clinical trials for our immuno-oncology and targeted product candidates," said James F. Oliviero, President and CEO of Checkpoint Therapeutics. "We look forward to working with Applied BioMath as we advance our product candidates through clinical development in support of potential FDA approvals."
Applied BioMath employs a rigorous fit-for-purpose model development process, referred to as Model-Aided Drug Invention (MADI), which aims to quantitatively integrate knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. In this collaboration, Applied BioMath will leverage MADI to predict optimal dosing regimens for Checkpoint Therapeutics' product candidates based on in vitro functional, in vivo efficacy, and preclinical toxicology data, as well as Phase 1 PK data.
"Our modeling approach incorporates all relevant available data which increases the model's fidelity to the biology of the drug and disease," said John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "Due to our model's loyalty to the biology, they have proven to generate highly accurate predictions as drugs progress into and through the clinic."
About Applied BioMath
Founded in 2013, Applied BioMath uses mathematical modeling and simulation to provide quantitative and predictive guidance to biotechnology and pharmaceutical companies to help accelerate and de-risk drug research and development. Their Model-Aided Drug Invention (MADI) approach employs proprietary algorithms and software to support groups worldwide in decision-making from early research through clinical trials. The Applied BioMath team leverages their decades of expertise in biology, mathematical modeling and analysis, high-performance computing, and industry experience to help groups better understand their candidate, its best-in-class parameters, competitive advantages, patients, and the best path forward into and in the clinic. For more information about Applied BioMath and its services, visit www.appliedbiomath.com.
Applied BioMath and the Applied BioMath logo are registered trademarks of Applied BioMath, LLC.
About Checkpoint Therapeutics
Checkpoint Therapeutics, Inc. ("Checkpoint") is a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is currently evaluating its lead product candidate CK-301, a fully human anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, in a Phase 1 clinical trial in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers. Checkpoint plans to develop CK-301 as a treatment for patients with non-small cell lung cancer ("NSCLC") and other solid tumors. In addition, Checkpoint is evaluating its small-molecule, targeted anti-cancer agent, CK-101, in the Phase 1 portion of a Phase 1/2 clinical trial for the treatment of patients with epidermal growth factor receptor ("EGFR") mutation-positive NSCLC. Checkpoint's pipeline also includes antibodies that target glucocorticoid-induced TNFR-related protein ("GITR") and carbonic anhydrase IX ("CAIX"), in addition to oral, small-molecule, targeted anti-cancer agents that inhibit bromodomain and extra-terminal ("BET") proteins and poly (ADP-ribose) polymerase ("PARP"). Checkpoint is a majority-controlled subsidiary of Fortress Biotech, Inc., and is headquartered in New York City. For more information, visit www.checkpointtx.com.
Checkpoint Therapeutics Forward‐Looking Statements
This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
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