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news.BIND Therapeutics (BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called Accurins, announced that the US Food and Drug Administration (FDA) has authorized the use of AstraZeneca’s Accurin AZD2811 in clinical trials under an investigational new drug (IND) application.
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BIND is collaborating with AstraZeneca on the development of AZD2811, an Aurora B Kinase inhibitor that has been shown to be active in both solid and hematological tumors in preclinical models, and the companies anticipate enrolling patients in a phase 1 clinical trial with AZD2811 in the fourth quarter of this year.
BIND will earn a $4 million milestone payment upon first dosing a patient in a phase 1 clinical trial with AZD2811.
Preclinical data on AZD2811 were presented at the 2015 American Association of Cancer Research (AACR) annual meeting in April 2015, including data demonstrating promising in vivo and in vitro tumor growth inhibition as monotherapy in models of diffuse large B-cell lymphomas (DLBCL) and small cell lung cancer (SCLC).
Additional data showed that AZD2811 delivers prolonged exposure to active drug while having the potential to adapt the dosing regimen, potentially achieving an improved therapeutic index. In addition, using mass spectrometric imaging, AZD2811 was shown to accumulate in tumors and achieve prolonged tumor drug exposure.
This represents the first time distribution of nanoparticles in tumors has been demonstrated. Previously, preclinical tumor model data were presented showing that AZD2811 minimizes the bone marrow toxicity seen with the parent compound, which has limited the clinical utility of Aurora B kinase inhibitors as a class.
"We have worked diligently with our collaborators at AstraZeneca to quickly advance the Aurora B kinase inhibitor program, AZD2811, through preclinical development," said Andrew Hirsch, president and chief executive officer of BIND Therapeutics.
"The data recently presented at AACR describing the optimized pharmacological properties of AZD2811 further demonstrate the unique attributes of Accurins as a new treatment modality with the potential to produce therapeutics with best-in-class profiles. With AZD2811 now cleared to begin a phase 1 study, we are positioned to have two Accurins in clinical development, with our lead Accurin BIND-014 currently in phase 2 studies."
BIND and AstraZeneca expect to enroll the first patient in a phase 1 clinical trial with AZD2811 in the fourth quarter of 2015. Under terms of the collaboration, AstraZeneca is responsible for clinical development and commercialization and BIND is responsible for conducting clinical manufacturing through at least the end of phase 2 clinical trials.
Accurins, a new class of targeted therapeutics developed using BIND’s Medicinal Nanoengineering platform, are nanoparticles engineered to have a profound impact on the treatment of disease. The elegant and novel design of Accurins allow for prolonged circulation, controlled and tunable release and selective targeting of a therapeutic payload to diseased tissue or cells while avoiding immune surveillance detection and systemic toxicities.