BIND Therapeutics, a Cambridge, Mass.-based clinical-stage nanomedicine company developing targeted and programmable therapeutics called Accurins, announces that AstraZeneca has initiated patient dosing in a phase I clinical trial of the Accurin AZD2811 drug candidate in solid tumors.
AZD2811, a novel, selective inhibitor of Aurora B kinase that has been shown to be active in both solid and hematological tumors in preclinical models, is the second Accurin candidate to enter clinical development. The phase I trial is enrolling patients with advanced solid tumors, including patients with small cell lung cancer, and is being conducted by AstraZeneca under the companies’ 2013 collaboration agreement with BIND managing all chemistry, manufacturing and control activities. BIND earned a $4 million clinical milestone for dosing of the first patient.
“The preclinical data seen to date suggest Accurin AZD2811 can overcome the limitations that have hindered development of this class of potent kinase inhibitors,” said BIND President and CEO Andrew Hirsch. “There has been a great deal of promise in the biology of inhibiting the Aurora B pathway but success to date has been limited due to on-target but off-tissue toxicities. Based on preclinical data we’ve seen to date, we believe our Accurin technology has the potential to overcome these limitations and make AZD2811 a best-in-class therapeutic with a profile unachievable through other therapeutic modalities. This milestone further demonstrates the value of our leading nanomedicine platform and we look forward to exploring the potential benefits this product may bring to patients with cancer.”
“We had already achieved clinical proof of principle with the Aurora Kinase B inhibitor in a phase II trial in elderly patients with acute myeloid leukemia,” said Susan Galbraith, head of AstraZeneca’s Oncology Innovative Medicines Unit. “Through our collaboration, we can now deliver this drug in a BIND Accurin nanoparticle. BIND’s Accurin technology has the potential to significantly improve the therapeutic activity of our Aurora B Kinase inhibitor and we look forward to sharing data from this trial as we advance AZD2811 through clinical development.”
The phase I clinical trial is designed to evaluate the safety and tolerability of AZD2811 at increasing doses. The first part of the two-part study will evaluate the maximum tolerated dose (MTD) and the recommended phase II dose will be identified. The study also will characterize the pharmacokinetic (PK) profile of AZD2811 and will explore the potential biological activity by assessing anti-tumor activity. The second part of the study will begin upon determination of the MTD and will further explore PK parameters, safety, tolerability and preliminary anti-tumor activity of AZD2811.