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BIND Therapeutics Announces Initiation of Clinical Studies with Accurin AZD2811 in Solid Tumors

19 November 2015

Dosing begins in phase 1 study of Aurora B kinase inhibitor nanomedicine developed in collaboration with AstraZeneca. BIND earns $4.0 million clinical milestone.

BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called Accurins™, today announced that AstraZeneca (NYSE: AZN) has initiated patient dosing in a phase 1 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 1 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 $4.0 million clinical milestone for dosing of the first patient.

“We had already achieved clinical proof of principle with the Aurora Kinase B inhibitor in a phase 2 trial in elderly patients with acute myeloid leukemia”

“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 Andrew Hirsch, president and chief executive officer of BIND Therapeutics. “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 2 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 1 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 2 dose will be identified. The study will also 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. Additional information on this study can be found at: https://www.clinicaltrials.gov

Preclinical data on the Accurin AZD2811 were presented at the 2015 American Association of Cancer Research (AACR) annual meeting in April 2015, including data that demonstrated promising in vivo and in vitro tumor growth inhibition as monotherapy in diffuse large B-cell lymphomas (DLBCL) and small cell lung cancer (SCLC) models. Additional data showed that Accurin AZD2811 delivers prolonged exposure of active drug with the flexibility to be delivered with different doses/schedules, offering the potential to adapt the therapeutic regimen to different tumors while achieving an improved therapeutic index. Previously, preclinical tumor model data were presented showing that Accurin 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.

Under terms of the collaboration, AstraZeneca is responsible for clinical development and commercialization and BIND is responsible for conducting clinical manufacturing. In addition to earning a $4.0 million milestone payment for the first patient dosed in a phase 1 clinical trial, BIND received an upfront payment of $4.0 million in 2013 and achieved a $1.0 million development milestone in March 2015. BIND has the potential to receive additional milestone payments totaling up to $60 million upon achievement by AstraZeneca of specified clinical events and up to $128 million in the aggregate upon achievement by AstraZeneca of all specified regulatory and commercial events, as well as tiered royalties in the low-single digit to the low-double digit percentages of aggregate worldwide net sales of licensed product, if any.

Based on the $4.0 million AstraZeneca clinical milestone payment, the previously announced $2.5 million Pfizer option exercise fee and anticipated R&D reimbursement for the next stage of the Pfizer collaboration, BIND reiterates that it expects that its cash, cash equivalents and short-term investments will fund operating expense and capital expenditure requirements into the fourth quarter of 2016. This expectation is based on BIND’s current operating plans and research and development funding that it expects to receive under its existing collaborations, but excludes any potential milestone payments under its collaboration agreements.

Source: Business Wire, 18.11.2015

Reference

BIND Therapeutics is a clinical-stage nanomedicine company developing a pipeline of Accurins™, its novel targeted therapeutics designed to increase the concentration and duration of therapeutic payloads at disease sites while reducing exposure to healthy tissue. BIND is leveraging its Medicinal Nanoengineering® platform to develop a pipeline of Accurins targeting hematological and solid tumors and has a number of strategic collaborations with biopharmaceutical companies to develop Accurins in areas of high unmet need. BIND's lead drug candidate, BIND-014, is a prostate-specific membrane antigen (PSMA) -targeted Accurin that contains docetaxel, a clinically-validated and widely-used cancer chemotherapy drug. BIND-014 is currently enrolling patients in a trial with BIND-014 for non-small cell lung cancer, or NSCLC, with KRAS mutations or squamous histology. In addition, BIND is enrolling patients in a clinical trial with BIND-014 for cervical, bladder, head and neck and cholangio cancers. BIND is advancing BIND-510, its second PSMA-targeted Accurin drug candidate containing vincristine, a potent microtubule inhibitor with dose limiting peripheral neuropathy in its conventional form, through important preclinical studies to position it for an Investigational New Drug (IND) application filing with the U.S. Food and Drug Administration. BIND is also developing Accurins designed to inhibit PLK1 and KSP, both of which BIND believes are promising anti-mitotic targets that have been limited in the clinic due to myelotoxicity at or below therapeutic doses.

BIND has announced ongoing collaborations with Pfizer Inc., AstraZeneca AB, F. Hoffmann-La Roche Ltd., Merck & Co., or Merck (known as Merck Sharp & Dohme outside the United States and Canada) and Macrophage Therapeutics (a subsidiary of Navidea Biopharmaceuticals) to develop Accurins based on their proprietary therapeutic payloads and/or targeting ligands. BIND’s collaboration with AstraZeneca has resulted in the Aurora B Kinase inhibitor Accurin AZD2811, which became the second Accurin candidate to enter clinical development. BIND’s collaboration with Pfizer has resulted in the selection of an Accurin candidate that is entering IND-enabling studies.

For more information, please visit the Company's web site at www.bindtherapeutics.com