Joint R&D on Accurins

The financial terms are not being disclosed, but BIND is expected to pay for research up through early-stage human testing, and if Merck takes over, it will pay BIND a fee and then royalties on any drug sales.

“This is an exciting and unique collaboration for BIND as it provides us with novel proprietary payloads to develop Accurin product candidates for our internal pipeline,” said Scott Minick, CEO of BIND, in a statement. “The structure of this agreement marks an advancement in our collaboration approach and demonstrates the strength of our leadership position in the field of nanomedicine.”

The lynchpin of the partnership is BIND’s Accurin nanoparticles, which encapsulate cancer-killing drugs in a biodegradable polymer shell that can bring them specifically to cancer cells, while avoiding healthy ones. The two potential drugs from Merck to serve as the first two anticancer agents under the new agreement are both kinase inhibitors.

“To select our next product candidate, we evaluated a broad range of therapeutic payloads and targeting ligand combinations to identify Accurin product concepts that we believe would have a meaningful impact on cancer treatment,” Minick tells DDNews, describing the thought process behind BIND’S product strategy. “We selected PSMA-targeted vincristine as our lead candidate.”

Vincristine is a clinically validated and highly potent vinca alkaloid microtubule-disrupting agent predominantly used in the CHOP chemotherapy regimen for non-Hodgkin’s lymphoma, Minick explains.

“While vincristine and the broader vinca alkaloid class are well established in both solid tumors and hematologic malignancies, their clinical utility in conventional form is limited by severe toxicities, specifically cumulative and sometimes irreversible neuropathy,” Minick says. “This limits the dose and duration of treatment, which prevents vincristine from achieving its full therapeutic potential across a broad range of tumor types. Using our nanomedicine platform, we believe that an Accurin containing vincristine has the potential to overcome these liabilities and emerge as a potent and well-tolerated drug with utility across a broad range of tumor types. BIND-510 is designed to concentrate high levels of vincristine in tumors while limiting exposure to healthy tissue.”

“We are in the process of selecting the lead formulation of BIND-510 and initiating IND-enabling tox studies and manufacturing scale-up for an IND submission in 2016,” he adds. “We plan to develop BIND-510 in both solid and hematological malignancies, and will have more specifics on tumor types as we get closer to the IND filing.”

Current treatment standards in oncology include many compounds that are prevented from achieving their full therapeutic potential due to on-target but off-tissue toxicities that limit the drug from achieving maximum therapeutic effectiveness, he notes, adding, “This is because tumor cells can be virtually identical to healthy cell types in many respects, including sensitivity toward cancer drugs. Our nanomedicine platform is designed to maximize the efficacy of highly potent compounds that can benefit from the ability of an Accurin to better distinguish between healthy and tumor tissue. By combining prolonged circulation, tumor targeting and controlled and timely release of the therapeutic payload, Accurins have the potential to significantly increase the clinical benefit, potentially resulting in efficacy and safety currently not achievable with conventional treatment standards.”

Accurins increase the concentration and duration of a broad range of therapeutic payloads at disease sites when compared to payloads administered in conventional form, he says.

In the near term, this agreement is unique for BIND because it enables the company to develop internal product candidates utilizing Merck-supplied pipeline molecules, one of which is a kinesin spindle protein (KSP) and the other of which is a polo-like kinase 1 (PLK1).

“Our collaboration with Merck represents a new type of agreement that provides us with access to innovative proprietary therapeutic payloads well suited to the Accurin platform,” Minick says. “Both KSP and PLK1 generated a great deal of excitement in the oncology community a few years ago as key regulators of cellular mitosis that are essential to the proliferation of cancer cells. PLK1 and KSP inhibitors showed strong promise preclinically, but not in the clinic due to toxicity issues.”

The high potency and narrow therapeutic window of the Merck compounds make them excellent candidates for the Accurin technology, he adds, saying, “Based on Merck’s extensive preclinical data for both compounds and our unique technology, we believe that these promising anti-mitotic agents have the potential to become significant additions to the armamentarium of novel cancer therapies.”

Overall, this agreement allows both companies to discover and develop novel nanomedicines for oncology by leveraging BIND’s proprietary technology for targeted Accurins and novel, potent payloads from Merck’s oncology pipeline.

“We are pleased to collaborate with BIND Therapeutics to expand Merck’s active oncology discovery programs,” stated Dr. Eric Rubin, vice president of clinical oncology for Merck Research Laboratories, in a news release. “Merck is focused on exploring immuno-oncology and other promising pathways, and we look forward to combining compounds from our oncology portfolio with BIND’s nanomedicine technology platform.”