AstraZeneca begins dosing in trial of its Bind-partnered cancer candidate

Accurin nanoparticle for cancer drug delivery--Courtesy of Bind

Cambridge, MA's Bind Therapeutics announced that patient administration of its Accurins nanoparticles has commenced in the trial of an AstraZeneca ($AZN) cancer candidate. Under the terms of the 2013 partnership with the Big Pharma, Bind earns a milestone payment of $4 million.

The Phase I trial of the candidate (AZD2811) consists of patients with advanced solid tumors, including those with small cell lung cancer. Bind says it has the potential to earn $128 million in milestone payments from its partnership with AstraZeneca as well as royalties in "the low-single digit to the low-double digit percentages of aggregate worldwide net sales of licensed product, if any."

In an interview, Bind CEO Andrew Hirsch said the goal of the partnership is to put AstraZeneca's Aurora B kinase inhibitor in the Accurins nanoparticles to spare exposure to healthy tissue, specifically bone marrow. Aurora B kinase inhibitors stop cell division, he said, unfortunately including in the bone marrow.

Bone marrow toxicity has held back adoption of the class of compounds or resulted in tradeoffs because they target cells that often exist in healthy tissue, Hirsch said. A previous iteration, AZD1152, did not make it to commercialization because of the toxicity and need for extensive infusion therapy--7 days continuously every 28 days.

In contrast, AZD2811 is administered via a 2-hour infusion on days 1 and 4 of a 28-day cycle, a Bind spokesman said in an email to FierceDrugDelivery.

"We had already achieved clinical proof of principle with the Aurora B kinase inhibitor in a Phase II trial in elderly patients with acute myeloid leukemia," said Susan Galbraith, head of AstraZeneca's Oncology Innovative Medicines Unit, in a statement. "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."

Bind's nanoparticles are delivered via infusion and consist of the payload (in this case AstraZeneca's Aurora B kinase inhibitor), a controlled-release polymer matrix, a polyethylene glycol "hydration shell" to protect the particle from the immune system, and targeting ligands for localized delivery, which can be small molecules, peptides, antibodies or antibody fragments, according to the company's website. The company says the platform achieves prolonged circulation in the bloodstream, targeted delivery and controlled and timely release.

Factors like polymer length and surface charge can be tweaked to meet the specifications of the payload and therapeutic area, according to Hirsch. "It's a classic Langer approach, which is let's take an engineering approach to a biological problem," Hirsch said, referring to drug delivery pundit Robert Langer of MIT, who is a Bind co-founder and serves on the company's board of directors.

Hirsch also touted Bind's manufacturing capabilities, saying production is a large hurdle for many nanoparticle developers. "Our particles self-assemble in a single step," Hirsch said, adding that the company is preparing to next year produce "double-digit kilograms" in a single batch of the nanoparticles intended for its lead program. Bind is responsible for all chemistry, manufacturing and control activities related to AZD2811 under its partnership with AstraZeneca.

Bind has partnerships with Pfizer ($PFE), Merck ($MRK) and Macrophage Therapeutics on cancer candidates, as well as one with Roche ($RHHBY) on therapeutic areas outside of oncology, with a goal of treating tissues and targets that have traditionally been hard to reach. Hirsch said the company is also studying the application of its nanoparticles as antibiotic agents and delivery vehicles for oligonucleotide payloads such as siRNA.

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