BIND Biosciences Inc., of Cambridge, Mass., signed a deal with Amgen Inc., of Thousand Oaks, Calif., worth up to $180.5 million. to collaborate on development of a nanotechnology-based therapeutic for solid tumors.
However, according to BIND, there is an allowance for additional payments for other indications as well as tiered royalties on future sales of the product.
"BIND is establishing itself as world leader in nanomedicine. It's going to be important step forward in treatment of cancer," BIND CEO Scott Minick told BioWorld Today.
Under the agreement, the companies will work together to develop a kinase-inhibiting drug for solid tumor targets formulated using BIND's Accurin nanoparticle technology. Up-front and development milestones total $46.5 million, with $134 million in potential regulatory and sales milestones for the first therapeutic indication.
The idea behind BIND's nanomedicine technology is to take cytotoxic drugs like docetaxel and target them at the molecular level to cancer cells, minimizing the toxic effects on healthy cells.
Minick said the company's Accurin technology involves three levels of targeting to accomplish the difficult task of distinguishing between diseased and healthy cells.
Targeting ligands coat the outside of the Accurin particle. The ligands recognize disease-associated cell-surface proteins or receptors.
A "stealth" layer shields targeted Accurin particles from immune surveillance. That is important because the threshold for nanoparticle size, usually about 100 nm, is also the size range of a viral particle, and the immune system is primed to detect and clear particles of that size.
According to Minick, the stealth layer attracts water. "It makes the nanoparticles look like a tiny water droplet, invisible to the immune system," Minick said.
Lastly, the therapeutic payload is encapsulated in a matrix of biocompatible polymers that mediate its release at the site of disease.
Unlike small-molecule targeted drugs, which interfere with the action of a specific protein to create a therapeutic effect, Accurins bind to a specific surface protein to concentrate the drug at the sites where it is needed.
"We hope to get maximal efficacy with minimal toxicity," Minick said. He called the collaboration a "tipping point," moving nanomedicine forward in terms of producing viable pharmaceuticals.
"We've been doing smaller collaborations with companies. What we're seeing now is the first of what we hope will be several more partnerships with pharma," Minick said.
BIND has seen some exciting early clinical progress in developing its internal pipeline. In April, it reported data on BIND-014, delivering docetaxel to prostate tumor cells and the vasculature of many types of solid tumors. (See BioWorld Today, April 5, 2012.)
BIND-014 demonstrated safety and tolerability, as well as trends toward efficacy, in a Phase I trial. It also showed evidence of antitumor activity in cancers that normally only respond minimally to docetaxel, including one durable confirmed partial response in cervical cancer, and five instances of stabilization of disease in various types of solid tumors.
Nanotechnology for drug delivery is not a new concept, but use of nanospheres has been complicated by obstacles such as composition, shape, rigidity and hydrophilicity of the particle, as well as drug type, solubility and kinetics for the drug payload.
BIND-014 may be only the first of a wave of new nanoparticle-based drugs poised to hit the market as scientists work out ways to package and deliver payloads to cells.
First-generation nanomedicines such as Doxil, a pegylated liposome-encapsulated form of doxorubicin, indicated for ovarian cancer, and AmBisome (amphotericin B liposome for injection), for fungal infections, are already on the market and enjoying some success.
In its guidance for industry on nanotechnology, Minick said the FDA has taken "a very pragmatic approach." Referring to the initial handful of liposome-based drugs on the market, Minick said, "Those first-generation drugs have a long track record of safety and efficacy."
According to Minick, stumbling blocks in nanotechnology tend to center on products like sunscreen that incorporate nanoparticles, which is an entirely new use of the technology, whereas liposome-based drugs have built a sense of comfort and safety.