Bind Therapeutics Inc. (BIND) plans to offer 4.7 million shares at $14-$16 per share in its IPO, according to its S-1 filing with the SEC. The company will be listed on the Nasdaq Global Market under the symbol "BIND," and the proposed maximum aggregate offering price of the offering is $86.5 million.
Bind uses nanotechnology to precisely deliver a large dose of chemotherapy right to cancer cells and blood vessels that feed a variety of tumors, without causing additional toxicity.
At the heart of Bind's innovation are the so-called Accurins.
Accurins are polymeric nanoparticles that incorporate a therapeutic payload and are designed to have prolonged circulation in the bloodstream, target the diseased tissue or cells, and provide for the controlled and timely release of the therapeutic payload. The prolonged circulation allows for a higher concentration of the cancer drug at the disease site, therefore Accurins can significantly increase the clinical benefit of the therapeutic payload.
Chemotherapies kill cancer cells but also are toxic to healthy cells since to get these drugs to the diseased cells, you have to treat the whole body. This leads to serious side effects, which in turn limits the amount of the chemos that can be used.
Improvement would require two things: a direct targeting of the diseased cells in a way that bypasses the healthy ones and increases the amount of the cancer drugs to make them more effective.
BIND's nanomedicine platform performs both of these improvements.
Bind's lead agent, BIND-014, delivers the cancer drug docetaxel directly to the site of solid tumors. Docetaxel, a widely used chemotherapy drug, is currently FDA-approved for breast cancer, non-small cell lung cancer (NSCLC), metastatic castrate-resistant prostate cancer (mCRPC), head and neck cancer, and gastric cancer.
The amount delivered is up to 10 times of the usual dose and it is delivered in a manner that preserves healthy tissue. Its ingredients, the "programmable" antibodies allow for control of when and where the drug is released. The Accurins are tiny enough to pass through openings in blood vessels at disease sites and bind to cancer cells while avoiding detection and attacks by the immune system.
The Accurins can incorporate different kinds of therapeutic payloads and potentially can treat diseases other than cancer, like inflammation and cardiovascular disorders.
Bind is running 3 trials. A Phase 1 trial is testing BIND-014 in a variety of solid tumors.
Two dosing schedules are tested: the Q3W is once every three weeks and the Q1W once weekly for three weeks followed by one week of no treatment over a four-week cycle.
The Q3W phase with 28 patients treated is now complete. In this group there was one complete response in a patient with cervical cancer and three partial responses in patients with NSCLC, mCRPC and ampullary cancer. Five additional patients had stable disease lasting longer than 12 weeks.
Complete response means the disappearance of all signs of cancer, while partial response means a decrease in the size of the tumor or the extent of cancer in the body.
The lung cancer trial has 40 patients enrolled and started in April. Completion is scheduled for January 2015. The prostate cancer trial with a similar number of patients also started in April and will be completed in December 2015.
BIND- 014 showed in preclinical studies that it is very different from, and superior to the docetaxel, as it is used in the clinic today. BIND-014 increases the concentration of docetaxel at the tumor site by up to an order of magnitude and results in substantial improvements in anti-tumor activity with no increase in toxicity.
One of the co-founders of Bind is inventor and MIT professor Robert Langer, a legend in the industry.
A chemical engineer by training, Dr. Langer has helped start 25 companies and has 811 patents, issued or pending, to his name. More than 250 companies have licensed or sublicensed the Langer Lab patents. His MIT lab provides work for more than 80 people and had a research budget of over $10 million for 2012, mostly from federal sources.
Langer has close ties with the venture community, particularly Polaris Venture Partners, a Boston venture capital firm that has invested $220 million in 18 Langer Lab-inspired businesses.
Polaris and other backers have made good returns on their investments in the Langer companies, such as Advanced Inhalation Research and Momenta Pharmaceuticals (MNTA).
Part of Langer's magic is his ability to attract talents from different disciplines like engineers, biologists, chemists and physicians in his lab and make them work together.
His entrepreneurial activity has made Langer a millionaire, but he says his overriding motivation is the desire to improve people's health.
Other members of Bind's management also have wide experience in nanotechnology.
Bind's current CEO was the CEO of Sequus Pharmaceuticals, the company that developed Doxil, now sold by Johnson & Johnson (JNJ), and both the chief medical officer and the head of regulatory affairs served in those roles at Abraxis Bioscience, Inc., the company that developed Abraxane, now marketed by Celgene (CELG). Doxil and Abraxane are early nanotech products.
Nanotechnology works with matter on an ultra-small scale. One nanometer is one-millionth of a millimeter and a single human hair is around 80,000 nanometers in width. The revolutionary technology stretches across the spectrum of science, medicine and engineering.
Bind's list of collaborators include Amgen (AMGN), Pfizer (PFE) and AstraZeneca (AZN) who all came to Bind to develop Accurins using their pipeline products as payloads. It is estimated that at least one of the collaborators will advance an Accurin product into the clinic by the end of 2014.
Bind's total take from all the collaborations could amount to $1 billion in upfront and milestone payments, including over $450 million in pre-commercial milestones.
Amgen has paid $5.0 million upfront and will make contingent payments up to $188 million. It also will pay tiered royalties on sales of licensed products.
Pfizer took out options for more products than Amgen. It paid upfront $4.0 million and will pay up to $110 million under each option upon achievement of Pfizer specified commercial events. Also it will pay royalties on sale of licensed products.
In addition to the economics, Bind's ability to attract major partners to its medicinal nanoengineering platform is significant because it represents a validation of the approach.
Competition is broad and multi-layered.
Current established second-line treatments for NSCLC include docetaxel and other chemotherapy agents such as Gemzar from Eli Lilly (LLY) and vinorelbine, as well as molecularly-targeted therapies such as Tarceva from Roche (RHHBY.OB) and Iressa from AstraZeneca and Teva (TEVA), and Xalkori from Pfizer.
In development are monoclonal antibodies, Bristol-Myers Squibb's (BMY) nivolumab targeting PD-1, and Roche's MPDL3280A targeting PD-L1, both currently in Phase 2.
In mCRPC, in addition to first-line chemotherapy agents such as docetaxel, the treatments include use of hormonal therapies such as Zytiga from Johnson & Johnson and Xtandi from Medivation (MDVN) and Astellas (ALPMY.PK). Jevtana from Sanofi (SNY), a second-line taxane chemotherapeutic, is also being tested against docetaxel.
Other therapies in development to treat mCRPC is an ADC (antibody-drug conjugate) by Progenics Pharmaceuticals, Inc. (PGNX) and a BITE (Bispecific T Cell Engager) antibody by Bayer Healthcare (BAYRY.PK) in collaboration with Amgen.
Bind is also facing competition from companies that develop nanomedicine platforms other than its own, like Alnylam Pharmaceuticals (ALNY) and New Jersey-based joint venture MidaSol for hypercholesterolemia and diabetes, respectively.
But Bind's product is more efficient to make. The preparation of nanoparticles often employs multiple steps for drug incorporation and for the attachment of the nanoparticles, which creates challenges in reproducibility, yield and scalability. Bind has two U.S. issued patents and four patents pending related to a simpler manufacturing processes.
Management believes that the Accurins can achieve concentrations of therapeutic payload at disease sites unachievable by the competition.
Revenues for the first 6 months of 2013 were $4.26 million, with a loss of $11.76 million.
Cash and cash equivalent holdings prior to the IPO proceeds were $21.3 million.
As of the end of June, the company had an accumulated a long-term deficit of $89.3 million. The deficit has been financed through private placements of preferred stock and convertible debt securities, borrowings under the credit facility from Hercules Technology Growth Capital, government grants and collaborations.
The proceeds of the IPO, together with the available cash, plus borrowings and funding from the collaborations, excluding any potential milestone payments, may fund the company through mid-2015, which would include the completion of the Phase 2 trials of BIND-014 and, if successful, the start of Phase 3 trials.
Assuming that the Accurins perform as expected in current and subsequent trials, they are indeed the next step in cancer treatment and possibly in the treatment of other diseases as well, and in the long run, this could make Bind Therapeutics a very successful company.