Bind Therapeutics Inc. plans to give the public a chance to invest in its pipeline of programmable therapeutics in an initial public offering worth $80.5 million. The cash influx will support development of its Accurins, compounds designed to target specific cells or tissues and deliver a payload to the site of disease. Bind's lead candidate, BIND-014, is in Phase II trials for non-small-cell lung cancer (NSCLC) and metastatic castrate-resistant prostate cancer (mCRPC).
In Phase I studies, treatment with BIND-014 led to one complete response in a patient with cervical cancer and three partial responses in patients with NSCLC, mCRPC and ampullary cancer. Five other patients had stable disease lasting longer than 12 weeks.
BIND-014 is a prostate-specific membrane antigen (PSMA)-targeted Accurin containing docetaxel. PSMA has been validated as a marker on prostate cancer cells and blood vessels of other types of solid tumors, including NSCLC.
Bind's Phase II trial is on schedule to report data in the second half of 2014.
Bind, of Cambridge, Mass., has collaborations with Amgen Inc., Pfizer Inc. and Astrazeneca plc, which have provided up-front payments and milestones to advance Bind's internal pipeline of Accurins.
Bind partnered with Astrazeneca in April in a deal worth up to $199 million to develop and commercialize an Accurin therapeutic based on a molecular targeted kinase inhibitor. Astrazeneca made an up-front payment, and agreed to pre-approval milestone payments of $69 million, with more than $130 million in regulatory and sales milestones.
That deal was signed shortly after Bind partnered with Pfizer Inc. for up-front and development milestones of $46.5 million plus $134 million in potential regulatory and sales milestones for the first therapeutic indication. (See BioWorld Today, April 4, 2013.)
New York-based Pfizer took an exclusive option to develop and commercialize multiple Accurins following collaborative preclinical research between the partners. If Pfizer exercises its option, the pharma will assume responsibility to develop and commercialize the selected Accurins, with Bind potentially receiving up-front and development milestone payments of approximately $50 million and regulatory and sales milestones of approximately $160 million for each commercialized Accurin, plus tiered sales royalties.
In January, Bind signed a deal with Thousand Oaks, Calif.-based Amgen, worth up to $180.5 million to collaborate on development of a nanotechnology-based therapeutic for solid tumors. Under that agreement, the companies are working together to develop a kinase-inhibiting drug for solid tumor targets formulated with Bind's Accurin technology. Up-front and developmental milestones total $46.5 million, with $134 million in potential regulatory and sales milestones for the first therapeutic indication. (See BioWorld Today, Jan. 9, 2013.)
Bind said its Accurins are the "next stage in the evolution of targeted therapies and nanomedicine." The targeting ligands on the surface of the Accurin bind to specific cell-surface markers. A "stealth" layer using polyethylene glycol (PEG) protects the Accurin from the immune system. That layer is necessary because the size threshold for a nanoparticle, 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.
Inside, a controlled-release polymer matrix traps the therapeutic payload and mediates its release at the disease site. The therapeutic payload can be any of a number of types of molecules including small-molecule compounds, peptides, or nucleic acids.
Accurins are intended to be an evolution of first-generation nanomedicines like Doxil, a pegylated liposome-encapsulated form of doxorubicin, indicated for ovarian cancer, and AmBisome (amphotericin B liposome for injection, Gilead Sciences Inc.), for fungal infections.
Bind recently dosed its first patient in a Phase II trial of BIND-014. The open-label, single-arm, multicenter trial will enroll 40 patients and is designed to determine efficacy of BIND-014 as measured by objective response in patients with Stage III/IV NSCLC who have failed a prior platinum-containing regimen.
Bind is classified as an emerging growth company under the Jumpstart Our Business Startups Act of 2012, and, as such, will be subject to certain reduced company reporting requirements.
The company reported revenue of $1.488 million for the quarter ending March 31, and it had $11.9 million in cash and cash equivalents.
In other financings news:
• Aastrom Biosciences Inc., of Ann Arbor, Mich., priced a public offering of 29 million shares of common stock and warrants to purchase up to 29 million additional shares of common stock at 30 cents per share, expecting to raise approximately $8.7 million. The warrants have an exercise price of 37 cents per share, may be exercised immediately and expire five years from the date of issuance. The company granted underwriters a 45-day option to purchase up to an additional 4.3 million shares of common stock and/or up to 4.3 million additional warrants to cover overallotments. Aastrom said net proceeds will be used to conduct clinical development programs, including the Phase IIb ixCELL-DCM trial, and for other corporate purposes. The offering is expected to close on or about Aug. 16, subject to customary conditions. Aegis Capital Corp. is acting as sole book-running manager for the offering, with Maxim Group LLC acting as a co-manager for the offering. Aastrom has struggled since terminating its Phase III REVIVE trial in critical limb ischemia in March and shifting its focus to dilated cardiomyopathy. On Tuesday, its shares (NASDAQ:ASTM) plummeted 43.4 percent in heavy trading, losing 23 cents to close at 30 cents. (See BioWorld Today, March 28, 2013.)
• Brainstorm Cell Therapeutics Inc., of New York, said it priced a $4 million underwritten public offering of 23,529,411 units at $0.17 per unit. Each unit consists of one share of common stock, par value $0.00005 per share, and 0.75 of a warrant to purchase one share of its common stock at an exercise price of $0.25 per share. The offering is expected to close on Aug. 16.
• Opexa Therapeutics Inc., of The Woodlands, Texas, closed an underwritten public offering of 12 million shares of common stock at $1.50 per share, generating gross proceeds of $18 million. Opexa granted the underwriters a 30-day option to purchase up to an additional 1.8 million shares of common stock to cover overallotments. The company plans to use the proceeds to fund further clinical development of Tcelna (imilecleucel-T) in an ongoing Phase IIb study of patients with secondary progressive multiple sclerosis and for other corporate purposes. Opexa also may use a portion of proceeds to repay all or a portion of its outstanding convertible secured promissory notes. Aegis Capital Corp. acted as sole book-running manager for the offering. Opexa has a potential $225 option and licensing deal for Tcelna with Merck Serono SA, a unit of Merck KGaA, of Darmstadt, Germany. (See BioWorld Today, Feb. 6, 2013.)