Overview

Growing antimicrobial resistance is a global, public health threat. Health organizations around the world have sounded the alarm and are calling for action. In fact, one recent analysis of this impending epidemic has indicated that drug resistant infections, often called “superbugs” will kill an extra ten (10) million people a year worldwide – more than currently die from cancer – by 2050 unless action is taken. This same analysis projected associated costs to spiral to over 100 trillion dollars. The combination of these multidrug resistant infections, coupled with the to-date unavoidable toxicity of many available drugs, has rendered many current therapies obsolete.

Matinas BioPharma, founded in 2012, is a publicly traded, clinical-stage biopharmaceutical company whose mission is to transform the way potent medicines are delivered and administered in order to provide physicians and patients with more tolerable, safer, effective and powerful therapeutic options in the battle against these superbugs. Using its proprietary, lipid-crystal, nanoparticle delivery technology, Matinas BioPharma is able to provide three critical and unique benefits: (1) oral administration and bioavailability of medicines which today are only able to be delivered intravenously, (2) multi-organ protection from otherwise highly toxic compounds in a stable, solid particle, (3) targeted delivery directly to sites of infection and/or inflammation, with the potential to achieve rapid tissue penetration, days ahead of what is available with injected drugs. Each of these benefits has been repeatedly demonstrated in a robust preclinical data package.

This disruptive, potentially game-changing technology, seals treatment drug in a soy-based lipid bilayer sheet, which rolls into a spiral structure called a “cochleate” with no internal aqueous space. The end product is a stable (can be boiled in detergent), solid nanoparticle. Once swallowed, the cochleate passes naturally through the walls of the intestinal tract. After being absorbed, scavenger immune cells that ingest foreign particles, such as macrophages, engulf the cochleate. Once engulfed by the macrophage, the cochleate enters the cytoplasm, an environment of low-calcium concentration inside the cell. The cochleates have been designed to unroll in intracellular low-calcium environments and purposefully release the drug on the inside of the macrophage, protecting the body from the toxic drug. In infected individuals, macrophages then follow a signal-molecule trail through the lymphatic vessels directly to the site of infection and deliver the drug precisely where it is needed.

The Company’s lead drug candidates are being developed in collaboration with the National Institutes of Health’s (NIH’s) National Institute of Allergy and Infectious Diseases (NIAID), which have been an integral part of all preclinical and clinical work conducted to date and provide independent scientific validation of the potential for this platform. MAT2203, an orally-administered, encochleated formulation of amphotericin B, is set to commence a Phase 2a study, funded and led by the NIAID, in patients with refractory mucocutaneous candidiasis in 2015, with data expected in 2016. Also in 2015, Matinas BioPharma plans to file an investigational new drug application (IND) for MAT2501, an encochleated formulation of amikacin, a broad spectrum aminoglycoside antibiotic used to treat gram negative bacterial infections.

On top of the improved clinical profile made possible by this technology, in assessing the unique opportunity of Matinas BioPharma one must also consider the associated health economic impact as a result of delivering potent medicines using cochleates. With the potential of successfully transitioning the standard of care from the IV-administration of drugs to orally available medications (something that has proved quite challenging to many anti-infective companies), on top of improved safety and efficacy, there are enormous savings to be achieved through reduced hospital stays and the reduction or elimination of the need for frequent blood tests. The improvement in the quality of life for patients, many of whom are immuno-compromised and require long term care, by providing the availability of oral drug therapy in the comfort of one’s home is another reason why Matinas BioPhama has the potential to have a transformational impact on the future of drug delivery for numerous medicines.

Beyond these lead clinical programs, promising preclinical and Phase I data, combined with the broad applicability of this delivery platform, indicates potential success in reformulating many drugs to take advantage of the oral bioavailability, improved safety and targeted delivery made possible using cochleates. Work has being conducted with anti-virals (ability to attack reservoirs), anti-inflammatories (no lesions in preclinical animal studies) and vaccines (significant improvement on traditional flu vaccines) and the Company has the potential eradication of diseases like HIV, tuberculosis and other infectious diseases in its sights. Unlike many binary biotech product plays, there seems to be no shortage of “what’s next” when considering downstream applications and products utilizing Matinas BioPharma’s proprietary cochleate technology.