Matinas BioPharma Holdings, Inc., a clinical-stage biopharmaceutical company, announced that it received a Notice of Allowance from the US Patent and Trademark Office (USPTO) for US Patent Application Serial No. 14/609,235 entitled, “Cochleates Made with Soy Phosphatidylserine.” Upon issuance, the patent will provide intellectual property protection through 2033.

The allowed patent claims cover proprietary methods related to the composition, methods, formulation and use of Matinas BioPharma’s lipid-crystal nano-particle cochleate formulation technology. The patent also includes pharmaceutical treatment of use claims for the company’s orally-administered lead anti-infective product candidates, MAT2203 (encochleated amphotericin B, a broad spectrum fungicidal medication) and MAT2501 (encochleated amikacin, a broad spectrum aminoglycoside antibiotic agent).

“Our novel method of preparing drug-loaded cochleates from soy-based phosphatidylserine produces cochleate delivery vehicles with vast potential as a broad-based technology for the delivery of a wide range of bioactive therapeutic products,” commented Roelof Rongen, president and chief executive officer. “Importantly, the purposefully designed bilayer structure of our proprietary cochleate platform has unique properties that have been shown to enhance oral bioavailability and targeted delivery of a wide array of biopharmaceutical formulations making them safer, more tolerable, less toxic and orally bioavailable.”

Jerome D. Jabbour, co-founder and chief business officer, said, “The issuance of this patent is a significant milestone for our intellectual property portfolio. In addition to providing protection related to the structure and production of our disruptive nano-encapsulation process, this patent specifically supports our proprietary pharmaceutical use of MAT2203 and MAT2501. These orally-delivered encochleated drug formulations of two very powerful anti-infective medicines and our unique cochleate bio-delivery platform technology have the potential to transform the way potent medicines are delivered and administered.”

As previously announced, Matinas is currently enrolling patients in its National Institutes of Health sponsored phase 2a study with MAT2203 for the treatment of refractory mucocutaneous candidiasis. The company also received US Food and Drug Administration clearance to initiate a phase 1 clinical study of MAT2501 for the treatment of non-tuberculous mycobacterium infections.

The company’s lipid-crystal nano-particle encapsulation technology was developed under the leadership of co-inventor, Dr. Raphael J. Mannino, Matinas BioPharma’s chief technology officer in collaboration with Rutgers, The State University of New Jersey, which has granted the company exclusive worldwide licenses under applicable patents. Based on the timing of this Notice of Allowance, Matinas BioPharma expects the forthcoming cochleate formulation patent to be issued in mid-2016.

MAT2203 is an orally-administered, encochleated formulation of amphotericin B (a broad spectrum fungicidal agent). Little to no clinical resistance has been reported to date with amphotericin B as compared to the rapidly emerging drug resistance seen in other antifungal therapies. Currently, IV-only administered amphotericin B is the only broad spectrum fungicidal available but its IV-delivery results in significant treatment-limiting side effects, including nephrotoxicity. The ability to provide amphotericin B via MAT2203's proprietary and novel oral formulation may offer a new and promising alternative for patients and doctors. In a clinical phase 1a single-dose, double-blind, dose-escalating, pharmacokinetic study of 48 healthy volunteers, oral MAT2203 demonstrated a positive safety and tolerability profile with no serious or dose-related adverse events reported, including little or no nephrotoxicity as compared to placebo. A phase 2a NIH/NIAID-funded clinical study with MAT2203 in patients with refractory mucocutaneous candidiasis commenced during the first quarter of 2016. MAT2203 is also being explored for treatment of additional anti-fungal indications and may have the potential for Orphan Drug designation in certain of these indications.

MAT2501 is an orally administered, encochleated formulation of the broad spectrum aminoglycoside antibiotic amikacin which may be used to treat different types of multidrug-resistant bacteria, including non-tubercular mycobacterial infections (NTM), as well as various multidrug-resistant gram negative and intracellular bacterial infections. Currently, amikacin cannot be absorbed enterally and must be given by intravenous, intramuscular or nebulization routes with the significant risk of nephrotoxicity and ototoxicity, which makes it an impractical choice when treating serious infections which often require long courses of therapy, often 12 to 18 months or longer. MAT2501, taking advantage of its disruptive, nano-encapsulation delivery technology, is being developed to provide an orally administered, safer and targeted therapy for improved treatment of these serious and life-threatening bacterial infections in patients, including those who are severely immunocompromised.