Plasmid-Cochleate formulations show promise as commercially viable effective oral and systemic vaccines

BEDMINSTER, NJ, USA I April 24, 2017 I Matinas BioPharma Holdings, Inc. (NYSE MKT:MTNB), a clinical-stage biopharmaceutical company focused on developing innovative anti-infectives for orphan indications, announced today that it presented positive preclinical data at the 27th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), being held April 22-25, 2017 in Vienna, Austria.

Raphael Mannino, Ph.D., Chief Scientific Officer of Matinas, presented the abstract (No. 6782) entitled, “Efficacious and Commercially Viable DNA Vaccines: Plasmids Formulated into Lipid-Crystal Nano-Particles for Oral and Systemic Immunization,” on Sunday, April 23, 2017 as a part of the “Immunity and Immunogenetics of Infections” session.

The use of DNA plasmids for protective and therapeutic vaccination continues to advance, however there still exists a need for safe, efficient and effective DNA vaccine formulations, and a delivery technology that is cost effective and commercially viable. This preclinical study evaluated Matinas’ proprietary, disruptive technology, which utilizes lipid-crystal nano-particle cochleates to nano-encapsulate oligonucleotides, making them safer, more tolerable, less toxic and orally bioavailable, as a potential solution for DNA plasmid delivery.

This preclinical study evaluated the oral or intramuscular injection administration of encochleated formulations of plasmid pCMV HIV-1 containing 3.5µg or 17µg of DNA, given to BALB/c mice. Investigators observed that oral administration of two 3.5µg or 17µg doses yielded strong splenocyte cytolytic responses (73 to 85% specific lysis at an E:T ratio of 100:1) analogous to intramuscular injection. Oral administration of a higher dose (50µg) of naked DNA, was inactive. Low doses (3.5µg) of orally administered encochleated DNA induced antigen specific splenocyte proliferation 8-11 fold above background, similar to intramuscular. Naked plasmid was negative. In an additional preclinical study, mice were immunized intramuscularly with HSV-2 gD2 DNA, 25µg/dose, (pc DNA 3.1 vector backbone) and two IL12 plasmids (equal mixture of the p35 and p40 subunits), 35µg/dose. From this study, investigators observed that the encochleation of gD and IL-12 plasmids induced 2X greater HSV-specific cytolytic T cell responses than Herpes infection, as well as enhancement of T helper 1 cellular responses and antibody. These studies affirmed that co-administration of cytokines can enhance the immunogenicity of a DNA-based vaccine. Naked DNA was inactive.

This preclinical research was led by Dr. Mannino and Ruying Lu of Matinas BioPharma.

Dr. Mannino commented, “Our cochleate technology has proven to be a uniquely stable, multilayered, essentially anhydrous lipid-crystal nano-particle that, following either oral or systemic delivery, safely and efficaciously delivers drugs and oligonucleotides to target tissues. The data from this study showed that cochleates successfully formulate and mediate in vivo delivery and efficacy of potential oligonucleotide based therapies, including DNA plasmids, and show promise as a commercially viable effective formulation for DNA vaccination and DNA plasmid delivery.”

About Matinas BioPharma

Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing innovative anti-infectives for orphan indications. The Company’s proprietary, disruptive technology utilizes lipid-crystal nano-particle cochleates to nano-encapsulate existing drugs, making them safer, more tolerable, less toxic and orally bioavailable.

The Company’s lead anti-infective product candidates, MAT2203 and MAT2501, position Matinas BioPharma to become a leader in the safe and effective delivery of anti-infective therapies utilizing its proprietary lipid-crystal nano-particle cochleate formulation technology. For more information, please visit www.matinasbiopharma.com and connect with the Company on Twitter, LinkedIn, Facebook, and Google+.

SOURCE: Matinas BioPharma