On November 10, 2022 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug development company, and Acuitas Therapeutics, a private biotechnology company focused on the development of delivery systems for nucleic acid vaccines and therapeutics based on lipid nanoparticles (LNP), reported the signing of an agreement to evaluate the combination of IMUNON’s PLACCINE nucleic acid vaccine constructs formulated with Acuitas’ proprietary lipid delivery technology (Press release, IMUNON, NOV 10, 2022, View Source [SID1234623819]). Under the agreement, IMUNON will evaluate administration of its vector constructs formulated in various Acuitas LNP formulations for gene expression and immunogenicity in murine models.

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"We are delighted to enter into this technology evaluation agreement with Acuitas Therapeutics, an organization renowned for its delivery technology capabilities, particularly with its LNP systems for mRNA vaccines," said Corinne Le Goff, Ph.D., President and Chief Executive Officer of IMUNON. "In light of the recent successes with our PLACCINE technology and promising proof-of-concept SARS CoV-2 data in non-human primates, we believe the time is right to explore the expansion of our technology to other types of delivery systems as we position our nucleic acid-based modality as the future of vaccinology."

IMUNON has demonstrated initial proof-of-concept of its PLACCINE nucleic acid vaccine platform in rodent and non-human primate models through intramuscular (IM) administration of PLACCINE plasmid DNA constructs expressing single or multiple SARS-CoV-2 antigens in combination with the PLACCINE delivery system. In October 2022, IMUNON reported partial results from an ongoing non-human primate study that examined a single plasmid DNA vector containing the SARS-CoV-2 Alpha variant spike antigen formulated with a synthetic DNA delivery system. In the study, Cynomolgus monkeys were vaccinated with the PLACCINE vaccine or a commercial mRNA vaccine on Day 1, 28 and 84.

Analysis of blood samples for IgG and neutralizing antibodies showed evidence of immunogenicity in both PLACCINE- and mRNA-vaccinated subjects. PCR analysis of bronchoalveolar lavage showed viral clearance by >90% of the non-vaccinated controls. In a majority of vaccinated animals, viral clearance from nasal swab followed a similar pattern and a similar clearance profile was observed when viral load was analyzed by the tissue culture infectious dose method. In an ongoing stability study, the physio-chemical properties and immunogenicity of PLACCINE vaccine did not change during storage at 4° C for up to six months.

Thomas Madden, Ph.D., President and Chief Executive Officer and co-founder of Acuitas Therapeutics, said, "We are excited to collaborate with IMUNON to evaluate nucleic acid-based vectors delivered using our LNP technology."

Acuitas Therapeutics was founded by Drs. Pieter Cullis, Michael Hope and Thomas Madden, who in September 2022 received Canada’s Governor General’s Innovation Award. This prestigious award recognized their work in developing LNP systems to deliver cancer drugs to tumors and to enable RNA- and DNA-based drugs for therapeutic use. Among other achievements, their work resulted in the LNP system that enables COMRINATY, the Pfizer/BioNTech COVID-19 mRNA vaccine.

About the PLACCINE Platform

PLACCINE, part of IMUNON’s proprietary nucleic acid technology with synthetic delivery systems platform, is the subject of multiple patent applications that cover a broad range of next-generation nucleic acid vaccines. An adaptation of the Company’s TheraPlas technology for therapeutic proteins, PLACCINE is a modality for prophylactic vaccines characterized by a single nucleic acid vector with multiple coding regions. The vaccine vector is designed to express multiple pathogen antigens along with the option to include a potent immune modifier. PLACCINE has potential to be easily modified to create vaccines against a multitude of infectious diseases, with benefits including:

Durability of protection – Durable antigen expression induces robust immunological response
Breadth of protection – Multi-cistronic vectors increase the breadth of immune response and allows for combination vaccines
Transmission advantage – Option for co-expression of potent immune modifiers increases the immune response and lowers the risk of viral shedding
Safe and convenient – Synthetic delivery systems present no risk of genotoxicity (i.e., no virus or cytotoxicity) and require no device; it also allows for convenient handling for pandemic control
Flexible manufacturing – Versatile platform enables rapid response to changing pathogens; stability at normal refrigerator temperatures simplifies handling and distribution