-Preclinical Data Published in Peer Reviewed Journals Support Advancing the Program into Human Clinical Trials-
-Company Plans to Initiate Discussions with Regulatory Agencies in Early 2021 to Review Its Strategy for IND or Equivalent Filing-
-Data Generated in Companion Animals with Naturally Occurring Tumors Support Potential Veterinary Applications-
NOVATO, CA / ACCESSWIRE / December 14, 2020 / Mosaic ImmunoEngineering Inc., (the "Company" or "Mosaic") (OTC PINK:PTSCD), a development-stage biotechnology company focused on bridging immunology and engineering to develop novel immunotherapies to treat and prevent cancer and infectious diseases, today provided an overview of its lead immuno-oncology candidate MI-O-101. The Company is prioritizing advancing the program to an Investigational New Drug application ("IND") or equivalent that would support a Phase I clinical trial in multiple cancer types. The company plans to initiate discussions with regulatory agencies in early 2021 in order to review its regulatory strategy for advancing the program for the treatment of cancer in humans while it continues to evaluate options for advancing the technology for veterinary applications in companion animals.
MI-O-101 is an experimental intra-tumoral immunotherapy agent designed to stimulate innate immune cell receptors to turn immunologically "cold" tumors "hot", thus making tumors more susceptible to attack by additional cells of the immune system. Importantly, preclinical experiments have demonstrated potent anti-tumor effects when MI-O-101 is given as a monotherapy and this activity is further enhanced when given in combination with current standard cancer treatments including radiation, chemotherapy and immune-checkpoint inhibitors across multiple tumor types. The technology platform has also demonstrated anti-tumor effects in naturally occurring cancer in canines.
MI-O-101 is based on cowpea mosaic virus ("CPMV") which is a plant virus that does not infect or replicate in human cells. Unlike oncolytic viruses that are tumor type specific because they rely on infecting and killing particular types of cancer, MI-O-101 is not specific to any tumor type. Rather, preclinical data indicate that MI-O-101 is able to induce an innate immune response upon intra-tumoral delivery. The molecular structure of CPMV is recognized as foreign by pattern recognizing receptors (PRRs) such as Toll-like-receptors (TLRs) on immune cells that are present within different tumor types and across different species. Once activated, the innate immune cells within the tumor kill tumor cells resulting in exposure of tumor-associated antigens in the tumor microenvironment. It is believed that these antigens are then processed by tumor-infiltrating immune cells, triggering a cascade of events that lead to tumor-specific adaptive immunity. Preclinical data has further shown that localized intra-tumoral treatment with CPMV can facilitate systemic anti-tumor activity and immune surveillance, attacking distant untreated tumors and protecting from metastatic disease.
Research leading to the identification of MI-O-101 as an optimal candidate has been and continues to be supported by numerous grants awarded to Mosaic's co-founders' laboratories including grants from agencies such as The National Institutes of Health, The National Science Foundation, and Congressionally Directed Medical Research Programs, as well as private foundations, such as the American Cancer Society, Susan G Komen, and American Heart Association totaling more than $21 million. This research is continuing under grant funding and will allow the Company to potentially identify new uses and therapy combinations for the platform.
"Our data, gathered over years of investigating the intra-tumoral administration of CPMV, document the consistency of powerful immune stimulation and impressive anti-tumor effects in multiple preclinical cancer models as well as naturally occurring cancer in canine patients. The consistency of the data across species has furthered our enthusiasm for this novel therapeutic candidate. This includes recent data in which we demonstrate that CPMV stimulates human immune cells similarly to those in earlier preclinical models, further supporting the transition to human clinical trials." said Nicole F. Steinmetz, Ph.D., acting chief scientific officer of Mosaic. "These consistent results across multiple species support our hypothesis that CPMV engages evolutionary conserved pattern recognition receptors on immune cells that act as a first line of defense against foreign pathogens. I am excited to help lead this unique approach to cancer treatment into clinical development."
The Company is also evaluating regulatory pathways for advancing the program into veterinary applications based on results observed utilizing CPMV in canine oncology patients. Data regarding CPMV treatment of tumors in companion animals has been published and studies are ongoing. The Company expects additional data to be presented and published over the coming months.
"Immunotherapy has become the standard of care for many cancers and yet there remains a large and growing market opportunity to make existing immuno-oncology and other standard cancer treatments more effective in a greater percentage of patients. The collective data generated to date with our immuno-oncology platform support its potential for the treatment of multiple cancer types in combination with standard of care therapies including checkpoint inhibitors such as PD-1, radiation and chemotherapy," said Steven King, president and chief executive officer of Mosaic. "The potential of veterinary oncology applications is complimentary to the development of MI-O-101 in humans and could represent an early market opportunity that we are continuing to evaluate. We look forward to updating our stockholders as we advance the program through new data publications, upcoming presentations and new guidance resulting from our regulatory discussions."
Mosaic's lead therapeutic candidate, MI-O-101, is derived from the cowpea mosaic virus, or CPMV, a plant-based pathogen that is non-contagious to humans or animals and has demonstrated the ability to stimulate both innate and adaptive immune responses in multiple preclinical models of cancer, including melanoma, breast, ovarian, brain, lung and other tumors. Unlike experimental intra-tumoral treatments intended to utilize viruses to invade and destroy cancer cells, known as oncolytic viruses, MI-O-101 represents a different approach to cancer treatment. MI-O-101, through direct intra-tumoral administration, has been shown to engage multiple receptors on immune cells in the tumor which have evolved to detect foreign invaders. It is believed that those cells then induce the production of chemicals that attract, activate and train additional immune cells to recognize and fight the tumor that was directly treated as well as attacking metastatic tumors in other areas of the body. MI-O-101 has demonstrated single agent activity in preclinical tumor models, while also showing enhanced anti-tumor effects when combined with immune checkpoint inhibitors and other standard cancer therapies. The candidate has also shown benefits when used as an adjuvant to boost the therapeutic effects of both viral and cancer vaccines.
About Mosaic ImmunoEngineering Inc.
Mosaic ImmunoEngineering Inc. is a development-stage biotechnology company focused on bridging immunology and engineering to develop novel immunotherapies to treat and prevent cancer and infectious diseases. Mosaic's core technology platform is based on Cowpea Mosaic Virus ("CPMV") which is non-infectious to humans or other animals but upon intra-tumoral administration, elicits a strong innate immune response resulting in potent anti-tumor activity against the primary and distant tumor sites. The broad potential of our lead candidate, MI-O-101, for the treatment of many different types of cancer and potential combination therapies continue to be supported by numerous publications and grant funding through our university collaborators. In addition, the core technology has a potential application as part of a modular vaccine platform which has already generated promising data in both cancer and infectious disease in preclinical models, including COVID-19. The vaccine research is currently being performed by one of our co-founders and is funded by the National Science Foundation with viral neutralization testing being performed by the National Institute of Allergy and Infectious Diseases (or NIAID). For additional information about Mosaic, please visit MosaicIE.com.
Previously, Mosaic's common stock was quoted on the OTC Markets Pink tier under the trading symbol "PTSC." As of December 2, 2020, our common stock was quoted on the OTC Markets Pink tier under the symbol "PTSCD" for 20 business days, after which time the symbol will change to the Company's new trading symbol, CPMV.
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss Mosaic's future operations and its ability to successfully advance the product candidates into Phase I clinical trials ; the nature, strategy and focus of Mosaic's business; and the development and commercial potential and potential benefits of any of Mosaic's product candidates. Mosaic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on Mosaic's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of these forward-looking statements could differ materially from those described in or implied by the statements in this press release, including: the uncertainties associated with raising sufficient capital to support our lead candidate and the requirement for significant additional capital to advance its product candidates, which may not be available on favorable terms or at all; uncertainties of advancing Mosaic's lead candidate into clinical trials, the clinical development and regulatory approval of Mosaic's product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; the potential that earlier preclinical studies of Mosaic's product candidates may not be predictive of future results; risks related to business interruptions, including but not limited to, the outbreak of COVID-19 coronavirus, which could seriously harm Mosaic's financial condition and increase its costs and expenses. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risks discussed in Mosaic's filings with the Securities and Exchange Commission. Except as otherwise required by law, Mosaic disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether, as a result of new information, future events or circumstances or otherwise.
Jay Carlson, Investor Relations
Mosaic ImmunoEngineering Inc.
SOURCE: Mosaic ImmunoEngineering Inc.