Newly Published Preclinical Data Highlight Broad Immune Activation of Mosaic ImmunoEngineering’s Lead Intratumoral Immunotherapy Candidate, MIE-101

  • Results Demonstrate Innate Immune System Activation Through Stimulation of Three Toll-Like Receptors (TLRs 2,4,7)
  • MIE-101 Therapy Reduced Tumor Growth by 80% Compared to Tumors Treated with Agents Targeting TLRs 2 and 4 or TLR 7 Alone

NOVATO, CA / ACCESSWIRE / June 29, 2021 / Mosaic ImmunoEngineering Inc. ("Mosaic" or the "Company"), (OTCQB:CPMV), a development-stage biotechnology company focused on immunotherapies to treat and prevent cancer and infectious diseases through innate and adaptive immune activation, today announced a new preclinical publication available online in the journal Biomaterials that further expand the understanding of the antitumor potency and mechanism of action of the Company's lead immuno-oncology candidate, MIE-101, (cowpea mosaic virus, CPMV) a novel Toll-like receptor (TLR) tri-agonist.

"Most intratumoral TLR agonists in development engage a single TLR. Our studies demonstrate an increase in immune activation and antitumor effects by engaging three TLRs with our single treatment candidate, MIE-101. These mechanistic insights help explain the breadth and consistency of antitumor results observed in these and prior studies evaluating MIE-101 as a single agent and in combination with standard cancer treatments in multiple tumor models and in different species," said Nicole F. Steinmetz, Ph.D., acting chief scientific officer of Mosaic. "The intratumoral administration of MIE-101 thus holds immuno-stimulatory advantages over agents that target a single TLR. Moreover, the size and physical structure of MIE-101 may also prove advantageous versus small-molecule TLR agonists by mediating optimal tumor coverage and sustained intratumoral retention."

The publication entitled, "Cowpea mosaic virus stimulates antitumor immunity through recognition by multiple MYD88-dependent toll-like receptors," details specific signaling pathways and anti-tumor immune stimulation induced by MIE-101 measured in both in vitro and in vivo studies. The data confirm that MIE-101 activates TLRs 2, 4 and 7 on immune cells capable of initiating and sustaining innate and adaptive antitumor effects. The studies also characterize immune stimulation following activation of these TLRs both individually and collectively. Results show that stimulation of TLRs 2 and 4 by MIE-101 is effective in the production of cytokines and chemokines that support the attraction and activation of immune cells to mount antitumor responses. However, the additional engagement of TLR 7 further increases these immune effects through the induction of Type I interferons (IFNs), which are known to activate and maintain T cells and B cells with the ability to recognize and fight both the primary treated tumor as well as distant untreated metastases.

In the preclinical studies, groups of mice challenged with highly aggressive B16F10 melanoma cells were administered different intratumoral TLR activating treatments or combinations. One group received Mosaic's first-in-class TLR tri-agonist, MIE-101, which engages TLRs 2, 4, and 7. A second group was administered a similar agent, eCPMV, that engages only TLRs 2 and 4. A third group received a single TLR agonist, R848, that engages TLR 7 alone. Measurements at the end of the study showed that tumors in the MIE-101-treated group that targeted TLRs 2, 4 and 7 were approximately 80% smaller as compared to tumors in the TLR 2 and 4-targeted group and in the TLR 7-targeted group. Additionally, MIE-101 treated tumors were approximately 70% smaller than tumors treated with a combination of agents (eCPMV+R848) that collectively target the same three TLRs.

Researchers also measured MIE-101's properties in both mouse and in human immune cells in vitro. Importantly, the results showed similar immuno-stimulatory effects in both groups. These data support the current understanding of the conservation of TLRs and their functions across mammalian species and may help to inform Mosaic's clinical development plans.

"These recent data confirm our lead candidate's position in the growing and promising field of intratumorally-administered immune stimulants designed to initiate and sustain antitumor effects, both locally and systemically. The results also differentiate the mechanism of our core technology platform through the stimulation of multiple TLRs, demonstrating the potential of MIE-101 to increase the potency of antitumor immune activation," said Steven King, president and chief executive officer of Mosaic. "We look forward to additional updates as we prepare for discussions with regulatory agencies with the goal of filing an Investigational New Drug (IND) or similar application in 2022."

About Toll-Like Receptors
Toll-like receptors (TLRs) are proteins found on the surface and interior of host immune cells that play a fundamental role in initiating immune responses by recognizing molecular patterns common to viruses, bacteria and other foreign microbes. Originally discovered in the 1980s, TLRs have proven to be an important and highly conserved first line of immune defense across mammalian species. In recent years, molecules that stimulate TLRs have demonstrated efficacy in multiple tumor models by activating immune cells to better recognize and fight cancer. The intratumoral administration of TLR agonists, a strategy called "in situ vaccination", has become an active area of research and product development in oncology with several treatment candidates showing promise in clinical trials.

About MIE-101
Mosaic's lead therapeutic candidate, MIE-101, is derived from the cowpea mosaic virus (CPMV), a plant virus that does not infect humans or animals, but can stimulate both innate and adaptive immune responses, as shown in multiple preclinical models of cancer, including melanoma, breast, ovarian, brain and lung. Unlike experimental intratumoral treatments intended to utilize viruses to directly invade and destroy cancer cells, known as oncolytic viruses, MIE-101 represents a different approach to cancer treatment. MIE-101 has been shown to engage multiple receptors (the aforementioned TLRs) on host immune cells in the tumor that have evolved to detect foreign invaders. Preclinical studies have demonstrated that these immune cells then attack the tumor, while also producing molecules that attract, activate and train additional immune cells to recognize and fight the tumor that was directly treated as well as attacking tumors in other areas of the body. MIE-101 has demonstrated single agent activity in preclinical tumor models and enhanced antitumor effects when combined with immune checkpoint inhibitors and other standard cancer therapies.

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, MIE-101, for the treatment of many different types of cancer and potential combination therapies continues 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 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 (NIAID). For additional information about Mosaic, please visit MosaicIE.com.

Forward-Looking Statements
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; 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 advance these product candidates, which may not be available on favorable terms or at all; advancing Mosaic's multiple products 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 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.

Contact:
Jay Carlson
Sr. Manager, Investor Relations
Mosaic ImmunoEngineering Inc.
info@mosaicie.com

SOURCE: Mosaic ImmunoEngineering Inc.


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