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Mosaic ImmunoEngineering Announces Issuance of U.S. Patent Covering Cancer Treatment with Its Lead Immuno-Oncology Candidate MIE-101

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- Issued patents include important claims covering methods of treating cancer using MIE-101 as a single agent or in combination with other treatment modalities -

- MIE-101 has demonstrated potent, durable, and systemic antitumor activity in multiple preclinical tumor models and in naturally occurring canine tumors -

NOVATO, CA / ACCESSWIRE / April 11, 2023 / Mosaic ImmunoEngineering, Inc. ("Mosaic" or the "Company"), (OTCQB:CPMV), a development-stage biotechnology company focused on the development of novel immunotherapies to treat and prevent cancer, today announced that the US Patent and Trademark Office (USPTO) has issued an additional patentto protect the technology behind Mosaic's lead immuno-oncology product candidate, MIE-101. Co-inventors of the newly patented technology include Mosaic co-founders Nicole F. Steinmetz, Ph.D., professor of NanoEngineering and director of the UC San Diego Center for Nano-ImmunoEngineering, and Steven N. Fiering, Ph.D., professor of microbiology and immunology at the Dartmouth Geisel School of Medicine.

"These patents provide important protection for the continued development of our lead immunotherapy candidate, MIE-101, derived from CPMV, and is a key component of our intellectual property covering the use of this first-in-class immune stimulant to fight cancer," said Steven King, president and chief executive officer of Mosaic. "The patents together add significant value to our intellectual property portfolio as we continue to advance our lead program. We look forward to continuing to translate the research of Mosaic co-founders Drs. Steinmetz and Fiering toward clinical development in humans and for the treatment of companion animals with cancer."

U.S. Patent No. 11,617,787 was recently issued to Case Western Reserve University ("CWRU") and Dartmouth College. The new patent builds on the key U.S. patent issued in 2022, U.S. Patent No. 11,260,121, which is the foundation of the patent portfolio in the United States. Both patents are covered under an exclusive worldwide license agreement between Mosaic and CWRU, granting the Company the exclusive rights to the technology.

The claims of both patents include methods of treating cancer by administering a plant-derived viral nanoparticle, known as cowpea mosaic virus (CPMV), directly into solid tumors, such as by intratumoral injection or by inhalation, in the case of lung cancer. U.S. Patent No. 11,260,121 broadly covers the treatment of human and animal patients, whereas U.S. Patent No. 11,617,787 is specifically directed to veterinary treatment. The claims of both patents cover the administration of CPMV either as a single agent therapy, or in combination with other treatments to a patient suffering from primary or metastatic cancer. Combination regimens broadly include the administration of CPMV with radiation, chemotherapy and immunotherapy.

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 colon. Unlike experimental intratumoral treatments intended to utilize viruses to directly invade and destroy cancer cells, known as oncolytic viruses, MIE-101 represents a novel approach to cancer treatment. MIE-101 has been shown to engage multiple pattern-recognition receptors 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 in canine companion animals with naturally occurring tumors. MIE-101 has also demonstrated enhanced antitumor effects when combined with immune checkpoint treatments and other standard cancer therapies.

About Mosaic ImmunoEngineering, Inc.
Mosaic ImmunoEngineering, Inc. is a development-stage biotechnology company focused on the development of 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 intratumoral 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 and co-founders at the UC San Diego Center for Nano-ImmunoEngineering and Dartmouth College. 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 of: raising sufficient capital or grant funding to advance these product candidates, which may not be available on favorable terms or at all; maintaining the rights to the licensed technology and complying with the underlying terms of the license agreement; advancing Mosaic's lead product into clinical trials, the clinical development and regulatory approval of Mosaic's product candidates, including potential delays in the commencement; initiation, 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

Strategic corporate inquiries can be sent to partnering@mosaicie.com

SOURCE: Mosaic ImmunoEngineering Inc.



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