Newly Published Data Further Support Mosaic ImmunoEngineering’s Lead Immuno-Oncology Candidate MIE-101 in Combination with OX40 Checkpoint Treatment in Melanoma

Rhea-AI Summary

Mosaic ImmunoEngineering's research reveals that inactivated Cowpea Mosaic Virus (inCPMV) combined with OX40 agonist antibodies elicits strong anti-tumor immunity, controlling tumor progression in a melanoma mouse model. The study, published in Molecular Pharmaceuticals, indicates that 70% of subjects survived for over 100 days without recurrence. This finding supports the potential of their lead candidate, MIE-101, to enhance responses to existing cancer therapies, addressing significant unmet medical needs in patient treatment.

Positive

• 70% survival rate of animals for over 100 days without tumor recurrence.
• Demonstrated synergy between inCPMV and OX40 agonist in tumor immunity.
• Potential for MIE-101 to improve outcomes for patients unresponsive to current treatments.

Negative

• None.

• Broad, durable, and systemic anti-tumor immunity observed using inCPMV with OX40 agonist antibodies
• Intratumoral inCPMV administration in combination with systemic anti-OX40 controlled the progression of the primary as well as secondary untreated tumors
• 70% of animals survived for at least 100 days post tumor challenge without development of recurrence or metastatic disease

NOVATO, CA / ACCESSWIRE / February 2, 2022 / Mosaic ImmunoEngineering, Inc. ("Mosaic" or the "Company"), (OTCQB:CPMV), a development-stage biotechnology company focused on bridging immunology and engineering to develop novel immunotherapies to treat and prevent cancer, today announced a new article published in the journal "Molecular Pharmaceuticals." Co-authors of the article include Mosaic co-founders Nicole F. Steinmetz, Ph.D., director of the UC San Diego Center for Nano-ImmunoEngineering, and Steven N. Fiering, Ph.D., professor of microbiology and immunology at the Geisel School of Medicine at Dartmouth University. The article, entitled, "Inactivated Cowpea Mosaic Virus in Combination with OX40 Agonist Primes Potent Antitumor Immunity in a Bilateral Melanoma Mouse Model," details broad immune activation of inactivated CPMV (termed inCPMV) and potent, systemic, and durable antitumor activity with the treatment combination in an aggressive two-tumor model of melanoma.

"Our studies demonstrate that intratumoral administration of inCPMV and systemic administration of an OX40 agonist antibody generates potent systemic antitumor immunity," said Dr. Steinmetz. "We observed that synergistic efficacy can be achieved through a combination of inCPMV with an OX40 agonist. InCPMV activates the innate immune system and reprograms the tumor microenvironment leading to processing of tumor-associated and neoantigens, therefore leading to adaptive anti-tumor immunity by T cells. The OX40 agonist further promotes T cell activation."

Data showed reduced tumor burden, prolonged survival, and induced tumor antigen-specific immunologic memory to prevent relapse - most importantly, systemic activity and abscopal effect was observed in a two-tumor melanoma mouse model.

"Tumor growth was controlled over the 100-day study with 10 out of 14 animals surviving; notably the survivors were tumor-free with no palpable tumors and no signs of metastatic disease," Steinmetz added.

These results extend earlier published data demonstrating immune activation and synergistic antitumor activity utilizing wild-type CPMV (MIE-101) in combination with an OX40 agonist antibody. Studies showed most animals surviving tumor challenge in the aggressive B16F10 melanoma model, with all survivors also demonstrating immunity to rechallenge. The combination treatment also showed efficacy in colon and ovarian cancer mouse models.

"These data further support the rationale for combining our lead immuno-oncology product candidate, MIE-101, with antibodies targeting OX40 which are currently showing promise in clinical development for the treatment of cancer. The potential of MIE-101 to turn immunologically cold tumors hot could allow checkpoint treatment approaches such as OX40 agonists to be effective in more patients who do not currently respond." said Steven King, president and chief executive officer of Mosaic. "Checkpoint targeted treatments have shown promising and durable results in melanoma patients, yet there remains a significant unmet medical need because only a minority of patients receive the full potential clinical benefit to currently approved therapies. These results published by Mosaic's co-founders reinforce our goal to continue identifying strategic partners to work with us as we advance MIE-101."

New Publication

Edward C Koellhoffer, Chenkai Mao, Veronique Beiss, Lu Wang, Steven N Fiering, Christine E Boone, Nicole F Steinmetz (2022) Inactivated Cowpea Mosaic Virus in Combination with OX40 Agonist Primes Potent Antitumor Immunity in a Bilateral Melanoma Mouse Model. Mol Pharm 2022 Jan 3.

Prior CPMV / anti-OX40 Published Data

Wang C. and Steinmetz N.F. (2020) A Combination of Cowpea mosaic virus and Immune Checkpoint Therapy Synergistically Improves Therapeutic Efficacy in Three Tumor Models. Advanced Functional Materials, 04 May 2020.

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 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 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 and co-founders at the UC San Diego Center for Nano-ImmunoEngineering. In addition, the core technology has a potential application as part of a Modular Vaccine Platform (MVP) that has already generated promising data in both cancer and infectious disease preclinical models, including COVID-19. The COVID-19 vaccine research is currently being performed by our co-founders and was funded by the National Science Foundation. 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; the risks associated with cold-chain requirements for each potential product; the timing of rapid development may take significantly longer than anticipated; the ease of administration may not be achieved; 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; 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 inquires can be sent to partnering@mosaicie.com.

SOURCE: Mosaic ImmunoEngineering Inc.

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FAQ

What are the key findings from Mosaic ImmunoEngineering's recent publication regarding CPMV and OX40 treatment?

The study shows that the combination of inCPMV and OX40 agonist antibodies induces broad anti-tumor immunity, successfully controlling tumor progression in a melanoma mouse model.

How does the combination of inCPMV and OX40 agonist affect cancer treatment?

The combination enhances systemic immune response, potentially allowing for effective treatment in previously unresponsive tumors.

What is MIE-101 and its significance in cancer therapy?

MIE-101 is Mosaic's lead candidate derived from CPMV that has shown promising anti-tumor activity in preclinical studies, particularly when combined with existing therapies.

When was the new data regarding CPMV and OX40 agonist published?

The new data was published on February 2, 2022.

What type of animal model was used to test the inCPMV and OX40 agonist combination?

The studies utilized a bilateral melanoma mouse model to assess the treatment's efficacy.