Predictive Oncology Announces Significant Progress with FluGen In the Development of First-of-Its-Kind Intranasal Flu Vaccine

Rhea-AI Summary

Predictive Oncology Inc. announces a collaboration with FluGen to develop a first-of-its-kind intranasal flu vaccine, funded by a $6.2 million Phase 2B grant from the DoD. Predictive Oncology's biologics team will work on creating a stable and soluble formulation for the vaccine, addressing the need for longer shelf-life and global distribution. The project aims to enhance the stability of FluGen's M2SR flu vaccine, enabling advanced clinical trials and promising outcomes.

Positive

• Collaboration with FluGen to develop a groundbreaking intranasal flu vaccine.

• $6.2 million Phase 2B grant from the DoD supporting the project.

• Focusing on creating a stable and soluble formulation for the flu vaccine.

• Addressing the need for longer shelf-life and global distribution.

• Utilizing exceptional technology and leading scientists for the project.

• Promising outcomes expected for advanced and stable flu vaccine development.

Negative

• None.

Insights

Biotech Industry Analyst

As we dissect the latest update from Predictive Oncology, it's essential to consider the financial backbone surrounding such scientific endeavors. A grant of 6.2 million from the Department of Defense is not merely a financial boost but a stamp of credibility and trust in the project's potential. This influx of capital is expected to fuel the advanced phase of clinical trials, which is a pivotal stage in the developmental lifecycle of a new vaccine.

The biotech sector is highly responsive to advancements in clinical trials and the pursuit of a novel intranasal flu vaccine, particularly one backed by the DoD, can be seen as a harbinger of potential revenue streams for Predictive Oncology. The market for flu vaccines is competitive, but a product that can offer improved stability and a longer shelf-life could distinguish itself, hence potentially driving Predictive Oncology's market share and investor interest.

Medical Research Analyst

The stability and solubility of a vaccine formulation are not just scientific jargon but are critical to a vaccine's success. Predictive Oncology's focus on creating a stable, refrigerated formulation could revolutionize vaccine distribution, particularly in remote areas where logistics are challenging. From a medical standpoint, an intranasal vaccine represents a leap in administration methods, possibly improving public compliance and vaccination rates.

Investors should note the impact of this development. An accessible intranasal vaccine not only has the potential to disrupt the market but also to expand it significantly by simplifying the vaccination process. However, the long-term success hinges on clinical trial outcomes and the ability to scale production to meet global demand.

PITTSBURGH, April 30, 2024 (GLOBE NEWSWIRE) -- Predictive Oncology Inc. (NASDAQ: POAI), a leader in AI-driven drug discovery and biologics, announces a collaboration with FluGen to bring a first-of-its-kind intranasal flu vaccine to market, as part of a $6.2 million Phase 2B grant awarded by the United States Department of Defense (DoD).

“Predictive Oncology will play a critical role in helping to make our M2SR flu vaccine more stable and sustainable as we advance our clinical trials,” says Paul Radspinner, President & Chief Executive Officer of FluGen. “The project looks to hold tremendous promise.”

Through a proprietary design of experiments, the Predictive Oncology biologics team will be developing a formulation that is soluble and stable in a refrigerated state, which is a vital part in the drug development process. Most importantly, this addresses the need for a longer vaccine shelf-life to support global distribution including remote locations. Predictive Oncology’s biologics capabilities are uniquely suited to help achieve maximum stability, one of the initial critical milestones.

“We are excited to advance these efforts for an intranasal flu vaccine that will be unlike any other on the market,” notes Larry DeLucas, Senior Vice President of Biologics at Predictive Oncology. “Utilizing our exceptional technology and supported by our team of leading scientists, this work will allow FluGen to continue its clinical trials with greater potential to bring a more advanced and stable flu vaccine to patients.”

About Predictive Oncology
Predictive Oncology (NASDAQ: POAI) is on the cutting edge of the rapidly growing use of artificial intelligence and machine learning to expedite early drug discovery and enable drug development for the benefit of cancer patients worldwide. The company’s scientifically validated AI platform, PEDAL, is able to predict with 92% accuracy if a tumor sample will respond to a certain drug compound, allowing for a more informed selection of drug/tumor type combinations for subsequent in-vitro testing. Together with the company’s vast biobank of more than 150,000 assay-capable heterogenous human tumor samples, Predictive Oncology offers its academic and industry partners one of the industry’s broadest AI-based drug discovery solutions, further complimented by its wholly owned CLIA lab and GMP facilities. Predictive Oncology is headquartered in Pittsburgh, PA.

About FluGen:
FluGen, Inc. is a clinical-stage vaccine company transforming vaccine efficacy in infectious respiratory diseases. The company’s lead candidate is M2SR, a supra-seasonal, live, single-replication, intranasal flu vaccine. Unlike standard of care flu vaccines, M2SR stimulates mucosal, humoral, and cellular immunity. In an unprecedented challenge trial, M2SR demonstrated protection against infection and illness across seven years of virus drift; and M2SR induces a durable antibody response with potential to cover an entire flu season and beyond. M2SR also has shown activity as a vaccine vector for other respiratory vaccines and infectious diseases, including a COVID-19/flu combination. For more information about FluGen, Inc., please visit http://www.FluGen.com/.

Contacts: 
Predictive Oncology Inc. 
Theresa Ferguson, Senior Director of Marketing  
Phone: (630) 566-2003 
tferguson@predictive-oncology.com 

Predictive Oncology Investor Relations  
Tim McCarthy 
LifeSci Advisors, LLC.
tim@lifesciadvisors.com 

FluGen
Paul Radspinner
President & CEO
(608) 658-6095
pradspinner@flugen.com

Forward-Looking Statements: 
Certain matters discussed in this release contain forward-looking statements. These forward- looking statements reflect our current expectations and projections about future events and are subject to substantial risks, uncertainties and assumptions about our operations and the investments we make. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue and financial performance, projected costs, prospects, changes in management, plans and objectives of management are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “would,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our actual future performance may materially differ from that contemplated by the forward-looking statements as a result of a variety of factors including, among other things, factors discussed under the heading “Risk Factors” in our filings with the SEC. Except as expressly required by law, the Company disclaims any intent or obligation to update these forward-looking statements. 

Acknowledgements:
The U.S. Army Medical Research Acquisition Activity, 808 Schreider Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office.” This work was supported by The Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $6,237,445 through the Peer Reviewed Medical Research Program under Award Number (HT9425-24-1-0233). Opinions, interpretations, conclusions, and recommendations are those of the author(s) and are not necessarily endorsed by The Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense. In conducting research using animals, the investigator(s) adhere(s) to the laws of the United States and regulations of the Department of Agriculture.