EV Biologics Designs Process for Scalable Exosome Biopharmaceutical Manufacturing

Rhea-AI Summary

EV Biologics Corp (OTC PINK: YECO) has approved a scalable biomanufacturing plan for exosome biopharmaceuticals during its Q1 R&D meeting. The company aims to establish a cGMP process utilizing optimized producer cells for extracellular vesicle (EV) production. CEO Daniel Mckinney emphasized that this initiative will facilitate reliable production for clinical studies. The company plans to initiate preclinical studies of its exosome candidates in Q4 2021. With 7.22 million shares outstanding and a float of 1,016,375 shares, EV Biologics is positioning itself in the biopharmaceutical market.

Positive

• Approval of a scalable biomanufacturing plan for exosome biopharmaceuticals.
• Collaboration with major biotech companies for cGMP bioprocessing.
• Initiation of preclinical studies for exosome candidates expected in Q4 2021.

Negative

• Reliance on third-party collaborations could pose execution risks.
• Market competition in the burgeoning biopharmaceutical sector may challenge growth.

NASHVILLE, TN / ACCESSWIRE / February 22, 2021 / EV Biologics Corp, (OTC PINK:YECO), today announced that during its Q1 R&D meeting, the executive board reviewed and has approved a plan for cGMP process development and scalable biomanufacturing of exosome biopharmaceuticals.

EV Biologics has designed a modular process for production of extracellular vesicles (EVs) with native therapeutic properties, beginning with optimized producer cells. The Company has been in talks with several major biotechnology and pharmaceutical manufacturing companies to develop cGMP bioprocessing and enable large-scale EV biomanufacturing based on this process.

EV Biologics CEO, Daniel Mckinney said "establishing a scalable, standardized, EV manufacturing process is just the beginning of our therapeutic exosome development initiative. This process will allow us to reliably produce and study both native exosomes and those engineered specifically for our selected clinical indications."

"Our EV production process, comprising automated modular systems for continuous bioprocessing, will standardize production of therapeutic exosomes for preclinical study. A rigorous biomanufacturing protocol will be essential in preparation of regulatory submissions for our investigational exosome biopharmaceuticals," said Dr. Jason Sanders, Chief Medical Officer, EV Biologics.

EV Biologics aims to begin preclinical studies of its first exosome biopharmaceutical candidates in Q4 2021.

The Company has recently updated its website with an EV News section highlighting developments in scientific and clinical research around the world. Please visit: https://www.evbiologics.com/updates/

Exosomes

Exosomes are nano-sized vesicles that serve as mediators for cell-to-cell communication. With their unique nucleic acids, proteins, and lipids cargo compositions that reflect the characteristics of producer cells, exosomes can be utilized as cell-free therapeutics. - Cells, 2020

The intrinsic properties of exosomes in regulating complex intracellular pathways has advanced their potential utility in the therapeutic control of many diseases, including neurodegenerative conditions and cancer. Exosomes can be engineered to deliver diverse therapeutic payloads, including short interfering RNAs, antisense oligonucleotides, chemotherapeutic agents, and immune modulators, with an ability to direct their delivery to a desired target. - Science, 2020

EV Biologics Corp.

EV Biologics (formerly Yulong Eco-Materials Limited) is a Wyoming, USA domiciled Biotechnology Company based in Nashville, TN, intent on bringing human mesenchymal stem cell "MSC" exosomes and other progenitor cell-derived products to market in the biopharmaceutical and cosmeceutical spaces. Initially, these novel products will be specifically provided to the international clinical research community, including universities and academic physicians, and will target advanced applications in the aesthetic and regenerative medicine markets. Using proprietary and patentable technologies, the Company is creating exclusive IP and IT inherent in these superior biological products. Further product development will be focused on investigation of novel stem cell exosome biopharmaceuticals designed and engineered for specific clinical conditions.

Please visit www.evbiologics.com

Forward-Looking Statements

This press release contains forward-looking statements, particularly as related to, among other things, the business plans of the Company, statements relating to goals, plans and projections regarding the Company's financial position and business strategy. The words or phrases "plans," "would be," "will allow," "intends to," "may result," "are expected to," "will continue," "anticipates," "expects," "estimate," "project," "indicate," "could," "potentially," "should," "believe," "think," "considers" or similar expressions are intended to identify "forward-looking statements." These forward-looking statements fall within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934 and are subject to the safe harbor created by these sections. Actual results could differ materially from those projected in the forward-looking statements as a result of a number of risks and uncertainties. Such forward-looking statements are based on current expectations, involve known and unknown risks, a reliance on third parties for information, transactions or orders that may be cancelled, and other factors that may cause our actual results, performance or achievements, or developments in our industry, to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from anticipated results include risks and uncertainties related to the fluctuation of local, regional, and global economic conditions, the performance of management and our employees, our ability to obtain financing, competition, general economic conditions and other factors that are detailed in our periodic reports and on documents we file from time to time with the Securities and Exchange Commission. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date, and the Company specifically disclaims any obligation, to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.

YECO has 7.22 million shares issued and outstanding with a float of 1,016,375 shares.

Contact:

Dennis Burns
Investor Relations
Tel(567) 237-4132
dburns@nvestrain.com

SOURCE: EV Biologics Corp.

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FAQ

What is the recent development from EV Biologics Corp regarding exosome biopharmaceuticals?

EV Biologics Corp has approved a scalable biomanufacturing process for exosome biopharmaceuticals.

When does EV Biologics plan to start preclinical studies for its exosome products?

Preclinical studies for its first exosome biopharmaceutical candidates are expected to begin in Q4 2021.

What are the potential benefits of EV Biologics' new biomanufacturing process?

The new biomanufacturing process aims to standardize production and improve the reliability of therapeutic exosomes for clinical studies.

What is the significance of cGMP in EV Biologics' manufacturing process?

cGMP ensures that the biomanufacturing process adheres to quality standards necessary for producing pharmaceutical products.

How many shares are outstanding for EV Biologics Corp?

EV Biologics Corp has 7.22 million shares issued and outstanding.