EV Biologics Signs LOI with Lonza Cell & Gene Therapy

Rhea-AI Summary

EV Biologics Corp. (OTC PINK: YECO) has signed a Letter of Intent with Lonza Cell & Gene Therapy for process development in biomanufacturing a novel therapeutic composition. This includes extracellular vesicles and factors from mesenchymal stromal cells, enhancing their potential as cell-free therapeutics for various diseases. The collaboration aims to leverage Lonza's expertise in cGMP manufacturing, ensuring compliance with regulatory standards for future clinical trials. EV Biologics is focused on optimizing the therapeutic activity of stem cell-derived products to support preclinical research and advanced clinical applications.

Positive

• Partnership with Lonza enhances capabilities in biomanufacturing and regulatory compliance.
• Focus on extracellular vesicles positions the company within a growing sector of regenerative medicine.
• Potential to develop therapeutics that may address neurodegenerative diseases and cancer.

Negative

• Reliance on third-party partnerships for manufacturing could pose operational risks.
• Forward-looking statements indicate uncertainty and potential challenges in achieving projected goals.

NASHVILLE, TN / ACCESSWIRE / July 22, 2021 / EV Biologics Corp., (OTC PINK:YECO) today announced that it has signed a Letter of Intent (LOI) with Lonza Cell & Gene Therapy for Process Development and Gap Analysis for biomanufacturing of a novel therapeutic composition, comprising extracellular vesicles (EVs) and particles, as well as other secreted factors derived from selected stem/progenitor cells, such as mesenchymal stromal cells (MSCs).

Lonza is one of the leading global manufacturers serving the biotechnology and pharmaceutical industries. The Lonza Cell & Gene Therapy division is a leader in biopharmaceutical manufacturing and has invested in the development of EV production and purification processes.

EV Biologics CEO, Daniel Mckinney said 'As we continue to advance our objective to optimize the therapeutic activity of EVs, including exosomes engineered for specific clinical indications, partnering with Lonza will facilitate a seamless transition between our ongoing scientific and technical innovation and scalable cGMP manufacturing of cell-derived and exosome-based therapeutics for preclinical research and future clinical trials.'

'Lonza's deep expertise in cGMP process development and scalable biomanufacturing of Cell & Gene Therapies will help EV Biologics to meet and exceed the rigorous requirements of the regulatory agencies and readily scale our technology for clinical trials and future commercialization, upon regulatory approval,' said Dr. Jason Sanders, Chief Medical Officer, EV Biologics.

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, intent on developing and enhancing the intrinsic therapeutic activity of mesenchymal stromal cell (MSC) secreted factors, as well as targeted delivery of bioactive molecules using engineered exosomes. The company is working to optimize cell lines for production of native bioactive nanoparticles and to establish an exosome-engineering platform to enhance specific therapeutic activity. Initially, these novel regenerative products will be produced for preclinical research on a number of clinical indications. Using proprietary and patentable technologies, the Company is creating exclusive IP and IT inherent in these bioengineered products. Further product development will be focused on investigation of novel stem cell-derived biopharmaceuticals designed for specific clinical conditions.

Forward-Looking Statements

This news 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

For more information on EV Biologics please visit:

www.evbiologics.com

SOURCE: EV Biologics Corp.

View source version on accesswire.com:
https://www.accesswire.com/656634/EV-Biologics-Signs-LOI-with-Lonza-Cell-Gene-Therapy

FAQ

What is the significance of the LOI signed by EV Biologics with Lonza?

The LOI facilitates collaboration in biomanufacturing, enhancing EV Biologics' capabilities for developing novel therapeutics.

What are the expected benefits of the partnership between YECO and Lonza?

The partnership aims to leverage Lonza's expertise to ensure compliance with regulatory standards and support scalable production for clinical trials.

What therapeutic areas is EV Biologics focusing on?

EV Biologics is concentrating on developing therapies targeting neurodegenerative diseases and cancer through extracellular vesicles technology.

What does the LOI mean for the future of EV Biologics?

The LOI indicates a strategic move to enhance EV Biologics' manufacturing capabilities, potentially leading to successful clinical applications.