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EV Biologics to Develop a Cell Biologics Incubator Lab

EV Biologics recently announced their intentions to build an incubator laboratory for the development of cell and extracellular vesicle (EV) based therapeutics.

The lab will be equipped for the development of a series of young new cells (naïve) and bioengineered cell lines including, mesenchymal stem cells (MSCs) and other progenitor cells. Isolated MSC-EVs have demonstrated remarkable and distinctive biological properties that the Company intends to develop into safe and effective clinical therapeutics.

The Company is also developing methods to optimize and use the unique biological properties of MSC and progenitor cell-derived EVs for specific clinical applications.

EV Biologics’ Chief Executive Officer, Daniel Mckinney, said that they are aggressively developing an R&D program for biopharmaceuticals as they also prepare for submission of INDs to the FDA.

EV Biologics is also currently negotiating with various stem cell companies under an acquisition.

(Source: Yahoo Finance, 2020)

Direct Biologics Commences Its Phase II EXIT COVID-19 Clinical Trial.

Direct Biologics,a dedicated regenerative medical product developer and manufactured recently announced the commencement of its  EXIT COVID-19,Phase II, multi-center clinical trial which examines the use of ExoFlo™ extracellular vesicles to treat COVID-19 associated acute respiratory distress syndrome (ARDS). 

The clinical trial enrolled 75 COVID-19 patients with moderate-to-severe ARDS at multiple research sites across the United States. The primary efficacy goal will be all-cause mortality and median days to recovery.

Direct Biologics’ Chief Executive Officer and Co-founder, Mark Adams said that they are excited to start enrolling patients in the study and looks forward to seeing the outcomes. 

(Source: PR Newswire, 2020)

Diomics Aims to Lead COVID-19 Race With Nasal Spray That Offers Monoclonal Antibody Protection.

Diomics aims to lead the race to find a treatment against COVID-19 by using nanosized biopolymer beads to deliver monoclonal antibody protection against COVID-19 through a nasal spray.

The nasal spray called Dioguard prophylactic spray is currently undergoing in vitro testing, pairs Diomics’ proprietary synthetic biopolymer material with human IgG monoclonal antibodies.

The target is to create a durable barrier of antibodies in the nasal cavity to capture, bind to, and neutralize the SARS-CoV-2 virus before it can reach and enter the cells that cause infection.

Creating a barrier that blocks the virus at its crucial first point of entry into the body which are the nasal passages, fills a huge void in the race to develop an effective vaccine for COVID-19.

Since both human monoclonal antibodies and Diomics’ biocompatible, bioresorbable Diomat polymer have already received FDA approval for other applications they hope to seek fast track authorization to accelerate human trials.

(Source: Business Wire, 2020)