RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
Thinly traded nano cap GT Biopharma (OTCQB:GTBP +20%) is, yet another, would-be player in the rush to develop a drug to treat COVID-19.
This morning, it announced a collaboration agreement with contract development and manufacturing services provider Cytovance Biologics aimed at advancing a TriKE candidate for severe acute respiratory syndrome associated with SARS-CoV-2 infection, the coronavirus causing the current outbreak.
Under the terms of the deal, the companies will focus on producing enough product for preclinical studies using Cytovance’s E. coli-based Keystone Expression System. Production will be scaled up with Cytovance’s GMP microbial manufacturing platform for human trials.
TriKEs (Tri-specific NK cell Engager) are small single-chain fusion proteins that bind to a certain receptor on natural killer (NK) cells, eliciting a more durable and potent immune response. GT’s first TriKE candidate was GTB-3550 for the potential treatment of acute myeloid leukemia (AML).
The Coalition for Epidemic Preparedness (CEPI) has awarded $4M to Novavax (NASDAQ:NVAX) to support the development of a COVID-19 vaccine. It is currently assessing multiple candidates in animal models.
The parties are in talks about additional funds to support the company’s costs through Phase 1 (expected to begin in late spring).
Novavax plans to use its proprietary Matrix-M adjuvant with its vaccine candidates to enhance immune responses.
Emergent BioSolutions (NYSE:EBS) will provide contract development and manufacturing services and will supply product through Phase 1 testing.
Shares up 17% premarket on light volume.
A generic drug used to treat malaria may be as promising as any that companies are currently scrambling for to treat COVID-19, the coronavirus-related disease spreading rapidly, Raymond James says.
Analyst Steven Seedhouse says chloroquine – a longtime oral anti-malarial that costs pennies per dose – could turn out “more effective, scalable, and affordable” than the candidates being studied by companies including AbbVie (NYSE:ABBV), Gilead (NASDAQ:GILD), and Regeneron (NASDAQ:REGN), not to mention Moderna (NASDAQ:MRNA), GlaxoSmithKline (NYSE:GSK), Pfizer (NYSE:PFE) and others.
After very early indications of efficacy in China, chloroquine is seeing increased demand suggesting it may be seeing real-world use already, though ultimate efficacy depends on data that still need to be gathered.
Citing the risks of the COVID-19 outbreak, the FDA is postponing most foreign inspections through April, effective immediately. In the meantime, the agency will consider ex-U.S. inspections deemed mission-critical on a case-by-case basis.
The FDA based its decision on the State Department’s Level 4 travel advisory (prohibits travel for U.S. government employees), CDC recommendations, access restrictions imposed on foreign visitors imposed by certain countries, guidance from the Office of Personnel Management and the importance of the health and safety of FDA staffers.
Mesoblast Limited (NASDAQ:MESO) plans to evaluate allogeneic mesenchymal stem cell product candidate remestemcel-L, branded as Ryoncil, in patients with acute respiratory distress syndrome (ARDS), the principal cause of death in patients with severe COVID-19 infection.
The company recently completed the filing of its U.S. application seeking approval to use remestemcel-L to treat pediatric steroid-refractory acute graft versus host disease.
Shares up 12% premarket on light volume.
