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.
Gilead Sciences (GILD -1.1%) has initiated a U.S. Phase 1a clinical trial evaluating an inhalable formulation of antiviral remdesivir in 60 healthy volunteers between the ages of 18 and 45.
The company says an inhalable version may enable more targeted and accessible administration in non-hospitalized COVID-19 patients and lower systemic exposure to the drug.
The intravenous formulation remains the only medicine approved in the U.S. for emergency use in hospitalized patients, receiving the FDA nod on May 1.
New Jersey Governor Phil Murphy says masks are now required in the state outdoors when social distancing isn’t possible.
The development has sent mask manufacturers Alpha Pro Tech (APT +8.2%), Allied Healthcare Products (AHPI +7.8%) and Lakeland Industries (LAKE +6.0%) higher.
Gap (GPS +0.4%) is slightly up on the day, but Etsy (ETSY -1.0%) is lower.
Goldman Sachs thinks the mask mandate is positive for the market in general. The firm sees upside as more Americans wear masks and more local governments institute rules, pointing to data showing the high correlation in Europe and Asia of widespread mask usage through policy or cultural norms to fewer COVID-19 cases, hospitalizations and fatalities. GS estimates national face covering in the U.S. could prevent a 5% hit to national GDP.
In a post on social media, Moderna (MRNA +2.0%) announces that it has completed enrollment in a Phase 2 clinical trial evaluating the safety, reactogenicity and immunogenicity of COVID-19 vaccine candidate mRNA-1273 in 600 healthy volunteers across two age cohorts: 18-55 years old and 55+ years old.
A Phase 3 study should launch this month.
Enrollment in cohorts of older adults (56-70 years old and 71+) in an NIH-led Phase 1 trial has been completed.
Company remains on track to deliver ~500M doses/year with an upside to 1B doses/year beginning in 2021.
The company is in one of the leaders in the horse race to the finish line for first mover status. Whoever can supply the vaccine at scale, assuming acceptable safety and efficacy of course, should generate substantial sales even at a modest per-dose price.
Dynavax (NASDAQ:DVAX) will partner with Medicago to develop a COVID-19 vaccine that combines the latter’s Coronavirus Virus-Like Particle and its CpG 1018 adjuvant (used in Heplisav-B).
A Phase 1 study should launch this month. If all goes according to plan, they expect to deliver initial doses of the vaccine in H1 2021.
The companies also intend to explore a broader collaboration aimed at other opportunities.
Yesterday, Medicago announced a similar deal with GlaxoSmithKline.
Shares up 4% premarket on modest volume.
Twist Bioscience (NASDAQ:TWST) unit Twist Biopharma inks an agreement with Takeda Pharmaceutical Company (NYSE:TAK) granting the latter a license to its panel of synthetic antibody phage display libraries for the discovery, validation and optimization of antibodies in Takeda’s pipeline of biologics for oncology, rare diseases, neuroscience, and gastroenterology.
Under the terms of the deal, Takeda will pay Twist annual licensing fees, milestones and royalties on all compounds discovered from the libraries.
Specific financial terms are not disclosed.
