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.
Novavax (NASDAQ:NVAX) will partner with AGC Biologics on large-scale production of Matrix-M, a perfusion protein adjuvant for its COVID-19 vaccine candidate NVX-CoV2373.
The deal significanlty expands NVAX’s capacity to deliver product this year and next.
Financial terms are not disclosed.
JAMA Dermatology has published complete results from a second Phase 3 clinical trial, JADE MONO-2, evaluating Pfizer’s (NYSE:PFE) JAK1 inhibitor abrocitinib in patients at least 12 years old with moderate-to-severe atopic dermatitis (AD). The company first reported the positive outcome in September 2019.
The study met all co-primary and key secondary endpoints while being generally well-tolerated.
At week 12, the IGA response rates in the abrocitinib 100 mg arm, 200 mg arm and placebo arm were 28.4%, 38.1% and 9.1%, respectively. The EASI-75 (at least a 75% improvement in AD symptoms) proportions were 44.5%, 61.0% and 10.4%, respectively.
On the safety front, the rates of serious adverse events were 3.2%, 1.3% and 1.3%, respectively.
An earlier Phase 3, JADE MONO-1, was also successful as was a third study, JADE COMPARE.
Additional data from other studies in the JADE program will be available later this year.
Inovio Pharmaceuticals (NASDAQ:INO) has filed litigation in a Pennsylvania court against VGXI and GeneOne Life Science (together “VGXI”) aimed at forcing the latter to transfer its DNA plasmid technology to INO’s contract manufacturers so they can produce sufficient quantities of COVID-19 vaccine candidate INO-4800 for clinical trials and potential supply to the market, if approved.
Under a December 2019 agreement, VGXI as been the sole supplier of DNA plasmids to INO under “most favored” status although there are no purchase commitments and pricing is determined on per-order basis.
VGXI has informed INO that it lacks the capacity to make the volume of material in the requested timeline and it will be unable to make the plasmids for commercial sales of INO-4800. INO subsequently engaged third-party contract manufacturers to fill the void but they need VGXI’s technology to do so, a development that VGXI is balking over.
INO is down 1% after hours.
Results from an 821-subject study, just published in the New England Journal of Medicine, evaluating malaria med hydroxychloroquine for preventing COVID-19 in people with moderate-to-high risk of exposure failed to beat placebo.
The drug also failed to make the illness less severe.
The study, conducted in the U.S. and Canada, did not assess its ability to prevent infection prior to exposure to a sick patient.
There was global interest in the medicine as a possible COVID-19 treatment stoked by President Trump’s “game changer” opinion of its potential and his disclosure that he was, at least for a time, taking the drug as a preventative.
Certain COVID-19 vaccine developers that the Trump administration left out of the final round of Operation Warp Speed are under pressure on the loss of potential federal funding to support their development efforts.
Selected tickers: Vir Biotechnology (VIR -9.5%), Novavax (NVAX -13.6%), Dynavax (DVAX -4.4%), Altimmune (ALT -6.6%), BioNTech (BNTX -1.0%), Arcturus Therapeutics (ARCT -11.6%), Soligenix (SNGX), GeoVax Labs (OTCPK:GOVX -3.9%), Inovio Pharmaceuticals (INO -12.8%), iBio (IBIO -5.2%), Vaxart (VXRT -6.3%)
