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.
As Johnson & Johnson (NYSE:JNJ) expects to deliver preliminary late-stage trial results at the end of January for its COVID-19 vaccine candidate, the analysts are optimistic over a compelling outcome for the single-dose shot subject to a reasonable efficacy rate.
Adam Barker, the Health care analyst at Shore Capital has told CNBC: “The J&J vaccine is more like the AstraZeneca vaccine, but it uses only one dose. So we know this approach works (viral-vector) and it targets the spike protein. We know that target works too. But, we’ll have to see what one dose does.”
Developed by JNJ’s Belgian unit, Janssen Pharmaceutica, the experimental vaccine, JNJ-78436735, also known as Ad26.COV2.S is based on a viral adenovirus vector technology, used to create the AstraZeneca (NASDAQ:AZN)/ University of Oxford vaccine.
The Company’s AdVac® technology platform was used to develop and manufacture Janssen’s European Commission approved Ebola vaccine and construct its Zika, RSV, and HIV vaccine candidates.
The health care team at Morgan Stanley wrote that vaccine candidate’s “unique elements and efficacy could surprise to the upside relative to AstraZeneca driving confidence in pandemic response and market recovery.”
The analysts are confident over the safety of the experimental vaccine given citing the early trial data “along with the prior success and safety profile demonstrated in their Ebola vaccine as well as in investigational use in HIV, RSV, and Zika.”
“If J&J’s Ad26 platform is able to confer 80%+ efficacy via a single-dose regimen, given the vaccine’s favorable handling requirements and significant manufacturing scale, we would view this as a compelling outcome,” the analysts wrote in the research note last week.
Unlike rigorous storage requirements needed for COVID-19 vaccines from Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE)/ BioNTech (NASDAQ:BNTX), with J&J’s technology, the vaccine is likely to remain stable for at least three months at normal refrigerated temperatures.
Deliverable at scale and are easier to administer than the mRNA shots, the vaccines from AstraZeneca and JNJ were identified as “the two workhorse vaccines” in a report by the Tony Blair Institute for Global Change, founded by the former British Prime Minister.
Eli Lilly (NYSE:LLY) gains 20% in premarket on promising results from Phase 2 TRAILBLAZER-ALZ study, evaluating donanemab, an antibody that targets a modified form of beta amyloid called N3pG, for Alzheimer’s disease (AD). The study met the primary endpoint of change from baseline to 76 weeks in AD rating scale.
Data showed that donanemab slowed the decline in a composite measure of cognition and daily function by 32%, compared to placebo.
Safety profile was consistent with observations from Phase 1 data.
Full results of the TRAILBLAZER-ALZ study will be presented at a future medical congress and submitted for publication in a peer-reviewed clinical journal.
Lilly plans to discuss these results with regulators to assess next steps for donanemab. In addition, TRAILBLAZER-EXT is an ongoing trial for those who participated in TRAILBLAZER-ALZ.
Safety, tolerability and efficacy of donanemab are also being evaluated in another Phase 2 study TRAILBLAZER-ALZ 2.
Progress on Alzheimer’s treatments was one reason cited by BofA in picking Lilly as a top name for 2021.
Sanofi (NASDAQ:SNY) to acquire Kymab, adding KY1005 to its pipeline, a human monoclonal antibody targeting key immune system regulator OX40L.
Under the terms of the agreement, Sanofi make an upfront payment of ~$1.1B and up to $350M upon achievement of certain milestones.
The transaction will result in Sanofi having full global rights to KY1005 and is expected to be completed in H1 2021.