In July Immunity Bio was in South Africa!- ImmunityBio gets OK from South Africa for dual-antigen T-cell for Covid booster 07/14/21 IBRX ImmunityBio announced authorization from the South Africa Health Products Regulatory Authority, SAHPRA to proceed with the South Africa Sisonke T-Cell Universal Boost trial. The Phase 1/2/3 study, which will begin in Q3 2021, is designed to evaluate hAd5 Spike + Nucleocapsid as a boost for South African healthcare workers previously vaccinated with an S-only vaccine. "With the virus continuing to spread, moving forward with this boost trial is crucial," said Leonard Sender, M.D., Chief Operating Officer of ImmunityBio. "We are encouraged by the preliminary safety findings in our ongoing Phase 1 studies in both the U.S. and South Africa. In addition, our U.S. data show that just a single prime subcutaneous vaccination with our COVID-19 vaccine candidate induces a 10-fold increase in T cell response-equivalent to T cell responses from patients previously infected with SARS-CoV-2. We have also shown that the T-cell responses are maintained against variants, which is critical to providing protection against this ever-changing virus." In the trial, the effect of combining vaccination by two routes of administration-subcutaneous and sublingual -will be assessed. This combination has the potential to deliver protection from the virus with a single jab followed by droplets placed under the tongue. Methods that do not require injection such as SL, intranasal, and oral capsule offer potential advantages depending on the participant's needs or situation. Sublingual administration results in the most rapid absorption, while nasal spray or oral capsule delivery have the potential to provide mucosal immunity, which could reduce both the chance of infection and potential spread of the virus via the respiratory tract. The three non-jab formulations also can be administered without a trained healthcare worker and are easier to transport and store. The SL and nasal routes of administration are also currently being tested in a separate Phase 1 trial in South Africa.
Immunity looks like they have a good pipeline too- Piper says ImmunityBio could have 'blockbuster opportunity' with Anktiva 10/19 IBRX After ImmunityBio announced that Cohort B in patients with papillary only disease, the second indication of its QUILT 3.032 Phase 2/3 study of intravesical BCG plus Anktiva in patients with BCG-unresponsive high-grade non-muscle invasive bladder cancer, or NMIBC, also met its primary endpoints, Piper Sandler analyst Joseph Catanzaro said he thinks this agent "could represent a blockbuster opportunity." The analyst, who noted Cohort A in CIS patients also met its primary endpoint, estimates that an initial indication in CIS represents about a $300M peak U.S. sales opportunity with the potential to expand into papillary disease and potentially BCG-naive patients. He has an Overweight rating and $25 price target on ImmunityBio shares.
"Even though the first COVID-19 vaccines were approved almost a year ago, and billions have been invested to develop those first-generation shots, just 40% of the global population is fully vaccinated today," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "What’s more, most of the people who have not yet received a vaccination are in low- and middle-income countries where cost and access are huge factors, and where the virus has ideal conditions for developing potent new variants. Not only do we believe our expanded platform approach will create powerful new vaccines, but we also believe that we already have the large-scale infrastructure in place to quickly and cost-effectively scale up production immediately. In addition, our vaccine candidates do not require the difficult storage conditions of several current vaccines, which we believe makes them more practical to make, store, and distribute to remote areas." Self-Amplifying, Self-Adjuvanted RNA vaccines are rapidly scalable and show enhanced antigen expression at lower doses than conventional mRNA vaccines In preclinical and clinical studies, next generation self-amplifying, self-adjuvanted RNA (SASA-RNA) COVID-19 vaccine, developed by IDRI, have shown enhanced antigen expression at lower doses than conventional RNA vaccines. Thus, more doses can be created per manufacturing run and the nano-lipid carrier can be manufactured independently of the SASA-RNA. Through a joint-venture agreement with Amyris, ImmunityBio will accelerate the commercialization and large-scale manufacture of this next-generation RNA COVID-19 vaccine. The vaccine candidate is currently part of a heterologous prime and boost Phase 1 / 2 trial design submitted to the South African Health Products Regulatory Authority (SAHPRA) for approval.
1- BCRX 2- IBRX 3- GRTS 4- INO ** GRTS presents twice this week* Conference: Evercore ISI 4thAnnual Health CONx Virtual Conference Date and Time:Wednesday, December 1, 2021 at 10:05 a.m. ET Presenter:Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer Conference:Piper Sandler 33rdAnnual Healthcare Conference Date and Time:November 30-December 2, 2021 Presenter:Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer
Key Points Gritstone is testing its vaccine candidate alone and as a booster. The candidate targets the spike protein and other viral proteins. If all goes smoothly, it could enter the vaccine market -- but farther down the road. So, down the road, the safest and most effective vaccines likely will rise above the rest. What makes Gritstone one to watch? Unlike Pfizer and Moderna, Gritstone uses self-amplifying mRNA. This mRNA replicates within cells -- and this means vaccines can do the job with a lower dose. This in and of itself is positive. It can lead to savings and speed when it comes to manufacturing. Even better, though, is the way Gritstone's candidate may work against variants. The candidate includes mRNA targeting the spike protein and other viral proteins that are less likely to mutate. This means that even if the spike changes drastically, the immune system still will recognize other bits of the coronavirus -- and fight back. Pfizer, Moderna, and other vaccine makers target the spike protein. The virus uses the spike to infect cells. So, it makes a logical target. Beyond the spike protein However, as we move forward and variants gain ground, it clearly is a good idea to expand beyond the spike.Today's vaccines are holding up against strains such as the delta and beta. But breakthrough infections are occurring. And we don't know if the vaccines will perform as well against other variants down the road. It's important to be proactive. Gritstone in March launched a phase 1 trial in the U.S. to test safety and immune activity. The company then expanded this trial to include individuals who already received authorized vaccines. Gritstone plans to report data by the end of the year. This month, Gritstone began another trial to study its candidate as a booster in those ages 60 and older. In this study, the candidate will be given to volunteers in the U.K. who already were vaccinated with theAstraZenecavaccine. Gritstone plans to report initial results early next year. Of course, vaccine giants Pfizer and Moderna are working on vaccine updates or next-generation vaccines. But if Gritstone shows its vaccine candidate may be more efficacious against variants, it could carve out market share. It's wise of Gritstone to explore booster possibilities too. It could become part of a vaccine mix-and-match option down the road. Time to invest? Now, what about buying the shares? Gritstone remains a risky investment right now. That's because the company doesn't yet have products on the market. Gritstone has four programs in the pipeline -- two in oncology and two in infectious diseases. The oncology program is farthest along, with several candidates in phase 2 trials. It's unlikely the coronavirus vaccine program will wrap up in time for an Emergency Use Authorization (EUA) request. The U.S. Food and Drug Administration offers EUAs during a public health emergency. Regulators will go back to the traditional evaluation process once the pandemic is over. So that means a longer time to market for potential products. Cautious investors should watch Gritstone -- but from afar. For aggressive investors who are looking for a future coronavirus winner, though, it may be a good idea to consider a small position in this biotech stock. That's from Motley Fool they have blessed Gritstone and to be honest this is the one I have heard of.. we should probably track volume to these names... I'm probably going to create a Covid basket of future ideas to combat the virus.
INO- Inovio Pharmaceuticals Inc said it had begun testing its vaccine candidate, INO-4800, to evaluate its effectiveness against the new variant. The company expects the testing to take about two weeks. Inovio also said it was simultaneously designing a new vaccine candidate that specifically targeted Omicron. "Best case scenario, INO-4800 ... will be completely resilient against omicron, but if that's not the case then we will have a newly designed vaccine ready to go if need be," said Kate Broderick, senior vice president of Inovio's R&D division. Earlier this month, Inovio resumed a late-stage trial of its vaccine in the United States after 14 months on clinical hold. Keith Speights:Yeah. Now, I will say this on Inovio. The company did just announce yesterday, I think, that it's received the U.S. FDA's go-ahead to move forward with the phase 3 study of its COVID-19 vaccine, INO-4800 in the U.S. That's good news for Inovio. But again, I think the question with both Inovio and Ocugen is will they be too late to the party? It's going to be a while before either of these companies really has a good chance of having their vaccines on the market. Brian Orelli:Yeah. I think Inovio is probably the better option is to go outside the U.S. where Ocugen doesn't have that option, except for Canada, because it's not their vaccine and they've only licensed it for U.S. and Canada. Keith Speights:Inovio also has a broader pipeline than Ocugen does. Ocugen does have some gene therapies targeting eye diseases in its pipeline, but they're really, really early. Inovio has more irons in the fire, and so it has a lot more going forward, I think, right now. Brian Orelli:Yeah.
Ok we have 4 stocks here. Which one are you recommending? I mean I realize you're just putting them out there and that's good, but if one of the four jumps 20% this week or the next, try to reel in the "I did it again" diatribe in the absence of a definitive pick. But whatever.... I see the new variant is apparently bad enough to garnish its very own a Greek. Omnicron. Looks like your Governor has already declared an emergency. +++++++++++++++++++++++++++ Gov. Kathy Hochul declares 'disaster emergency' in New York until mid-January over omicron despite no cases of new variant in the US yet News Paul Sacca November 27, 2021 New York Gov. Kathy Hochul declared a "disaster emergency" for the state in anticipation of the newly-identified omicron variant of COVID-19. The Democratic governor declared a state of emergency for the entire state of New York through Jan. 15, 2022, when it will be evaluated if the order needs to be extended. The previous coronavirus-related state of emergency was enacted by former Gov. Andrew Cuomo from March 7, 2020, until June 24, 2021. Hochul admitted that there have yet to be any omicron variant cases in New York state. "We continue to see warning signs of spikes in COVID this winter, and while the new Omicron variant has yet to be detected in New York State, it's coming," Hochul tweeted on Friday. "Today I signed an Executive Order to help @HealthNYGov boost hospital capacity ahead of potential spikes. Through this action, we will also be able to acquire critical supplies more quickly to combat the pandemic. I urge New Yorkers to take advantage of our greatest weapon in this pandemic: the vaccine. Get vaccinated and get the booster as soon as you are able." +++++++++++++++++++++++++++++++++++ Has anyone ever done an audit on this guy, his family, friends, (neighbors?) to see which stocks they own? He sure does talk alot. VVVVVVVVVVVVVVVVVVVVVVVVVVVV Omicron variant may already be in US, Fauci says by Jessica Schladebeck • New York Daily News • November 27, 2021 Dr. Anthony Fauci prepares to receive his first dose of the COVID-19 vaccine at the National Institutes of Health on Dec. 22, 2020 in Bethesda, Maryland. (Patrick Semansky/Pool/Getty Images/TNS) The omicron variant, a new strain of COVID-19 triggering fears worldwide, could already be in the United States. Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said Saturday that while there is no indication the mutated virus has made its way over from South Africa, where it was initially detected earlier this week, citizens should take special care and avoid letting their guards down. When asked whether he believed omicron has already arrived in the United States, Fauci said he "would not be surprised" if it has. "We have not detected it yet, but when you have a virus that is showing this degree of transmissibility and you're already having travel-related cases that they've noted in Israel and Belgium and other places, when you have a virus like this, it almost invariably is ultimately going to go essentially all over," Fauci said during an interview on the "Today" show on Saturday.
I am narrowing down the field Van and you will know when we alert the readers to a buy order. In my 30+ years of investing this is how you must do it. Just off my gut I might say INO because I know the company very well. And they could get a second wind here.
We Have Snow On The Ground! I saw The White Deer and her baby yesterday ( a very good sign!) Fed's Bostic played down risks from the new Omicron variant 17:40 $ECON Fed's Bostic played down risks from the new Omicron variant and its impact on the economy in a Fox New interview. Though there could be some slowing in overall activity, he doubted it would be as much as with Delta. He noted there is a lot of momentum in the economy and added it is certainly possible the FOMC could hike rates twice in 2022, stressing the Fed is not going to let inflation get out of control. He remains "very open" to speeding up the pace of the slowing in asset purchases. He sees late Q1 or early Q2 as a possible timeframe for ending purchases. Bostic is a voter this year and was on the dovish side of the spectrum until the last few months as inflation remained elevated.
Omicron = Bad Name Not Scary! Sounds like another DC or Marvel Super Hero. I thought Covid was very scary. " I got The Covid...." Omicrom? Hey I got Omnicrom.. That's good cable they have the sports networks but you still cut the cord... and it's 5G