* BLUEBELL CAPITAL SENDS LETTER TO CHAIRMAN OF GSK
* BLUEBELL CAPITAL SAYS BELIEVES GSK SHOULD ADDRESS IN THE SHORT TERM, THE LEADERSHIP FOR “NEW GSK”
* BLUEBELL CAPITAL: ASK GSK BOARD TO ACCELERATE FURTHER APPOINTMENTS TO GSK BOARD WITH OBJECTIVE TO INCREASE BIOPHARMACEUTICALS, SCIENTIFIC EXPERIENCE
* BLUEBELL CAPITAL: ASKS GSK TO LAUNCH IMMEDIATELY AFTERWARDS THOROUGH, ROBUST PROCESS TO IDENTIFY BEST(INTERNAL OR EXTERNAL) CANDIDATE TO LEAD NEW GSK
* BLUEBELL CAPITAL: ASKS GSK TO TAKE A PROACTIVE APPROACH TO CONSIDER AVAILABLE ALTERNATIVE TRANSACTIONS TO DEMERGER OF CONSUMER HEALTHCARE
* BLUEBELL CAPITAL SAYS VIEWS GSK VACCINE FRANCHISE AS GENERALLY UNDERVALUED BY MARKET - LETTER
* BLUEBELL WRITES TO GSK IN RELATION TO INVESTMENT AND/OR ECONOMIC INTEREST IN GSK COMMON EQUITY SHARES BY BLUEBELL ACTIVE EQUITY MASTER FUND ICAV
* BLUEBELL CAPITAL SAYS BELIEVES GSK'S EMMA WALMSLEY WOULD HAVE BEEN A VERY CREDIBLE CANDIDATE FOR THE POSITION OF CEO AT CONSUMER HEALTHCARE
Vaccine maker Serum Institute of India (SII) will invest 50 million pounds ($68 million) in Oxford Biomedica to help fund the development of a plant that manufactures COVID-19 shots, the British company said on Wednesday.
Serum - the world's largest vaccine manufacturer by volume - and Oxford Biomedica both produce AstraZeneca's COVID-19 vaccine.
Serum Life Sciences Ltd, a unit of India-based SII, will pick up a 3.9% stake in Oxford Biomedica as part of the deal.
Oxford Biomedica, spun off from Oxford University in 1995, said it would use the funds to develop the fallow area at its Oxbox plant into a manufacturing space expected to come online in mid-2023.
The Oxbox plant currently makes COVID-19 shots, and the new space is expected to include a capacity to produce viral vector-based products including vaccines, Biomedica said.
Shares of the British firm were up 5% on the London Stock Exchange, as of 0745 GMT.
Serum's investment comes four months after Oxford Biomedica doubled its sales estimates from the AstraZeneca shot to more than 100 million pounds by 2021-end.
A representative for SII did not immediately respond to Reuters' request for a comment.
For Serum, the deal is the second in as many weeks, following its planned purchase of a 15% stake in Indian drugmaker Biocon's biologics unit.
The Oxford-based company said on Wednesday it swung to a profit after its half-yearly revenue more than doubled.
Following Friday's decision by the FDA's vaccine advisory panel to only recommend the use of boosters for patients who are a) immunocompromised, b) overweight or c) both, Bloomberg reports that the FDA has decided to accept the advisory panel's conclusions, as expected - representing a major victory for "the science" over President Biden's political priorities.
The Vaccines and Related Biological Products Advisory Committee - also known as VRBPAC - is a panel of senior advisors for the FDA, and after a long public meeting on Friday, it voted overwhelmingly against approving a third dose of the Pfizer-BioNTech jab for every patient over the age of 16 (though it did leave a door open to approving booster jabs for all eventually).
Now, the FDA on Wednesday has decided to accept VRBPAC's recommendations, according to Bloomberg.
The expected emergency clearance for the number of booster jabs will be for people 65 and older, those most susceptible to severe disease and people whose jobs put them at risk, Bloomberg's source added.
Most importantly, the FDA's decision will scuttle - well, at least for now - the Biden Administration's plan to start doling out third "booster" jabs to any American over the age of 16 (in Israel, they have been available to anyone over the ae=ge ofthat the Biden administration would have to forgo, temporarily, a wider rollout of boosters that it had proposed last month. Third doses are already authorized for certain people with compromised immune systems.
While hundreds of thousands of Americans have already received a third dose (the CDC has allowed them for older, sick patients), only 54.8% of America's adult population has been fully inoculated.
Along with the Biden Administration, which is scrambling to do everything in its power to combat the delta variant (even if some of those moves, like mandatory masking, aren't as effective as one might expect) Pfizer is also bound to be disappointed by the FDA's decision.
This isn't the final word on whether the entire population will eventually be required - or aggressively "incentivized" - to get a third dose of one of the mRNA vaccines. The FDA has room to change its recommendations or decisions as more scientific data and research comes in.
Looking ahead, the CDC's Advisory Committee on Immunization Practices is expected to meet Thursday to make its own recommendations about who should receive the additional dose.
AbCellera(Nasdaq: ABCL) andEverest Medicines Limited(HKEX 1952.HK, “Everest”) announced today that they have entered into a multi-year collaboration and license agreement to discover therapeutic antibodies for up to 10 targets selected by Everest. The partnership will help to expand Everest’s portfolio of novel medicines across multiple indications, with the initial programs focusing on targets in oncology.
“We are proud to partner with Everest as they build a robust pipeline of innovative medicines for patients in Asia and beyond,” said Carl Hansen, Ph.D., CEO and President of AbCellera. “We believe our full-stack discovery engine, combined with Everest’s clinical development capabilities, creates synergy and the opportunity to speed the delivery of therapies to patients around the world.”
By partnering with AbCellera, Everest will benefit from an operating system that supports many antibody modalities to unlock new target classes and open new disease areas to therapeutic access. The collaboration will leverage the full breadth of AbCellera’s technology stack, including sourcing fully humanized antibodies from the Trianni Mouse®, sourcing single domain antibodies from camelids, and combining any two antibodies to create native bispecifics using the OrthoMabTM protein engineering platform.
“This collaboration will allow us to gain access to AbCellera’s cutting edge, AI-powered antibody discovery platform, which will greatly accelerate and increase the efficiency of our internal discovery efforts,” said Jennifer Yang, Ph.D., Chief Scientific Officer of Everest Medicines.
Under the terms of the agreement, Everest will have the rights to develop and commercialize antibodies resulting from the collaboration. AbCellera will receive research payments and is eligible to receive from Everest downstream clinical and commercial milestone payments and royalties on net sales of products.
A new sensor can detect not only whether a virus is present, but whether it's infectious—an important distinction for containing viral spread.
Researchers at the University of Illinois Urbana-Champaign and collaborators developed the sensor, which integrates specially designed DNA fragments and nanopore sensing, to target and detectinfectious virusesin minutes without the need to pre-treat samples. They demonstrated the sensor's power with two key viruses that cause infections worldwide: The human adenovirus and thevirusthat causes COVID-19.
Yi Lu, a professor emeritus of chemistry, and Benito Marinas, a professor of civil and environmental engineering, co-led the work with University of Illinois Chicago professor Lijun Rong; professor Omar Azzaroni, of the National University of La Plata in Argentina; and María Eugenia Toimil-Molares, of the GSI Helmholtz Centre for Heavy Ion Research in Germany. They reported their findings in the journal Science Advances.
"The infectivity status is very important information that can tell us if patients are contagious or if an environmental disinfection method works," said Ana Peinetti, the first author of the study, who performed the work while a postdoctoral researcher at Illinois. She now leads a research group at the University of Buenos Aires in Argentina. "Our sensor combines two key components: Highly specific DNA molecules and highly sensitive nanopore technology. We developed these highly specific DNA molecules, named aptamers, that not only recognize viruses but also can differentiate the infectivity status of the virus."
The "gold standard" of viral detection, PCR tests detect viral genetic material but cannot distinguish whether a sample is infectious or determine whether a person is contagious. This can make it more difficult to track and contain viral outbreaks, the researchers said.
"With the virus that causes COVID-19, it has been shown that the level of viral RNA has minimal correlation with the virus's infectivity. In the early stage when a person is infected, the viral RNA is low and difficult to detect, but the person is highly contagious," Lu said. "When a person is recovered and not infectious, the viral RNA level can be very high. Antigen tests follow a similar pattern, though even later than viral RNA. Therefore, viral RNA and antigen tests are both poor in informing whether a virus is infectious or not. It may result in delayed treatment or quarantine, or premature release of those who may still be contagious."
Tests that detect infectious viruses, called plaque assays, exist but require special preparation and days of incubation to render results. The new sensing method can yield results in 30 minutes to two hours, the researchers report, and since it requires no pre-treatment of the sample, it can be used on viruses that will not grow in the lab.
Being able to distinguish infectious from noninfectious viruses and to detect small amounts from untreated samples that may contain other contaminants is important not only for rapid diagnosis of patients who are in the early stage of infection or who are still contagious after treatment, but for environmental monitoring as well, Marinas said.
"We chose human adenovirus to demonstrate our sensor because it is an emerging waterborne viral pathogen of concern in the United States and throughout the world," Marinas said. "The capability to detect infectious adenovirus in the presence of viruses rendered noninfectious by water disinfectants, and other potentially interfering background substances in wastewaters and contaminated natural waters, provides an unprecedented novel approach. We see potential for such technology to provide more robust protection of environmental and public health."
The sensing technique could be applied to other viruses, the researchers say, by tweaking the DNA to target different pathogens. The DNA aptamers used in the sensor can be readily produced with widely available DNA synthesizers, similarly to the RNA probes produced for PCR tests. Nanopore sensors are also commercially available, making the sensing technique readily scalable, said Lu, now a professor at the University of Texas, Austin.
The researchers are working to further improve the sensors' sensitivity and selectivity, and are integrating their DNA aptamers with other detection methods, such as color-changing dipsticks or sensors to work with smartphones, to eliminate the need for special equipment. With the ability to distinguish noninfectious from infectious viruses, the researchers said they hope their technology could also aid in understanding mechanisms of infection.
"In addition, the aptamer technology could be further developed into multichannel platforms for detecting other emerging waterborne viral pathogens of public and environmental health concern, such as norovirus and enteroviruses, or for variants of the virus that causes COVID-19," Marinas said.
More information: Ana S. Peinetti et al, Direct detection of human adenovirus or SARS-CoV-2 with ability to inform infectivity using DNA aptamer-nanopore sensors, Science Advances (2021). DOI: 10.1126/sciadv.abh2848
A technology developed at Vanderbilt University Medical Center has led to the discovery of an “ultra-potent” monoclonal antibody against multiple variants of SARS-CoV-2, the virus responsible for COVID-19, including the delta variant.
The antibody has rare characteristics that make it a valuable addition to the limited set of broadly reactive antibody therapeutic candidates, researchers reported Sept. 15 in the journal Cell Reports.
The technology, called LIBRA-seq, has helped speed up the discovery of antibodies that can neutralize SARS-CoV-2. It also enables researchers to screen antibodies against other viruses that have not yet caused human disease but which have a high potential of doing so.
Ivelin Georgiev, PhD
“This is one way to proactively build a repertoire of potential therapeutics” against future outbreaks, said Ivelin Georgiev, PhD, director of the Vanderbilt Program in Computational Microbiology and Immunology and associate director of the Vanderbilt Institute for Infection, Immunology and Inflammation.
“The pathogens keep evolving, and we’re basically playing catch-up,” said Georgiev, associate professor of Pathology, Microbiology & Immunology and a member of the Vanderbilt Vaccine Center.
A more proactive approach that anticipates future outbreaks before they occur is needed to prevent a repeat of COVID-19, “or something worse happening in the future,” he said.
In their report, Georgiev and his colleagues describe the isolation of a monoclonal antibody from a patient who had recovered from COVID-19 that “shows potent neutralization” against SARS-CoV-2. It also is effective against variants of the virus that are slowing efforts to control the pandemic.
The antibody has uncommon genetic and structural characteristics that distinguish it from other monoclonal antibodies commonly used to treat COVID-19. The thought is that SARS-CoV-2 will be less likely to mutate to escape an antibody it hasn’t “seen” before.
LIBRA-seq stands for Linking B-cell Receptor to Antigen Specificity through sequencing. It was developed in 2019 by Ian Setliff, PhD, a former graduate student in Georgiev’s lab who now works in the biotechnology industry, and by Andrea Shiakolas, a current Vanderbilt graduate student.
Setliff wondered if he could map the genetic sequences of antibodies and the identities of specific viral antigens, the proteins markers that antibodies recognize and attack, simultaneously and in a high-throughput way. The goal was to find a faster way of identifying antibodies that will hone in on a specific viral antigen.
With the help of VUMC’s core genomics laboratory, Vanderbilt Technologies for Advanced Genomics (VANTAGE), the Vanderbilt Flow Cytometry Shared Resource, and Vanderbilt University’s Advanced Computing Center for Research and Education (ACCRE), Georgiev put Setliff’s idea to the test. It worked.
The efforts led by Setliff and Shiakolas culminated in a manuscript describing proof-of-concept development of the LIBRA-seq technology that was published in the journal Cell in 2019.
“It would have been impossible three or four years ago to move at the speed that we are right now,” Georgiev said. “A lot has changed in a very short period of time when it comes to monoclonal antibody discovery as well as vaccine development.”
There is no time to lose. “If we give the virus enough time,” he said, “there will so many other variants that arise,” one or more of which — by evading current vaccines — may be even worse than the delta variant.
“That’s exactly why you need to have as many options as possible,” Georgiev said. The antibody described in this paper “basically gives you another tool in the toolbox.”
Georgiev and Jason McLellan, PhD, at the University of Texas at Austin, are the paper’s corresponding authors. Kevin Kramer and Nicole Johnson, graduate students at VUMC and UT Austin, respectively, are the paper’s first authors.
In addition to Shiakolas, other VUMC coauthors are Naveen Suryadevara, PhD, Nagarajan Raju, PhD, Seth Zost, PhD, Lauren Walker, Steven Wall, Clinton Holt, Rachel Sutton, Ariana Paulo, James Crowe, Jr., MD, and Robert Carnahan, PhD.
The research was supported in part by National Institutes of Health grants AI131722, AI157155, AI127521 and AI095202, the Hays Foundation COVID-19 Research Fund, the Dolly Parton COVID-19 Research Fund at Vanderbilt, Fast Grants, the Welch Foundation and the Mercatus Center of George Mason University.
The new emergency rule, 64DER21-15, covers the changes to the state’s emergency rules in school settings and addresses mitigation methods for COVID-19. The rule also dips into mask policies in Florida’s schools.
The big takeaway from the new rule, now in effect, is that if students are exposed to someone with COVID-19, and they remain asymptomatic, they can continue to go to school and school activities. Additionally, the order does not require that those who come into contact with a COVID-positive individual be tested for the virus themselves.
This means that, effectively, if a student is in contact with someone with COVID, if they don’t present symptoms, they won’t have to stay home and they won’t have to be tested. It is unclear how this will affect the spread of COVID-19 in schools.
New protocols, no symptoms, no testing
The new rule by the Surgeon General does go into some detail about updated protocols.
From the text of the order, the new procedures for schools focuses on encouraging mitigation, not enforcing it, as far as “routine cleaning of classrooms and high-traffic areas” and having students “practice routine handwashing throughout the day.”
The new emergency rule does say that students will stay home if they are sick, and allows schools to adopt mask requirements. Still, “the school must allow for a parent or legal guardian of the student to opt the student out of wearing a face covering or mask at the parent or legal guardian’s sole discretion.”
The order also outlines what direct contact is, relating to exposure to COVID-19, defined as “cumulative exposure for at least 15 minutes, within 6 feet.”
For symptomatic or COVID-19 positive students, the new rule contains protocols for how to handle school activities.
“Schools will ensure students experiencing any symptoms consistent with COVID-19 or who have received a positive diagnostic test for COVID-19 shall not attend school, school-sponsored activities, or be on school property,” the rule says.
The protocols are effective for COVID-positive students until they have received a negative diagnostic test and is asymptomatic, or if it has been 10 days since the onset of symptoms or positive test results and that the student has not had a fever for 24 hours, and symptoms are improving.
Additionally, the student must receive written permission to return to school from a medical doctor licensed under chapter 458, an osteopathic physician licensed under chapter 459, or an advanced registered nurse practitioner licensed under chapter 464.
There are further protocols for students who are exposed to COVID-19.
Schools will have to allow parents or guardians the authority to choose how their students receive their education after being in contact with someone who is COVID-19 positive.
Should their student be exposed to COVID-19, parents will be able to choose if their student will continue to attend school, school-sponsored activities, or be on campus “without restrictions or disparate treatment” as long as they’re asymptomatic, or parents can choose to quarantine a student for no longer than seven days from when they were in direct contact with someone who is COVID-19 positive.
If the student becomes symptomatic after being exposed to COVID-19 by someone with the virus, or tests positive for the virus, they will be subject to protocols for COVID-19 positive students and prevented from being on campus, going to school events, or being in school until they test negative for COVID and is asymptomatic, or 10 days have passed since symptoms began and they have not had a fever for 24 hours.
Now signed by Dr. Ladapo as the State Surgeon General, the rule is immediately in effect.
