Phase 2 study to be conducted in the U.S. and Singapore, and will evaluate both single dose and two dose priming regimens of ARCT-021 in up to 600 participants
Anticipate interim Phase 2 data in early 2021; targeting global Phase 3 study start in Q2 2021 which could allow application for emergency use authorization/conditional approval in H2 2021
Arcturus Therapeutics Holdings Inc. (the "Company", "Arcturus", Nasdaq: ARCT), a leading clinical-stage messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, today announced that the Company has received allowance of the Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for the Phase 2 clinical study of its vaccine candidate ARCT-021 following review of data from the Phase 1/2 study.
Magellan Health (NASDAQ:MGLN)+11.1% pre-market after Centene (NYSE:CNC)agrees to acquire the pharmacy benefits manager in a deal valued at $2.2B including debt.
Centene says it will buy Magellan Health for $95/share in cash, a 14.7% premium to the last closing price, to be funded through debt financing and a $2.38B bridge financing commitment from J.P. Morgan.
The deal will add 5.5M new members to Centene's government sponsored health plans, 18M third-party customers of specialty health services, 2M pharmacy benefit manager members and 16M medical pharmacy members.
Activist investor Carl Icahn has sold more than half his stake in Herbalife Nutrition Ltd for $600 million and is planning to give up the five seats on the company’s board held by his representatives, the Wall Street Journal reported.
Icahn, who had a 15.5% stake in Herbalife as of Sept. 30, sold about 10% back to the company in recent days, the newspaper reported on Sunday, citing people familiar with the matter.
That has left him with a roughly 6% stake, worth $400 million, in the multi-level marketing company, whose products include dietary supplements, according to the report on.wsj.com/3b4a4UR.
Representatives for Icahn and Herbalife did not immediately respond to Reuters’ requests for comment on Sunday.
Icahn began buying Herbalife shares in 2013 while extolling the company and had since been its largest shareholder.
Gov Andrew Cuomo's push to make New York's vaccination effort truly stand out is at risk of backfiring spectacularly, as new rules imposed by the governor create risks that are already slowing down the process.
The governor is issuing an executive order making it a crime for health-care providers to "intentionally disregard prioritization" while also making "eligibility certification by recipients a mandatory part of the vaccination process."
Here's more from the governor in his own words.
Should a clinic administer the vaccine to somebody before their turn, they could face a fine of up to $1MM.
The reasoning behind the executive order appears to be preventing a "black market" for vaccines, or otherwise tying the system to wealth
At this point, distributing vaccines to people out of turn hasn't emerged as a problem. Instead, 3 weeks into the most ambitious vaccination campaign in modern US history, far fewer people than expected are being immunized against the virus as the process moves slower than officials had projected and has been beset by confusion and disorganization in many states. Of the more than 12 million doses of vaccines from Moderna and Pfizer-BioNTech that have been shipped, fewer than 3MM have been administered, per data from the CDC. As of Sunday, the state of NY has doled out roughly 1/3rd of the nearly 775K doses that have been distributed.
While reporting delays have been blamed, other issues have emerged, like news of several shipments of vaccine doses spoiling on its way to hospitals in Texas.
While reporting delays have been blamed, other issues have emerged, like news of several shipments of vaccine doses spoiling on its way to hospitals in Texas.
The Orwellian nature of Cuomo's reign just went to '11' on the Spinal Tap amplifier of conspiracy-theory-turned-fact as SaraACarter's Ben Wilson reports that a proposed bill in the state of New York would allow for the “removal and detention” of people who are carriers or come into contact with any virus that, in the opinion of the Governor, “may pose an imminent and significant threat.” The Governor can detain people based on merely a “reasonably specific description.”
Bill A416 gives the governor the right to - after determining in his/her opinion that the virus is a threat - ”order the removal and/or the detention of such a person or group of such persons by issuing a single order.”
A clear issue with the legislation is that it allows for the detention of anyone since one would not have to be sick but merely deemed to have been in contact with someone who contracted said virus - all, of course, is determined by the governor and his/her opinion.
"Upon determining by clear and convincing evidence that the health of others is or may be endangered by a case, contact or carrier, or suspected case, contact or carrier of a contagious disease that, in the opinion of the governor, after consultation with the commissioner, may pose an imminent and significant threat to the public health resulting in severe morbidity or high mortality, the governor or his or her dele-gee, including, but not limited to the commissioner or the heads of local health departments, may order the removal and/or detention of such a person or of a group of such persons," reads the bill.
To take it even further, the bill allows for detention of people based on a “description,” meaning a specification by name is not necessary for Governor Cuomo to send his people in and swoop up any poor soul who was within a distance of any virus.
“Identifying such persons either by name or by a reasonably specific description of the individuals or group being detained. such person or group of persons shall be detained in a medical facility or other appropriate facility or premises designated by the governor,” the bill says.
Whether the state of New York will grant Governor Cuomo and his future successors the right to arbitrarily kidnap anyone that potentially came into contact with a virus will be seen in the coming months.
But what else should we expect from a governor who sent thousands of COVID-19 positive patients back to long-term care homes, directly contributing to his state's massive death toll?
Former FDA commissioner Dr. Scott Gottlieb on Sunday predicted that the contagious, new strain of COVID-19will account for the “majority” of cases in the US by March.
“There are some estimates that the new variant probably represents about 1 percent of all infections in this country. By March, it’s going to be the majority of infections,” Gottlieb said on CBS’ “Face the Nation.”
Gottlieb said it will “grow quickly” and its arrival adds more pressure to ensure COVID-19 vaccines are distributed as soon as possible.
“I think the existence of this new variant that spreads more readily really creates more urgency around trying to get this vaccine out more quickly and get more people vaccinated — even if it’s more general population,” Gottlieb said.
“There’s a lot of excess demand for the vaccine right now, particularly in the elderly population. I think we ought to think about moving quickly through these stages that we’ve delineated and start moving more quickly into a general vaccination program for those people who are 65 and above,” he continued.
At least three states — Colorado, California and Florida — have confirmed cases of the new strain of coronavirus, which first emerged in the United Kingdom.
British Prime Minister Boris Johnson has warned that the new variant of the coronavirus could be 70 percent more transmissible than other known strains.
Emanuele Andreano1
, Giulia Piccini2
, Danilo Licastro4
, Lorenzo Casalino5
, Nicole V. Johnson6
, Ida
Paciello1
, Simeone Dal Monego4
, Elisa Pantano1
, Noemi Manganaro1
, Alessandro Manenti2,3
,
Rachele Manna2
, Elisa Casa2,3, Inesa Hyseni2,3, Linda Benincasa3
, Emanuele Montomoli2,3,7
,
Rommie E. Amaro5
, Jason S. McLellan6
, Rino Rappuoli1,8,*
doi: https://doi.org/10.1101/2020.12.28.424451
ABSTRACT
To investigate the evolution of SARS-CoV-2 in the immune population, we co-incubated authentic
virus with a highly neutralizing plasma from a COVID-19 convalescent patient. The plasma fully
neutralized the virus for 7 passages, but after 45 days, the deletion of F140 in the spike N-terminal
domain (NTD) N3 loop led to partial breakthrough. At day 73, an E484K substitution in the
receptor-binding domain (RBD) occurred, followed at day 80 by an insertion in the NTD N5 loop
containing a new glycan sequon, which generated a variant completely resistant to plasma
neutralization. Computational modeling predicts that the deletion and insertion in loops N3 and N5
prevent binding of neutralizing antibodies. The recent emergence in the United Kingdom and South
Africa of natural variants with similar changes suggests that SARS-CoV-2 has the potential to
escape an effective immune response and that vaccines and antibodies able to control emerging
variants should be developed.
The coronavirus vaccines wouldn’t be possible without advancements developed at the University of Pennsylvania, which has been touting its contribution in news releases and TV ads. But it turns out the school wasn’t very supportive of the scientist who led the charge.
Former Penn researcher Dr. Katalin Karikó’s dedication to the promise of using messenger RNA (mRNA) in medicine paved the way for the vaccines now giving society hope.
As Karikó worked for decades toward adapting mRNA to bring out its therapeutic qualities, her efforts were repeatedly dismissed by the university, she has said. When she was unable to find funding, Penn demoted her, taking her off the track to full professorship.
“Usually, at that point, people just say goodbye and leave because it’s so horrible,” Karikó, known as Kati, told Stat News in November.
The breakthrough finally came in 2005, after Karikó found a colleague whose passion for the topic mirrored hers in Dr. Drew Weissman. Now 65, she’s a VP at a biotech firm. Both she and Weissman, a professor at Penn’s Perelman School of Medicine, were quoted in a recent release from the university.
“I feel humbled, and happy,” says Karikó in the release, referred to as an adjunct professor. “I am more [of] a basic scientist, but I always wanted to do something to help patients.”.
Penn officials declined to comment on their relationship with Karikó, previous or current. “We are unable to discuss specifics about faculty or staff employment matters,” spokesperson Stephen Maccarthy told Billy Penn.
Despite the university’s original attitude toward Karikó’s research, it holds the patent on the tech used in the COVID-19 vaccines.
From Hungary to Temple to Penn
It was 1961 when scientists first discovered mRNA was how DNA got translated into the proteins that make up the body. It was the missing link, the way genes get expressed in everyday life.
Over the next couple decades, researchers began to explore whether they could use mRNA to teach the body to make its own medicine. But with few advancements, the topic fell out of fashion.
Except for one Hungarian biochemist.
Karikó started studying gene therapy at the University of Szeged in her native country. She finished her PhD in 1982, with an unrelenting passion for mRNA advancements.
“I always thought that the majority of patients don’t actually need new genes, they need something temporary like a drug, to cure their aches and pains,” Karikó told Wired earlier this month.
With mRNA research more popular in the United States, Karikó opted to immigrate with her husband and 2-year-old daughter. At the time, Hungarians were prohibited from taking their money to a new country — so when Karikó sold her car, according to France24, she stashed the cash in her daughter’s teddy bear.
The hopeful scientist scored a job at Temple, and moved to Philly in 1985. Four years later, she left because of a dispute with her boss, who attempted to have her deported, per Wired. (Temple did not respond to a request for comment.)
Karikó moved on to the University of Pennsylvania, where she diligently searched for research funding. She applied for grants and hit up venture capitalists in New York City. No one would bite.
“They initially promised to give us money,” Karikó said of the venture capitalists, “but then they never returned my phone calls.”
After six years, her bosses at Penn were reportedly so frustrated by the lack of momentum that they cut her salary and demoted her.
“I thought of going somewhere else, or doing something else,” Karikó told Stat News. “I also thought maybe I’m not good enough, not smart enough. I tried to imagine: Everything is here, and I just have to do better experiments.”
A sympathetic colleague, and a move to biotech
Things didn’t look up until 1997, when colleague Drew Weissman got to Penn.
He and Karikó met over their department’s copy machine, per Wired, where they realized their shared interests and started working together. It took seven years, but the pair eventually figured out how to make mRNA therapy work.
In 2005, Karikó and Weissman published their groundbreaking study. The University of Pennsylvania licensed the technology and patented it. (Researchers’ patents are often held by the institutions where they work.)
Karikó stayed on at Penn for eight years, but was never reinstated her to the tenure track position she held before she was demoted.
“We are grateful for Dr. Karikó’s important contributions both during her time at Penn,” said university spokesperson Maccarthy, “where she continues to hold an appointment as an adjunct associate professor.” The school’s promo video about mRNA technology focuses on Weissman, mentioning Karikó only in passing.
In 2013, she gave up on the Ivy League institution and took a senior VP role at BioNTech, a pharma firm valued at almost $20 million. The company partnered with Pfizer to make the first COVID vaccine, with Karikó working as a key player.
She herself was vaccinated last week — at Penn.
“I’m hopeful,” Karikó said, “now that there is so much interest and excitement for this research, that it will be possible to develop and test this mRNA vaccine technology for prevention and treatment of other diseases, too.”
