Arcturus Collaborates with Vingroup to Establish Manufacturing Facility in Vietnam

 Arcturus will receive $40 million upfront payment and potential royalties based on vaccines produced

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, announced today an agreement with Vinbiocare Biotechnology Joint Stock Company (“Vinbiocare”), a member of Vingroup Joint Stock Company, regarding a collaboration to establish a manufacturing facility in Vietnam for the manufacture of Arcturus’ investigational COVID-19 vaccines, for sale and use within Vietnam.

Under the terms of the arrangement, Vinbiocare will, with consultation from Arcturus, build out a manufacturing facility in Vietnam, and Arcturus will provide to Vinbiocare access to proprietary technologies and processes for the manufacture of Arcturus’ investigational COVID-19 vaccines. Arcturus will provide Vinbiocare with an exclusive license to manufacture the vaccines in Vietnam at the facility solely for distribution in Vietnam. The license and technology transfer applies toward drug product manufacturing but not toward mRNA drug substance manufacturing. Technology transfer is underway.

Vinbiocare will make an upfront payment of $40 million and be responsible for costs associated with the technology transfer. Vinbiocare will also pay for mRNA drug substance supplied by Arcturus and royalties on vaccines produced at the Facility.

Arcturus investigational COVID-19 vaccines utilize Arcturus’ self-transcribing and replicating (STARR™) mRNA technology, and the STARR™ mRNA is delivered with Arcturus’s lipid-mediated delivery system called LUNAR® delivery system.

https://www.biospace.com/article/releases/arcturus-therapeutics-collaborates-with-vingroup-to-establish-manufacturing-facility-in-vietnam-for-arcturus-investigational-mrna-vaccines-for-covid-19/

FDA Clears Vaxart's IND Application for S-Only Oral Tablet COVID-19 Vaccine Candidate

 Vaccine candidate expressing S-only protein produced higher serum antibodies than construct expressing both S and N in NHP study

Phase II clinical trial with S-only candidate to begin in 2H21

Development of this and other S-only constructs will proceed in parallel with that of S+N construct, as previously announced

https://finance.yahoo.com/news/fda-clears-vaxarts-ind-application-120000515.html

Cytokinetics Starts Phase 3 Trial of Reldesemtiv in Amyotrophic Lateral Sclerosis

 Pivotal Trial Builds on Results from FORTITUDE-ALS which Demonstrated Slowing of Decline

of SVC and ALSFRS-R in Patients on Reldesemtiv Compared to Placebo

Company Is Planning to Provide Continued Access to Patients Who Complete COURAGE-ALS
and Patients Who Previously Participated in Cytokinetics Sponsored ALS Trials

https://finance.yahoo.com/news/cytokinetics-announces-start-courage-als-113000575.html

Pfizer, Merck, Shionogi Developing Pill That Could Lessen COVID Symptoms

 As it currently stands, more than 80 million people across England, Scotland, Wales, and Northern Ireland have received their first dose of the coronavirus vaccine, with 37 million people in the UK now recorded to be fully vaccinated. The vaccines have been lauded as the best defence against the virus, but as the fight to end the pandemic continues, international scientists are said to be also working on a COVID-19 pill. Pfizer is among the list of global companies working on pills that could be made available “as early as this year,” but what is the COVID-19 pill and is it available in the UK?

Drugmakers are aiming to create a pill “that those who get a positive COVID-19 test could take at home while their symptoms are mild,” reveals a report by the Wall Street Journal. It’s hoped the oral pills could help prevent the worsening of COVID-19 symptoms and “neutralise the virus” within a few days, reports WSJ.

Pfizer, Merck, and Japanese-based company Shionogi are all reportedly trialing oral antiviral drugs of this kind.

Back in March, Pfizer (an American drugs company that created one of the three available vaccines available in the UK) revealed it was trialing a tablet people could take “twice a day.” It’s been given the snappy title of PF-07321332 and, unlike the vaccines, which are preventative, the pill would help treat a person infected with the virus.

Interestingly, Pfizer’s “game-changing” pill is classed as a “protease inhibitor,” which are used to treat other viral pathogens such as HIV and Hepatitis C.

“Tackling the COVID-19 pandemic requires both preventions via vaccine and targeted treatment for those who contract the virus,” said Pfizer in a statement back in March 2021. “We have designed PF-07321332 as a potential oral therapy that could be prescribed at the first sign of infection, without requiring that patients are hospitalized or in critical care. At the same time, Pfizer’s intravenous antiviral candidate is a potential novel treatment option for hospitalized patients.”

According to CNBC, while Pfizer’s experimental drug could be “ready to hit the market as soon as this year” it is still in the midst of clinical trials — so, as to be expected, it’s not yet been confirmed if and when they’d be approved for use in the UK.

Meanwhile, American chemicals company Merck has struck a deal in the U.S. to provide 1.7 million cases of oral antiviral drug Molnupiravir upon approval by the FDA, while Japanese company Shionogi has started trialling a “convenient” once-a-day pill this month. Although it is in its early stages, per Wall Street Journal, Shionogi hopes that if the drug shows promise it could be distributed internationally.

https://www.bustle.com/life/what-is-the-covid-antiviral-pill

COVID-19 Vaccine Breakthrough Cases: Data from the States

 While COVID-19 vaccines are highly effective at preventing severe disease, hospitalization, and death from COVID-19 and also reduce the likelihood of mild or asymptomatic infection, a small share of fully vaccinated individuals do become infected, and some become hospitalized or have died. These rare occurrences are known as “breakthrough cases” which are to be expected, and historically known to occur with other vaccines as none is 100% effective.

The Centers for Disease Control and Prevention (CDC) currently monitors hospitalizations and deaths, from any cause, among fully vaccinated individuals with COVID-19, but not breakthrough infections, which it stopped monitoring as of May 1. CDC presents this data in aggregate at the national level but not by state, and there is no single, public repository for data by state or data on breakthrough infections, since the CDC stopped monitoring them.

We therefore reviewed the websites and other official state sources for all 50 states and D.C. to see which are providing data on COVID-19 breakthrough cases, hospitalizations and deaths, how regularly, and what those data may tell us. We only used data from official state sources (we did not include data available only in news media reports, for example). Where a state did not provide comparable data on overall COVID-19 cases, hospitalizations, or deaths reported over the period in which it captured breakthrough events, we obtained data on cases and deaths from the Johns Hopkins University COVID-19 Dashboard and on hospitalizations from the U.S. Department of Health & Human Services for the appropriate period (see methods for more detail).

Importantly, not all hospitalizations and deaths of those fully vaccinated and diagnosed with COVID-19 are due to COVID-19 or have a known cause at the time of reporting. The CDC reports that as of July 19, of 5,601 hospitalized breakthrough cases, 27% were asymptomatic or not related to COVID-19 and of 1,141 fatal cases, 26% were asymptomatic or not related to COVID-19. States differ in whether they provide this detail. DC, for example, reports that as of July 11, 50% of hospitalized breakthrough cases were due to COVID-19, 19% were not, and 31% were of unknown reason. However, few states made these distinctions. Where they did, we only included breakthrough hospitalizations and deaths due to COVID-19. In other cases, some of these breakthrough events may be due to causes other than COVID-19.

Overall, we find that:

• Half of states (25) report some data on COVID-19 breakthrough events (see Table 1). Twenty-four provide data on breakthrough cases, 19 on hospitalizations and on deaths.
• Fifteen of these states regularly update these data, often on a weekly basis. The rest use a different frequency, have one-time reports, have stopped updating, or have an unclear reporting frequency.
• The data reported from these states indicate that breakthrough cases, hospitalizations, and deaths are extremely rare events among those who are fully vaccinated against COVID-19 (see Figure 1). The rate of breakthrough cases reported among those fully vaccinated is well below 1% in all reporting states, ranging from 0.01% in Connecticut to 0.90% in Oklahoma.
  • The hospitalization rate among fully vaccinated people with COVID-19 ranged from effectively zero (0.00%) in California, Delaware, D.C., Indiana, New Jersey, New Mexico, Vermont, and Virginia to 0.06% in Arkansas. (Note: Hospitalization may or may not have been due to COVID-19.)
  • The rates of death among fully vaccinated people with COVID-19 were even lower, effectively zero (0.00%) in all but two reporting states, Arkansas and Michigan where they were 0.01%. (Note: Deaths may or may not have been due to COVID-19.)

• Almost all (more than 9 in 10) COVID-19 cases, hospitalizations, and deaths have occurred among people who are unvaccinated or not yet fully vaccinated, in those states reporting breakthrough data (see Figure 2).
  • The reported share of COVID-19 cases among those not fully vaccinated ranged from 92.02% in Oklahoma to 99.85% Connecticut.
  • The share of hospitalizations among those with COVID-19 who are not fully vaccinated ranged from in 95.02% in Alaska to 99.93% in New Jersey. (Note: Hospitalization may or may not have been due to COVID-19.)
  • The share of deaths among people with COVID-19 who are not fully vaccinated ranged from to 96.91% in Montana to 99.91% in New Jersey. (Note: Deaths may or may not have been due to COVID-19.)

Implications

While information on breakthrough events is still limited and incomplete, this analysis of available state-level data indicates that COVID-19 breakthrough cases, and especially hospitalizations and deaths, among those who are fully vaccinated are rare occurrences in the United States. Moreover, this data indicate the vast majority of reported COVID-19 cases, hospitalizations, and deaths in U.S. are among those who are unvaccinated or not fully vaccinated. These findings echo the abundance of data demonstrating the effectiveness of currently authorized COVID-19 vaccines. Moving forward, particularly as the more transmissible Delta variant is now the dominant strain of COVID-19 circulating in the U.S., more robust state-level data will help to monitor ongoing vaccine effectiveness and inform discussions about booster vaccinations.

Methods

We reviewed the websites and other official state sources for all 50 states and D.C. to assess which states are providing data on COVID-19 breakthrough cases, hospitalizations, and deaths, how regularly these data are updated, and what those data reveal. We only included data from official state sources (excluding data where the only available source was the news media, for example) and data provided for a period longer than one month (data from South Carolina was only available for June and was not included in this analysis). Each state collects and provides these data across varying time periods. To account for this, we used overall COVID-19 cases, deaths, and hospitalizations during the applicable time period for each state. If a state reported breakthrough data as cumulative, we assumed a January 1, 2021 start date. We used state-provided data where available. Where these data were not available from the state, we relied on data from Johns Hopkins University for cases and deaths totals, and the U.S. Department of Health and Human Services for hospitalization totals. Hospitalization totals include only confirmed COVID-19 hospitalizations for both adults (18+ years old) and children (younger than 18 years). For the total number of fully vaccinated individuals by state, we relied on state-reported totals where available, and data from Johns Hopkins University otherwise, again using the applicable time period for each state. We utilize two approaches in our analysis. The first assesses the share of fully vaccinated individuals that have experienced a COVID-19 event (i.e. diagnosis, hospitalization, or death) within each state. The second assesses the share of total COVID-19 cases, hospitalizations, and deaths attributable to fully vaccinated individuals compared to individuals who are not fully vaccinated within each state. Individuals who are not fully vaccinated may include those who are not vaccinated, partially vaccinated, or have an unknown vaccination status. In some cases, it is not possible to determine whether a hospitalization or death of a vaccinated individual with COVID-19 was due to COVID-19. https://www.kff.org/policy-watch/covid-19-vaccine-breakthrough-cases-data-from-the-states/

Galmed: FDA agrees on use of improved compound in Phase 3 NASH study

 Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and inflammatory diseases announced today that the FDA agreed with its plan to use Aramchol meglumine (in lieu of Aramchol free acid) in its Phase 3 ARMOR study without the need to conduct additional nonclinical and clinical studies other than planned limited pharmacology studies relating to Aramchol meglumine.

Allen Baharaff, Galmed co-founder and CEO commented, "We consider the FDA's agreement a significant validation of Galmed's consistent efforts to maximize the potential of Aramchol in developing a NASH treatment. The transition to Aramchol meglumine is the final step in our drug product optimization which started with the move to the BID Aramchol free acid regimen (with it higher exposure than the once daily regimen used in our Phase IIb study).  The data on the optimization of treatment duration and potential Non-Invasive Tests (NITs) associated with NASH and fibrosis, which will be revealed from the ongoing open label part of the ARMOR study, is aimed at de-risking our clinical development plan while increasing the probability of success of Aramchol's ARMOR registrational Study."

https://www.prnewswire.com/news-releases/fda-agrees-with-galmeds-plan-to-use-aramchol-meglumine-in-the-randomized-double-blind-placebo-controlled-part-of-the-phase-3-armor-study-301345943.html

Fauci: Amount of virus in breakthrough delta cases 'almost identical' to unvaccinated

 

Anthony Fauci, President Biden's chief medical adviser, on Sunday discussed new Centers for Disease Control and Prevention (CDC) data that showed the levels of coronavirus in breakthrough cases of the delta variant among those who are fully vaccinated are "almost identical" to the levels seen among unvaccinated individuals.

Appearing on CBS's "Face the Nation," Fauci stressed that the majority of breakthrough cases involving the delta variant saw "minimal symptoms or no symptoms at all."

Guest host John Dickerson asked Fauci what the CDC's reasoning was for recommending masks be worn by both vaccinated and unvaccinated people indoors.

"What we learned that's new, John, in answer to your question, is that when you look at the level of virus in the nasopharynx of people who are vaccinated who get breakthrough infections, it's really quite high and equivalent to the level of virus in the nasopharynx of unvaccinated people who get infected," Fauci said.

The nasopharynx is part of the nasal cavity located above the back of the throat. Fauci stated that it was "troubling" to find that the level of virus from the delta variant in both vaccinated and unvaccinated people is "really quite similar, almost identical."

According to Fauci, these findings differ from what was observed in cases involving the previously dominant alpha variant.

"So we know now that vaccinated people who get breakthrough infections can spread the virus to other people," Fauci said. "The fundamental basis for the CDC modifying their guidelines and saying now, 'If you're an area of a high or substantial trend of level of virus, namely a red or an orange zone, when you're in an indoor public setting, you need to wear a mask.' That's the fundamental reason for that change."

https://thehill.com/homenews/sunday-talk-shows/565831-fauci-amount-of-virus-in-breakthrough-delta-cases-almost-identical