Pfizer shares hit record high with COVID-19 vaccine stocks on a tear

 Shares of Pfizer Inc hit a record high on Tuesday for the first time in more than 20 years as shares of COVID-19 vaccine makers have surged amid rising coronavirus cases in the United States.

Pfizer shares were last up 4.9% at $48.25, climbing as high as $48.57 during the session. The stock’s previous intraday high was $47.44, reached on April 12, 1999.

The percentage gain was the stock’s biggest one-day rise since Nov. 9, when Pfizer released positive data for its COVID-19 vaccine.

“I think they are finally getting credit for the vaccine,” said Jeff Jonas, a portfolio manager at Gabelli Funds, which owns Pfizer shares.

While investors had treated the vaccine before as “a one-time cash infusion ... it is really going to be a durable business, unfortunately,” Jonas said, adding that Pfizer should be able to leverage the vaccine’s technology for use against other types of disease as well.

Pfizer’s share gains come as those of another coronavirus vaccine maker, Moderna Inc, have also been on a tear.

While Moderna’s shares were down 4% on Tuesday, they have soared some 78% since mid July, when S&P Dow Jones Indices announced it was adding the biotech company’s stock to the benchmark S&P 500 index.

U.S.-traded shares of Pfizer’s partner on the vaccine, Germany’s BioNTech, were down over 5% on Tuesday, but have climbed about 30% this month.

Shares of Novavax, which last week delayed its timeline for its COVID-19 vaccine, were up 11% on Tuesday.

The rapid spread of the Delta variant of the coronavirus has pushed cases and hospitalizations in the United States to a six-month high.

“The Delta variant has scared a lot of people into getting inoculated,” said Peter Tuz, president of Chase Investment Counsel and an investor in Pfizer.

Pfizer in late July raised its 2021 sales forecast for its COVID-19 vaccine by 29% to $33.5 billion.

Ashtyn Evans, a healthcare analyst at Edward Jones, said Pfizer will be able to use the cash flow from the vaccine “for both internal research and development and for acquisitions to strengthen their pipeline.”

https://www.reuters.com/article/pfizer-stocks/pfizer-shares-hit-record-high-with-covid-19-vaccine-stocks-on-a-tear-idUSL1N2PH204

A pandemic-like response to cancer prevention

 In 2020, a year of unimaginable tragedy, an estimated 375,000 people died from Covid-19 infections in the United States alone. Much of the suffering and death due to the disease was preventable in three ways: through avoidance by wearing masks and social distancing; by screening and treatment; and by vaccination.

One of the lessons of the Covid-19 pandemic has been that effective prevention strategies and widely used screening tests, combined with treatment and vaccines, can be developed and deployed rapidly across the country. We need to do the same thing for cancer prevention.

During the first pandemic year, more than 1.8 million Americans heard the frightening sentence, “You have cancer.” During the same period, nearly 600,000 Americans died from cancer, many more than the number who died from Covid-19 that year. But unlike the precipitous declines in Covid-19 cases and deaths, cancer will likely take a similar toll year after year.

In the 50 years since the passage of the National Cancer Act of 1971, we have learned that cancer prevention using those same strategies — avoidance, screening, and vaccination — along with intercepting precancerous changes averts more cancer deaths than cancer therapy does.

Prevention is the first and best line of defense for many cancers. When it works — and it does work — prevention generally goes unnoticed. In contrast, it is easy to build excitement around advances in treatment when new therapies yield benefits in patients. These are visible, helping people with cancer live longer, healthier lives. But when prevention works, there is nothing to show. Cancer simply does not occur. Healthy people stay healthy.

Proven opportunities to prevent cancer abound, yet the uptake of these readily available strategies has been imperfect.

Cancers can be prevented by avoiding things that cause them. Take tobacco as an example. Never using tobacco products, or stopping their use, has proven cancer-preventing effects. While fewer people smoke today than in years past, thanks to policy changes and education campaigns, approximately 1 in 14 adults and 1 in 8 high school students still use tobacco products. Avoiding weight gain by eating a healthy diet and exercising helps reduce cancer risk partly because obesity and type 2 diabetes (which is linked to weight) contribute to the development of several cancers.

Screening tests have been proven to reduce the number of cases and deaths for certain cancers. These include screening for colorectal cancer, for lung cancer among those who are or have been heavy smokers, and for breast and cervical cancer among women.

More than half of cervical cancers diagnosed in the U.S. occur in women who have not been tested for the disease, or tested only sporadically for it, and this type of cancer is found at later stages than in women who are routinely screened for it. Almost one-third of adults are not up to date on their colorectal cancer screening. Less than 10% of those eligible for lung cancer screening follow through with it. And while there is effective testing and treatment of hepatitis C, a major cause of liver cancer in the U.S., approximately half of those who have the virus that causes the disease do not know they have been infected with it.

Effective vaccines exist that prevent cancer-causing infections. Vaccination against human papillomavirus is highly effective at preventing HPV infection, which causes virtually all cervical and anal cancers, as well as many penile, vulvar, vaginal, and mouth and throat cancers. Yet more than 50% of adolescents ages 13 years to 17 years have not completed their HPV vaccination series. Hepatitis B is a major cause of liver cancer worldwide, and though vaccines against it have existed for more than 40 years, approximately 75% of Americans are not vaccinated against it.

Unlike Covid-19, preventive agents for cancer go beyond vaccines. A variety of non-vaccine agents can help prevent cancer, including daily, low-dose aspirin for some people at risk of colorectal cancer, and selective estrogen receptor modulators such as tamoxifen and raloxifene for women at elevated risk of breast cancer.

The future of cancer prevention research is promising. Scientists are identifying new ways to make it more accessible and convenient. People can already check for colorectal cancer with at-home kits. It will soon be possible to test for cervical and liver cancer at home. By making it easier for people to get checked for cancer, more people will do it.

Researchers also are evaluating new blood tests, sometimes called liquid biopsies or multi-cancer early detection tests, which can spot multiple cancers from one sample. And who knows what other interesting cancer prevention research ideas may emerge from the proposed Advanced Research Projects Agency for Health (ARPA-H), which is in the president’s FY2022 budget?

Physicians will increasingly “personalize” cancer prevention, just as they are doing in other areas of cancer care. The day is approaching when physicians will be able to use knowledge about individuals’ lifestyles, biology, and genetics to tailor cancer prevention approaches for them. Physicians can use this information, for example, to decide who needs to start cancer screening earlier and who can safely wait. The National Cancer Institute is working on identifying specific agents to intervene and modify precancerous changes in cells before they become cancerous. Vaccines that harness the immune system to attack these precancerous changes are on the horizon as well.

Prevention is the 21st century “cure” for cancer. While it is unlikely we will ever be able to prevent all cancers, many can be prevented now and many more can be prevented in the future. Ending cancer as we know it is the mission of the National Cancer Institute. What better way to achieve that goal than by preventing as many cancers as we can?

Philip E. Castle is the director of the National Cancer Institute’s Division of Cancer Prevention.

https://www.statnews.com/2021/08/09/applying-a-pandemic-like-response-to-cancer-prevention/

American Academy of Pediatrics urges FDA to expedite COVID vaccine for young

 The American Academy of Pediatrics (AAP) urged the FDA to expedite authorizing the COVID-19 vaccines for children under 12 years old.

"We need to be approaching the trials in the authorization of the COVID vaccine for children with the same urgency that we did with adults. Just as it's a serious disease in adults, it can be a very serious disease in children," AAP President Dr. Lee Savio Beers said.

Experts are still working to learn if the delta variant of COVID-19 is more dangerous for children.

According to CDC data, the rate of pediatric hospital admissions -- which is children 17 and under per 100,000 people -- is now 3.75 times higher than it was one month ago; the rate is also now equal to its highest point in the pandemic in January 2021.

https://abc11.com/covid-nc-vaccine-for-kids-fda/10942272/

Arcturus Jumps On mRNA COVID-19 Vaccine Update

 

• Arcturus Therapeutics Holdings Inc (NASDAQ:ARCT) reported a Q2 EPS loss of $(2.07), beating the consensus of $(2.14).
• The cash balance totaled $433.6 million. After the end of the quarter, Arcturus received the remaining $30 million of upfront payment from Vinbiocare. 
• The company's cash position is sufficient to support operations for more than two years based on the current pipeline.
• In its Q2 release, Arcturus Therapeutics said that preclinical data of its COVID-19 mRNA vaccine candidate, ARCT-154, demonstrated strong neutralizing immunogenicity in non-human primates to the four variants.
• ARCT-154 elicits 14.4 to 25.9-fold higher neutralizing antibody titers than ARCT-021 in non-human primates, including an observed increase of 17.8-fold higher neutralizing antibody titers against the Delta variant.
• Arcturus has advanced ARCT-154 toward multiple clinical development studies. 
• The ARCT-154 vaccine targets the D614G spike protein mutation that has become dominant globally.
• Last week, the Vietnam Ministry of Health signed off Arcturus's trial application to advance ARCT-154 targeting variants of concern.
• The company also said that ARCT-021 had been selected by a global entity to be included in a multinational COVID-19 Phase 3 vaccine trial. 
• The placebo-controlled study will evaluate a 5-mcg dose of ARCT-021 administered as a single injection regimen. The Phase 3 study will be sponsored and funded by the entity.

https://markets.businessinsider.com/news/stocks/arcturus-therapeutics-stock-jumps-on-mrna-covid-19-vaccine-update-1030713659

COVID-19 During Pregnancy Associated with Preterm Birth

 ndividuals who contract COVID-19 while pregnant face a higher risk of having a very preterm birth, as well as any preterm birth, according to a large study led by researchers at UC San Francisco.

Risk of very preterm birth, which occurs at less than 32 weeks of gestation, was 60 percent higher for people infected with COVID-19 at some point in their pregnancy, while the risk of giving birth at less than 37 weeks (all preterm births) was 40 percent higher in those with infection. For those who also had hypertension, diabetes and/or obesity as well as COVID-19, the risk of preterm birth rose 160 percent.

The paper was published online July 30, 2021, in The Lancet Regional Health - Americas.

“Preterm birth is associated with many challenging outcomes for pregnant people and babies, and very preterm births carry the highest risk of infant complications,” said lead and corresponding author Deborah Karasek, PhD, assistant professor in the Department of Obstetrics, Gynecology & Reproductive Sciences, and researcher with the California Preterm Birth Initiative at UCSF.

“Our results point to the importance of preventative measures to reduce COVID-19 infection among pregnant people to prevent preterm birth, including vaccination,” she said. “Pregnant people may have concerns about vaccines and the health of their baby, so being able to have an open dialogue that values those concerns, describes evidence about safety, and conveys the risks posed by COVID-19 infection during pregnancy is critically important.”

On July 30, the American College of Obstetricians and Gynecologists (ACOG) issued updated guidance strongly recommending that all pregnant individuals get vaccinated against COVID-19. Pregnant people are considered a high-risk population for COVID-19 infection, yet less than a quarter have received at least one dose of vaccine, according to the U.S. Centers for Disease Control and Prevention (CDC).

The UCSF study was the first of its kind large enough to identify the risks of COVID-19 by specific subtype of preterm birth, as well as by race, ethnicity, and insurance status. The study data reflected both existing disparities in preterm birth rates for Black, Indigenous and other people of color (BIPOC) compared to whites, and the known outsized burden of the pandemic on communities of color. Latinx, American Indian/Alaska Native, Native Hawaiian/Pacific Islander people, as well as people with public insurance, had disproportionately higher COVID-19 rates during pregnancy. For example, while 47 percent of pregnant people in the study overall were Latinx, they represented 72 percent of the people with COVID-19 diagnoses.

“Given that the burden of COVID-19 is greater in these populations, as is the burden of pre-term birth, it really points to the need for an equity approach,” said Karasek. “With the surge in infections and increase in the Delta variant, we must think about pregnant people, especially Black and Brown populations, as the groups that need to be prioritized, with supportive policies to reduce exposure and stress, and increase access to care.”

The researchers analyzed all live births between July 2020 and January 2021 documented by California Vital Statistics birth certificates. Of the 240,157 recorded births, nearly 9,000, or 3.7 percent, indicated a COVID-19 diagnosis in pregnancy. The preterm birth rate among birthing people with a COVID-19 diagnosis was 11.8 percent compared with 8.7 percent among those without COVID-19.

The overall sample included 47.2 percent Latinx, 26.8 percent white, 4.9 percent Black, 13.2 percent Asian, 0.03 percent American Indian/Alaskan Native, 0.4 percent Hawaiian/Pacific Islander and 7.3 percent identified as other, unknown, or two or more races. Forty percent of people in the study had public insurance at the time they gave birth, and 15.9 percent had hypertension, diabetes, obesity, or a combination of these.

Having comorbidities along with COVID-19 infection increased the risk of preterm birth. Individuals with hypertension, diabetes and/or obesity as well as a COVID-19 diagnosis had a 160 percent higher risk of very preterm birth and a 100 percent higher risk of preterm birth compared to those without comorbidities or COVID-19.

Researchers found that preterm birth rates didn’t vary by whether the births were spontaneous or medically-indicated, which may indicate multiple pathways between COVID-19 diagnosis and preterm birth, Karasek said.

Limitations of the study included that it couldn't determine when during pregnancy the individuals contracted COVID-19, or how serious the infections were. These are important details for understanding the mechanisms by which COVID-19 affects preterm birth risk and Karasek said they are currently being studied at UCSF and elsewhere.

https://www.ucsf.edu/news/2021/08/421181/covid-19-during-pregnancy-associated-preterm-birth

MyMD Unit Oravax to Commence Clinical Trials for Oral COVID-19 Vaccine

 MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage pharmaceutical company committed to extending healthy lifespan by focusing on developing two therapeutic platforms, today reported that its subsidiary Oravax Medical Inc. (“Oravax”), partially owned with its majority partner Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (“Oramed”), is preparing to commence clinical trials for its oral COVID-19 vaccine, first in Israel, then in additional clinical sites internationally. Oravax’s COVID-19 vaccine is being developed for use both as a standalone vaccine and as a booster for people who have been previously vaccinated for COVID-19.

Oramed and MYMD are currently evaluating several options with respect to their interest in Oravax including a potential distribution of Oravax shares to both Oramed and MYMD shareholders. This would make Oravax a publicly held company that may then apply for listing on Nasdaq if eligible. MyMD’s ownership of Oravax consists of 13% of Oravax’s outstanding shares of capital stock and a 2.5% royalty on all future net sales.

“The potential spin-off of Oravax could be beneficial to MyMD shareholders through our ownership stake and due to Oravax’s strong position in the public markets as an oral vaccine developer,” said Josh Silverman, Chairman of the Board of MyMD Pharmaceuticals. “Oravax’s studies of its VLP vaccine for COVID-19 should be of particular interest to MyMD shareholders given our own upcoming Phase 2 clinical trial of MYMD-1 to treat immune mediated depression and cytokine elevation in COVID-19 patients. We are excited about the possibilities for both technologies in the global fight against COVID-19.”

As a triple antigen targeting three SARS CoV-2 virus surface proteins instead of one, including proteins less susceptible to mutation, MYMD believes that Oravax’s COVID-19 vaccine candidate could be a better candidate to provide protection even against emerging mutated viruses. The oral delivery of the vaccine could allow for widescale inoculation and easier distribution than injection.

MyMD recently announced that a human cell research study of its lead clinical compound MYMD-1 found the drug to be effective in suppressing the cytokine storm, a major cause of severity and death in COVID-19 patients. A Phase 2 trial of MYMD-1 as a therapy for COVID-19-associated depression and cytokine elevation is expected to begin by the fourth quarter of 2021 with initial trial data expected in the first quarter of 2022.

About Oravax Medical

Oravax was established in March 2021 by Oramed Pharmaceuticals Inc. (Nasdaq: ORMP), the largest shareholder in Oravax, along with MYMD, Premas Biotech and certain other shareholders, with a mission to bring an oral COVID-19 vaccine to the market. Oravax combines cutting edge vaccine technology acquired from Premas Biotech and the proprietary POD™ oral delivery technology of Oramed Pharmaceuticals. For more information, please visit www.ora-vax.com.

https://www.streetinsider.com/Corporate+News/MyMD+Pharmaceuticals+%28MYMD%29+Subsidiary+Oravax+Medical+Preparing+to+Commence+Clinical+Trials+for+Oral+COVID-19+Vaccine/18795784.html

Fulcrum has positive interim results in Phase 1 sickle cell trial

 

• Achieved dose proportional pharmacodynamic changes in HBG mRNA and F-reticulocytes in whole blood
  

  • Mean 4.5-fold induction in HBG mRNA at 10mg after 14 days of once-daily dosing

  • Mean 4.2-fold increase in F-reticulocytes at 10mg after 14 days of once-daily dosing
    
    

• Achieved maximal target engagement by day seven in 6mg and 10mg cohorts
  
  

• FTX-6058 was generally well tolerated with no serious adverse events observed to date
  
  

• Company plans to initiate enrollment in a Phase 1b clinical trial in sickle cell patients in 4Q 2021
  
  

• Company plans to submit Investigational New Drug (IND) application in non-sickle cell hemoglobinopathies (e.g., beta-thalassemia) by year-end 2021
  
  

• Company to review clinical results on second quarter earnings call today at 8:00am ET

Fulcrum will host a conference call and webcast today at 8:00 am ET to discuss these results and the company’s second quarter financial results. The webcast will be accessible through the Investor Relations section of Fulcrum’s website at www.fulcrumtx.com. Following the live webcast, an archived replay will also be available.

Dial-in Number
U.S./Canada Dial-in Number: 800-527-6973
International Dial-in Number: 470-495-9162
Conference ID: 3291056

Replay Dial-in Number: 855-859-2056
Replay International Dial-in Number: 404-537-3406
Conference ID: 3291056

https://finance.yahoo.com/news/fulcrum-therapeutics-announces-positive-interim-110000744.html