Aptevo's lead drug achieves second remission in early-stage blood cancer study

• In addition to the one previously announced, Aptevo Therapeutics (NASDAQ:APVO) says a second patient in cohort 6 has achieved complete remission (CR) in a Phase 1 trial evaluating its lead candidate APVO436 in patients with acute myeloid leukemia and myelodysplastic syndromes.
• Patient bone marrow blasts were 33% at screen, exhibited a rise to 46% after the first cycle of treatment, and subsequently dropped to 8% after the second cycle, and to 4% after the fourth cycle of treatment.
• The patient's platelet count and absolute neutrophil count met complete remission criteria.
• Also, data showed that one patient exhibited stable disease status, and six patients where the disease had progressed.
• https://seekingalpha.com/news/3633486-aptevos-lead-drug-achieves-second-remission-in-early-stage-blood-cancer-study
  

Bristol Myers' deucravacitinib successful in mid-stage psoriatic arthritis study

• Bristol Myers Squibb (NYSE:BMY) announces positive results from a 203-subject Phase 2 clinical trial evaluating oral tyrosine kinase 2 (TYK2) inhibitor deucravacitinib in adults with psoriatic arthritis. The results are being presented today at the American College of Rheumatology Annual Meeting.
• The study met the primary endpoint of at least a 20% improvement in signs and symptoms of disease (ACR 20) at week 16 versus placebo in both the 6 mg and 12 mg arms (52.9%, 62.7% vs. 31.8%).The proportions achieving ACR 50 (at least a 50% improvement in disease severity) were 24.3%, 32.8% and 10.6%, respectively.
• All key secondary endpoints were also met.
• On the safety front, the most common treatment-emergent adverse events compared to control were nasopharyngitis (5.7%, 17.9%, 7.6%), rash (4.3%, 6.0%, 0%) and headache (7.1%, 1.5%, 4.5%).
• The company is assessing the candidate in a range of other immune-mediated disorders including psoriasis, lupus and inflammatory bowel disease.
• https://seekingalpha.com/news/3633585-bristol-myers-deucravacitinib-successful-in-mid-stage-psoriatic-arthritis-study
  

Biden's first stimulus plan may be a skinny one, Goldman says

• Assuming that the Republicans keep control of the Senate, some Wall Street strategists expect that Joe Biden, as president, will only be able to get a stimulus bill of $500B-$1T through Congress.
• That's significantly below the $3T package the House passed in May and the $2T plan that House Speaker Nancy Pelosi floated on a compromise plan with the Trump administration before the election.
• “We think the base case is a fiscal stimulus package of around $1 trillion,” Goldman Sachs Chief economist Jan Hatzius wrote in a note to clients.
• Overall, the strategists hold little hope of a new stimulus bill passing during the remainder of President Trump's term.
• As for the next administration, expect a trimmed-down relief bill to focus on measures that will help households in the near-term, they say.
• Hatzius expects such a package to include expanded eligibility and extended duration of unemployment insurance, along with a supplemental payment of ~$400 per week; new funding for the Paycheck Protection Protection Program; aid for state and local governments; and more funding for COVID-19 public health efforts. Another round of stimulus checks to individuals also may be possible, he wrote.
• Meanwhile, markets are looking to a vaccine to control the coronavirus after Pfizer/BioNTech's COVID-19 vaccine candidate shows 90% effectiveness seven days after a second dose in a Phase 2/3 clinical trial.
• The companies are expected to apply for emergency use authorization once the required safety milestone is reached, expected in the third week of November.
• https://seekingalpha.com/news/3633572-president-elect-bidens-first-stimulus-plan-may-be-skinny-one-goldman-says
  

Pfizer/BioNTech COVID-19 vaccine 90% effective, U.S. EUA application seen this month

• The first interim efficacy analysis of the large-scale Phase 2/3 clinical trial evaluating Pfizer (NYSE:PFE) and BioNTech's (NASDAQ:BNTX) COVID-19 vaccine candidate, BNT162b2, showed it to be more than 90% effective seven days after the second dose in preventing infection in participants with no evidence of prior SARS-CoV-2 infection.
• 94 confirmed cases of COVID-19 were evaluated.
• The companies plan to review the results with global regulatory authorities.
• No safety signals were observed.
• The study will continue through the final analysis of 164 confirmed cases.
• An emergency use authorization (EUA) application will be made after the required safety milestone is achieved, expected to occur in the third week of November.
• COVID-19 vaccine-related tickers: Moderna (NASDAQ:MRNA) (+6%), Johnson & Johnson (NYSE:JNJ) (+4%), Merck (NYSE:MRK) (+1%), Sanofi (NASDAQ:SNY) (+2%), GlaxoSmithKline (NYSE:GSK) (+3%), Dynavax (NASDAQ:DVAX), Novavax (NASDAQ:NVAX), AstraZeneca (NASDAQ:AZN) (+1%).
• https://seekingalpha.com/news/3633509-pfizer-biontech-covidminus-19-vaccine-90-effective-u-s-eua-application-expected-this-month
  
  

1.7M New Yorkers infected with SARS-CoV-2; virus in NYC earlier than reported

The virus that causes COVID-19 was present in New York City long before the city's first case of the disease was confirmed on March 1, researchers at the Icahn School of Medicine at Mount Sinai report. Their study found that more than 1.7 million New Yorkers—about 20 percent of the city's population—have already been infected with the virus, known as SARS-CoV-2, and that the infection fatality rate of the virus is close to 1 percent, ten times deadlier than the flu. 

Results of the retrospective surveillance study of more than 10,000 plasma samples taken from the beginning of February to July will be published in Nature on Tuesday, November 3.

A sharp rise in infections in New York City occurred in the week ending March 8, followed by a significant increase of COVID-19 deaths during the week ending March 15. New York State implemented a stay-at-home order March 22, after which daily case numbers in New York City started to plateau and then decreased in April and May.

Very little testing capacity was available at the beginning of the local epidemic in early March, but, "We now know there were many asymptomatic and mild to moderate cases that likely went undetected," said Emilia Mia Sordillo, MD, Ph.D., Associate Professor of Pathology, Molecular and Cell Based Medicine, Director of Clinical Microbiology, an attending physician in Infectious Diseases at the Icahn School of Medicine and the Mount Sinai Health System, and a senior author on the paper. "In this study, we aimed to understand the dynamics of infection in the general population and in people seeking urgent care."

The study findings are based on a dataset of 10,691 plasma samples from Mount Sinai Health System patients obtained and tested between the weeks ending February 9 and July 5. The first group included 4,101 samples from patients seen in Mount Sinai's emergency departments and from patients that were admitted to the hospital for urgent care. This group, termed the "urgent care" group, served as a positive control group designed to detect increasing SARS-CoV-2 infections in individuals with moderate to severe COVID-19 as the local epidemic progressed. The second group of 6,590 samples, termed the "routine care" group, were obtained from patients at OB/GYN visits, labor and deliveries, oncology-related visits, hospitalizations due to elective surgeries and transplant surgeries, preoperative medical assessments and related outpatient visits, cardiology office visits, and other regular office/treatment visits. Researchers reasoned that these samples might resemble the general population more closely because the purposes for these scheduled visits were unrelated to acute SARS-CoV-2 infection. The urgent care group comprised 45.5 percent females while the routine care group included 67.6 percent females. The majority of individuals in the urgent care group were over 61 years of age while the routine care group had a more balanced age distribution that more closely resembled the general population adult population.

To estimate true infection rates, researchers measured the presence of antibodies to past SARS-CoV-2 infections, rather than the presence of the virus, in weekly intervals. The antibody test used in this research—an enzyme-linked immunosorbent assay (ELISA)— was developed and launched at Mount Sinai and is able to detect the presence or absence of antibodies to SARS-CoV-2, as well as the titer (level) of antibodies an individual has. The high sensitivity and specificity of this test—meaning that the rate of false negatives and false positives is low—allowed it to be among the first to receive emergency use authorization from New York State and the U.S. Food and Drug Administration.

"Our two-step ELISA test confirms the presence and level antibodies. The use of two sequential tests reduces the false positive rate and favors high specificity resulting in a sensitivity of 95 percent and a specificity of 100 percent," said Viviana Simon, MD, Ph.D., Professor of Microbiology, and Medicine; a member of the faculty of the Global Health and Emerging Pathogens Institute at the Icahn School of Medicine; and a senior author on the paper.

Seroprevalence increased at different rates in both groups, rising sharply in the urgent care group. Notably, seropositive samples were found as early as mid-February (several weeks before the first official cases) and leveled out at slightly above 20 percent in both groups after the epidemic wave subsided by the end of May. From May to July, seroprevalence and antibody titers stayed stable, suggesting lasting antibody levels in the population.

"Our data suggests that antibody titers are stable over time, that the seroprevalence in the city is around 22 percent, that at least 1.7 million New Yorkers have been infected with SARS-CoV-2 so far, and that the infection fatality rate is 0.97 percent after the first epidemic wave in New York City," said Florian Krammer, Ph.D., Mount Sinai Professor in Vaccinology at the Icahn School of Medicine and corresponding author on the paper. "We show that the infection rate was relatively high during the first wave in New York but is far from seroprevalence that might indicate community immunity (herd immunity). Knowing the detailed dynamics of the seroprevalence shown in this study is important for modeling seroprevalence elsewhere in the country." 

More information: Daniel Stadlbauer et al, Repeated cross-sectional sero-monitoring of SARS-CoV-2 in New York City, Nature (2020). DOI: 10.1038/s41586-020-2912-6

https://medicalxpress.com/news/2020-11-million-yorkers-infected-sars-cov-virus.html

Biden team held COVID-19 talks with Operation Warp Speed drugmakers before election

U.S. President-elect Joe Biden’s healthcare advisers have held talks with drugmaker executives on the U.S. government’s Operation Warp Speed program to accelerate development of a possible COVID-19 treatment, a Biden spokesman said on Sunday.

Under the Trump administration, Operation Warp Speed has struck deals with several drugmakers in an effort to help speed up the search for effective treatments for the disease amid the global coronavirus pandemic.

The U.S. COVID-19 death toll stands at over 237,000, with more than 9.9 million cases now reported in the country since the outbreak began, according to a Reuters tally.

“As we previously said in September, because President-Elect Joe Biden is absolutely committed to helping develop a safe and effective coronavirus vaccine as soon as possible, campaign medical advisers have received briefings from companies working to produce vaccines in order to be informed about the process,” Biden’s spokesman Andrew Bates said in an emailed statement.

Biden’s advisers met with companies that have COVID-19 vaccines or therapies in late-stage clinical trials in September and October, Bloomberg News had reported earlier.

The report added that the meeting was aimed at gathering information about the development, manufacturing and distribution of shots to ward off the novel coronavirus and therapies to treat the sick.

Biden has vowed to “listen to the science”, with his coronavirus plan calling for scaling up testing and contact tracing and promising to appoint a “supply commander” to oversee supply lines of critical equipment.

Late in October, Health and Human Services Secretary Alex Azar said the United States is likely to have enough safe and effective COVID-19 vaccines available to inoculate the most vulnerable Americans by the end of 2020.

In their talks, Biden’s advisers indicated to drug company officials that his administration would not be interested in making changes to Warp Speed that would disrupt work in getting new drugs and vaccines to market, Bloomberg reported, adding his administration will want to assist the companies’ efforts when Biden assumes office.

The coronavirus outbreak has been worsening in recent weeks as cold weather pushes Americans indoors, raising the chance of contracting the virus.

https://www.reuters.com/article/us-health-coronavirus-usa-vaccine-biden/biden-team-held-covid-19-talks-with-operation-warp-speed-drugmakers-before-election-idUSKBN27P022

Inovio Pharmaceuticals Q3 2020 Earnings Preview

• Inovio Pharmaceuticals (NASDAQ:INO) is scheduled to announce Q3 earnings results on Monday, November 9th, after market close.
• The consensus EPS Estimate is -$0.19 (+24.0% Y/Y) and the consensus Revenue Estimate is $3.05M (+250.6% Y/Y).
• Over the last 1 year, INO has beaten EPS estimates 0% of the time and has beaten revenue estimates 0% of the time.
• Over the last 3 months, EPS estimates have seen 0 upward revisions and 5 downward. Revenue estimates have seen 0 upward revisions and 2 downward.
• https://seekingalpha.com/news/3633410-inovio-pharmaceuticals-q3-2020-earnings-preview