Novavax expects it can meet U.S. COVID-19 vaccine demand in 2021

Novavax Inc’s manufacturing capacity is sufficient to meet the U.S. demand for COVID-19 vaccines in 2021, which it believes could be as high as 500 million to 600 million doses, company executives said on Monday.

Novavax said last week its experimental vaccine produced high levels of antibodies against the novel coronavirus, according to initial data from a small, early stage clinical trial.

Novavax expects to begin producing vaccine at large scale in the beginning of 2021 and to be able to make “well over” 2 billion doses of its vaccine annually overall, the executives added during an investor call.

Novavax is still waiting on the U.S. Food and Drug Administration to review data from its early stage study of its vaccine candidate, but has said it expects to start a large Phase III trial as soon as late September.

Novavax research chief Gregory Glenn told Reuters last week the late-stage clinical trial could potentially glean enough data to obtain regulatory approvals as early as December.

Maryland-based Novavax has said its vaccine candidate, NVX-CoV2373, produced higher levels of the antibodies in healthy volunteers after two doses than those found in recovered COVID-19 patients, raising hopes for its eventual success.

The Novavax vaccine is among the first of a handful of programs singled out for U.S. funding under Operation Warp Speed, the White House program to accelerate access to vaccines and treatments that can fight the virus.

The U.S. government in July agreed to pay Novavax $1.6 billion to help cover costs related to testing and manufacturing the vaccine, with the aim of procuring 100 million doses by January 2021.

https://www.reuters.com/article/us-health-cornavirus-novavax-vaccine/novavax-expects-it-can-meet-u-s-covid-19-vaccine-demand-in-2021-executives-say-idUSKCN2562MP

COVID-19 cases in U.S. children soared in late July

The number of new COVID-19 cases among children in the United States rose 40% in the last two weeks of July, according to a report released just weeks before tens of millions of American students are scheduled to begin the new school year.

Health experts are keeping an eye on coronavirus infections among kids and teenagers as officials struggle with the thorny question of whether to reopen schools for in-person classes, adopt a virtual learning model or a hybrid of the two.

President Donald Trump, who is seeking a second term in the White House in a Nov. 3 election, has pushed states to allow students to physically return to classrooms, but health officials have expressed caution about doing so in areas where cases have been rising sharply.

The new report by the American Academy of Pediatrics and the Children’s Hospital Association found that more than 338,000 children have tested positive for COVID-19 since the onset of the U.S. epidemic, with 97,078 new cases reported in the July 16-30 period.

Most of the new infections in this group occurred in states in the U.S. South and West, according to the report, which was based on data from 49 states, New York City, the District of Columbia, Puerto Rico and Guam.

It did not give a reason for the recent spike. Testing for the novel coronavirus overall has risen in the United States and concerns about children as possible spreaders of the virus have been sparked by new studies showing they can catch it.

The American Academy of Pediatrics noted the data showed that severe illness due to COVID-19 appears to be rare among children. The U.S. Centers for Disease Control and Prevention also has said that children who get the virus are less likely to have severe symptoms.

The CDC recently updated its guidance to recommend that schools reopen to some degree unless their communities were experiencing an uncontrolled or high rate of transmission of the virus.

Some cities including Chicago and Los Angeles plan to start the school year with online classes, while New York City, once the epicenter of the U.S. epidemic, plans to have at least some in-person learning in all its school districts in the fall.

Children account for a tiny fraction of the more than 162,000 people who have died from COVID-19 in the United States. More than 5 million people in the country have been infected with the virus, representing about one-quarter of the total worldwide cases.

https://www.reuters.com/article/us-health-coronavirus-children/covid-19-cases-in-u-s-children-soared-in-late-july-report-says-idUSKCN2562FS

Addus HomeCare EPS beats by $0.25, beats on revenue

Addus HomeCare (NASDAQ:ADUS): Q2 Non-GAAP EPS of $0.73 beats by $0.25; GAAP EPS of $0.43 beats by $0.01.

Revenue of $184.58M (+23.9% Y/Y) beats by $12.46M.

Press Release

https://seekingalpha.com/news/3603776-addus-homecare-eps-beats-0_25-beats-on-revenue

Guardant edges Roche in liquid biopsy approval

The liquid biopsy era is finally here.

In the race to be first to get US approval for a pan-cancer liquid biopsy the field had narrowed to just two serious contenders: Roche and Guardant Health. On Friday the latter company won, and the FDA’s rubber-stamp should boost usage of the Guardant360 blood test.

The assay was already on sale in the US as a so-called lab-developed test, without official FDA oversight. Its formal approval for comprehensive genomic profiling – essentially picking out all the targetable mutations carried by any sort of solid tumour – gives Guardant the opportunity to get its test established as the reliable choice before other liquid biopsies get a pass from the regulator.

Many oncologists and researchers are somewhat sceptical of liquid biopsies, feeling that while they are faster and cheaper than surgical biopsy their accuracy is simply not as good (Liquid biopsies: the future of cancer diagnosis?, June 12, 2019). Guidelines published by Esmo and the National Comprehensive Cancer Network recommend their use only in cases where tumours are not suitable for biopsy, or where not enough tissue can be harvested. Up to 25% of cancer patients fall into these categories.

Crucially the FDA’s approval does not require that a doctor assess whether tissue biopsy is possible or not before using Guardant360. The approval could thus help persuade cancer organisations to recommend the blood test’s use in all patients.

It could also bring more payers on board, though the reimbursement situation for Guardant360 is already pretty good. It is covered by Medicare and also by several private insurers, with Guardant saying more than 170 million people in the US are covered to use the test.

The competition

While the approval for comprehensive genomic profiling is the important achievement, the FDA also issued a separate approval for Guardant360, as a simple companion diagnostic for Astrazeneca’s lung cancer drug Tagrisso.

Given that Roche is the world’s largest diagnostics company, and one that is unusually eager to obtain regulatory approval for its products, it is somewhat surprising that the company will come second at best in the far more important pan-cancer setting. FoundationOne Liquid, the pan-tumour blood test developed by Foundation Medicine before Roche acquired it in 2015, is filed with the FDA, and approval could come by the end of this year.

Another surprising laggard is Grail. The Illumina spin-out is spectacularly well funded, with venture investors having sunk more than $2bn into the group. Its Galleri test is in several huge cancer trials, but is not yet on sale, and the company has said nothing about regulatory filings.

Several other companies have pan-solid tumour tests in development and are serious about getting the FDA’s approval. Guardant will have to make the most of its first-mover advantage.

Selected liquid biopsies – progress update
Company	Liquid biopsy	Type	Status in US	Company funding ($m)
Guardant Health	Guardant360	Pan-cancer; helps assign targeted therapy	Approved	$550m VC funding; floated in 2018,  current MC $8.5bn
	Lunar-1	Postsurgical, detects disease recurrence	Sold for research use only
	Lunar-2	Screening for colon cancer	Clinical trials
Foundation Medicine (Roche)	FoundationOne Liquid	Pan-cancer; helps assign targeted therapy	Sold as LDT; submitted to FDA	$115m VC funding; bought by Roche for $2.5bn in 2015
Grail	Galleri	Pan-cancer; early detection and identification of tumour origin	FDA breakthrough device status	$2.1bn VC funding
Thrive Earlier Detection	CancerSeek	Pan-cancer; early detection	FDA breakthrough device status	$367m VC funding
Natera	Signatera	Pan-cancer; postsurgical, detects disease recurrence	FDA breakthrough device status	$152m VC funding; floated in 2015, current MC $4.2bn
Archer DX	Stratafide	Pan-cancer; helps assign targeted therapy	FDA breakthrough device status	$150m VC funding; bought by Invitae in 2020 for $1.5bn
Source: EvaluateMedTech & company websites.

https://www.evaluate.com/vantage/articles/news/policy-and-regulation/guardant-pips-roche-liquid-biopsy-approval

ChemoCentryx, Inc. EPS beats by $0.63, beats on revenue

ChemoCentryx, Inc. (NASDAQ:CCXI): Q2 GAAP EPS of $0.29 beats by $0.63.

Revenue of $49.44M (+589.5% Y/Y) beats by $41.19M.

Press Release

https://seekingalpha.com/news/3603680-chemocentryx-inc-eps-beats-0_63-beats-on-revenue

Esperion Therapeutics EPS beats by $2.09, beats on revenue

Esperion Therapeutics (NASDAQ:ESPR): Q2 GAAP EPS of $4.32 beats by $2.09.

Revenue of $212.24M (+21557.1% Y/Y) beats by $64.27M.

Shares +0.94%.

Press Release

https://seekingalpha.com/news/3603626-esperion-therapeutics-eps-beats-2_09-beats-on-revenue

China’s Sinopharm starts Phase III trial of COVID-19 vaccine in Bahrain

Chinese state-owned pharmaceutical company Sinopharm has begun Phase III clinical trials of a COVID-19 vaccine in Bahrain, after launching similar trials in the United Arab Emirates last month, Bahrain’s health ministry said on Monday.

The human trial, which launched in the UAE capital Abu Dhabi in mid-July, is a partnership between Sinopharm’s China National Biotec Group (CNBG) and Abu Dhabi-based artificial intelligence and cloud computing company Group 42 (G42).

G42 Healthcare CEO Ashish Koshy said expanding the trial to the small island state of Bahrain will increase the numbers of participants on a par with trials underway in nations with much larger populations.

The study, which uses an inactivated vaccine, will include around 6,000 citizens and resident volunteers in Bahrain over 12 months, the health ministry said.

No COVID-19 vaccine has yet been approved for commercial use.

The trial in the UAE, which was expanded from Abu Dhabi to include another centre in Sharjah emirate, on Thursday reached a milestone of 5,000 vaccinations, a joint statement from the trial organisers said.

Bahrain, with a population of 1.5 million, has recorded more than 44,000 cases of the new coronavirus and 162 deaths.

https://www.reuters.com/article/us-health-coronavirus-bahrain-vaccine/chinas-sinopharm-starts-phase-iii-trial-of-covid-19-vaccine-in-bahrain-idUSKCN2561V1