EyePoint Pharma in eye med license deal with Equinox Science

EyePoint Pharmaceuticals (NASDAQ:EYPT) +11% after-hours on news it signed an exclusive license agreement with Equinox Science to develop vorolanib, a tyrosine kinase inhibitor, for the treatment of wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion.

EyePoint is developing vorolanib as EYP-1901, utilizing a miniaturized, injectable, sustained-release intravitreal drug delivery system with a six-month duration.

The company says it recently completed a positive Type B pre-Investigational New Drug meeting with the Food and Drug Administration clarifying the pathway for a phase 1 clinical trial, which it expects will provide data in H2 2021.

https://seekingalpha.com/news/3537714-eyepoint-pharma-inks-exclusive-license-deal-equinox-science

Footage of New Military-Operated Coronavirus Hospital in Wuhan

Huoshenshan Hospital construction nears completion in Wuhan, China on Feb. 2, 2020. (Stringer/Getty Images)

Coronavirus Outbreak

A newly built hospital in the city of Wuhan, the epicenter of the coronavirus outbreak in central China, began operations on Feb. 3 under the supervision of China’s military.
Medical staff there will comprise workers from different organizations, such as military medical universities and military hospitals. The People’s Liberation Army (PLA) Joint Logistic Support Force will oversee the operations.

The hospital, which isn’t open to the public, will only receive patients as arranged by the local government in Wuhan.
Netizens and Chinese media shared videos showing the interior of the facility, which corroborate footage released by the authorities.
In video footage published on Feb. 2, a member of the construction crew that worked on the hospital demonstrates that all of the doors are locked from the outside, meaning that patients can’t freely enter or leave their rooms or the facility.
“This so-called hospital is actually a prison. You can’t leave if you are inside,” the man says. “Basically, [patients] are waiting to die here. They will then be sent to the crematorium after death.”
That information couldn’t be independently verified by The Epoch Times.

Hospital

On Feb. 3, the Huoshenshan Hospital was officially in operation. Chinese state media Xinhua praised that this hospital was built quickly, because more than 4,000 workers only spent 10 days to build this 1,000-bed capacity hospital.
Another state media China Pictorial reported that the total construction area of the hospital is 59,000 square meters (635,070 square feet). The isolated ward area is 34,000 square meters (365,970 square feet).
The other buildings inside the hospital are living quarters for medical staff and soldiers.
Another new facility built in Wuhan in response to the outbreak, Leishenshan Hospital, will be handed over to the army on Feb. 5 and put into operation on Feb. 6, according to the report. Leishenshan Hospital is bigger, and can accomodate 1,300 coronavirus patients.
As with the Huoshenshan Hospital, the Leishenshan Hospital will also be guarded by soldiers and only receive patients arranged by Wuhan authorities.

A Prison?

On Feb. 2, state-run media and Chinese netizens shared photos and videos of the Huoshenshan Hospital.
From the released photos, the makeshift container rooms are compact and clean. Each patient’s room has a window facing the corridor, but the window is sealed by iron bars.

An inside view of the Huoshenshan hospital in Wuhan City, Hubei Province, China, on February 2, 2020. (STR/AFP via Getty Images)

Next to the window is a small box, where food trays can be inserted. The box can be opened from the room and the corridor.
Inside the room, there are two doors: one is connected to an adjoining bathroom, and the other opens to a so-called “buffer room” where medical staff prepare their treatments. The buffer room has a hand washbasin and a door to the corridor.
On the other wall of the patient’s room is a large double door, but it cannot be opened from the inside.
Twitter is blocked inside China, but some use VPN software to circumvent the firewall. @Dubha3 said on Twitter on Feb. 2: “The Huoshenshan hospital is like a prison or cage. I’m worried that patients won’t be allowed to leave, before they [die and] are sent to a funeral house for cremation.”
Guyan Gonggong posted on Pincong, a Chinese social media platform, on Feb. 2: “The hospital is managed by the army, which means everything inside are military secrets. It’ll be a crime if somebody leaks it out.”
“Nobody can enter the military-managed areas freely. Family and friends [of the patients] won’t know if a person died inside,” Twitter user @Zhanyoutongmeng feared.

Pollution Concerns

Chinese netizens are also worried that construction of the facilities has polluted nearby water sources.
Huoshenshan Hospital is located on the bank of Zhiyin Lake, one of Wuhan’s freshwater sources. Although the hospital has wastewater integration equipment installed on Jan. 30, people are still worried whether the device can effectively filter biowaste and prevent the coronavirus from spreading into water sources.
Chinese media Economy Observer quoted Wuhan government officials on Jan. 25, who acknowledged that the hospital could be a potential pollution source to the Wuhan water supply system. They said they have contacted device suppliers to find the best wastewater treatment equipment for the hospital.
https://www.theepochtimes.com/footage-of-new-military-operated-coronavirus-hospital-in-wuhan-reveals-prison-like-environs_3225863.html

Gilead Sciences Q4 2019 Earnings Preview

Gilead Sciences (NASDAQ:GILD) is scheduled to announce Q4 earnings results on Tuesday, February 4th, after market close.

The consensus EPS Estimate is $1.67 (+16.0% Y/Y) and the consensus Revenue Estimate is $5.74B (-1.0% Y/Y).

Over the last 2 years, gild has beaten EPS estimates 75% of the time and has beaten revenue estimates 63% of the time.

Over the last 3 months, EPS estimates have seen 4 upward revisions and 4 downward. Revenue estimates have seen 6 upward revisions and 3 downward.

https://seekingalpha.com/news/3537438-gilead-sciences-q4-2019-earnings-preview

New ACIP adult immunization schedule recommends changes to several vaccines

1. New ACIP Adult Immunization Schedule recommends changes to several vaccines
ACIP now recommends shared decision-making for HPV, PCV13, and Meningitis B vaccines
Abstract: http://annals.org/aim/article/doi/10.7326/M20-0046
URL goes live when the embargo lifts
The Advisory Committee on Immunization Practices (ACIP) released its 2020 Recommended Immunization Schedule for adults with changes to the administration of the influenza, human papillomavirus (HPV), hepatitis A, hepatitis B, meningococcal B, and pneumococcal conjugate vaccines. The schedule, which can be complex and challenging to implement, features revised content, format, and graphics to make it easier to follow. The complete schedule, including changes in the vaccine notes section, is being simultaneously published in Annals of Internal Medicine and on the Centers for Disease Control and Prevention (CDC) web site.
The schedule is streamlined for ease of reference. Physicians should pay careful attention to the details found in the vaccine notes section, as they clarify who needs what vaccine, when, and at what dose.
In addition to changes in the administration of some vaccines, the 2020 schedule includes new instructions for shared clinical decision-making for several vaccines. First, the HPV vaccine is recommended for some patients aged 27 through 45 who are not adequately vaccinated. Clinicians should consider discussing HPV vaccination with those who are most likely to benefit from it based on a detailed list of considerations. Second, the pneumococcal 13-valent conjugate vaccine (PCV13) should be discussed with adults 65 years or older who do not have an immunocompromising condition, cerebrospinal fluid leak, or cochlear implant, and who have not previously received PCV13. And third, clinicians should consider discussing the meningitis B vaccine with adolescents and young adults age 16 through 23 who are not at increased risk for meningococcal disease.
The ACIP is comprised of 15 voting members, ex officio members who represent other federal agencies, and non-voting representatives of liaison organizations, including the American College of Physicians, that bring related immunization expertise. Each year, ACIP reviews the CDC’s Recommended Adult Immunization Schedule to ensure it reflects current clinical recommendations for licensed vaccines. The recommendations are intended to guide physicians and other clinicians about the appropriate vaccines for their adult patients.
https://www.eurekalert.org/pub_releases/2020-02/acop-naa012820.php

New therapeutic approach may help to cure chronic hepatitis B

Researchers at Helmholtz Zentrum München, Technical University of Munich (TUM) and the German Center for Infection Research (DZIF) have developed a novel therapeutic approach to cure chronic hepatitis B. The scientists found that the large amount of hepatitis B virus proteins expressed in the liver prevents the body’s immune system to defeat the virus, consequently preventing an effective therapy. The researchers were able to show that knocking down the expression of the virus’ proteins enables successful vaccination with TherVacB, a novel therapeutic vaccine.
Around 260 million humans, more than three percent of the world’s population, are chronically infected by the hepatitis B virus. As a result, every year, 880,000 people worldwide die of liver failure or hepatocellular carcinoma. Currently no curative therapy is available. The therapies available to date inhibit virus replication, but need to be given long-term. As long as infected people cannot form an adequate immune response, the virus will survive. This is precisely where Prof. Ulrike Protzer, head of the Institute of Virology at Helmholtz Zentrum München and TUM, and her team start.
Novel therapeutic approach
Using a preclinical mouse model, the researchers found that proteins of the hepatitis B virus prevent that certain immune cells of the body, so-called CD8+ T-cells become effective. Based on these finding, the scientists developed a novel therapeutic approach: first, the expression levels of the virus proteins are knocked down, and then the immune cells are activated by therapeutic vaccination. In contrast to conventional vaccinations, which aim to prevent diseases before outbreak, such a therapeutic vaccination aims to cure already existing chronic diseases.
Successful suppression of virus proteins in mice
Consequently, the researchers first developed a method to suppress the hepatitis B virus proteins. They used siRNAs, small ribonucleic acid molecules that bind to the messenger RNA of the virus’ proteins. By labelling the messenger RNA with siRNA, the infected cell receives the signal that the viral RNA is undesired and removes it. In this way protein expression is knocked down. However, the suppression of protein expression alone was not sufficient to reverse the inhibition of the CD8+ T-cells in chronically infected mice.
Infection cured in mice
The scientists therefore had to go one step further: “We then combined the siRNA method with a therapeutic vaccination developed by us. This enabled us to trigger a strong immune response against the virus. This led to cure of hepatitis B virus infection in two different mouse models,” explains Dr. Thomas Michler, physician and one of the two first authors of the study.
Novel therapeutic vaccination soon in a clinical trial
The newly developed vaccine, called TherVacB, will be tested as an immunotherapy in a two-year clinical trial starting in 2021. “The therapeutic vaccine we have developed is indeed very promising as it induces neutralizing antibodies and T-cell responses,” said Dr. Anna Kosinska, the other first author of the study. The vaccine will be administered in three doses every four weeks. It has been designed to target the majority of all hepatitis B viruses and therefore will be beneficial to most people infected worldwide.
“We are very pleased that for the clinical trials of TherVacB we are able to cooperate with a consortium of Europe’s leading virologists, immunologists and hepatologist, guided by Helmholtz Zentrum München,” adds Protzer. The consortium will receive funding of more than € 10 million from the European Union within the program Horizon 2020 (H2020-SC1-2019).

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Original publication
T. Michler et al., 2020: Knockdown of Virus Antigen Expression Increases Therapeutic Vaccine Efficacy in High-titer HBV Carrier Mice. Gastroenterology, DOI: 10.1053/j.gastro.2020.01.032.
Helmholtz Zentrum München, the German Research Center for Environmental Health, pursues the goal of developing personalized medical approaches for the prevention and therapy of major common diseases such as diabetes, allergies and lung diseases. To achieve this, it investigates the interaction of genetics, environmental factors and lifestyle. The Helmholtz Zentrum München is headquartered in Neuherberg in the north of Munich and has about 2,500 staff members. It is a member of the Helmholtz Association, a community of 19 scientific-technical and medical-biological research centers with a total of about 37,000 staff members. http://www.helmholtz-muenchen.de/en
The Institute of Virology (VIRO) investigates viruses that chronically infect humans and can cause life-threatening diseases. The research activities of the institute focus mainly on the HI virus which causes AIDS, on endogenous retroviruses, which are integrated into our germline, and hepatitis B and C viruses, which cause liver cirrhosis and hepatocellular carcinoma. Molecular studies identify new diagnostic and therapeutic concepts to prevent and treat these viral diseases or to prevent the formation of virus-induced tumors. http://www.helmholtz-muenchen.de/viro
https://www.eurekalert.org/pub_releases/2020-02/hzm–hbn020320.php

‘Wristwatch’ monitors body chemistry to boost athletic performance, curb injury

Engineering researchers have developed a device the size of a wristwatch that can monitor an individual’s body chemistry to help improve athletic performance and identify potential health problems. The device can be used for everything from detecting dehydration to tracking athletic recovery, with applications ranging from military training to competitive sports.
“This technology allows us to test for a wide range of metabolites in almost real time,” says Michael Daniele, co-corresponding author of a paper on the work and an assistant professor of electrical and computer engineering at North Carolina State University and in the Joint Department of Biomedical Engineering at NC State and the University of North Carolina at Chapel Hill.
Metabolites are markers that can be monitored to assess an individual’s metabolism. So, if someone’s metabolite levels are outside of normal parameters, it could let trainers or health professionals know that something’s wrong. For athletes, it could also be used to help tailor training efforts to improve physical performance.
“For this proof-of-concept study, we tested sweat from human participants and monitored for glucose, lactate, pH and temperature,” Daniele says.
A replaceable strip on the back of the device is embedded with chemical sensors. That strip rests against a user’s skin, where it comes into contact with the user’s sweat. Data from the sensors in the strip are interpreted by hardware inside the device, which then records the results and relays them to a user’s smartphone or smartwatch.
“The device is the size of an average watch, but contains analytical equipment equivalent to four of the bulky electrochemistry devices currently used to measure metabolite levels in the lab,” Daniele says. “We’ve made something that is truly portable, so that it can be used in the field.”
While the work for this paper focused on measuring glucose, lactate and pH, the sensor strips could be customized to monitor for other substances that can be markers for health and athletic performance – such as electrolytes.
“We’re optimistic that this hardware could enable new technologies to reduce casualties during military or athletic training, by spotting health problems before they become critical,” Daniele says. “It could also improve training by allowing users to track their performance over time. For example, what combination of diet and other variables improves a user’s ability to perform?”
The researchers are now running a study to further test the technology when it is being worn by people under a variety of conditions.
“We want to confirm that it can provide continuous monitoring when in use for an extended period of time,” Daniele says.
“While it’s difficult to estimate what the device might cost consumers, it only costs tens of dollars to make. And the cost of the strips – which can last for at least a day – should be comparable to the glucose strips used by people with diabetes.
“We’re currently looking for industry partners to help us explore commercialization options for this technology,” Daniele says.

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The paper, “Wearable multiplexed biosensor system toward continuous monitoring of metabolites,” is published in the journal Biosensors and Bioelectronics. First author of the paper is Murat Yokus, a Ph.D. student at NC State. Co-corresponding author of the paper is Alper Bozkurt, a professor of electrical and computer engineering at NC State. The paper was co-authored by Tanner Songkakul, a Ph.D. student at NC State; and Vladimir Pozdin, a postdoctoral researcher in the Joint Department of Biomedical Engineering at NC State and UNC.
Funding for the work comes from NC State’s National Science Foundation-funded Advanced Self-Powered Systems of Integrated Sensors and Technologies (ASSIST) Center under grant EEC1160483. The mission of the ASSIST Center is to create self-powered wearables capable of long-term multi-modal sensing without having to replace or charge batteries.
https://www.eurekalert.org/pub_releases/2020-02/ncsu-mb020320.php

Private payers unlikely to take major hit from Medicaid block grant plan

The Trump administration is proposing to alter how it funds a portion of the nation’s insurance program for low-income Americans, raising questions about how some private insurers will fare given they provide coverage to a significant portion of Medicaid beneficiaries.
Almost every state — to some degree — has subcontracted with Medicaid managed care organizations such as Centene and UnitedHealthcare to have them provide coverage to eligible residents. More than two-thirds of the nation’s more than 70 million Medicaid members receive some or all of their care from Medicaid managed care organizations, according to the Kaiser Family Foundation.

The Trump administration wants to give states the option to cap the federal funding they receive to care for some of the poor adults in the program, mainly those who became eligible for coverage under the Affordable Care Act. In exchange for agreeing to a cap, or what some refer to as a block grant, states will have more administrative flexibility.
Placing a ceiling on spending may be enticing for state leaders who worry about healthcare costs taking up a greater portion of their budgets. However, critics warn that capping the federal allotment leaves them financially exposed to all costs above the cap.
Even with a potential clamp on future federal funds, analysts said the demonstration does not pose major headwinds for Medicaid managed care companies, noting the arrangement is optional and only applies to a subset of the overall Medicaid population.
And any such risk is a distant worry, they say.
“There are a lot of questions out there still. It’s a long way off if it ever happens at all,” Bradley Ellis, senior director of North American insurance ratings​ for Fitch Ratings, told Healthcare Dive.
Centene, Anthem and UnitedHealthcare have a significant footprint in the Medicaid managed care space. Together, they cover more than 21 million Medicaid beneficiaries across the country. The government sector, both Medicare and Medicaid, are viewed as big growth areas for insurers.
Analysts with Cantor Fitzgerald said they maintain a positive view on the manged care sector following the block grant news last week. “It remains to be seen if/when/how many states will opt into the initiative,” the analysts said in a recent note. “We continue to view Medicaid as a compelling growth area.”
The nation’s health insurance lobby didn’t take a position on the measure, but stressed the importance of having flexibility in the program and the need to cover everyone​.
“We support offering state policymakers flexibility to design their Medicaid programs to best meet the needs of their citizens. At the same time, funding mechanisms for Medicaid should not undermine Americans’ access to the care they need and deserve,” America’s Health Insurance Plans said in a statement Friday.
Even if states were interested in implementing the policy, legal experts told Healthcare Dive the demonstration is unlikely to get off the ground — as a fight in the courts is all but certain.
“It is blatantly illegal,” Sidney Watson, a health law expert at St. Louis University, told Healthcare Dive.
https://www.healthcaredive.com/news/private-payers-unlikely-to-take-major-hit-from-medicaid-block-grant-plan/571518/