Altimmune COVID vax candidate, tested at U Alabama, to start Phase 1

The Altimmune Inc. vaccine candidate that was tested preclinically at the University of Alabama at Birmingham last year is expected to start patient enrollment for its Phase 1 clinical trial next week.

Maryland-based biopharmaceutical company Altimmune announced that the United States Food and Drug Administration has cleared the company's Investigational New Drug application for its Phase 1 clinical trial of AdCOVID, a novel, single-dose, intranasal COVID-19 vaccine candidate.

The UAB preclinical testing of AdCOVID last spring and summer was led by Fran Lund, Ph.D., chair of the UAB Department of Microbiology, and it included 23 other researchers from six UAB labs in the UAB School of Medicine -- all working under strict COVID-19 safety protocols that required masking and social distancing. The UAB researchers found potent serum neutralizing antibody responses, T cell responses and a robust induction in mucosal immunity in mice following a single intranasal dose of AdCOVID.

The vaccine candidate has tantalizing promises, according to Altimmune. No need of refrigeration. Simple one-dose administration by a spray into the nose. The power to elicit mucosal immunity at the linings of the nose and lungs would protect not only against infection but also against transmission. Existing intramuscular COVID-19 vaccines are not known to elicit this kind of immunity.

Altimmune says it expects that these simple and convenient handling requirements, together with the potential ability to block SARS-CoV-2 transmission, could position AdCOVID as a leading intranasal COVID-19 vaccine.

"We believe deployment of intranasal vaccines like AdCOVID will be essential to a successful global response to the pandemic," said Vipin K. Garg, Ph.D., president and chief executive officer of Altimmune. "Developing vaccines that can effectively prevent transmission is a growing imperative to block the spread of disease and combat the emergence of new variants."

Altimmune's Phase 1 clinical trial will evaluate safety and immunogenicity of AdCOVID in up to 180 healthy volunteers between the ages of 18 and 55. AdCOVID will be administered as a nasal spray at one of three dose levels. Altimmune will look primarily for safety and tolerability, but it will also measure immunogenicity of AdCOVID by serum IgG binding and neutralizing antibody titers, mucosal IgA antibody from nasal samples and T cell responses.

Lund said of last year's preclinical testing, "In animals, intranasal vaccination initiated immune responses to the SARS-CoV-2 virus in the nose and lungs, which are the sites that are first infected by the virus.

"If the vaccine works similarly in humans, then we hope that vaccination via the intranasal route might not only protect the vaccinated person from serious illness but also help minimize virus transmission within the community. We look forward to seeing the first data from the human studies."

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At UAB, Lund holds the Charles H. McCauley Chair of Microbiology.

https://www.eurekalert.org/pub_releases/2021-02/uoaa-cvc021921.php 

Immunic's lead drug fails to impress in 2 separate trials

 — and it's blaming some of its woes on the pandemic

The pandemic has posed a serious challenge to the way drugmakers do business, which has made it an easy scapegoat for clinical trial duds. Once looking to solve Covid-19, Immunic’s lead drug has now flopped one study and failed to impress in another — is it fair to blame the pandemic for that?

On Wednesday, the biotech revealed a study for its lead program in Covid-19 could not be evaluated for its primary and secondary endpoints. Then on Thursday, Immunic said the same program hit statistical significance in primary sclerosing cholangitis — though only barely — while noting the study population ended up much smaller than expected because of pandemic restrictions.

The Covid-19 news from Wednesday sent Immunic $IMUX shares down about 20%, while Thursday’s PSC update left a more muted impression on Wall Street: in early morning trading, the company stock was flat.

The Immunic program in question is an oral treatment called IMU-838, which aims to block the enzyme dihydroorotate dehydrogenase, or DHODH, and inhibit the intracellular metabolism of activated T and B cells. DHODH inhibitors can also produce a host-based antiviral effect regardless of specific virus proteins and structure, and Immunic is hopeful this can lead to use as the treatment of several different viruses.

Immunic largely pinned the Covid-19 trial miss on the way the treatment landscape has changed throughout the pandemic. Researchers launched the study almost a year ago — back in March, to be exact — when there was nearly zero scientific consensus on how to treat the disease.

As a result, Immunic went after ventilation in moderate Covid-19 cases. They sought to measure how well its program could reduce the need for invasive ventilation after four weeks in moderate cases. But over the course of the study, they found that less than 1% of hospitalized Covid-19 patients with moderate cases needed ventilators at all, essentially preventing them from measuring how effective their program is in this population.

Similar miscalculations occurred in the secondaries as well. Going for 28-day mortality, survival without respiratory failure and reducing ICU admissions in moderate cases, Immunic again found incidence rates that were too low to conduct analyses. Their study found mortality to be under 2% and less than 4.5% of patients required an ICU stay.

Given how little was known about the novel coronavirus at the outset of the pandemic, it’s certainly possible that Immunic is far from the only biotech to shoot for these aggressive endpoints and come up short. But they tried to pull a positive out of the data, highlighting that the program showed a numeric advantage in time to recovery over placebo: in patients who were 90% likely to recover from Covid-19, those taking IMU-838 felt better after 18.9 days as opposed to the 26.8 days needed in the placebo arm.

Immunic also presented data that the therapy could be helpful against “long Covid,” where patients who have successfully flushed the virus from their systems continue to suffer from symptoms and an overactive immune system, sometimes for months. A post-hoc analysis of 27 patients saw lower numeric levels of long Covid-related fatigue in the drug arm.

CEO Daniel Vitt said in a conference call Thursday morning that the company expects to speak with regulators about how to proceed in Covid-19 and can hopefully plan a Phase III trial, but isn’t sure what that trial might look like yet.

The pandemic also affected the program’s study in PSC, as much of the treatments were administered at the Mayo Clinic in Minnesota. Patients had to travel to the site, which sometimes proved challenging over the last several months, Vitt said. Originally planning to enroll 30 patients, Immunic ended up only being able to administer the experimental drug to 18 patients while only 11 finished the 24-week treatment course. And in late 2020 the principal investigator determined the trial needed to be stopped.

Looking to reduce serum ALP in adults with PSC after 24 weeks, researchers found IMU-838 decreased levels by an average of 5.76 IU/L every 30 days in these 11 patients. That was good for a p-value of p=0.041, hitting statistical significance but coming close to the p=0.05 border.

The program did not hit statistical significance in the 18-patient population that included those who didn’t finish the study, registering an average baseline change of -2.11 and hitting a p-value of 0.578. Both studies found the candidate to be safe and well-tolerated, and Immunic is planning to move forward with another trial in PSC as well.

In addition to Covid-19 and PSC, the candidate is also being studied to treat multiple sclerosis, ulcerative colitis and Crohn’s disease. Last August, the company released topline data in relapsing-remitting MS patients, saying the experimental drug reduced the cumulative number of combined unique active MRI lesions after 24 weeks compared to placebo.

https://endpts.com/immunics-lead-drug-fails-to-impress-in-2-separate-trials-and-its-blaming-some-of-its-woes-on-the-pandemic/

Free ransomware protection service for private hospitals rolled out

 Private hospitals in the U.S. can access a free ransomware protection service funded by the Center for Internet Security. 

The Malicious Domain Blocking and Reporting service prevents IT systems from connecting to harmful web domains. CIS will use the cybersecurity and intelligence firm Akamai to support the program. CIS reports investing $1 million into the project so far.

CISalready offers this service for all public hospitals, health departments and healthcare organizations with funding from the U.S. Department of Homeland Security's Cybersecurity & Infrastructure Security Agency.

To learn more, click here.

https://www.beckershospitalreview.com/cybersecurity/cis-rolls-out-free-ransomware-protection-service-for-private-hospitals.html

FDA acknowledges skin pigmentation may affect pulse oximeter accuracy

 The FDA issued an alert Feb. 19 saying that pulse oximeters have limitations and that certain factors, including skin pigmentation, may affect the device's accuracy. 

The FDA pointed to a study published in The New England Journal of Medicine in December that suggested pulse oximeters were more often less reliable in Black patients than white patients. In January, three senators wrote a letter to the FDA urging the agency to review the accuracy of pulse oximeters in people of color. 

Pulse oximeters are used to determine a patient's blood oxygen level, and use of the devices has spiked during the COVID-19 pandemic, according to the FDA. 

In the alert, the FDA said that pulse oximeter readings can be affected by multiple factors, including skin pigmentation, skin thickness, poor circulation, skin temperature, tobacco use and fingernail polish. 

"The most current scientific evidence shows that there are some accuracy differences in pulse oximeters between dark and light skin pigmentation; this difference is typically small at saturations above 80 percent and greater when saturations are less than 80 percent," the FDA wrote.  

The FDA said it believes the study's findings highlight the need to further evaluate and understand the association between skin pigmentation and oximeter accuracy, and that it will review more studies on pulse oximeter accuracy. 

"The FDA has been working on additional analysis of premarket data, as well as working with outside stakeholders, including manufacturers and testing laboratories, to analyze additional postmarket data to better understand how different factors, including skin pigmentation, may affect pulse oximeter accuracy," the agency wrote. 

Read the full alert here. 

https://www.beckershospitalreview.com/supply-chain/fda-acknowledges-skin-pigmentation-may-affect-pulse-oximeter-accuracy.html

Facebook stops collection of user health data after NY probe

 Facebook will no longer collect unauthorized data about people's medical and other sensitive information following recommendations from a New York Department of Financial Services investigation, The Wall Street Journal reports.

The state began investigating Facebook after a 2019 WSJ report claimed that personal health apps, including period and pregnancy tracker app called Flo, were quietly passing data to the social media giant.

Facebook's official terms had prohibited app developers from giving the company data from children about health and other sensitive topics, but the company told the New York financial services department it had "routinely obtained" such information from developers, going against its own service terms and policies, according to the Feb. 18 report.

Flo Health reached a settlement in January with the Federal Trade Commission in which it said it would now get users' consent before sharing the health information.

After admitting it had received sensitive data without permission, Facebook rolled out actions to block app developers from providing data that included 70,000 terms related to topics such as sexual health and medical conditions. The company also built a machine learning system to improve its detection of private data, according to the report.

https://www.beckershospitalreview.com/cybersecurity/facebook-stops-collection-of-user-health-data-after-new-york-investigation.html

Biden: 'Ready to declare major disaster' in Texas

 U.S. President Joe Biden said on Friday he was ready to declare a major disaster in storm-slammed Texas as soon as the declaration hits his desk, and that he would travel to the state as long as he was not a burden to local authorities.

Millions of residents in the state are struggling with power outages after a major winter storm.

https://www.reuters.com/article/us-usa-weather-texas-biden/biden-says-he-is-ready-to-declare-major-disaster-in-texas-idUSKBN2AJ20A

U.S. extends travel restrictions at land borders with Canada, Mexico through March 21

 U.S. land borders with Canada and Mexico will remain closed to non-essential travel until at least March 21, the one-year anniversary of the restrictions to address COVID-19 transmission concerns, the U.S. government said Friday.

The new 30-day extension is the first announced under President Joe Biden and comes as the White House has been holding meetings about potentially tightening requirements for crossing at U.S. land borders in North America, officials said.

Canada has shown little interest in lifting the restrictions and recently imposed new COVID-19 testing requirements for some Canadians returning by land crossings.

On Jan. 26, the U.S. government began requiring nearly all international air travelers to get negative COVID-19 test results within three days of travel, but has no similar requirements for land border crossings.

In an executive order issued last month, Biden directed U.S. officials to “immediately commence diplomatic outreach to the governments of Canada and Mexico regarding public health protocols for land ports of entry.”

It added U.S. agencies should submit a plan to Biden within 14 days “to implement appropriate public health measures at land ports of entry.”

“The plan should implement CDC (U.S. Centers for Disease Control and Prevention) guidelines, consistent with applicable law, and take into account the operational considerations relevant to the different populations who enter the United States by land,” it said.

Biden also directed a similar review of sea travel and to “implement appropriate public health measures at sea ports.”

https://www.reuters.com/article/us-health-coronavirus-usa-borders/u-s-extends-travel-restrictions-at-land-borders-with-canada-mexico-through-march-21-idUSKBN2AJ22P