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Monday, August 17, 2020

Novavax begins mid-stage study of COVID-19 vaccine in South Africa

U.S. drug developer Novavax Inc said on Monday it started a mid-stage study of its experimental COVID-19 vaccine in South Africa, as the country experiences a surge in coronavirus cases.

South Africa is the fifth worst affected country with 583,653 coronavirus cases and 11,677 deaths, according to a Reuters tally.

“Because South Africa is experiencing a winter surge of COVID-19 disease, this important Phase 2b clinical trial has the potential to provide an early indication of efficacy,” Novavax research chief Gregory Glenn said.

The trial of Novavax’s NVX-CoV2373, backed by a $15 million grant from Bill & Melinda Gates Foundation, was being conducted in two separate groups, one comprising 2,665 healthy volunteers and the other, 240 HIV-positive adults.

Novavax expects its vaccine, once approved, would be supplied to South Africa through a deal signed earlier this year with the Serum Institute of India to develop and commercialize NVX-CoV2373.

The vaccine candidate is one of nearly 30 globally being tested in human clinical trials.

Early-stage data from a small clinical trial of the vaccine has shown that it produced high levels of virus-fighting antibodies, and the company aims to begin larger studies to obtain regulatory approvals as early as December.

Novavax intends to begin Phase 2 of the small clinical trial in the United States and Australia in the near future and said it would include about 1,500 candidates. It also aims to begin Phase III as soon as late September.


University Students Play ‘Corona-Cops,’ Report Peers Who ‘Might’ Have COVID

As colleges across America reopen for in-person learning this fall, some are asking students to report peers who might not be following guidelines that universities have set up to prevent the spread of COVID-19.

For example, the University of Miami has set up a system where “students are encouraged to report concerns about unsafe behaviors” of their peers, and administrators will review the concern.

Texas A&M University has a similar system where faculty members and administrators can file a report if they are concerned someone else on campus has COVID-19 or has come into contact with the virus.

Tulane University also has a system where university members can report “problematic behavior” related to COVID-19, and depending on the circumstance, are asked to call the university police.

“Do you really want to be the reason that Tulane and New Orleans have to shut down again?” Tulane Dean of Students Erica Woodly wrote on the reporting page announcement.

Yale University is even encouraging students to “make reports concerning COVID-19” to the university hotline.

The University of North Georgia has set up a similar “COVID-19 Concern for Others Form,” which prompted a letter to the university from the Southeastern Legal Foundation, which claims that the form may violate students’ right to privacy and could possibly censor speech.

“Colleges have a duty to protect student health and safety, especially during uncertain times like these. However, even in unprecedented times, students’ First Amendment rights remain unchanged. That means colleges and universities cannot engage in viewpoint or content-based discrimination, cannot enact vague and overbroad policies, and cannot chill student expression,” the letter stated.

“With a Concern Form at students’ fingertips, students wishing to prevent a controversial speaker from visiting campus or to stop a student organization from garnering interest in their cause can simply report members of that organization as symptomatic. Without stricter reporting guidelines and limits, it appears that such events could be shut down entirely with the press of a button. This may sound unlikely, but then again, who would have predicted 2020 to turn out as it has?” the letter added.

The SLF also said that the form could violate students’ Fourth Amendment rights by forcing students to get tested for COVID-19, even when there is no cause.

Under the Fourth Amendment, individuals cannot be subject to unreasonable searches and seizures. The Supreme Court has even considered that right in the context of cheek swabs. The Court has held that a criminal arrested and charged with a serious crime can be subjected to a DNA cheek swab, so long as the charges are supported by probable cause, meaning there must be sufficient likelihood that the crime occurred. However, a swab is unconstitutional if there is no probable cause, the charge is not criminal, or if the DNA is used to gather medical information about the criminal,” SLF explained.
“Will UNG, upon receiving a report of a symptomatic student, subject that student to an invasive COVID-19 swab? Surely the university understands that this action would violate the Fourth Amendment,” the group adds.

In addition to encouraging other students to report their peers if they have concerns about their possible exposure to COVID-19, other schools are implementing different student volunteer programs to reduce the spread of the virus.

Columbia University, for example, is implementing a “Student Ambassador” program, where students will become a “peer leader” and “expert” on “COVID-19 prevention, the Columbia Community Health Compact and resources for students.”

The University of Denver is taking things a step further and is requiring students to “install an application on their mobile devices” that will track their location to aid with contact tracing efforts, as Campus Reform previously reported.

While universities across the country are involving students in their COVID-19 prevention plans, two Ivy League academics urged universities to not make students “the coronavirus police” in a New York Times op-ed.

Karen Levy, an assistant professor at Cornell University and Lauren Kilgour, a doctoral candidate at Cornell both agree that involving students “makes sense,” but that the systems may not be very effective and “put students in very tough positions.”

“Of course, many students understand the high stakes of a coronavirus outbreak and have a desire to help keep their communities safe. Some students may feel a sense of civic duty to participate in policing their classmates’ behavior,” they wrote. “But others may be loath to report on their friends, especially when doing so could result in harsh penalties.”

“People report on one another (truthfully or falsely) for a number of personal reasons, including competition, revenge, leverage and everyday aggravations. There’s every reason to assume that these motivations will bubble up in the college context, too. Students have their own loyalties, broken hearts, rocky roommate relationships and fraternity codes of silence,” Levy and Kilgour added.


Roche risdiplam application for spinal muscular atrophy accepted in Europe

Under PRIME status, the European Medicines Agency (EMA) has accepted for review Roche’s (OTCQX:RHHBY) marketing application seeking approval of Evrysdi (risdiplam) for the treatment of spinal muscular atrophy (SMA).

PRIME, akin to Breakthrough Therapy status in the U.S., provides for more intensive guidance on development and accelerated review of the market application.

The action triggers a $15M milestone payment to licensor PTC Therapeutics (NASDAQ:PTCT).

The FDA approved the survival of motor neuron 2 splicing modifier on August 7.


Aytu BioScience to manufacture Healight devices for COVID-19 studies

Aytu BioScience (NASDAQ:AYTU) rises ~8% in premarket, after the company announces delivery of Healight investigational devices, for use in upcoming COVID-19 clinical studies. The device is designed by Sterling Medical Devices.

The pilot scale devices employ proprietary methods of administering intermittent ultraviolet A light via a respiratory tract device.

Pre-clinical findings indicate the technology’s significant impact on reducing a range of viral and bacterial loads, including the coronavirus HCoV-229E.


Unity Biotech down on stumble with lead drug

Unity Biotechnology’s (NASDAQ:UBX) lead candidate UBX0101, a p53/MDM2 interaction inhibitor, failed to sufficiently separate from placebo at week 12 in a Phase 2 clinical trial in patients with moderate-to-severe osteoarthritis of the knee. Specifically, there was no statistically significant difference between any of the three dose arms and the control arm as measured by the primary endpoint, a scale called WOMAC-A.

The company does not expect to advance UBX0101 into pivotal studies, opting instead to concentrate on its ophthalmologic and neurologic disease programs.

The results will be submitted for presentation at a future medical conference.


Microbot Medical up on successful study of surgical robot

Thinly traded nano cap Microbot Medical (NASDAQ:MBOT) jumps 39% premarket on robust volume in reaction to positive results from an animal study assessing the feasibility of its Liberty Robotic System, a device it calls the world’s first fully disposable surgical robotic system.

The study met all endpoints with no intraoperative adverse events, supporting the company’s plan to allow doctors to conduct catheter-based procedures from outside the cath lab thereby avoiding radiation exposure, physical strain and risk of cross-contamination.

The data will be presented today at the Needham Virtual Med Tech & Diagnostics Conference.


XBiotech up on discovery of COVID-19 candidates August 17, 2020

Thinly traded micro cap XBiotech (NASDAQ:XBIT) is up 16% premarket on modestly higher volume in reaction to its announcement that it has identified True Human antibodies, derived without modification from humans, that could potentially be used to treat COVID-19.

It discovered the antibodies in blood samples from people who recovered quickly from the respiratory infection provided by collaboration partner BioBridge Global who is participating in a program to provide convalescent plasma to treat severely ill COVID-19 patients.

Aimed at accelerating advancement of its pipeline, the company is expanding its existing manufacturing and research center in Austin, TX with a new 30K sq. ft. infectious disease R&D facility.