CytoDyn Treats 1st Patient in Pivotal Phase 3 COVID Trial in Brazil

 An interim analysis will be conducted 28 days following enrollment of 245 patients (40% of targeted trial patients)

CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the treatment of the first patient in its pivotal Phase 3 COVID-19 trial in Brazil for patients with severe symptoms. An interim analysis will be conducted 28 days following the enrollment of 245 patients, which is 40% of the total number of patients to be enrolled in the trial.

As previously announced, this pivotal Phase 3 trial for severe COVID-19 patients is being conducted by Academic Research Organization (“ARO”) Albert Einstein Israelite Hospital. This trial is intended to provide Brazil’s regulatory authority ANVISA (Agência Nacional de Vigilância Sanitária) with the requisite data to consider advancing the availability of leronlimab to Brazilians infected with COVID-19. The trial will be conducted in up to 35 clinical sites with 612 patients who are hospitalized and in need of oxygenation support.

Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “We are very encouraged enrollment for this first trial is underway and look forward to reaching our interim analysis target as soon as possible. We believe our second trial in Brazil will also initiate very soon as ANVISA has cleared the trial with a condition of more information about CMC, which will be provided to ANVISA no later than September 13. Today marks the first day of the much anticipated clinical trial in Brazil that we have been waiting for and we are so grateful to our team who conducted the CD12 trial in U.S. that produced a wealth of information for us to be able to appropriately design and power these two studies. We also give especial thanks to the ARO team for a job well done and look forward to many more trials to be conducted by them in Brazil with leronlimab. We also thank the BIOMM team for exceptional work to finalize this protocol with ANVISA and providing very valuable guidelines to our team.”

https://www.biospace.com/article/releases/cytodyn-announces-treatment-of-the-first-patient-in-its-pivotal-phase-3-covid-19-trial-in-brazil-for-patients-with-severe-symptoms/

Bharat's Intranasal Vaccine Speeds into Phase II on Heels of Strong Data

 Bharat Biotech's intranasal COVID-19 vaccine candidate is expected to enter the Phase II portion of a Phase II/III study within the next few weeks. This marks the second vaccine against the novel coronavirus developed by the India-based company.

It’s a significant milestone for intranasal formulations. The nod from India’s Health Authority makes Bharat’s BBV154 candidate the first intranasal vaccine in development for COVID-19 in the country. 

Phase I data from the intranasal formulation, is promising. Not only was the vaccine candidate well-tolerated, but the medication also blocks viral entry into the body. Full details of the study will be presented at a later date.  

The company has suggested that an intranasal formulation of the vaccine provides a broad immune response at the site of infection, the mucus membranes of the nasal passages. There is a school of thought that this type of administration will provide a stronger immune response than intramuscular injections currently used in multiple vaccines, including Bharat’s Covaxin, a whole virion inactivated COVID-19 vaccine, which has already been authorized in India. This is essential for blocking infection within an individual and the ability to transmit the virus. 

The company and its U.S.-based partner Ocugen, are seeking authorization for Covaxin in the United States as well. However, earlier this summer, the Pennsylvania-based Ocugen ran into some trouble with its plans to bring Bharat’s vaccine to the U.S.  

As BioSpace previously reported, Ocugen was forced to change its application from potential emergency use to a full Biologics License Application. And that requires additional data. Bharat aims to use real world data from the millions of doses of Covaxin administered in India as part of a planned Phase IV study. 

The intranasal approach Bharat is taking with its second COVID-19 vaccine candidate is also one unsuccessfully attempted by Maryland-based Altimmune. In June, the company announced its intranasal vaccine candidate, dubbed AdCOVID, fell short in a Phase I study. 

The company acknowledged that the immunogenicity data generated in the study “exhibited very low immune responses in every parameter where it was tested.” As a result, Altimmune halted the development of that particular vaccine candidate. 

According to the U.S. Centers for Disease Control and Prevention, approximately 54% of the eligible population in the United States is fully vaccinated against COVID-19. About 75.3% of eligible adults have received at least one jab of the available vaccines. 

https://www.biospace.com/article/bharat-biotech-soon-to-begin-phase-ii-testing-of-intranasal-covid-19-vaccine-/

Education Department opens civil rights probe into Florida mask mandate ban

 The Department of Education has opened a civil rights investigation into whether Florida Gov. Ron DeSantis’s (R) executive order banning mask mandates violates the rights of students with disabilities. 

The Department of Education’s Office for Civil Rights (OCR) said in a Friday letter addressed to Florida Education Commissioner Richard Corcoran that it was “opening a directed investigation” into whether the statewide ban on mask requirements in schools “may be preventing school districts in the state from considering or meeting the needs of students with disabilities.” 

“OCR’s investigation will focus on whether, in light of this policy, students with disabilities who are at heightened risk for severe illness from COVID-19 are prevented from safely returning to in-person education, in violation of Federal law,” Suzanne Goldberg, the Education Department’s acting assistant secretary for civil rights, added in the letter. 

She went on to say that the probe will look at whether Florida "may be preventing schools from making individualized assessments about mask use so that students with disabilities can attend school and participate in school activities in person, consistent with their right to receive a free appropriate public education and to be free from discrimination based on their disability.” 

The announcement of the probe comes the same day the First District Court of Appeals reinstated DeSantis’s ban on school mask mandates after a Leon County circuit judge blocked the executive order. 

DeSantis has continuously defended the ban, arguing that the decision for a child to wear a mask at school should be up to their parents. 

However, local school districts have continued to defy his order, arguing that the absence of masking requirements puts children at risk, especially since young people under the age of 12 are not yet eligible to receive the COVID-19 vaccine. 

The OCR’s probe into the Florida mandate follows similar investigations launched into school officials in Iowa, Oklahoma, South Carolina, Tennessee and Utah over their statewide bans on school mask requirements. 

The investigations are specifically looking at whether the bans violate components of the Rehabilitation Act of 1973 and the Americans with Disabilities Act, which prohibit disability-based discrimination and grant all students the right to free public schooling.

In a statement shared with The Hill on Friday, Education Secretary Miguel Cardona said he had “heard from parents from across the country – particularly parents of students with disabilities and with underlying medical conditions – about how state bans on universal indoor masking are putting their children at risk and preventing them from accessing in-person learning equally.” 

“It's simply unacceptable that state leaders are putting politics over the health and education of the students they took an oath to serve,” he continued. “The Department will fight to protect every student's right to access in-person learning safely and the rights of local educators to put in place policies that allow all students to return to the classroom full-time in-person safely this fall.”

The Hill has reached out to the Florida education commissioner, as well as the governor’s office, for comment on the new probe.

https://thehill.com/homenews/administration/571794-education-department-opens-civil-rights-probe-into-florida-mask

Biden administration releases $25B in COVID-19 relief for providers

 The Biden administration on Friday said it plans to release more than $25.5 billion in funding to help hospitals and other health providers with costs associated with the COVID-19 pandemic.

The money comes from the $178 billion Provider Relief Fund, which was created last year. But it's been 11 months since the last round of funding was released, and bipartisan lawmakers and industry groups have been pressuring the Department of Health and Human Services (HHS) to release more.

According to a government watchdog report from May, about $44 billion remains unspent, along with $8.5 billion Congress allotted in March for medical care in rural areas. The report called on HHS to tell Congress when it planned to distribute the money

The funding announced Friday includes the $8.5 billion for rural providers, as well as an additional $17 billion for a broad range of providers who can document revenue loss and expenses associated with the pandemic.

“This funding critically helps health care providers who have endured demanding workloads and significant financial strains amidst the pandemic,” HHS Secretary Xavier Becerra said in a statement. “The funding will be distributed with an eye towards equity, to ensure providers who serve our most vulnerable communities will receive the support they need.”

Payments will be based on providers’ lost revenues and expenditures between July 1, 2020, and March 31, 2021, according to HHS. That time frame excludes hospitals that are currently struggling due to the delta variant and the influx of patients.

HHS said the newest funding will reimburse smaller providers — who tend to operate on thin margins and often serve vulnerable or isolated communities — at a higher rate compared to larger providers.  

The first deadline for providers to report how they used grants they have already received is Sept. 30, but HHS on Friday announced a 60-day grace period "in light of the challenges providers across the country are facing due to recent natural disasters and the Delta variant."

Under the plan for the funds that was drawn up by the Trump administration, the initial tranche was sent out quickly, and was based on a hospital’s volume of Medicare patients. As a result, much of that first wave bypassed hospitals in states on the front lines of the areas hardest hit by the coronavirus.

Subsequent funding distributions were specifically targeted at providers in hot spots, as well as nursing homes. 

https://thehill.com/policy/healthcare/571714-biden-administration-releases-25-billion-in-covid-relief-for-providers

Appeals court reinstates DeSantis mask mandate ban for Florida schools

 The First District Court of Appeals on Friday reinstated Florida’s ban on mask mandates for schools, granting Gov. Ron DeSantis's motion. 

The court’s ruling means the state is now able to go after schools financially that decide to impose mask mandates.

A spokesman for DeSantis, a Republican, quickly hailed the decision on Twitter.

“1st District Court of Appeals just granted the State of Florida's request to reinstate the stay — meaning, the rule requiring ALL Florida school districts to protect parents' rights to make choices about masking kids is BACK in effect!” DeSantis spokesperson Christina Pushaw said on Twitter Friday. 

The ruling by the judge comes two days after DeSantis filed an emergency appeal after a Leon County circuit judge blocked the measure. 

DeSantis has been at the center of controversy over his efforts to ban mask mandates in schools as cases of the coronavirus rise.

He has argued the decision should be up to parents, and that schools should not be allowed to require the masking of students.

Opponents argue DeSantis's policy is putting children at risk. 

The governor has been going after the salaries of local school board members who vote to impose a mask mandate on students in school. 

One of the attorneys opposing DeSantis criticized the decision.

“We are disappointed by the ruling of the 1st DCA that reinstates the stay and will be seeking pass through jurisdiction of the Supreme Court of Florida since this matter involves statewide issues. With a stay in place, students, parents and teachers are back in harm’s way,” said the attorney, Charles Gallagher, in a tweet.

 

Alachua County Public Schools Superintendent Carlee Simon, leader of one of the schools defying DeSantis’s ban on mask mandates, said they are disappointed in the ruling on Friday and will continue to enforce masking in schools despite it. 

“Despite the threat of continued sanctions, we will continue to enforce universal masking in our schools. Fortunately, we have a number of options for replacing funding taken by the state,” Simon said. 

The U.S. Department of Education announced they will provide funding to schools that get cut off due to implementing mask mandates.

https://thehill.com/homenews/state-watch/571727-appeals-court-reinstates-mask-mandate-ban-for-florida-schools

Missouri governor eying special session to fight Biden's vaccine mandate

 Missouri Gov. Mike Parson (R) is considering holding a special legislative session to fight President Biden's new rule mandating COVID-19 vaccinations or weekly testing for employers with 100 or more employees. 

Parson said in an interview with the Kansas City Star that his state will oppose the Biden administration's plan and alluded to the possibility of a special session. 

“I don’t plan on letting that happen in Missouri,” Parson told the local newspaper. “I think the president is totally wrong on the policy he’s setting forth.”

Parson is already facing calls to hold a special session from some GOP lawmakers in his state, the City Star reports. Missouri Senate Majority Leader Caleb Rowden (R) tweeted that the state's legislature should act "ASAP." 

Parson's comments come as his state battles an uptick in coronavirus cases. Missouri on Friday reported 2,544 new cases, 20 new deaths and an increase of 74 hospitalizations, according to The Associated Press.

Fifty-three percent of people eligible for the COVID-19 vaccine in Missouri have received at least one dose, according to data from the Centers for Disease Control and Prevention. 

Biden's new vaccine requirement for workers could affect nearly 80 million employees, and if a business fails to comply with the rule it could face fines of up to $14,000 for each violation. 

"This is not about freedom or personal choice. It’s about protecting yourself and those around you — the people you work with, the people you care about, the people you love,” Biden said during a speech Thursday at the White House where he announced the order. “My job as president is to protect all Americans.” 

https://thehill.com/homenews/state-watch/571782-missouri-governor-considering-special-session-to-fight-bidens-vaccine

Kansas OKs using $50M in federal funds to up nurses' pay

 Kansas hospitals will receive $50 million of federal relief funds that will go to nurses, The Associated Press reported.

The plan, which was approved by a state task force Friday, will require Kansas hospitals to report on how many nurses they lose each month and why in exchange for the funds, according to the AP.

Senate President Ty Masterson (R), who serves on the task force, proposed the addendum mandating hospitals to report on nurses they lose, the AP noted. Masterson also criticized President Biden's new vaccine requirements for workers, calling them "dictatorial edicts." 

"We’ve had frontline workers — I mean, you can call them heroes — on the front lines for the last year and a half,” Masterson told the AP. 

Masterson earlier this week proposed to make hospitals enforcing vaccine requirements ineligible for retention incentives, which failed to pass the Kansas Senate by a 5-2 vote, the AP reported.

Kansas Republicans are promising a fight against Biden's vaccine mandates, including state Attorney General Derek Schmidt (R) who suggested that he's likely to join other GOP state officials in challenging the requirements, according to the AP. Sen. Roger Marshall (R) tweeted that the orders are "a terrifying glimpse of the new Marxist Dem Party."

Kansas currently trails behind the U.S. as a whole in vaccinations as of Friday, with 49.3 percent of its residents fully vaccinated as opposed to 53.6 percent of U.S. residents nationwide, according to the AP. 

https://thehill.com/homenews/state-watch/571787-kansas-approves-using-50m-in-federal-funds-to-increase-nurses-pay