Humanigen (OTCQB:HGEN+4.2%) will host an investor call and webcast to discuss the National Institute of Health’s selection of lenzilumab, its proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody drug candidate, as an agent to be evaluated in the NIAID-sponsored Big Effect Trial in hospitalized patients with COVID-19.
Call and webcast scheduled for today at 4:30 pm ET.
Co-Diagnostics (NASDAQ:CODX)announces that partner privately held Clinical Reference Laboratory (CRL) has received the FDA nod for the emergency use of CRL Rapid Response, a saliva-based COVID-19 test for which samples can be self-collected using CODX’s patented CoPrimer technology.
AC Immune (NASDAQ:ACIU) has initiated preclinical studies for therapeutic antibody targeting TDP-43 (TAR DNA-binding protein 43), that functions primarily in the nucleus as a regulator of gene transcription and RNA metabolism.
TDP-43 pathology is associated with cognitive decline and episodic memory loss in neurodegenerative diseases.
The antibody binds all forms of TDP-43 with high affinity, and the company says that it is the only antibody with reported in vivo activity, demonstrating antibody’s ability to mitigate TDP-43 neuropathology in a mouse model.
RedHill Biopharma (NASDAQ:RDHL) has replaced its existing 2015 co-commercialization agreement with Daiichi Sankyo (OTCPK:DSKYF) for Movantik (naloxegol) with a new royalty-bearing agreement, under April 2020 acquisition agreement with AstraZeneca (NYSE:AZN).
Under the terms of the new agreement, RedHill will bear all responsibilities and costs for commercializing Movantik in the U.S. and will pay Daiichi a mid-teen royalty, in addition to three lump sum payments.
Additionally, the companies also entered a subscription agreement under which Daiichi received 283,387 ADSs of RedHill as a partial consideration in relation to Movantik.
RDHL acquired the global rights, excluding Europe, Canada and Israel, to Movantik for the treatment of opioid induced constipation from AstraZeneca in April 2020.
Pacific Biosciences of California (NASDAQ:PACB) and Asuragen, a molecular diagnostics company announce clinical research collaboration to develop molecular assays based on PacBio’s Single Molecule, Real-Time (SMRT) Sequencing technology combined with Asuragen’s AmplideX PCR technology.
The initial focus of the collaboration will be on research in support of assay development for the carrier screening market.
Lannett Company (NYSE:LCI)launched Cediprof Inc.’s FDA approved Levothyroxine Sodium Tablets USP, under the companies recently announced interim exclusive supply and distribution agreement.
Cediprof, Inc. is a part of the Neolpharma Pharmaceutical Group family of companies.
LCI also said they have prevailed in separate legal challenges by Cediprof’s previous distributor of the product.
A woman in Little Village sobs after learning she is the latest member of her family to test positive for COVID-19. She fears she won’t be able to take care of her grandson.
A worker at a West Side food-processing company explains how no precautions are taken to protect employees who are herded into a small room to punch timecards.
A young woman is frustrated that the customers at her small Lake County store won’t social distance or wear masks.
These are stories told to contact tracers, the people who investigate interactions between those infected with COVID-19 and their family, friends or anyone else potentially exposed to the virus. The aim: to identify and isolate infected people before they spread the virus.
Hundreds of millions of dollars of federal money is being funneled to health departments across Illinois, including those in Chicago and Cook County, to hire hundreds of contact tracers. The state says robust contact tracing of at least 90% of reported cases within 24 hours of a diagnosis is necessary to be able to safely reopen. But officials admit that’s not happening in suburban Cook County, for example. And it’s not clear which local health departments are meeting that goal.
Months into the pandemic, the state is still “in the middle of” compiling data on the extent of local efforts, a spokeswoman for Gov. J.B. Pritzker’s health department said. State health officials now say the contact tracing goal was a guideline rather than a requirement for communities to partially reopen this past spring.
Large-scale tracing efforts are only just getting started in Illinois. Chicago and Cook County-backed programs have yet to even make their first hires.
These efforts now will begin as an uptick in cases makes it difficult to keep up and as widespread testing with timely results — essential to identifying who needs to be traced — remains inaccessible to many.
How Illinois’ efforts compare to other states is hard to gauge. Cities including New York and Houston have experienced missteps and uneven success — pointing to another serious shortfall in the nation’s patchwork approach to fighting the virus.
“Unfortunately, due to our overall disjointed pandemic response, there is no nationalized or centralized means of contact tracing,” said Dr. Aniruddha Hazra, an infectious diseases researcher and assistant professor of medicine at the University of Chicago.
‘Calls can be intense’
Every contact of an infected person provides a clue to the virus’ spread and can save lives. But it’s not an easy task to trace them, according to those attempting to do it in Illinois. The workers have the unenviable job, for instance, of telling people they could be infected, news that sometimes met with distrust or hostility. And that’s if the contacts can even be reached.
“Some of our calls can be very intense,” said Erik Garcia, who trains and supervises contact tracers and also makes calls for Howard Brown Health. “I’ve had patients crying on the phone.”
That was the case with a Latina woman in Little Village who lived with multiple family members infected with the virus. After testing positive, she cried while on the phone with Garcia and worried aloud that she wouldn’t be able to care for her grandson. Garcia referred the woman to social service workers to help the family with groceries.
In another case, Garcia was told employees of a food-processing company were being crowded into small spaces. The information pointed to a potential source for the virus’ spread. At the request of an infected worker who feared retaliation, Garcia didn’t contact the company directly, instead providing the employee with a number for a federal hotline to report unsafe working conditions.
Howard Brown, which has decades of experience with contact tracing HIV and sexually transmitted infections, has been tracking COVID patients in Chicago since March. Despite the Chicago health center’s efforts, Garcia said some people refuse to get tested or to isolate.
“People are telling [tracers] they don’t want to get tested. ‘I’ll get rid of it. I’m young,’” Garcia said.
In May, the Lake County Health Department was selected for one of two pilot projects backed by the state to expand its tracking program and try software to be used by contact tracers across Illinois. The county is receiving $4.9 million to hire more tracers, a job that largely has been done so far by existing health department workers and volunteers in a county that recorded almost 12,000 cases of the coronavirus.
Many unwilling to talk
Derick Bonewitz, a Libertyville resident and retired Abbott Laboratories scientist, began volunteering for Lake County in April. His goal: to speak with eight people a day. Lake health officials say tracers have been able to reach about three-quarters of the reported infected people over the last few weeks.
At first, Bonewitz talked with a number of people who appeared to be getting infected at their workplaces. In recent weeks, that’s changed as Illinois and other states began reopening.
“Since then, a lot of what I’m handling seems to be shifting, going toward more social gatherings,” he said. “People who travel to a college town or travel to a vacation site. The Fourth of July weekend seemed to be particularly active.”
Not everyone is willing to talk, Bonewitz said. A woman afraid of losing her job or taking heat from her boss refused to give any information and hung up, he said.
In another case, a young woman who “was quite sick” appeared to have been infected at a small store where she was a manager.
“She was concerned so many people had been coming in to the store and not observing requirements to wear masks or practice social distancing,” Bonewitz said. “Now, her family is sick. She’s sick. She’s frustrated with how this is going on in the community.”
The limits of tracing
Contact tracing has been a public health strategy for over a century and was used during the 1918 flu pandemic. But its effectiveness has limits. And the practice must be done in connection with widespread testing with quick results and paired with multiple safeguards including social distancing and the wearing of face masks, experts say.
“You cannot separate testing from contact tracing,” said Dr. Howard Ehrman, an assistant professor at the University of Illinois at Chicago and former assistant commissioner of the Chicago Department of Public Health. “We could’ve saved hundreds of lives in this city, particularly African American and Latino lives, if we would’ve set up testing correctly. People know how to do this. This is not difficult to do.”
Cook County and city of Chicago officials said they are attempting to address racial disparities by recruiting contact tracers in neighborhoods with a heavy concentration of outbreaks.
“We want to be able to resource people that come from the communities that have been most affected by the pandemic,” said Dr. Rachel Rubin, senior medical officer for the Cook County Department of Public Health. “So that means mostly our Black and Brown communities, our impoverished communities.”
Not close to 90%
Cook County received $41 million in federal funding to hire 400 new county employees to support tracing efforts. The county has been doing limited contact tracing, with existing staff focusing on outbreaks at 178 congregate settings such as nursing homes and almost 70 other settings, including workplaces, Rubin said. The county traced around 6,600 cases of the more than 40,000 reported suburban cases it tracks.
“We are still ramping up,” Rubin said. “We are not close to meeting the 90% metric for cases contacted 24 hours after being diagnosed.”
The city is about to put most of its contact tracing program in the hands of a workforce development group, awarding $56 million to Chicago Cook Workforce Partnership. The group is partnering with several private organizations and at least 30 community groups to hire 600 contact tracers in addition to 200 the city already has.
The city says it tries to open investigations into every infected person within a day of a reported infection. But that doesn’t mean anyone is contacted. One day in late July, city tracers reached only about 40% of their contacts. About 15% of all reported cases include incorrect or incomplete phone numbers, said Dr. Jennifer Layden, chief medical officer for the city’s public health department.
“There are often challenges we face when we initiate contact,” Layden said. “It’s a long process that takes complicated investigation.”
Even after tracers are hired, tracing will be ineffective if test results in many cases continue to take a week or more to come back, said Dr. Ronald Hershow, associate professor of epidemiology at UIC School of Public Health.
“You have to get to them in 72 hours,” said Hershow, citing research published in The Lancet. “Your contact tracing is toast if you have to wait seven days.”
With recent daily case counts of the coronavirus well over 1,000 statewide, the numbers are going to be difficult to manage without stronger mitigation efforts, said Dr. Robert Murphy, executive director of the Institute for Global Health at Northwestern University.
“Contact tracing is good, but it’s only part of the program,” Murphy said. “Once you get the numbers down, contact tracing is great.”
