SAB Biotherapeutics is hoping to continue work on its COVID-19 antibody treatment after the National Institutes of Health (NIH) shut down a funded phase 3 clinical trial when the omicron wave slowed earlier this year.
With NIH out of the picture, SAB is hoping to forge ahead with SAB-185, the company said in a fourth-quarter earnings update earlier this week. The company is expecting a full data readout in mid-2022 from a previous phase 2.
SAB said the treatment, which is derived from bovine antibodies, could be used for immunocompromised patients or to help battle future variants of the coronavirus. But the NIH's shutdown of ACTIV-2 leaves the study without enough data to determine statistical significance. SAB-185 was being evaluated in patients with mild to moderate infections at higher risk of progression to hospitalization.
Analysts from Chardan noted that the NIH’s position “does not imply a lack of efficacy for SAB-185,” in a Friday note.
The company is now evaluating ways to continue studying the therapy in COVID-19 patients, especially in targeted patient populations who may benefit. SAB specifically highlighted the potential for use as a prophylactic or therapeutic in high-risk populations. The company is also considering developing an injectable formulation.
SAB says data collected on the candidate already support continued advancement. SAB-185 cleared a phase 2 and was advanced to the phase 3 trial and was shown to neutralize the omicron variant in tests conducted in vitro.
As for its financials, SAB said existing cash and government funding already received through Dec. 31, 2021, will provide a runway into the third quarter of 2023. The company tallied $57.2 million in research expenses for 2021 compared to $27.9 million the year before.
Can a 0% response rate represent success in an oncology clinical trial? Investors said yes on Wednesday, sending shares in 4D pharma up 30% after enough patients in its Keytruda combination trial had stable disease for the study tohitits primary endpoint.
To meet the primary endpoint in the second part of the kidney cancer trial, 4D needed to show that giving its microbiome therapy MRx0518 in combination with Keytruda provided clinical benefit to more than three out of 30 patients. The trial defined clinical benefit as complete response, partial response or stable disease for at least six months.
So far, 4D has enrolled 20 renal cell carcinoma (RCC) patients who previously progressed after treatment with an immune checkpoint inhibitor. Four of the first 16 evaluable patients had stable disease for at least six months after receiving MRx0518 in combination with Keytruda, causing the clinical trial to hit its primary goal.
“Meeting the primary efficacy endpoint for this group is crucial for the future development of MRx0518, and these data are highly informative for our strategy going forward as we determine next steps in RCC,” Alex Stevenson, chief scientific officer at 4D, said in a statement. Investors agreed, sending shares in 4D up 30% to over $6 each in premarket trading.
The excitement reflects the early sign that 4D’s live biotherapeutic may be able to enhance the effects of checkpoint inhibitors. Some patients who previously progressed on a checkpoint inhibitor stabilized when they began taking daily capsules of MRx0518. Yet, in a field typically defined by evidence that interventions shrink tumors and prolong lives, success based on stable disease in four patients could be seen as slight.
4D is now preparing for further tests of its candidate. The British biotech plans to talk to its advisory board about the development path, including a potentially pivotal study in RCC patients who are refractory to immune checkpoint inhibitors.
If you’re a patient, avoiding a potentially invasive surgical procedure is a pretty obvious goal—especially if it involves the heart. Bristol Myers Squibb is presenting data this weekend that shows its targeted heart drug mavacamten helped reduce the risk of needing septal reduction therapy.
In the phase 3 VALOR study, mavacamten significantly reduced the need for the procedure in patients with severely symptomatic obstructive hypertrophic cardiomyopathy. In this disease, the wall of the heart thickens, sometimes progressing to the point where blood flow is obstructed.
At the end of the study’s 16 weeks, 82% of patients taking mavacamten had not proceeded with septal reduction therapy and no longer met the criteria for the procedure. In the placebo arm, just 23% patients had the same result. The results are being presented Saturday at the American College of Cardiology’s 71st Annual Scientific Session & Expo.
Septal reduction therapy can be done one of two ways. In the less invasive procedure, a catheter is threaded from the groin up to the heart to inject an alcohol solution to “cause a controlled heart attack,” according to Amy Sehnert, BMS VP and mavacamten clinical development team lead, speaking to Fierce Biotech. The solution kills the heart muscle in a very targeted way to reduce the thickened wall and form scar tissue.
But not all patients are eligible for that less invasive option. For those that are not, the procedure must be done via open-heart surgery to physically remove muscle from the wall in the lower chambers of the heart. Either way, the procedures come with risks.
“They're both very mechanical, they're obviously not treating the underlying cause of the disease or function,” Sehnert said.
Patient may also require a pacemaker or defibrillator post-surgery due to scarring. About 2,500 to 3,000 of these procedures are performed in the U.S. each year, she added.
“Alternative treatment options … appear to be very much desired by the patients themselves and many of them do continue on the study, which was designed to have continuation beyond Week 60,” Sehnert said.
Previous data collected on mavacamten have shown the therapy works well with traditional beta blocker therapies, improved heart function and oxygen consumption. The VALOR trial also has an open label extension.
The VALOR results are the latest to pile on to the record for mavacamten, the heart disease drug BMS picked up from the $13 billion buyout of MyoKardia in 2020. BMS is awaiting an FDA decision on the therapy based on earlier results from the phase 3 EXPLORER program. The FDA is due to make its decision by April 28, a date that slid from January to the spring as the agency worked out a Risk Evaluation and Mitigation Strategy (REMS).
The REMS program was always in the plan given mavacamten’s mechanism of action, according to Marie-Laure Papi, VP and cardiovascular development program lead at BMS. She said the FDA needed a bit more time to work on the program, and BMS continues to work with the agency to fine-tune the details.
“The optimal outcome of the label and the REMS and the approval for mavacamten is to make sure that we continue seeing the excellent benefit-risk profile that we see in the trial, and we think that having a well-defined REMS program will help us achieve that,” said Papi.
Sehnert said the data package BMS has collected so far “has been very satisfying as a clinical researcher,” given its consistency across multiple findings.
The Red Cross was renewing efforts to evacuate civilians in a convoy from the besieged port of Mariupol on Saturday as Russian forces looked to be regrouping for fresh attacks in southeast Ukraine.
Encircled since the early days of Russia's five-week old invasion, Mariupol has been Moscow's main target in Ukraine's southeastern region of Donbas. Tens of thousands of civilians are trapped there with scant access to food and water.
The International Committee of the Red Cross (ICRC) sent a team on Friday to lead a convoy of about 54 Ukrainian buses and other private vehicles out of the city, but they turned back, saying they were unable to proceed.
"They will try again on Saturday to facilitate the safe passage of civilians," the ICRC said in a statement on Friday. A previous Red Cross evacuation attempt in early March failed.
Russia and Ukraine have agreed to establish various humanitarian corridors during the war to allow the evacuation of civilians from cities, and have traded blame when evacuations failed.
People who have managed to get out of Mariupol and through Russian lines to reach the city of Zaporizhzhia described their journey as an ordeal during which Russian soldiers repeatedly stopped them to check for the presence of Ukrainian fighters.
"They stripped the men naked, looked for tattoos," said Dmytro Kartavov, a 32-year-old builder, adding that the troops paid particular attention to the men's knees.
"I work, I do repairs, naturally my knees - these are working knees. They say - (you) climbed trenches, dug, and the like."
Another group said they were stopped around 17 times at Russian checkpoints as they made their way out of Mariupol.
New research led by a team from Cornell University and the University of British Columbia has demonstrated a novel nasal spray can prevent infection from SARS-CoV-2. The experimental treatment was found to be effective in preliminary animal studies with the researchers now looking to optimize the spray and move to human trials in the near future.
A nasal spray that can protect a person from a SARS-CoV-2 infection is certainly a compelling prospect. Imagine taking a few short puffs in the morning before heading out in the world and knowing that you are protected from one of the most infectious airborne viruses known to humanity. It’s an ambitious goal, and a new study is indicating it could be possible.
An article published in Nature is describing the discovery and development of a new small molecule that can inhibit the entry of SARS-CoV-2 particles into animal cells. The molecule, dubbed N-0385, was discovered as researchers explored a variety of ways to inhibit the mechanisms SARS-CoV-2 uses to enter human cells.
To test the new molecule the researchers turned to a special kind of engineered mouse model. Normal mice, the mainstay of lab research, unfortunately are not useful for most COVID-19 studies because they don’t carry the same receptors that SARS-CoV-2 attaches to in humans. Scientists have, however, genetically engineered a specific mouse model to express those human receptors and enable effective testing of new COVID-19 treatments.
The new research tested intranasal dosages of N-0385 in this particular mouse model and found it effectively prevented SARS-CoV-2 infection. The nasal spray was protective against the original strain of SARS-CoV-2, as well as several variants including Alpha and Delta. It has yet to be tested against Omicron, but the researchers expect it to remain effective.
As well as working successfully as a prophylactic the nasal spray was found to also serve as an effective treatment, reducing disease when it was administered within 12 hours of the animals being exposed to the virus. Hector Aguilar-Carreno, senior author on the study, said this new molecule is unique in its ability to work as both a preventative tool and an antiviral treatment.
"There are very few, if any, small molecule antivirals that have been discovered that work prophylactically to prevent infection," said Aguilar-Carreno. "This is the first of its kind. One advantage is that it works early in the infection, even after someone has already acquired the virus."
The research is not the first to look at developing a nasal spray that can prevent SARS-CoV-2 infection. A human clinical trial is already underway in Australia testing a widely used anti-coagulant called heparin for this very purpose. That Australian research expects to have some results to report later this year.
The team behind N-0385 optimistically suggest it is possible the treatment could be available by the end of the year. But that timeframe depends on large volumes of money being quickly raised and every stage of human trials going perfectly.
It is more likely this research will move a little more slowly as plenty of work is still needed to establish the safety of this new molecule in humans. Aguilar-Carreno does indicate this molecule is promising as it could hypothetically be used to target a number of viral infections such as influenza and other coronaviruses that rely on this same mechanism of cellular entry.
"The N-0385 therapy is simpler and less expensive to mass produce than other types of COVID-19 treatments, such as monoclonal antibodies," added Aguilar-Carreno.
The new study was published in the journal Nature.
A new type of ultraviolet light that is safe for people took less than five minutes to reduce the level of indoor airborne microbes by more than 98%, a joint study by scientists at Columbia University Vagelos College of Physicians and Surgeons and in the U.K. has found.
…Far-UVC light has a shorter wavelength than conventional germicidal UVC, so it can’t penetrate into living human skin cells or eye cells. But it is equally efficient at killing bacteria and viruses, which are much smaller than human cells.
In the past decade, many studies around the world have shown that far-UVC is both efficient at destroying airborne bacteria and viruses without causing damage to living tissue. But until now these studies had only been conducted in small experimental chambers, not in full-sized rooms mimicking real-world conditions.
…The efficacy of different approaches to reducing indoor virus levels is usually measured in terms of equivalent air changes per hour. In this study, far-UVC lamps produced the equivalent of 184 equivalent air exchanges per hour. This surpasses any other approach to disinfecting occupied indoor spaces, where five to 20 equivalent air changes per hour is the best that can be achieved practically.
“Our trials produced spectacular results, far exceeding what is possible with ventilation alone,” says Kenneth Wood, PhD, lecturer in the School of Physics and Astronomy at the University of St. Andrews and senior author of the study. “In terms of preventing airborne disease transmission, far-UVC lights could make indoor places as safe as being outside on the golf course on a breezy day at St. Andrews.”
Here and here and here are my previous posts on UV-C sanitization. We are moving slower than I would like but the picture is of a UVC robot being used at Pittsburgh airport so kudos to them.
The citywide rate of chronic absenteeism among NYC public-school students has risen to a staggering 40 percent, The Post has learned.
With 938,000 students enrolled in NYC’s schools, that means some 375,000 kids are missing too much school and falling too far behind.
But that number is likely an undercount because students out with COVID or quarantined could be marked present if they logged in online or had minimal contact with a teacher.
“It seems shocking the number is so high, but it could be even higher because they’re not always marking kids absent,” said education watchdog Leonie Haimson of Class Size Matters.
It’s a major problem facing cities nationwide. In New York, chronic absenteeism is when a student misses 10 percent or more of the academic year, at least 18 days, for any reason excused or unexcused. The loss often results in low academic achievement, truancy, dropping out, delinquency and substance abuse, child advocates warn.
Chronic absenteeism is when a student misses 10 percent or more of the academic year.Getty Images
Schools Chancellor David Banks has ordered his deputies to stem the hemorrhage. “It will be 40 percent if no actions are taken. We are taking actions,” a spokesman said.
The 40 percent is up from 26 percent in 2018-19, before the COVID-19 crisis.
The city Department of Education has not posted chronic absenteeism data for the last two years.
The rate is likely worse because principals say schools were told to mark COVID-stricken or quarantined students present if a teacher or administrator simply made contact with the kids or their parents in an email or phone call.
“We were told they have to be marked present no matter what,” a Brooklyn principal told The Post.
The DOE said kids “may be marked present if they engage in learning remotely.”
Many families worried about safety kept their kids home in the first weeks after NYC schools opened for all in-person classes in September, Haimson and others said. Also, nearly 140,000 students have tested positive since then, staying home sick, while untold thousands of exposed classmates had to quarantine.
The DOE said kids “may be marked present if they engage in learning remotely.”Shutterstock / Monkey Business I
Heightened anxiety, depression, fear of bullying, and restrictions on fun after-school activities such as sports have also led to lagging attendance, principals say.
They also cite the DOE’s policy since early in the pandemic to no longer use attendance as a requirement for students to pass.
“They know everyone’s going to get promoted,” a principal said. “There’s no fear of not getting promoted, so they don’t have to come in if they don’t want to.’
Chancellor Banks has made tackling the crisis a priority.
“The chancellor’s office is focusing on reducing chronic absenteeism,” Terrence Paulin, a liaison in the Brooklyn HS superintendent’s office, said in a recent memo to principals and attendance officials leaked on Twitter.
“The Central goal is to reduce the current citywide CA [chronic absenteeism] rate of 40% to 30% by June,” the memo says.
Each district was given a “target goal,” Paulin said. Schools also have target goals, principals said. Pre-pandemic, chronic absenteeism ranged from less than 10 percent to 50 percent or more in different schools and districts, data show.
Paulin also said he noticed several absences at a school due to COVID back in January “were not coded 65 [present].” He said one student had 16 absences “but it may not be correct.”
That alarmed David Bloomfield, a Brooklyn College and CUNY Grad Center education professor. He called the chancellor’s goal “well-intentioned,” but blasted the bureaucratic suggestion to fix records retroactively.
“It’s clearly data manipulation, and doesn’t change the experience of any children,” Bloomfield said.
“It’s cooking the books,” a Brooklyn principal said. “You can do your best to make sure they come to school every day, but you can’t change the past unless you change the data. I’m sure that’s why they’re giving that directive.”
The DOE countered that such fixes are routine: “Schools regularly verify attendance records for students to confirm the correct codes were entered,” a spokesman said.
Other cities are also plagued by absenteeism. Last week, the LA Times reported 46 percent of the city’s public-school students, more than 200,000 kids, have missed at least 9% of the academic year, more than twice the number pre-pandemic.
“I’ve heard of chronic absenteeism rates of 50% or more since the start of the pandemic,” said Joanna Smith-Griffin, CEO and Founder of AllHere, a Boston-based company that helps districts boost attendance.
Calling it “the canary in the mine,” she said, “Education leaders need to see dropping attendance and, even more alarmingly, enrollment, for what they really mean – a student population still reeling from the physical, social and emotional trauma of a pandemic and an overall breakdown of trust in public institutions, including schools.”
DOE spokesman Nathaniel Styer said officials expect the problem to lessen with more attention to it. “Twenty eight percent of our students will be chronically absent at the end of this year,” he projected.
“We are laser focused on ensuring every student attends school every day. This includes proactively identifying students who are at risk and taking steps to prevent chronic absenteeism. We expect each superintendent to make this a priority and to provide every student facing attendance barriers with the support they and their family need to end the year strong,” Styer said.
