Veru, Immunome Tout Positive Data for COVID-19 Therapeutics

 Veru Inc. shares were climbing rapidly in the early hours of trading Wednesday, up more than 16% after the company announced the publication of positive Phase III results from its COVID-19 antiviral therapeutic that could lead to potential Emergency Use Authorization.

Florida-based Veru said Phase III data showed sabizabulin, a novel dual antiviral and anti-inflammatory agent, demonstrated a 55.2% reduction in deaths in moderate to severe hospitalized patients compared to placebo. The results were both statistically significant and clinically meaningful, the company said.

In the study of 210 hospitalized moderate to severe COVID-19 patients, patients received sabizabulin plus standard of care treatment or placebo plus standard of care, which included remdesivir, dexamethasone, anti-IL6 receptor antibodies and JAK inhibitors, the company noted.

Additionally, sabizabulin hit its secondary endpoints, showing significant reductions in the number of days patients spent in the intensive care unit, as well as days spent on mechanical ventilation and total hospital days. Specifically, sabizabulin is being developed for the treatment of hospitalized moderate-severe COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS). Data from the Phase III study was published in the New England Journal of Medicine (NEJM) Evidence.

Sabizabulin was well-tolerated, and the company noted it had a more favorable safety profile compared to placebo.

Based on the data, Veru submitted an Emergency Use Authorization to the U.S. Food and Drug Administration.

Gary Barnette, Ph.D., chief scientific officer of Veru and co-author of the data published in NEJMEvidence, expressed excitement over the late-stage data. He said the overall conclusion of the Phase III study is that “sabizabulin treatment has a clear mortality benefit compared to placebo in hospitalized COVID-19 patients at high risk for ARDS” patients who also received standard of care treatment.

“This landmark study published in The New England Journal of Medicine Evidence shows the high consistency of sabizabulin treatment to significantly reduce deaths across patient subgroups regardless of standard of care treatment received, baseline WHO scores, age, comorbidities, vaccination status, COVID-19 variant, or geography,” Dr. Mitchell Steiner, chairman, president and CEO of Veru and co-author of the NEJM Evidence publication, said in a statement. “We have submitted a request for emergency use authorization with FDA and are in discussions with other regulatory authorities across the world.”

Veru wasn’t the only company to announce positive data from a COVID-19 therapeutic. Pennsylvania-based Immunome, Inc. said its antibody cocktail, dubbed IMM-BCP-01, “retained activity” against the BA.4/5 and BA.2.12.1 subvariants in pseudovirus testing.

The antibody cocktail is in Phase Ib studies. It is being assessed in clinical trial sites where the predominant SARS-CoV-2 variants are BA.2.12.1, BA.4, BA.5 and BA.2. According to the U.S. Centers for Disease Control and Prevention, as of June 25, the BA.4, BA.5 and BA.2.12.1 subvariants of the Omicron variant represent more than 90% of the COVID-19 cases in the United States.

IMM-BCP-01 is a three-antibody cocktail with each antibody having a different mechanism of action. According to the company, IMM20190 binds to a composite epitope involving the receptor binding ridge and an area adjacent to the receptor-binding loop preventing binding to ACE2.

“We are pleased that IMM-BCP-01 retains effectiveness against the currently dominant BA.4/.5 and BA.2.12.1 subvariants,” Purnanand Sarma, Ph.D., president and CEO of Immunome, said in a statement. “Further, as several existing antibody treatments lose their potency against the Omicron subvariants, IMM-BCP-01 continues to retain activity against these variants in preclinical testing and we believe our cocktail has potential to play a significant role in managing the pandemic. We also look forward to announcing topline data from our Phase Ib clinical study in the second half of 2022.”

https://www.biospace.com/article/veru-immunome-have-positive-covid-drug-results/

Humanigen Publishes on Early Hospital COVID Treatment with Lenzilumab C-Reactiv,e Protein

 

• A sub-analysis of the Phase 3 LIVE-AIR study of lenzilumab showed a strong correlation between C-reactive protein (CRP) and outcomes with lenzilumab treatment with the greatest clinical benefit experienced by patients with baseline CRP<150 mg/L

• In these patients, likelihood of survival without mechanical ventilation (SWOV) was achieved in 90% of LIVE-AIR patients treated with lenzilumab plus standard of care compared to 79% treated with placebo plus standard of care, which was highly statistically significant (HR 2.54, p=0.0009)

• Lenzilumab-treated patients had a 62% relative reduction in the risk of progression to invasive mechanical ventilation or death (OR=0.38; p=0.0053)

https://finance.yahoo.com/news/humanigen-announces-peer-reviewed-publication-120000385.html

Inspira Technologies Develops Non-Invasive Blood Sensor, Targets $2.5 B Market

 Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ: IINN) (NASDAQ: IINNW) (the "Company" or "Inspira Technologies"), a groundbreaking respiratory support technology company, revealed the development of the HYLA™ blood sensor. Without the need to take actual blood samples from patients, Inspira's non-invasive optical blood sensor is being designed to perform real-time and continuous blood monitoring to alert physicians of immediate signs of changes in a patient's clinical condition. The HYLA blood sensor is targeting the potential $2.5 billion Point of Care testing, ABG (Arterial Blood Gas) analyzer market.

https://finance.yahoo.com/news/inspira-technologies-develops-non-invasive-123000344.html

From Today, All New Vehicles In The EU Will Have Surveillance Black Boxes

 by Paul Joseph Watson via Summit News,

From today, all new vehicles sold in the EU will have mandatory black boxes fitted that record technical data and will be accessible by authorities, greasing the skids for surveillance-powered speed limiting technology.

While for the time being, drivers can opt-out of using the feature, privacy advocates fear the technology will become mandatory once it is properly rolled out.

Back in 2019, the European Transport Safety Council (ETSC) announced that July 6 would mark the day when all car manufacturers would be forced to fit new models with a system that keeps track of technical data.

The data recorded will include “the vehicle’s speed, braking, steering wheel angle, its incline on the road, and whether the vehicle’s various safety systems were in operation, starting with seatbelts.”

Although insurance companies won’t have immediate access to the data, it will be available to law enforcement.

Authorities claim the data will be “anonymized,” meaning the information can’t be used to identify the owner of the vehicle, although only the incredibly naive would plausibly believe that.

Such systems are expected to eventually include speed-limiting technology.

As Reclaim the Net’s Didi Rankovic explains, the most common method of speed limiting technology is Intelligent Speed Assistant (ISA).

“ISA works using GPS data alone, cameras for traffic sign recognition fitted to the front of the car, or a combination of the two. A speed limiter affects the engine power and in that way decreases speed.”

“Like the name suggests, speed limiters are designed to prevent drivers from exceeding certain speed limits, and prompt them via audio, visual, and haptic warnings until they “obey” and slow down.”

For decades, governments have been pushing for all cars to be fitted with black boxes that track location data.

The ultimate dystopian scenario involves giving police the power to utilize similar technology to completely disable the functioning of a vehicle if the driver is deemed to have committed an infraction.

This doesn’t need to be a criminal offense, if the pursuit of social credit score schemes continues to become more invasive, it would eventually be used as a form of punishment for everything from unpaid utility bills to offensive comments posted on social media.

https://www.zerohedge.com/political/today-all-new-vehicles-eu-will-have-surveillance-black-boxes

Dez Bryant on Demaryius Thomas: ‘A lot of us living with CTE and NFL know it’

 NFL wide receiver Dez Bryant on Tuesday said many professional football players are living with chronic traumatic encephalopathy (CTE) but are afraid to speak out about their symptoms.

Bryant’s tweet came the same day as a New York Times report that said former Denver Broncos wide receiver Demaryius Thomas, who played a key role in the team’s 2015 Super Bowl championship run, had been posthumously diagnosed with stage 2 CTE.

“DT88 my heart weak bro… it’s a lot of us living with CTE and the NFL know it…most importantly the Athletes who have those symptoms are scared to speak,” Bryant, who spent eight seasons with the Dallas Cowboys, wrote in a tweet on Tuesday. “1 thing about me ain’t living no false life…my love and support for athletes are on a much deeper level than most.”

Thomas, a four-time Pro Bowl selection at wide receiver, died in December at his home in Roswell, Ga. Authorities believe his death was caused by medical complications stemming from a 2019 vehicle crash.

A Concussion Legacy Foundation medical professional said that Thomas struggled with both CTE and seizures caused by the crash. \Thomas’s family members also told the Times that they saw the signs of CTE, which can be formally diagnosed only after death, during the star wide receiver’s last year of life, during which he suffered from memory loss, paranoia and isolation. 

Thomas is among a growing list of former NFL players who have been diagnosed with the degenerative brain disease, including former San Diego Chargers and Tampa Bay Buccaneers wide receiver Vincent Jackson, whose family said in November that the 38-year-old star player, who was found dead in a hotel room earlier that year, suffered from stage 2 chronic CTE. 

https://thehill.com/blogs/blog-briefing-room/3546920-dez-bryant-on-demaryius-thomas-a-lot-of-us-living-with-cte-and-the-nfl-know-it/

Bayer’s Larotrectinib Data Hint at Potentially Curative Impact

 It’s been a month since cancer drug developers presented their latest research at the American Society of Clinical Oncology (ASCO) annual meeting, and the highlights are still reverberating across the industry.

Updates on Bayer’s Vitrakvi (larotrectinib) were presented across several sessions, including one regarding the efficacy and safety of the oral medicine in pediatric patients with tropomyosin receptor kinase (TRK) fusion-positive cancer.

BioSpace connected with Theodore Laetsch, M.D., lead investigator of the pediatric SCOUT trial, to gain more insight into the drug, the study and how patients' lives are being affected.

Laetsch is a pediatric oncologist who serves as director of both the developmental therapeutics program (DVL) and the very rare malignant tumors program (VRMTP) at the Children’s Hospital of Philadelphia. He is also an associate professor of pediatrics at the University of Pennsylvania.

He shared with BioSpace that he originally began working in medicine because his mom was a pediatrician. When Laetsch was in high school, she helped to connect him with a pediatric oncologist from Arizona who simultaneously did laboratory research and cared for patients. “I really loved that mix of being able to help individual patients, but also being able to try to enhance the field. I never changed my mindset.”

Mechanism of Action Against NTRK Fusions

Bayer’s larotrectinib works by blocking neurotrophic tyrosine receptor kinase (NTRK) gene fusions, which are genetic changes that occur in certain cancers. Laetsch said they believe these fusions are one of the events that can prompt the formation of cancer.

“This medicine blocks that genetic change, which turns off the signaling that drives cancers,” he said. “We've seen that it causes many cancers to shrink quickly in the setting of having one of those genetic changes, but it doesn't work in any tumors that don't have that genetic change.”

NTRK fusions happen across a range of cancer types. Laetsch explained that in some rare pediatric cancers, such as infantile fibrosarcoma and congenital mesoblastic nephroma, there can be NTRK fusion-positive tumors. “There are common pediatric cancers, like brain tumors, where NTRK fusions do occur, but rarely. Most children don’t have an NTRK fusion, but a few do. The medicine works in both of those types of tumors,” he said.

Larotrectinib is effective in both pediatric and adult patients. “In adults, the same kind of genetic changes happen in lung cancer and colon cancer. The medicine works regardless of the tumor type if there's an NTRK gene fusion present.”

Larotrectinib is Showing Curative Potential

Updates on the ongoing trial announced at ASCO include that “we’ve continued to accrue patients and also follow patients for longer, which means that we have longer follow-up data. We have more patients with a few additional diagnoses that weren't seen in the original data set that we published and presented before,” Laetsch said.

He shared the story of one of the very first patients in the trial, a girl with a large sarcoma in the back of her abdomen that was wrapped around her aorta and spread to her lungs. “She had a lot of fluid from the tumor in her abdomen,” he said.

They started the medicine, and within a couple of weeks, the fluid had resolved. Laetsch said that “the first scan showed that the tumor had shrunk dramatically. She went on to have a complete response, which meant that there was no more tumor that we could find in her body. She has now been on therapy and doing quite well for more than five years.”

He also highlighted patients with localized tumors, most of whom were suffering from infantile fibrosarcoma. Larotrectinib caused their tumors to shrink to the point that surgical removal was possible, and then they were able to stop taking the medicine altogether. “We have examples of patients that have been able to stop the medicine for several years and not have tumors reoccur. We're hopeful that for those patients this combination of medicine and surgery may be curative, and that they may not need any further therapy.”

Larotrectinib was approved by the U.S. Food and Drug Administration (FDA) in 2018 for children and adults with NTRK gene fusions in metastatic or locally advanced tumors, or in patients without other treatment options. “We’re continuing to study and gain additional information about how best to use this drug in children, and what the long-term effects of the medicine are,” Laetsch said.

For some patients, this medication could take the place of chemotherapy. “We're now conducting a study through the Children's Health Group to evaluate the use of larotrectinib as the first therapy that patients with NTRK fusion-positive cancer receive to try to see if we can spare the need for traditional chemotherapy and its associated side effects.”

The doctor shared that for some patients, such as the girl with a sarcoma in her abdomen, the treatment can have a life-changing impact. “She had a tumor that had progressed through standard chemotherapy. There really were no other treatment options for her. This therapy was clearly life-saving,” he said. “I think there are different impacts in different patients, but certainly we've seen profound impacts on patients for whom these genetic alterations have been identified.”

The SCOUT trial will continue to follow patients, monitoring long-term side effects.

An important aspect of larotrectinib is that it only works for patients who have NTRK fusions. Laetsch emphasized the importance of testing tumors for these genetic mutations as well as others. “If you don’t test, you'll never know whether the patient may benefit. There are other medications targeting other genetic changes in tumors that are showing really promising results recently. I focus a lot of my time on suggesting that patients get genetic testing to try and understand the driver of their tumor.”

https://www.biospace.com/article/follow-up-data-on-bayer-s-larotrectinib-hints-at-potentially-curative-impact/

FDA grants Priority Review to Roche’s Lunsumio in Lymphoma

 

• Lunsumio® (mosunetuzumab) could be the first CD20xCD3 T-cell engaging bispecific antibody approved by the FDA for the treatment of any type of non-Hodgkin lymphoma
• Application is based on results from the pivotal phase I/II study showing Lunsumio induced high and durable complete response rates in people with follicular lymphoma who received two or more prior therapies
• Lunsumio is a fixed-duration treatment option with the potential to be administered in an outpatient setting

https://www.globenewswire.com/news-release/2022/07/06/2474498/0/en/FDA-grants-Priority-Review-to-Roche-s-Lunsumio-for-people-with-relapsed-or-refractory-follicular-lymphoma.html