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Friday, June 2, 2023

LAVA: Janssen Picks Lead Antibody to Move Toward Clinical Development

 

  • Through a research collaboration with Janssen, a lead candidate was identified for further development towards clinical studies.

  • In May 2020, LAVA entered into a research collaboration and license agreement with Janssen for the discovery and development of novel bispecific antibody-based gamma delta T cell engagers for the treatment of cancer. The agreement was facilitated by Johnson & Johnson Innovation.

  • LAVA is also eligible to receive potential development, regulatory and commercialization milestone payments and tiered royalties.

BioNTech, OncoC4: Positive Phase 1/2 Data for Antibody n Hard-to-Treat NSCLC at ASCO

 

  • BNT316/ONC-392 is a next-generation anti-CTLA-4 monoclonal antibody candidate jointly developed by BioNTech and OncoC4 as monotherapy or combination therapy in a range of solid tumor indications, including non-small cell lung cancer (NSCLC)
  • Interim data of BNT316/ONC-392 from the ongoing Phase 1/2 trial to be presented at this year’s ASCO Annual Meeting demonstrate encouraging signs of clinical anti-tumor activity and a manageable safety profile in patients with metastatic, PD-(L)1-resistant NSCLC
  • Initiation of a pivotal Phase 3 trial with BNT316/ONC-392 as monotherapy in immunotherapy-resistant NSCLC patients is planned in Q3 2023, following FDA’s Fast Track designation in 2022
  • Lung cancer remains one of the most commonly diagnosed malignant cancer types and the leading cause of cancer deaths worldwide, with NSCLC1 making up approximately 85% of all lung cancers

CDC Data Show 'Most Important Virus You’ve Never Heard Of' Surged This Spring

 by Jack Phillips via The Epoch Times (emphasis ours),

Human metapneumovirus, or hMPV, has risen across the United States this winter and springaccording to recent data published by the U.S. Centers for Disease Control and Prevention (CDC).

The percent of tests positive for hMPV increased 19.6 percent for antigen and 10.9 percent for PCR tests at the start of March, when the virus surged this year, the CDC data shows. Around the same time, the percentage of positive COVID-19 and respiratory syncytial virus, or RSV, stood at 7 percent and 2 percent, respectively.

“That peak itself is about 36 percent  higher than what is normally seen before the pandemic,” Dr. Bruce Lee, a professor of health policy and management at City University of New York School of Public Health, told ABC News this week.

“So, it’s an indirect way of getting a sense of the prevalence of hMPV infections out there. It does suggest that there is at least significant activity.”

The virus causes generally mild symptoms for most people and goes away on its own, without any need for additional treatment.

The virus, discovered in 2001, can cause upper and lower respiratory disease, but it especially impacts older people, young children, and those with compromised immune systems, according to the CDC. It says that cough, fever, nasal congestion, and shortness of breath are the primary symptoms.

But it noted that “clinical symptoms of HMPV infection may progress to bronchitis or pneumonia and are similar to other viruses that cause upper and lower respiratory infections. The estimated incubation period is 3 to 6 days, and the median duration of illness can vary depending upon severity but is similar to other respiratory infections caused by viruses.”

Dr. John Williams, a pediatrician at the University of Pittsburgh, said that hMPV isn’t well-known and claimed it is “the most important virus you’ve never heard of.” And blood tests, he said, show that most children have had it before the age of 5.

RSV, influenza, and hMPV are ” the three major viruses,” he told CNN. “Those are the big three in kids and adults, the most likely to put people in the hospital and cause severe disease, most likely to sweep through nursing homes and make older people really sick and even kill them.”

https://www.zerohedge.com/medical/cdc-data-show-most-important-virus-youve-never-heard-surged-spring

NHTSA planning to require automatic emergency braking on new vehicles

 The National Highway Traffic Safety Administration (NHTSA), the top federal roadway safety agency, proposed a rule Wednesday to require all new vehicles to include automatic emergency brakes. 

The agency said in a release Wednesday that the proposed rule would “dramatically” reduce the number of crashes with pedestrians and rear-end collisions. It projects that the rule would save 360 lives and reduce injuries by 24,000 every year. 

“Today, we take an important step forward to save lives and make our roadways safer for all Americans,” Transportation Secretary Pete Buttigieg said in the release. “Just as lifesaving innovations from previous generations like seat belts and air bags have helped improve safety, requiring automatic emergency braking on cars and trucks would keep all of us safer on our roads.” 

The Transportation Department (DOT) aruges that the rule would prevent many crashes from occurring at all and make those that happen less destructive. 

The rule is part of the department’s National Roadway Safety Strategy, which the administration launched in January 2022 to address traffic fatalities and injuries. 

The agency noted that it has received “unprecedented” funding from President Biden’s bipartisan infrastructure law from 2021, and the department announced more than $800 million in grants for communities in high-crash areas. 

A provision of the infrastructure law required DOT to issue a rule ensuring all vehicles manufactured in the U.S. have an automatic emergency braking system. 

NHTSA chief counsel Ann Carlson said 90 percent of new vehicles already include the emergency braking through a voluntary program. But she said the agency wants to have the brakes become more effective at higher speeds and better at avoiding pedestrians. 

She said the rule would require all vehicles to be able to stop and avoid contact with a vehicle in front of them up to 62 miles per hour. 

“With this proposal, we could change a high-speed crash from a deadly one to a lower-speed crash with minor injuries or just property damage,” she said. 

Members of the public will have a 60-day period to submit comments before the agency finalizes the rule. 

https://thehill.com/policy/transportation/4028674-nhtsa-planning-to-require-automatic-emergency-braking-on-new-vehicles/

Poll: 80% of older voters concerned prescription drug reform will hurt drug innovation

 A poll commissioned by American Commitment, a conservative-leaning advocacy group, showed that 80 percent of older voters fear the prescription drug reforms included in President Biden’s landmark Inflation Reduction Act will negatively impact drug innovation while 14 percent of those voters think it will lower their drug costs.  

The survey found that 60 percent of respondents 55 or older view health insurance-related costs as the most concerning issue related to health care affordability and that 85 percent of them do not support using the savings from empowering Medicare to negotiate lower prescription drug prices to offset the cost of unrelated programs, such as electric vehicle tax credits and Affordable Care Act subsidies. 

Among those surveyed, 90 percent said the Medicare drug savings produced from the Inflation Reduction Act’s reforms should be passed directly to individuals on Medicare.  

The poll also found that 85 percent of the seniors surveyed expressed concern that more than half of AARP’s operating revenue comes from royalties — and much of it from UnitedHealthcare.  

And 95 percent said AARP should not have backed the Inflation Reduction Act because the federal savings from prescription drug reform would be used to offset other programs in the bill. 

“The total disconnect between the priorities of AARP and seniors shows that AARP advocates on behalf of its corporate partners and its own bottom line, period,” said Phil Kerpen, the president of American Commitment.

“AARP has abused its reputation to advance public policies seniors clearly do not support, while ignoring the top concerns of seniors, because those concerns implicate AARP’s principal revenue source: UnitedHealth.” 

The poll of 1,600 likely voters 55 and older, including nearly 700 AARP members, was conducted from April 23 to 30 by McLaughlin & Associates, which has done polling for former President Trump and is currently his pollster in the presidential election.  

Jim McLaughlin, president of McLaughlin & Associates, said the survey data shows “it is more apparent than ever that older Americans, including AARP members, disagree with the so-called ‘seniors advocacy’ organization’s policy positions.” 

“The question now becomes whether AARP will put older Americans’ priorities first by abandoning its corporate ties with the nation’s largest health insurer, UnitedHealthcare, or continue to advocate for liberal policies like the Inflation Reduction Act that seniors and its members are concerned about,” he said.   

Laura Segal, senior vice president for external relations at AARP, pushed back on the survey.  

“This poll lacks any credibility. American Commitment is a PhRMA funded front group who put out this deceptive push poll in an effort to keep charging unfair, astronomically high prices for prescription drugs,” she said. 

“The Congressional Budget Office has said this law will save seniors and taxpayers billions of dollars, and only a front group for big drug companies would claim that is a bad thing for seniors,” she added.  

In a follow-up interview with The Hill, McLaughlin said the AARP is “playing politics and they’re out of touch with their members.”

“A good example is the Inflation Reduction Act. They come out for this thing called the Inflation Reduction Act and what does it do, it cuts Medicare by like $280 billion,” he said.

“There’s a reason why Donald Trump says he’s not going to cut Medicare,” he said. “It’s an important program. It’s vital to people’s retirement and unless you’re doing something to make Medicare better, people aren’t going to support it.” 

https://thehill.com/policy/healthcare/4030264-poll-shows-80-percent-of-older-voters-concerned-prescription-drug-reform-will-hurt-drug-innovation/

DHS ups monthly appointments for processing asylum seekers to nearly 40,000

 The Biden administration on Thursday announced an increase in its processing of asylum seekers at the southern border, allowing nearly 40,000 migrants each month to book appointments to make their case.

The appointment slots, distributed through the CBP One app run by U.S. Customs and Border Protection, will jump from 1,000 to 1,250 a day.

“Today we are announcing an increase in available CBP One appointments to 1,250 a day, effective June 1st. This is a continuation of the Biden Administration’s expansion of lawful pathways and opportunities to access them, including CBP One appointments,” a Department of Homeland Security (DHS) spokesman said in a statement. 

“The process cuts out smugglers while also providing a safe, orderly, and humane process for noncitizens to access ports of entry instead of attempting to enter the United States unlawfully.”

The expansion of appointments follows the end of Title 42, which allowed for the rapid expulsion of migrants without allowing them to seek asylum.\

The termination of the pandemic-era policy has not yet resulted in an uptick of migration to the border, though DHS officials say it’s too early to determine if that trend will hold.

Those seeking asylum protections must use the CBP One app to seek an appointment, during which they will face an initial screening to see if they qualify.

Though the figure represents a substantial increase in potential asylum cases, the Biden administration has rolled out other limitations on the process, including on those who do not first seek protections elsewhere along their route.

“We are continuing to enforce consequences for migrants who cross unlawfully, and those who do not establish a legal basis to remain in the United States will be removed. CBP will evaluate further expansion of daily available appointments as operations and efficiencies permit,” DHS said in a statement.

https://thehill.com/policy/national-security/4030871-dhs-ups-monthly-appointments-for-processing-asylum-seekers-to-nearly-40000/

Billions spent on cancer research but only small percentage goes to treatment

 Only a small percentage of cancer research funding gets invested into primary treatments, a study by the University of Southampton and Queen's University Belfast has revealed.

The investigation, published in the journal Lancet Oncology, represents the first comprehensive global analysis of  research funding, covering approximately $24.5 billion of global investment, from 66,388 public and philanthropic awards between 2016 and 2020.

Results of the Southampton and Queens study showed that treatments such as surgery receives just 1.4 percent of funding, and radiotherapy only 2.8 percent, meaning little direct benefit for patients.

Cancer is one of the leading causes of death worldwide. GLOBOCAN estimates that in 2020 almost 10 million deaths were deemed attributable to cancer and 19.3 million new cancer cases were diagnosed, a value projected to increase to 28.4 million by 2040.

Dr. Michael Head, Senior Clinical Research Fellow at the University of Southampton, co-led the study. He said, "There will be long-term consequences of the pandemic on other areas of health, including cancer. We need to understand the worst of the , which can potentially be filled with new research. Our analysis can help cancer experts better set priority areas for funding, ultimately for the benefit of future cancer patients."

The study provides crucial information and recommendations for agencies that fund cancer research globally, policymakers, and those developing cancer research funding strategies.

Cancer research works to understand evolving patterns of cancer burden and to inform policies aimed at providing more effective, efficient, and equitable care. However, there is an urgent need to review research investment priorities globally to align with population needs to ensure finite

Dr. Stuart McIntosh, Clinical Reader from the Patrick G Johnston Centre for Cancer Research at Queen's University Belfast, led the study. He said, "Our analysis has shown that current cancer research investment does not align well with either the current global distribution of cancer (including overarching cancer control strategies), nor with the main treatments that are used for patients with cancer. There is an urgent need to look at research funding priorities globally to ensure that finite resources can be used to maximize patient benefit."

The study showed almost three quarters of cancer research  is dedicated to pre-clinical or medicinal research, not directly involving patients. Although pre-clinical research has inherent value in improving the knowledge and understanding of cancer, there are usually lengthy delays translating this to patient benefit, with time lags of up to 17 years cited.

Compared with previous studies, the researchers also demonstrated cancer research investment is decreasing year on year, with a larger drop in 2020 corresponding to the start of the COVID pandemic.

Despite the known rapidly increasing burden of cancer in  and , only a fraction of  investment is into cancer as a global health problem.

More information: Stuart A McIntosh et al, Global funding for cancer research between 2016 and 2020: a content analysis of public and philanthropic investments, The Lancet Oncology (2023). DOI: 10.1016/S1470-2045(23)00182-1\


https://medicalxpress.com/news/2023-06-billions-spent-cancer-small-percentage.html