American Renal Associates Holdings (ARA) and UnitedHealthcare, a UnitedHealth Group company (UNH) announced that they have executed a binding Settlement Term Sheet and will be negotiating terms of a definitive settlement by August 1, 2018. Under the terms of the Agreement, ARA will pay $32M and will follow certain procedures and share information with UnitedHealthcare. In conjunction with the Agreement, ARA and UnitedHealthcare will enter into a three-year network agreement, effective August 1, 2018, that will provide UnitedHealthcare plan participants with more cost effective, in-network access to all of ARA’s dialysis clinics in 26 states and the District of Columbia. The network agreement will include UnitedHealthcare’s health benefit products across the commercial, Medicare Advantage and Medicaid managed care markets, and will allow chronically-ill end-stage renal disease patients to better coordinate their access to care with ARA’s clinics and ARA-affiliated nephrologist partners who are part of the UnitedHealthcare network. The network agreement will also include certain value-based contracting features designed to improve quality and lower hospitalization costs for UnitedHealthcare plan participants who receive kidney care at ARA clinics. In a joint statement, the companies said, “We are pleased to have reached a resolution on this matter and we look forward to building a more cooperative relationship that enables us to collaborate on high quality care for dialysis patients.”
Monday, July 9, 2018
Weight Watchers started at buy by KeyBanc
Weight Watchers initiated with an Overweight at KeyBanc. KeyBanc started Weight Watchers with an Overweight rating and $115 price target.
HTG Molecular started at buy by Leerink
Leerink today initiated coverage of HTG Molecular with an Outperform rating for its stock and a target price of $6 per share.
In a note to investors, analyst Puneet Souda said that HTG has a growing funnel of biopharma partnerships and projects that have the potential to convert to US Food and Drug Administration-approved companion diagnostics and drive “significant revenue upside.”
He noted that the firm has about “40 early-stage projects in the mix from biopharma with hopes of increasing that number to 60 as the project funnel continues to grow.” Though timing remains unclear, he said, 10 percent of those should become “full-blown CDx projects” in the long term.
“We believe [HTG] will continue to differentiate itself from rest of the tumor-tissue diagnostics offerings on the market, given its unique chemistry and workflow that delivers higher sensitivity at low sample requirements,” Souda added. He further noted that despite the recent failure of a biopharma partner project trial in May, HTG’s upcoming project pipeline looks solid, given a backdrop of more than 3,000 oncology trials in the market.
Souda specifically pointed to a partnership agreement HTG inked with Qiagen in November 2016, noting that support from the partnership means HTG can deliver on the need of biopharma companies conducting oncology trials who are seeking partners that can deliver on companion diagnostics from assay development to regulatory approval. As part of the exclusive agreement, the companies are combining their technological and commercial strengths to offer pharma companies a next-generation sequencing solution for the development and commercialization of companion diagnostic tests with a focus on oncology.
HTG’s full-year revenue is likely to wind up at the lower end of its guidance of $21 million to $25 million for 2018, Souda said. However, he added, the firm’s research-use-only business — about 46 percent of its total sales — “should continue to deliver” with a long-term compound annual growth rate of 28 percent.
For good sleep for baby, food may be key
If there’s one thing frazzled new parents crave, it’s that their baby sleeps well.
Now, research suggests that the odds for good infant slumber rise when solid foods are introduced relatively early.
The British findings contradict some long-held guidelines on infant feeding, however, and were met with mixed reviews by experts in the United States.
Dr. Michael Grosso directs pediatrics at Northwell Health’s Huntington Hospital in Huntington, N.Y. He agreed with the findings, which he said are “debunking the widely held belief that infants woke up at night — or didn’t — for reasons that have nothing to do with food.”
But neonatal dietitian Meghan Reed, of Lenox Hill Hospital in New York City, disagreed. She said that “while there was a short period of time in which the infants [in the study] seemed to sleep better, it can be argued that the benefits [of early solid foods] do not outweigh the risks and possible future negative effects.”
Currently, the American Academy of Pediatrics recommends exclusive breast-feeding for new babies for the first six months of life. The AAP also notes that introducing solid foods to baby before 4 months of age has been linked to excess weight gain and body fat as children grow.
In short, conventional wisdom by experts has been that infant sleep is not influenced by how babies are fed.
Many parents have long disagreed, however. To help sort the issue out, researchers at King’s College London tracked the sleep and nutrition of more than 1,200 infants in the United Kingdom who were breast-fed only for their first three months.
The babies were then divided into two groups, with one group continuing to breast-feed exclusively for another three months, while the other group started solid foods while still being breast-fed.
Infants in the group that began solid foods at 3 months slept longer, woke less frequently at night and had fewer serious sleep problems than those who were breast-fed exclusively until 6 months of age, the researchers reported July 9 in JAMA Pediatrics.
Those differences peaked at 6 months, with the group introduced to solid foods earlier sleeping for nearly 17 minutes longer per night and nearly two hours longer per week, and the night waking decreasing from just over two times per night to 1.74 times per night.
“The results of this research support the widely held parental view that early introduction of solids improves sleep,” said study co-lead author Gideon Lack, professor of pediatric allergy at King’s College London.
“While the official guidance is that starting solid foods won’t make babies more likely to sleep through the night, this study suggests that this advice needs to be re-examined in light of the evidence we have gathered,” Lack said in a school news release.
U.S. pediatrician Grosso agreed, saying the study could prompt a new look at guidelines.
“This whole area seems to have been controversial for decades,” he noted. “Generations of pediatricians on both sides of the Atlantic have encouraged parents to delay the introduction of solid foods, [in part] based on expert opinion which said that this would limit food allergy.”
But Grosso noted that recent studies have suggested that the early and controlled introduction of certain allergens — peanut, most notably — can actually help prevent food allergies.
Likewise, with infant sleep, the new study may support early solid foods as a helpful measure, he said.
“A full tummy may turn out to be as good for making infants sleepy as it is for us big folk,” Grosso.
But Reed remained cautious. She still backs the directive that “if an infant seems hungry before 6 months of age, it is recommended to increase the volume of breast milk provided rather than introducing solid foods early.”
Reed said the study also left out one important group: babies who, for whatever reason, are formula-fed. She stressed that while breast milk is strongly preferred, it’s not clear what the study might mean for the millions of U.S. babies who gain their nutrition via bottle-feeding.
And Reed suggested that “this study could also be identified as subjective. One parent’s perception of a ‘very serious sleep problem’ might be ‘not a problem at all’ to another.”
More information
The American Academy of Pediatrics has more on babies and feeding.
SOURCES: Michael Grosso, M.D., chair, pediatrics, Northwell Health’s Huntington Hospital, Huntington, N.Y.; Meghan Reed, R.D., C.S.P., C.D.N., neonatal dietitian, Lenox Hill Hospital, New York City; King’s College London, news release, July 9, 2018
Torque’s T cell ‘backpacks’ may boost immune attack against solid tumors
T-cell therapies like Gilead’s Yescarta and Novartis’ Kymriah have generated enthusiasm because of their high response rates in patients with lymphoma and leukemia. But the technology—which involves removing immune-boosting T cells from patients and then engineering them to recognize and kill cancer—has proven difficult to translate to solid tumors.
Researchers from the Massachusetts Institute of Technology believe they’ve found a solution to that problem: nanoparticle “backpacks” that can be attached to T cells. The backpacks are filled with drugs that stimulate the immune system, and they’re showing promise in mouse studies—so much promise that MIT spinoff Torque Biotherapeutics is now planning clinical trials for the treatment in several tumor types, according to a statement.
The team is applying the new technology to a technique called adoptive T-cell therapy, in which the immune-boosting cells are taken directly from patients’ tumors, grown outside the body, and then infused back into the body. The technology has been tried in various tumor types in the past, but it hasn’t generated a strong enough immune response. Immune-boosting drugs called cytokines can be injected along with the treatments, but because those drugs stimulate every T cell, they can cause harmful inflammatory side effects.
So the MIT researchers developed nanoparticles that can carry cytokines but that don’t release the drugs until the tumor-specific T cells hit their intended target. The particles consist of a gel made from the cytokine Il-15. A chemical change in the surface of T cells acts as a signal of sorts, prompting the nanoparticle to degrade and release its payload when it reaches the tumor.
“That allowed us to link T cell activation to the drug release rate,” said Darrell Irvine, Ph.D., a professor of biological engineering and of materials science and engineering, in the statement. “The drug is most efficiently being released at the sites where you want it and not in some healthy tissue where it might cause trouble.”
In 60% of mice whose T cells were engineered to express a target of melanoma, the nanoparticle-armed cells caused the tumors to disappear completely, Irvine and his colleagues reported in the journal Nature Biotechnology. They also discovered that the nanoparticles allowed them to give the mice eight times as much IL-15 than they could if they injected the drug directly into the body. Irvine was the senior author of the paper and a co-founder of Torque.
Torque was founded in Boston last year after raising a $21 million A round. Its founding management team is stocked with biopharma veterans, including chief medical officer Becker Hewes, M.D., formerly of Novartis, and CEO Bart Henderson, who previously founded Rhythm.
Deploying tumor-derived T cells against cancer is considered to be a promising, personalized approach to addressing solid tumors. One idea, being examined at the Ludwig Institute for Cancer Research in Switzerland, involves enriching “highly reactive” tumor-infiltrating lymphocytes (TILs) from ovarian tumors, for example. A University of North Carolina team is developing a CAR-T to treat the brain cancer glioblastoma that zeroes in on a surface protein called CSPG4, and Lion Biotechnologies is working on TIL technologies targeting sarcomas and pancreatic cancer.
MIT’s Irvine believes that any tumor type with a “known target”—meaning something the T cells can be programmed to recognize—could be enhanced with the cytokine-carrying nanoparticles. As Torque proceeds with clinical trials of the IL-15-infused cells in solid tumors, Irvine plans to study whether other cytokines may be even better at stimulating T cells to attack cancer.
Malaria drug could make cancer treatments more effective
An existing malaria drug could improve the effectiveness of a new class of cancer therapies, called glutaminase inhibitors, if used in combination, researchers at Weill Cornell Medicine-Qatar (WCM-Q) discovered in a new study.
The research, published May 17 in Cancer Letters, analyzed the metabolic processes of cancer cells to show that the U.S. Food and Drug Administration-approved, quinine-based malaria drug Chloroquine could boost the effectiveness of the new glutaminase inhibiting drugs, which are currently being developed by global pharmaceutical companies. The findings could offer doctors and researchers a relatively simple way to improve outcomes for cancer patients who are prescribed glutaminase inhibitors.
Glutaminase inhibitors target a chemical process called glutaminolysis, in which the amino acid glutamine is broken down, releasing energy that cancer cells use to grow. Glutaminase inhibitors seek to disrupt this process, thereby depriving cancer cells of their energy source and slowing or stopping their growth. However, certain cancer cells can activate alternative ways to generate energy and thereby escape the drug’s action. This is where a new research approach called “rational metabolic engineering” comes in.
“We expose cancer cells grown in the laboratory to different doses of an anti-cancer drug and then measure the changes in almost all of the small molecules that are present in the cells, using a technique called metabolomics,” said lead author Dr. Anna Halama, a research associate in physiology and biophysics. “Using sophisticated computational methods, we then identify the molecules that the cancer cells are using to escape the drug’s actions, and conceive ways to block that escape route.”
In this first application of approach to glutaminase inhibitors, the researchers focused on two specific energy pathways that cancer cells use: lipid catabolism, which is the breakdown of fats, and autophagy, in which cells derive energy by degrading parts of their own structure. They found that both of these energy pathways were accelerated when the glutaminolysis pathway was suppressed with drugs, which allowed the cancer cells to survive.
“Since the anti-malaria drug Chloroquine is known to disrupt some of these energy-producing mechanisms,” Dr. Halama said, “our research prompted us to theorize that giving Chloroquine in combination with the glutaminase inhibiting drugs could lead to an improved suppression of tumor cells, which turned out to be the case.”
“The beauty of metabolomics profiling is that it lets us see how the cell’s metabolism behaves in different situations and with a very high level of detail,” said senior author Dr. Karsten Suhre, a professor of physiology and biophysics and director of the bioinformatics core at WCM-Q. “So with this method we can get very useful insights into the effects a drug has on the metabolism of tumor cells, helping us to understand how the disease works and to identify targets for potential new treatments.”
The findings may provide physician-scientists with a new strategy that can be replicated in other therapies. “The combined approach used in this study is uniquely relevant for future therapeutic strategies in cancer treatment and can be easily generalized to other drugs. The next important step is to test the efficacy of Chloroquine in combination with glutaminolysis inhibitors in a clinical trial.”
Dr. Khaled Machaca, associate dean for research at WCM-Q, said: “This type of research combining deep -omics phenotyping under specific pathological conditions identifies novel therapeutic interventions, in this case applied to cancer, that could be powerful in terms of disease interventions. The funding provided by QNRF for this type of research goes a long way toward both improving our basic knowledge base and generating potential therapeutic tools for Qatar and the world.”
More information: Anna Halama et al. Accelerated lipid catabolism and autophagy are cancer survival mechanisms under inhibited glutaminolysis, Cancer Letters (2018). DOI: 10.1016/j.canlet.2018.05.017
Majority of drivers don’t believe texting while driving is dangerous
People who text while driving are six times more likely to be involved in a car crash. To combat this problem, more and more states are adopting driving laws that require people to use hands-free devices in the car. Yet a new study shows that many drivers are still willing to take the risk, as ‘fear of missing out’ and separation anxiety keep them from abiding by the law. The study, published in Risk Analysis: An International Journal, reveals that many drivers don’t perceive texting and driving to be dangerous in certain driving scenarios.
In the U.S., mobile phone usage has been a factor in one quarter of all car collisions. However, actual crash risks vary based on the type of task being performed and the extent of its cognitive and physical demands on the driver. Talking on a mobile device increases crash risk by 2.2 times whereas texting increases risk by 6.1 times.
Observational studies have found that as many as 18 percent of drivers in high-income countries, and up to 31 percent in low- and middle-income countries, use their mobile devices while on the road, contributing to significantly reduced road safety. Despite laws prohibiting such behavior, mobile phone use while driving is expected to increase.
In the study, “Should I text or call here? A situation-based analysis of drivers’ perceived likelihood of engaging in mobile phone multitasking,” researchers found that drivers who are female, are frequent users of phones for texting/calling, have negative attitudes towards safety and are highly disinhibited report much stronger intentions of engaging in distracted driving. The research team included Oscar Oviedo-Trespalacios, Md. Mazharul Haque and Mark King from Australia Queensland University of Technology, and Simon Washington from the University of Queensland.
The researchers found that drivers engage in self-regulation when deciding whether to use their phones while driving, which is a process through which individuals develop strategies to cope with environmental factors while maintaining a high level of performance. For example, many drivers make use of stops to initiate using their mobile device, and many are able to restrain themselves to using phones only while stopped at intersections with signals. Many other researchers have also noted that drivers usually restrict engagement in heavy traffic or along curved sections of both urban and rural roads. This study sought to identify what factors contribute to self-regulation.
In the study, 447 drivers in South East Queensland, Australia, answered questions about perceived crash risk, perceived driving comfort, perceived driving difficulty, perceived driving ability, perceived likelihood of engaging in a voice call and perceived likelihood of engaging in texting.
The authors conclude that females are more likely than males to engage in mobile phone use while driving. More experienced drivers are less likely to engage in distracted driving. Results show that as the number of years with license increase, the probability of participating in distracted driving decreases, and drivers who are more disinhibited are more likely to drive distracted.
The researchers also found that drivers who hold the following beliefs are more likely to use a mobile device while driving: effects on driver are minor; I need a lot of convincing to believe it is dangerous; effects will last after the task is finished. Sixty-eight percent of participants reported needing a lot of convincing to believe in the dangers of texting and driving. However, demanding traffic conditions and the presence of law enforcement were reported as effective measures in reducing the likelihood of distracted driving. These results support high-visibility police enforcement programs as a means to combat distracted driving.
“Drivers are not good at identifying where it is safe to use their phone, it is safer for drivers to just pull over in an appropriate place to use their phone quickly and then resume their journey,” stated Oviedo-Trespalacios.
Drivers were much more likely to talk on their phones while driving than they were to use their phones to text. This is expected since the visual demands of texting compete directly with those of driving, whereas talking on the phone is mostly auditory.
The results from this study may contribute to more targeted distracted driving campaigns by highlighting opportunities for interventions. These campaigns should target safety attitudes to more effectively curb drivers’ motivations for engaging with their phones while driving. This study also confirmed the need to profile and target high-risk groups, particularly novice drivers and those who are overly attached to their phones, to develop messaging that considers their particular motivating factors.
More information: Oscar Oviedo-Trespalacios et al, Should I Text or Call Here? A Situation-Based Analysis of Drivers’ Perceived Likelihood of Engaging in Mobile Phone Multitasking, Risk Analysis (2018). DOI: 10.1111/risa.13119
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