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Precision NanoSystems sets time and place to open new Genetic Medicine GMP Biomanufacturing Centre in Vancouver, BC – PRNewswire

Posted: August 18, 2021 at 2:20 am

Precision NanoSystems, Inc. 50 655 West Kent Ave North Vancouver, BC Canada V6P 6T7 1-888-618-0031

VANCOUVER, BC, Aug. 11, 2021 /PRNewswire/ - Precision NanoSystems (PNI), a global leader in innovative solutions for genetic medicine development, will expand its global headquarters with a 75,000-square-foot facility currently under construction. Slated for completion in Q4 2022, the new site will be located at 1055 Vernon Drive, in the Evolution Block building, in the False Creek Flats area of Vancouver. PNI's new genetic medicine GMP Biomanufacturing Centre will also be housed at the site.

PNI intends to expand capabilities to include the clinical manufacturing of RNA vaccines and therapeutics.

PNI's rapidly expanding team of more than 180 life science professionals will work from the site. James Taylor, General Manager, Precision NanoSystems, says: "This is a huge leap forward in our mission to accelerate the creation of transformative medicines that significantly impact human well-being. We are proud to contribute to the Canadian biotechnology industry by enabling them to develop and manufacture the next generation of medicines."

The Biomanufacturing Centre will support PNI's client base of leading drug developers through clinical development, as well as Canada's efforts for future pandemic preparedness through the manufacture of RNA vaccines.

PNI continues to rapidly expand its clinical manufacturing organization. The Biomanufacturing Centre is led by Elaine Copsey, VP of Biomanufacturing Operations, and Lloyd Jeffs, Senior Director of Biomanufacturing Services. Hiring is ongoing to find scientists, engineers, and other skilled professionals.

Elaine Copsey says: "PNI is excited to build on our successful preclinical services to include clinical and GMP production. We are growing our expertise as one of the industry leaders and will be hiring professionals with expertise in GMP operations including RNA and lipid nanoparticles manufacturing, process development, analytical testing, quality control, sterility, and quality assurance. PNI is looking forward to working with our clients to support all stages of their drug development process resulting in expedited therapeutic batches for clinical trials and routine production."

The Biomanufacturing Centre has been partially funded with CAD 25.1 million dollars from Canada's Strategic Innovation Fund (SIF).

The Honourable Franois-Philippe Champagne, Minister of Innovation, Science and Industry, says: "We are continuing to safely restart our economyby investing in companies like PNI that will help create well-paying jobs and ensure Canada is more prepared for future pandemics. By accelerating the creation of drugs and therapeutics, PNI will contribute to the strengthening of Canada's biomanufacturing sector and to building a stronger and healthier country for all of us."

PC Urban Properties is overseeing the construction of the new site. Brent Sawchyn, CEO, PC Urban Properties, says: "PNI's new lease solidifies the False Creek Flats area of Vancouver as a growing biotech and health science hub. We're excited to welcome PNI toEvolution Block, a pioneering stacked industrial development that will help transform one of the city's oldest industrial neighborhoods into its reimagined future."

About PNIPNI is a global leader in ushering in the next wave of genetic medicines in infectious diseases, cancer and rare diseases. We work with the world's leading drug developers to understand disease and create the therapeutics and vaccines that will define the future of medicine. PNI offers proprietary technology platforms and comprehensive expertise to enable researchers to translate disease biology insights into non-viral genetic medicines.

SOURCE Precision Nanosystems

http://www.precisionnanosystems.com

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Cannabis use disorder: another COVID risk factor – Washington University in St. Louis Newsroom

Posted: August 18, 2021 at 2:20 am

Should doctors take particular care to talk to patients about the potential dangers of COVID-19 if those patients have a problematic relationship with pot?

New research from Washington University in St. Louis suggests perhaps they should.

Diabetes, obesity and a history of smoking cigarettes are all considered risk factors for poorer COVID-19 outcomes. Warnings and tailored information are targeted to people with these conditions, and doctors are acutely aware of the elevated risks they pose.

Findings from the lab of Ryan Bogdan, associate professor in the Department of Psychological & Brain Sciences in Arts & Sciences, suggests cannabis use disorder (CUD) should be added to the list because the genetic predisposition to CUD is overrepresented in people with poor COVID-19 outcomes. More work is needed to determine if there is direct causation.

The research is in press in the journal Biological Psychiatry: Global Open Science.

As sociocultural attitudes and laws surrounding cannabis use become increasingly permissive, and COVID-19 continues to spread, we need to better understand how cannabis use as well as heavy and problematic forms of use are associated with COVID outcomes, Bogdan said.

First author Alexander S. Hatoum, a postdoctoral researcher in the Washington University School of Medicine, used genetic epidemiological models to determine that genetic predisposition to CUD is related to risk for a severe reaction to COVID-19 (i.e., being hospitalized with COVID-19).

Hatoum combined existing datasets to test whether being at higher genetic risk for cannabis use disorder was correlated to the risk of COVID hospitalization.One set of data involved 357,806 people, including 14,080 with CUD; the other involved 1,206,629 people, including 9,373 who were hospitalized with COVID. He also looked at 7 million genetic variants to assess the association between CUD and severe COVID.

Having genetic variants does not mean a person has CUD or that the person has used cannabis.

In comparing people with the variants to their COVID outcomes, the researchers found genetic liability for CUD accounted for up to 40% of genetically influenced risk factors, such as body mass index (BMI) and diabetes, for a severe COVID-19 presentation.This association suggested that heavy and problematic cannabis use may represent a modifiable pathway to minimize severe COVID-19 presentations.

The results of this study point to two possible outcomes: That a predisposition to CUD and severe COVID-19 are due to a common biological mechanism, like inflammatory conditions causing individuals to develop worse symptoms of COVID-19 and/or dependence on cannabis; or that they are associated because of a causal process.

If we know the genes that predispose individuals to cannabis use disorder, and if cannabis use disorder is a risk factor for COVID-19 hospitalization, you will see the genes influencing cannabis use disorder as predictors of severe COVID-19 cases, Hatoum said. We found that a persons genetic risk for cannabis use disorder is correlated with their risk for COVID-19, without having to ask directly about illegal substance use.

The genetic association between CUD and COVID-19 severity was similar in size to genetic correlations between COVID-19 severity and BMI, a well-known risk factor for severe COVID-19 presentations. Moreover, it was present even when accounting for genetic liability to BMI as well as other risk factors for a severe reaction to COVID-19, including metabolic traits (e.g., fasting glucose, hypertension); respiration traits (e.g., forced expiratory volume, COPD); socioeconomic status; alcohol and tobacco use; and indices of impulsivity.

That the genetic relationship between CUD and COVID-19 is independent of these factors raises the intriguing possibility that heavy and problematic cannabis use may contribute to severe COVID-19 presentations. As such, it is possible that combating heavy and problematic cannabis use may help mitigate the impact of COVID-19, Hatoum said.

This information needs to be incorporated into any strategy to defeat this disease, Hatoum said.

These data suggest that heavy cannabis users may have a more adverse reaction to COVID-19 and that, much like quitting tobacco smoking or reducing BMI, reducing and/or stopping heavy cannabis use may protect against severe COVID-19 reactions.

Julia Strait contributed to this story.

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Coriell Life Sciences Makes its Debut on the Inc. 5000 as One of America’s Fastest-Growing Private Companies – The Wellsboro Gazette

Posted: August 18, 2021 at 2:20 am

PHILADELPHIA, Aug. 17, 2021 /PRNewswire/ -- Coriell Life Sciences, an international leader in precision medicine, announced today its debuton the annual Inc. 5000 list, the most prestigious ranking of the nation's fastest-growing private companies. The list represents a unique look at the most successful companies within the American economy's most dynamic segment.

Our scalability enables us to deliver turnkey precision medicine solutions to people and organizations around the world.

"Having Coriell Life Sciences' growth story recognized is a tremendous honor for our entire team," says Scott Megill, President & CEO of Coriell Life Sciences. "The most important part of this story goes beyond our traction in rolling out personalized medication safety programs to help a growing number of employers and payers improve population health and lower healthcare costs. It's also about the scalability that we're introducing to the market. This scalability enables us to deliver turnkey precision medicine solutions to organizations and individuals around the globe and empower a healthier world."

Precision medicine is at a tipping point, especially as more employers and health plans offer personalized medication safety benefits to their employees, retirees, and members. CLS' Corigen Medication Safety Program is the most comprehensive medication risk management program on the market. It uses the science of pharmacogenomics (PGx) to identify which medications are the safest and most effective for individuals based on their unique DNA. In addition to minimizing adverse effects and improving individual health, it reduces healthcare costs for sponsoring organizations by minimizing the inefficiencies of trial-and-error prescribing.

"The 2021 Inc. 5000 list feels like one of the most important rosters of companies ever compiled," says Scott Omelianuk, editor-in-chief of Inc. "Building one of the fastest-growing companies in America in any year is a remarkable achievement. Building one in the crisis we've lived through is just plain amazing. This kind of accomplishment comes with hard work, smart pivots, great leadership, and the help of a whole lot of people."

To learn more, visit coriell.com.

About Coriell Life Sciences

Coriell Life Sciences (CLS), a leader in genetic science,is spearheading innovation in precision medicine to reduce healthcare costs and empower a healthier world.With advanced bioinformatics technology, CLS bridges the gap between genetic knowledge and clinical application and offers the most comprehensive medication risk management program on the market.Visit coriell.com, email info@coriell.comor follow @CoriellLife.

Media Contact:

Pamela Caruolo

For Coriell Life Sciences

pamela@caruolocommunications.com

484.574.2946

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People working night shift face increased risk of developing heart problems: Study – Hindustan Times

Posted: August 18, 2021 at 2:20 am

People who work night shifts are at increased risk of developing an irregular and often abnormally fast heart rhythm called atrial fibrillation (AF), according to a new study led by a team of international researchers.

The findings were published in the European Heart Journal.

The study is the first to investigate the links between night shift work and AF. Using information from 283,657 people in the UK Biobank database, researchers found that the longer and more frequently people worked night shifts over their lifetimes, the greater their risk of AF. Night shift work was also linked to an increased risk of heart disease, but not to stroke or heart failure.

In addition, the researchers, led by Professor Yingli Lu, of Shanghai Ninth People's Hospital and Shanghai JiaoTong University School of Medicine, Shanghai, China, and Professor Lu Qi, of Tulane University School of Public Health and Tropical Medicine, New Orleans, USA, investigated whether genetic predisposition to AF could play a role in the increased risk.

They evaluated the overall genetic risk on the basis of 166 genetic variations known to be associated with the condition but found that the genetic risk levels did not affect the link between working night shifts and AF risk, regardless of whether participants had a low, medium, or high genetic risk.

Prof. Lu said: "Although a study like this cannot show a causal link between night shifts and atrial fibrillation and heart disease, our results suggest that current and lifetime night shift work may increase the risk of these conditions.

"Our findings have public health implications for preventing atrial fibrillation. They suggest that reducing both the frequency and the duration of night shift work may be beneficial for the health of the heart and blood vessels."

The study included 286,353 people who were in paid employment or self-employed. A total of 283,657 of these participants did not have AF when they enrolled in UK Biobank, and 276,009 did not have heart failure or stroke.

Information on genetic variants was available for 193,819 participants without AF, and 75,391 of them answered in-depth questions about their lifetime employment in a questionnaire sent out in 2015. Among the participants free of heart disease and stroke when they joined the study, 73,986 provided information on their employment history. During an average follow-up time of over ten years, there were 5,777 AF cases.

The researchers adjusted their analyses for factors that could affect the results, such as age, sex, ethnicity, education, socioeconomic status, smoking, physical exercise, diet, body mass index, blood pressure, sleep duration and chronotype (whether someone was a 'morning' or an 'evening' person).

They found that people who currently worked night shifts on a usual or permanent basis had a 12 per cent increased risk of AF compared to people who only worked during the day. The risk increased to 18 per cent after ten or more years for those who had a lifetime duration of night shifts. Among people who worked an average of three to eight-night shifts a month for ten years or more, the risk of AF increased to 22 per cent compared to daytime workers.

Among participants currently working night shifts, or working night shifts for ten or more years, or working a lifetime of three to eight night shifts a month, the risk of coronary heart disease increased by 22 per cent, 37 per cent and 35 per cent respectively compared to daytime workers.

Prof. Qi said: "There were two more interesting findings. We found that women were more susceptible to atrial fibrillation than men when working night shifts for more than ten years. Their risk increased significantly by 64% compared to day workers. People reporting an ideal amount of physical activity of 150 minutes a week or more of moderate-intensity, 75 minutes a week or more of vigorous-intensity, or an equivalent combination, had a lower risk of atrial fibrillation than those with non-ideal physical activity when exposed to a lifetime of night shift work. Thus, women and less physically active people may benefit particularly from a reduction in night shift work."

A strength of the study is its size, with detailed information on over 283,000 people. In addition, it is the first study to link these data with genetic information in a population that also has detailed histories available on current shift work and lifetime employment.

Limitations of the study include the fact that it cannot show shift work causes heart problems, only that it is associated with them; some cases of atrial fibrillation may have been missed; lifetime employment was assessed only when people joined UK Biobank, was self-reported, and, therefore, may have changed or been prone to some errors; there may be unknown factors that might affect the results, and the people in UK Biobank were mainly white British and so it may not be possible to generalise the findings to other ethnic groups.

Prof. Lu said: "We plan to analyse the association between night shift work and atrial fibrillation in different groups of people. This may strengthen the reliability of these results and serve as a warning to groups working in certain types of occupations to get their hearts checked early if they feel any pain or discomfort in their chests."

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Generation Bio Reports Business Highlights and Second Quarter 2021 Financial Results – GlobeNewswire

Posted: August 18, 2021 at 2:20 am

CAMBRIDGE, Mass., Aug. 11, 2021 (GLOBE NEWSWIRE) -- Generation Bio Co. (Nasdaq: GBIO), a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases, reported recent business highlights and second quarter 2021 financial results.

This quarter we announced our shift to rapid enzymatic synthesis, or RES, for production of our closed-ended DNA, ceDNA, constructs and our signing of a lease to establish significant internal current Good Manufacturing Practice, or cGMP, manufacturing capacity. These are important steps toward our goal of extending the reach of our durable, redosable genetic medicines to patients with prevalent diseases, said Geoff McDonough, M.D., chief executive officer of Generation Bio. We will continue to advance the platform throughout the rest of the year and expect factor VIII expression data with ceDNA produced using RES in non-human primatesfor our hemophilia A program by year-end.

Business Highlights

Second Quarter 2021 Financial Results

About Generation Bio

Generation Bio is innovating genetic medicines to provide durable, redosable treatments for people living with rare and prevalent diseases. The companys non-viral genetic medicine platform incorporates a novel DNA construct called closed-ended DNA, or ceDNA; a unique cell-targeted lipid nanoparticle delivery system, or ctLNP; and a highly scalable capsid-free manufacturing process that uses proprietary cell-free rapid enzymatic synthesis, or RES, to produce ceDNA. The platform is designed to enable multi-year durability from a single dose, to deliver large genetic payloads, including multiple genes, to specific tissues, and to allow titration and redosing to adjust or extend expression levels in each patient. RES has the potential to expand Generation Bios manufacturing scale to hundreds of millions of doses to support its mission to extend the reach of genetic medicine to more people, living with more diseases, around the world.

For more information, please visit http://www.generationbio.com.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the company, including statements about our strategic plans or objectives, our technology platform, our research and clinical development plans, the expected timing of the submission of IND applications and preclinical data, our manufacturing plans, our expectations regarding our new facility and other statements containing the words believes, anticipates, plans, expects, and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the conduct of research activities, the initiation and completion of preclinical studies and clinical trials and clinical development of the companys product candidates; uncertainties as to the availability and timing of results from preclinical studies and clinical trials; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; uncertainties regarding the timing and ability to complete the build-out of the companys manufacturing facility and regarding the new manufacturing process; expectations regarding the timing of submission of IND applications; expectations for regulatory approvals to conduct trials or to market products; challenges in the manufacture of genetic medicine products; whether the companys cash resources are sufficient to fund the companys operating expenses and capital expenditure requirements for the period anticipated; the impact of the COVID-19 pandemic on the companys business and operations; as well as the other risks and uncertainties set forth in the Risk Factors section of our most recent annual report on Form 10-K and quarterly report on Form 10-Q, which are on file with the Securities and Exchange Commission, and in subsequent filings the company may make with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the companys views as of the date hereof. The company anticipates that subsequent events and developments will cause the companys views to change.However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so.These forward-looking statements should not be relied upon as representing the companys views as of any date subsequent to the date on which they were made.

Contacts:

InvestorsMaren KillackeyGeneration Bio541-646-2420mkillackey@generationbio.com

MediaAlicia WebbGeneration Bio847-254-4275awebb@generationbio.com

Lisa RaffenspergerTen Bridge Communications617-903-8783lisa@tenbridgecommunications.com

GENERATION BIO CO.CONSOLIDATED BALANCE SHEET DATA (Unaudited)(In thousands)

GENERATION BIO CO.CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited)

(in thousands, except share and per share data)

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The HIPAA Right of Access and Data Sharing – The Regulatory Review

Posted: August 18, 2021 at 2:20 am

Recent changes to patient right of access policies could open the door to increased privacy challenges.

Twenty-five years in, the Health Insurance Portability and Accountability Act (HIPAA) and its related privacy and security regulations have been both celebrated and criticized. Recent developments are transforming patient right of access into a gateway for third parties. Where this transformation ultimately leads is uncertain.

One possibility is a learning health system, fueled by patient contributed data and sophisticated data science and governed with an eye to advancing population health and equity while protecting privacy and maintaining trust. Another possibility is health related corporate surveillance on steroids.

The 1973 report, Records, Computers and the Rights of Citizens, credited with originating the term fair information practice, included an access right, which made data about individuals fully available to them, upon request, in a comprehensible form. Section 164.524 of the 2000 HIPAA Privacy Rule gave patients a right to inspect and obtain a copy of their information, with only a few exceptions. The Health Information Technology for Economic and Clinical Health (HITECH) Act updated the access right for the era of electronic health records (EHRs).

Rights on the books and in practice are, of course, two different things.

Problems soon surfaced when patients tried to exercise their access right. For example, the American Civil Liberties Union filed a complaint on behalf of patients seeking their full genetic records from Myriad Genetics. Subsequently, Congress enacted the 21st Century Cures Act, which mandated a Government Accountability Office report on barriers to access. In addition, the U.S. Department of Health and Human Services Office for Civil Rights launched a HIPAA Right of Access Initiative. Ciitizen, a consumer health technology company, published a scorecard that suggests compliance with the HIPAA right of access is finally improving.

Announced earlier this year, a proposed modification to the HIPAA Privacy Rule added the right to direct the transmission of certain protected health information in an electronic format to a third party, which provides that an individual has a right of access to direct a covered health care provider to transmit an electronic copy of protected health information in an electronic health record directly to another person designated by the individual. The individuals request would need to be clear, conspicuous, and specific. There is, however, no point-by-point specification of required elements for the request, as would be the case with an authorization.

Although examples of possible recipients are provided in the proposed modification, there are no limits on who can be a third-party recipient, and the access right redirect extends to any person or entity the individual chooses. There is request for comment about whether health care providers should be required to inform patients about the privacy and security risks of transmitting information to entities that are not covered by HIPAA.

Efforts to develop a pathway for patients to share data with researchers have also been supercharged by the Precision Medicine Initiatives (PMI) All of Us research program, which aims to enroll over one million Americans. Diversity is a priority, and so is bringing together many different types of data, including EHR data.

The technology to transmit EHR data to All of Us, and potentially to other research studies, is being developed through a publicprivate partnership known as Sync for Science (S4S). A pilot involving four EHR vendors resulted in a successful launch of connectivity at six provider sites. Given the challenges, widespread adoption may take time, but this effort is proof of principle for patient EHR sharing with researchers through application programming interfaces (APIs).

An important part of the story, in addition to technical feasibility, is the ethical and policy framework for implementation. In 2017, the Office of the National Coordinator for Health Information Technology published a report on privacy and security considerations for health care APIs. Linked to S4S, it cites the Precision Medicine Initiative Privacy and Trust Principles and Data Security Policy Principles and Framework as important guides.

The report advises that, in accordance with the principle of transparency, individuals approving data transfers should be warned that the health care providers responsibility stops once data are transmitted to the third party. As a tip for implementers, it suggests that EHR patient portals give patients a way to view and manage all third-party apps that have access to information about them, including revoking HIPAA access requests.

Interestingly, the PMI Privacy and Trust Principles begin with governance, and the first principle under governance is substantive participant representation at all levels of program oversight, design, implementation, and evaluation. The All of Us Research Program has invested in an ambassador program that integrates participant representatives in governance in line with this principle. Justifications for the All of Us ambassador program include respect for persons, relationship to trust, and the recognition that more ethical weight has been placed on transparency and individual consent than they can bear.

Combining a vision of patient driven research progress with commitments to diversity, equity, and inclusion and trust enhancing privacy, security, and governance principles is the promised land for advocates of HIPAA access right facilitated data sharing.

But perhaps the HIPAA access right facilitated data sharing could just as easily lead elsewhere. If usual patterns hold, at least initially, patient-driven data sharing may exacerbate the diversity problem affecting genomic and other research databases. Early adopters will likely come from the most privileged tier of society. This is especially true in the United States, where inequality is increasing and many less privileged groups have limited access to technology and experience social and economic insecurity that makes them justifiably averse to privacy risks.

Furthermore, critics have already raised the alarm about the flow of de-identified information permitted under HIPAA. The addition of a process that may be easy to manipulate to gain relatively unrestricted access to identifiable patient information, including sensitive genomic data, may take data privacy from leaky to hemorrhaging.

In response, the CARIN Alliance developed a voluntary code that incorporates many important protections. Unfortunately, the history of technology companies such as Facebook does not foster faith in the power of wisdom and benevolence to mitigate a move fast and break things mindset.

Tips and codes are great, but the health care sector also needs requirements. For example, an easy-to-find and easy-to-navigate dashboard within patient portals should be a must have rather than a nice to have feature for access requests directing EHR data to third parties.

In addition, the individual is no match for entities that skillfully manage attention and manipulate choices that would be contrary to their interests. Laws and regulations that reach beyond HIPAA should impose data use limitations in line with reasonable expectations, spur more robust and inclusive governance structures, and provide better protection from downstream harms such as discrimination.

Mary Anderlik Majumder is a professor with the Center for Medical Ethics and Health Policy at the Baylor College of Medicine.

This essay is part of a six-part series, entitledReflecting on 25 Years of HIPAA.

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These Okra Health Benefits Will Make You Rethink This Summer Veggie – msnNOW

Posted: August 18, 2021 at 2:19 am

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Known for its slimy texture when cut or cooked, okra often gets a bad rep; however, the summer produce is impressively healthy thanks to its lineup of nutrients such as antioxidants and fiber. And with the right techniques, okra can be delicious and goo-free promise. Read on to learn about okra's health benefits and nutrition, plus ways to enjoy okra.

Though it's usually prepared like a vegetable (think: boiled, roasted, fried), okra is actually a fruit (!!) that originally hails from Africa. It grows in warm climates, including the southern U.S. where it flourishes thanks to the heat and humidity and, in turn, "ends up in a lot of southern dishes," explains Andrea Mathis, M.A., R.D.N., L.D., an Alabama-based registered dietitian and founder of Beautiful Eats & Things. The entire okra pod (including the stem and seeds) is edible. But if you happen to have access to a whole okra plant (e.g. in a garden), you can also eat the leaves, flowers, and flower buds as greens, according toNorth Carolina State University Extension.

Okra is a nutritional superstar, boasting plenty of vitamins and minerals such as vitamin C, riboflavin, folic acid, calcium, and potassium, according to an article in the journal Molecules. As for that thick, slimy stuff that okra releases when it's cut and cooked? The goo, scientifically called mucilage, is high in fiber, notes Grace Clark-Hibbs, M.D.A., R.D.N., registered dietitian and founder of Nutrition with Grace. This fiber is responsible for many of okra's nutritional benefits, including digestive support, blood sugar management, and heart health.

Here's the nutritional profile of 1 cup (~160 grams) of cooked okra, according to the United States Department of Agriculture:

If its roster of nutrients isn't enough to make you add this summer produce to your rotation, okra's health benefits may do the trick. Ahead, discover what this green machine of an ingredient can do for your body, according to experts.

Okra happens to be an A+ source of antioxidants. "The main antioxidants in okra are polyphenols," says Mathis. This includes catechin, a polyphenol that's also found in green tea, as well as vitamins A and C, making okra one of the best antioxidant foods you can eat. And that's a BFD because antioxidants are known to neutralize or remove free radicals (aka unstable molecules) that can damage cells and promote illnesses (e.g. cancer, heart disease), explains Mathis.

If going number two feels like a chore, you might want to find a place on your plate for okra. "The mucilage in okra is particularly high in soluble fiber," says Clark-Hibbs. This type of fiber absorbs water in the gastrointestinal tract, creating a gel-like substance that firms up stool and helps curb diarrhea. The okra pod's "walls" and seeds also contain insoluble fiber, notes Susan Greeley, M.S., R.D.N., registered dietitian nutritionist and chef instructor at the Institute of Culinary Education. Insoluble fiber increases fecal bulk and promotes intestinal muscle movements, which can offer relief from constipation, according to the Mayo Clinic. (Related: These Benefits of Fiber Make It the Most Important Nutrient In Your Diet)

By forming that gel-like substance in your gut, the soluble fiber in okra can also slow down the absorption of carbohydrates, thus preventing blood sugar spikes and reducing your risk of type 2 diabetes, says Clark-Hibbs. A 2016 study found that regular intake of soluble fiber can improve blood sugar levels in people who already have type 2 diabetes. "Okra is also rich in magnesium, a mineral that helps your body secrete insulin," says Charmaine Jones, M.S., R.D.N., L.D.N., registered dietitian nutritionist and founder of Food Jonezi. In other words, magnesium helps keep your levels of insulin the hormone that controls how the food you eat is changed into energy in check, thereby helping to normalize your blood sugar levels, according to a 2019 article.

Gallery: What Happens To Your Body When You Eat Pork (Eat This, Not That!)

And need not forget about those supercharged antioxidants, which may lend a hand, too. Oxidative stress (which happens when there's an excess of free radicals in the body) plays a role in the development of type 2 diabetes. But a high intake of antioxidants (e.g. vitamins A and C in okra) can lower the risk by fighting these free radicals and, in turn, oxidative stress, according to a 2018 study. (Related: The 10 Diabetes Symptoms Women Need to Know About)

As it turns out, the fiber in okra is quite the multi-tasking nutrient; it helps lower LDL ("bad") cholesterol "by collecting extra cholesterol molecules as it moves through the digestive system," says Clark-Hibbs. The fiber then brings along cholesterol as it's excreted in the stool, notes Mathis. This decreases the absorption of cholesterol into the blood, helping manage your cholesterol levels and reducing your risk of heart disease.

Antioxidants, such as the phenolic compounds found in okra (e.g. catechins), also protect the heart by neutralizing excess free radicals. Here's the deal: When free radicals interact with LDL cholesterol, the physical and chemical properties of the "bad" stuff change, according to a 2021 article. This process, called LDL oxidation, contributes to the development of atherosclerosis or plaque buildup in the arteries that can lead to heart disease. However, a 2019 scientific review notes that phenolic compounds can prevent LDL oxidation, thus potentially protecting the heart.

Okra is rich in folate, aka vitamin B9, which everyone needs to form red blood cells and support healthy cell growth and function, says Jones. But it's especially crucial for proper fetal development during pregnancy (and thus found in prenatal vitamins). "Low folate intake [during pregnancy] can cause birth abnormalities such as neural tube defects, a disease that causes defects in the brain (e.g. anencephaly) and spinal cord (e.g. spina bifida) in a fetus," she explains. For context, the recommended daily intake of folate is 400 micrograms for men and women age 19 and older, and 600 micrograms for pregnant people, according to the National Institutes of Health. One cup of cooked okra offers about 88 micrograms of folate, according to the USDA, so okra is sure to help you meet those goals. (Another good source of folate? Beets, which have 80 mcg per ~100-gram serving. The more you know!)

Prone to kidney stones? Go easy on the okra, as it's high in oxalates, which are compounds that increase your risk of developing kidney stones if you've had them in the past, says Clark-Hibbs. That's because excess oxalates can mix with calcium and form calcium oxalates, the main component of kidney stones, she says. A 2018 review suggests that eating a lot of oxalates in a sitting increases the amount of oxalates excreted via the urine (which travels through the kidneys), boosting your chances of developing kidney stones. So, folks "who are more susceptible to developing kidney stones should limit the amount of oxalate-containing foods they eat at one time," she notes.

You might also want to proceed with caution if you're taking anticoagulants (blood thinners) to prevent blood clots, says Mathis. Okra is rich in vitamin K, a nutrient that aids in blood clotting the exact process blood thinners aim to prevent. (ICYDK, blood thinners help prevent blood clots in patients with certain conditions such as atherosclerosis, thus decreasing the risk of heart attack or stroke.) Suddenly increasing your intake of vitamin K-rich foods (such as okra) can interfere with the purpose of blood thinners, says Mathis.

TL;DR If you're susceptible to stones or taking a blood thinner, check with your doc to determine how much you can safely eat before chowing down on okra.

"Okra can be found fresh, frozen, canned, pickled, and in dried powder form," says Jones. Some stores might also sell dried okra snacks, such as Trader Joe's Crispy Crunchy Okra (Buy It, $10 for two bags, amazon.com). In the freezer aisle, it's available on its own, breaded, or in pre-made packaged meals. That being said, fresh and frozen non-breaded options are the healthiest, as they have the highest nutrient content without added preservatives such as sodium, explains Jones.

As for okra powder? It's used more like a seasoning, rather than a replacement for the whole vegetable. "[It's] a healthier alternative to using salts or pickled ingredients," says Jones, but you probably won't find it at your next Whole Foods jaunt. Instead, head to a specialty store or, not shockingly, Amazon, where you can snag a product such as Naturevibe Botanicals Okra Powder (Buy It, $16, amazon.com).

When buying fresh okra, pick produce that's firm and bright green and steer clear of that which is discolored or limp, as these are signs of rotting, according to the University of Nebraska-Lincoln. At home, store unwashed okra in a sealed container or plastic bag in the refrigerator. And be warned: Fresh okra is super perishable, so you'll want to eat it ASAP, within two to three days, according to the University of Arkansas.

While it can be eaten raw, "most people cook okra first because the skin has a slight prickly texture that becomes unnoticeable after cooking," says Clark-Hibbs. Fresh okra can be roasted, fried, grilled, or boiled. But as mentioned earlier, when cut or cooked, okra releases the slimy mucilage that many people dislike.

To limit the slime, cut the okra into larger pieces, because "the less you cut it, the less you will get that signature slimy texture," shares Clark-Hibbs. You might also want to use dry cooking methods (e.g. frying, roasting, grilling), notes Jones, vs. moist cooking methods (e.g. steaming or boiling), which add moisture to okra and, in turn, enhances the goo. Dry cooking also involves cooking at high heat, which "shortens the amount of time [the okra's] being cooked and therefore decreases the amount of slime being released," adds Clark-Hibbs. Lastly, you can minimize the slime by "adding an acidic ingredient such as tomato sauce, lemon, [or] garlic sauce," says Jones. Goo, be gone!

Ready to give okra a spin? Here are a few tasty expert-approved ways to use okra at home:

As a roasted dish. "One of the easiest and most mouthwatering ways to [cook] okra is to roast it," says Clark-Hibbs. "Line a cookie sheet with aluminum foil or parchment paper, lay out the okra in a single layer, drizzle some olive oil, and finish with salt and pepper to taste. This will soften the okra while keeping it crispy and preventing the slimy texture that can [happen with boiling]."

As a sauteed dish. For another simple take on okra, saut it with your fave spices. First, "heat oil in a large pan over medium-high heat. Add okra and cook for about four to five minutes, or until bright green. Season with salt, pepper, and other seasonings before serving," says Mathis. Need inspo? Try this recipe for bhindi, or crispy Indian okra, from the food blog My Heart Beets.

In stir-fry. Elevate your next weeknight stir-fry with okra. The dish calls for a quick cooking method, which will help reduce the slime. Check out this four-ingredient okra stir-fry from the food blog Omnivore's Cookbook.

In stews and soups. With the right approach, the mucilage in okra can work in your favor. It can thicken dishes (think: stew, gumbo, soup) just like cornstarch, according to Mathis. "Simply add diced okra [into your soup] about 10 minutes before [you finish] cooking," she says. Try this mouthwatering seafood gumbo recipe from food blog Grandbaby Cakes.

In a salad. Make the most of summer produce by pairing okra with other warm-weather veggies. For example, "[cooked okra] can be cut up and added to a delicious summery tomato and corn salad," says Greeley.

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Researchers Gaze into Space to Envision Future of Regenerative Medicine – UPMC & Pitt Health Sciences News Blog – UPMC

Posted: August 18, 2021 at 2:17 am

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About 250 miles above sea level, a unique laboratory circles the planet. Here in low-Earth orbit on the International Space Station (ISS), gravitys tug is faint enough that objects appear to be weightless. These microgravity conditions cause living things from people to organs and cells to function differently than on terra firma. Researchers from UPMC and the University of Pittsburgh aim to use the ISS U.S. National Laboratory (ISSNL) to conduct biomedical research not possible on Earth and advance space-based biomanufacturing.

In recent years, microgravity research has become more accessible through the ISSNL. At the same time, breakthroughs in gene editing, stem cell research and development of mini lab-grown organs have helped advance regenerative medicine, the discipline that focuses on replacing or repairing damaged or diseased body parts. Progress in these two areas means that now is the right moment to consider the future of biomanufacturing in space, according to Dr. William Wagner, director of the University of Pittsburghs McGowan Institute for Regenerative Medicine and distinguished professor of surgery, chemical engineering and bioengineering at Pitt.

Dr. William Wagner and Gary Rodrigue discuss the future of biomanufacturing in space.

We are truly blessed to be at a point in humankind where access to low-Earth orbit and access to microgravity is available, Wagner said during a fireside chat with Gary Rodrigue, director of programs and partnerships at the Center for the Advancement of Science in Space (CASIS), at the 10th annual International Space Station Research and Development Conference. The question is, how are we going to leverage the unique aspects of this environment?

To help answer this question, the McGowan Institute and CASIS, the organization that manages the ISSNL, brought together more than 100 experts in regenerative medicine, tissue engineering and aerospace for the Biomanufacturing in Space symposium last year. Originally planned as an in-person event, the symposium pivoted to a series of virtual meetings that took place weekly over several months.

In a review article recently posted to Preprints, symposium attendees identified areas that hold the greatest promise for space-based biomanufacturing for tissue engineering and regenerative medicine.

Its an incredible privilege to try to answer the question of what makes sense to do in microgravity, said Wagner. Its a similar feeling to being an explorer on a ship and heading to some uncharted land. I think many people who were on those calls shared that sense of exploration.

The researchers identified organs-on-a-chip miniature devices that mimic human organs as one important subject for future research in space. Because disease-like characteristics develop in these systems under microgravity, insight into disease pathways and development of drugs that block these pathways can be accelerated in low-Earth orbit.

Stem cell research is another area that could be advanced in microgravity, according to the article. Stem cells, which can be turned into any type of cell, have many potential applications for treating diseases, injuries and birth defects. Because these cells behave differently in low gravity, research on the ISS could improve stem cellbased treatments and enhance fundamental understanding of processes such as aging and organ development.

The third target area that the researchers identified is 3D printing of tissues for transplantation and disease modeling. The near absence of gravity on the ISS could enable more consistent deposition of complex molecules and reduce the need for structural support, which have been hurdles in the production of these 3D tissues.

The researchers also outline commercial opportunities and potential business models for developing a sustainable market for space-based biomanufacturing. According to Wagner, these considerations are important for ensuring that new therapies make it to patients.

We cant just run experiments; we cant just publish papers. We have to think about how it is going to get to the patient, said Wagner. If we dont get it to the patient, we always say that we havent succeeded in our mission.

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Acute Myeloid Leukemia Treatment: What You Need to Know – Healthline

Posted: August 18, 2021 at 2:17 am

The umbrella term of leukemia encompasses several distinct types of leukemia, including acute myeloid leukemia (AML).

In 2021, its estimated that over 20,000 new cases of AML will be diagnosed, according to the National Cancer Institute (NCI). Since treatment varies depending on the specific kind of leukemia present, an accurate diagnosis is crucial.

There are a variety of treatments for AML. Your doctor will explain them and help choose a treatment plan based on the type of cancer you have and your individual situation.

Read on to learn more about the various treatment options for AML.

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow. It affects white blood cells (WBCs), making them abnormal. In some forms of AML, they may also multiply very quickly.

Other names for AML include:

Read this for more information about AML.

Once the diagnosis is confirmed, your healthcare team will develop a plan to treat AML. Depending on the specific type and stage of AML, you may receive one or more of these treatments:

Chemotherapy is the main form of treatment for AML. Its divided into two phases:

Since AML can progress quickly, treatment is usually started as soon as possible after diagnosis. Other treatments may be used as well.

Chemotherapy, also called chemo, is the use of anti-cancer drugs to treat cancer. This is the main treatment for AML.

These drugs can be injected into a vein or under the skin, allowing the chemotherapy to travel through the bloodstream to attack cancer cells throughout the body. If leukemia has been found in the brain or spinal cord, chemo medication may be injected into the cerebrospinal fluid (CSF).

Chemo medications most often used to treat AML include:

Other chemo medications may include:

Side effects of chemotherapy can vary depending on the drug, dosage, and duration. They can include:

While chemotherapy is the main treatment for AML, for a subtype of AML called acute promyelocytic leukemia (APL), other non-chemotherapy drugs are more effective.

APL is caused by a specific gene mutation that affects WBCs. Some medications work better than chemo to help those cells develop normally. Two of these medications are:

ATRA can be given with chemotherapy or with ATO for the initial treatment of APL. Both drugs can also be given during consolidation.

Side effects of ATRA include:

Side effects of ATO can include:

Radiation therapy uses high-energy radiation to kill cancer cells. While its not the main treatment for those with AML, it can be used in treating AML. In AML, the radiation used is external beam radiation, which is similar to an X-ray.

Radiation can be used in AML to treat:

Side effects of radiation can include:

Surgery is rarely used in AML treatment. Leukemia cells are spread through the bone marrow and blood, making the condition impossible to improve with surgery. On rare occasions, a tumor or mass related to leukemia may form that may be treated with surgery.

Prior to chemotherapy, a small surgery to place a central venous catheter (CVC) or a central line, is often done. During this procedure, a small flexible tube is placed into a large vein in the chest. The end of it is either right under the skin or sticks out in the chest or upper arm.

Having a central line installed allows the treatment team to give intravenous medication and chemotherapy through the CVC, and to draw blood from it, reducing the number of needle sticks an individual has to have.

While chemotherapy is the main treatment for AML, it has its limits. Since high doses of these medications are toxic, the dosage must be limited. A stem cell transplant allows for higher doses of chemotherapy medications.

In a stem cell transplant, very high doses of chemotherapy medications, sometimes combined with radiation, are given. All of the individuals original bone marrow is destroyed on purpose.

Once this stage of therapy is over, blood-forming stem cells are given. These stem cells will grow, rebuilding the bone marrow. Healthy, cancer-free stem cells replace the destroyed bone marrow.

Read this article for more information about a stem cell transplant.

Targeted therapy drugs are medications that target only certain parts of cancer cells. They can be very effective for some people with AML. Most targeted therapy drugs are taken orally, except for gemtuzumab ozogamicin (Mylotarg), which is given as an intravenous infusion.

Talk with your treatment team about the potential side effects of each drug and what you should watch for when taking it. Some targeted therapy medications include:

One type of targeted therapy medication called FLT3 inhibitors targets the FLT3 gene. In some people with AML, a mutation in the FLT3 gene causes the creation of a protein, also called FLT3, that enables cancer cells to grow. Drugs in this category include:

Side effects of these drugs may include:

In some people with AML, there is a mutation in the IDH2 gene. These mutations stop bone marrow cells from maturing in a normal way. Medications called IDH inhibitors block IDH proteins produced by these mutated genes, allowing these bone marrow cells to grow normally and remain healthy.

Drugs in this category include:

Side effects can include:

AML cells contain a protein called CD33. A medication called gemtuzumab ozogamicin (Mylotarg) attaches to this CD33 protein and helps deliver chemotherapy medications directly to cancer cells so that these drugs are more effective.

Common side effects include:

There are less common but serious side effects like:

Venetoclax (Venclexta) is a BCL-2 inhibitor. This drug targets BCL-2, which is a protein that helps cancer cells live longer. The drug stops the BCL-2 protein from helping cancer cells survive so that these cancer cells die sooner. This medication can be used along with other chemotherapy drugs.

Side effects include:

AML can cause cellular mutations that prevent cells like bone marrow cells from developing and functioning normally. These mutations may affect the pathway cells use to send necessary signals. This pathway is called hedgehog. For some people with AML, especially those over age 75, strong chemo medications may be so harmful that chemo is not an option. For these individuals, a medication called, Glasdegib (Daurismo), may help them live longer. This medication helps stop the mutations and allows bone marrow cells to function normally.

Side effects of this medication may include:

Refractory AML happens when an individual is not in remission even after one to two cycles of induction chemotherapy, which means they have a blast count of 5 percent or more. Ten to 40 percent of people with AML have refractory AML.

If treatment isnt successful with one course of chemo, another one may be done. If a person is still not in remission after the second course of chemo, they may be given other medications or an increased dose of their current chemotherapy medications.

Other treatment options include stem cell transplant or a clinical trial of new therapies.

When an individual has no evidence of disease after treatment, its called remission or complete remission. Remission means these three criteria are met:

If there is no evidence at all of leukemia cells in the bone marrow, using highly sensitive tests, its called complete molecular remission. Minimal residual disease (MRD) occurs when, after treatment, leukemia cells cannot be seen in the bone marrow with standard tests but more sensitive tests like PCR tests do find leukemia cells.

Even after an individual has entered remission, they will likely need follow-up care and will need to be monitored by their doctor and healthcare team. This may mean additional tests, more frequent physical exams, and other care.

Although chemotherapy is the main treatment for AML, there are a variety of treatment options, depending on the AML subtype or whether you have a specific mutation. Treatment also depends on your response to initial treatment and whether or not remission is sustained.

Your treatment team will explain all of your treatment options and help you choose the treatment plan that is best for you and your individual situation.

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Study Calls for COVID-19 Vaccination in Patients With Cancer to Enable Optimal Treatment Delivery During Pandemic – OncLive

Posted: August 18, 2021 at 2:17 am

When utilizing a validated antibody assay against the SARS-CoV-2 spike protein, investigators revealed a high seroconversion rate of 94% among 200 patients with cancer in New York City who had received a full dose of 1 of the FDA-authorized COVID-19 vaccines.

Patients with solid tumors experienced an impressive seroconversion rate of 98% compared with a rate of 85% in those with hematologic malignancies, 70% in those who had received highly immunosuppressive therapies like anti-CD20 agents, and 73% in those who had previously undergone stem cell transplantation. Notably, patients who received treatment with immune checkpoint inhibitors or hormonal therapies experienced seroconversion rates of 97% and 100%, respectively, following vaccination.

We saw very encouraging [data] showing that most patients with a cancer diagnosis have a really high chance of responding to vaccinationsas long as the vaccinations are done in an appropriate manner, [with] both doses administered, Balazs Halmos, MD, MS, study author, director of Thoracic Oncology, and director of Clinical Cancer Genomics at Montefiore Medical Center, told OncLive in an exclusive interview on the research. This was [true] even for [patients who were receiving] active treatment with chemotherapy, targeted therapy, or immunotherapy.

Halmos and colleagues launched this study to develop a better understanding with regard to the immunogenicity of vaccines in a group of patients with a cancer diagnosis in New York City by examining the rates of anti-spike immunoglobulin G (IgG) antibody positivity after receiving 1 of the 3 authorized COVID-19 vaccines.

A total of 213 patients were enrolled to the study through an informed-consent process. Twenty-nine additional patients with cancer who received the SARS-CoV-2 spike IgG testing were identified through retrospective chart review.

A total of 18 patients did not have this test conducted following consent, and thus, they were excluded from the analysis. Twenty additional patients were excluded because they had their test done before having received full vaccination in accordance with FDA guidance. Four additional patients were excluded for other reasons.

As such, 233 patients with cancer were noted to have received all required doses of their COVID-19 vaccine; all these patients were included in the safety analysis. A subset of 200 patients received the IgG test and were included in the immunogenicity analysis. Serological information from these patients were utilized in association studies between cancer subtypes and therapies.

Investigators also examined the link between the quantitative titer of SARS-CoV-2 spike IgG and cancer subtypes and therapies. If the 200 patients, 185 had available IgG titers that were at least 2 days following the last vaccine dose. A total of 15 patients were excluded from the vaccination cohort with titers; these patients had received the vaccine, but titers were checked less than 1 week from their last dose.

Among those included in the efficacy analysis (n = 200), the median age was 67 years (range, 27-90), 58% were female, and 42% were male. The study population was noted to be representative of the diverse population that resides in the Bronx, New York, with 32% of patients identifying as African American, 39% as Hispanic, 22% as Caucasian, 5% as Asian, and 3% as other ethnicities.

Additionally, 67% of patients had a solid tumor diagnosis and 33% had a hematologic malignancy. Among those with solid tumors, 26% had breast cancer, 14% had gastrointestinal cancer, 9% had genitourinary cancer, 5% had gynecologic cancer, 13% had thoracic or head and neck cancer, 1% had skin or musculoskeletal cancer, and 1% had carcinoma of an unknown primary. Among those with hematologic malignancies, 13% had lymphoid disease, 9% had myeloid disease, and 11% had plasma cell disease.

Seventy-five percent of patients had an active malignancy and 67% were receiving active treatment at the time that they received the COVID-19 vaccine. Fifty-six percent of patients were on active chemotherapy. Moreover, 19% of patients were on active chemotherapy within 48 hours of receiving at least 1 of their COVID-19 vaccine doses.

Fifty-four percent of patients completed vaccination with the Pfizer vaccine, 31% with the Moderna vaccine, and 10% with the Johnson & Johnson vaccine. A total of 3 patients had received a complete mRNA vaccination series but the information regarding the type of vaccine (Pfizer vs Moderna) are not yet available.

Additional findings from the study showed that significantly higher titer values were observed in solid tumors vs hematologic malignancies among a subgroup of 185 patients with available IgG titers longer than 7 days post vaccination, at a median of 7858 AU/mL vs a median of 2528 AU/mL, respectively (P = .013).

When comparing patients who were receiving active cancer treatment vs those who were not, no significant differences in seroconversion were reported, at 96% and 93%, respectively. However, investigators did report lower seropositivity rates in those who were on active cytotoxic chemotherapy versus other treatments, at 92% vs 99%, respectively (P = .04). Moreover, significantly lower seroconversion rates were also noted in those who received immunosuppressive therapies like stem cell transplant (73%; P = .0002), CD20 antibody therapy (70%; P = .0001), or CAR T-cell therapy (all seronegative; P = .0002).

Significantly lower titer levels were observed in patients who received CD20 antibody therapy vs the overall patient population, which underscored the susceptibility of patients receiving these treatments during the pandemic.

No statistically significant associations between age, ethnicity, time since immunosuppressive therapy, steroid use, or treatment within 48 hours of a vaccine dose, and seropositivity were reported.

Although all patients who were receiving CDK4/6 inhibitor treatment demonstrated positive anti-spike IgG test results, notably antibody titers were noted to be very low in this subset (n = 5), at a median of 1242 AU/mL vs a median of 6887 AU/mL in the overall cohort. Given the known involvement of the CDK4/6 pathway in immune activation, this might be biologically plausible and warrants further studies into the impact of CDK4/6 inhibitors on vaccine efficacy, the study authors noted.

A trend to lower titers were also reported among subsets of patients who received BCL-2 or BTK inhibitors.

Among a subset of 22 patients with cancer who had previously been infected with COVID-19, the seroconversion rate was 95%. Notably, antibody titers in those who had prior infection with the virus were found to be significantly higher than those who did not have a known prior infection, at a median of 46,737 AU/mL and a median of 5296 AU/mL, respectively (P < .001).

Our study, along with other emerging data, strongly highlights the continued need to vaccinate patients with a cancer diagnosis urgently and broadly, as vaccinations are likely to be highly effective, the study authors concluded. On the other hand, our study highlights at-risk cohorts of patients, in particular patients with hematologic malignancies following receipt of immunosuppressive therapies such as stem cell transplantation, anti-CD20 therapies, and CAR T-cell treatments. These cohorts of patients could potentially benefit from passive immunization with anti-COVID antibodies in the face of the ongoing pandemic.

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