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Category Archives: Cell Medicine

Antibody treatment for MIS-C works by depleting inflammatory immune cells – National Institutes of Health

Posted: October 16, 2021 at 2:03 am

News Release

Friday, October 15, 2021

Intravenous immune globulin (IVIG) a common treatment for multisystem inflammatory syndrome in children (MIS-C) likely works by depleting immune cells called neutrophils, according to a recent study funded by the National Institutes of Health (NIH). MIS-C is a rare condition that usually affects school-age children who initially had only mild COVID-19 symptoms or no symptoms at all. The researchers also found that IVIG works in a similar manner for treating Kawasaki disease, another rare inflammatory condition that affects children and shares symptoms with MIS-C. The findings are published in the Journal of Clinical Investigation.

MIS-C is marked by severe inflammation of two or more parts of the body, including the heart, lungs, kidneys, brain, skin, eyes and gastrointestinal organs. Its symptoms overlap with Kawasaki disease, and treatments for MIS-C are guided in part by what is known about treating Kawasaki disease. IVIG, which is made up of antibodies purified from blood products, is a common and effective treatment for heart complications caused by Kawasaki disease. For MIS-C patients, however, IVIG alone does not always resolve symptoms, and healthcare providers may need to prescribe additional anti-inflammatory drugs.

To better understand how IVIG works and to improve treatments for children with MIS-C, researchers led by Ben A. Croker, Ph.D., and Jane C. Burns, M.D., from the University of California San Diego School of Medicine, profiled immune cells from patients with MIS-C or Kawasaki disease. The team sampled cells before treatment began as well as 2 to 6 weeks after patients received IVIG. The researchers found that neutrophils from these patients were highly activated and a major source of interleukin 1 beta (IL-1), which is one driver of inflammation in the body. After IVIG treatment, these activated neutrophils were significantly depleted in patients with MIS-C or Kawasaki disease.

According to the study authors, their findings are the first to explain why IVIG is effective for both conditions. However, more work is needed to understand how IVIG causes cell death in these activated neutrophils and why certain patients with MIS-C require additional anti-inflammatory treatments. Overall, the research will help healthcare providers as they determine the most effective methods to treat patients with MIS-C.

The study is funded by NIHs Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Heart, Lung, and Blood Institute (NHLBI), and the National Institute of General Medical Sciences (NIGMS). The work is supported by NIHs CARING for Children with COVID, PreVAIL kIds and RADxSM-rad research programs.

Rohan Hazra, M.D., acting director of NICHDs Division of Extramural Research, is available for comment.

Zu YP et al., Immune response to intravenous immunoglobulin in patients with Kawasaki disease and MIS-C. JCI DOI: 10.1172/JCI147076 (2021)

About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD leads research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. For more information, visit https://www.nichd.nih.gov.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

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Dr. Erba on the Evolution of Treatment in MCL – OncLive

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Harry Paul Erba, MD, PhD, discusses the evolution of treatment in mantle cell lymphoma.

Harry Paul Erba, MD, PhD, instructor, clinical investigator, Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University School of Medicine, member, Duke Cancer Institute, director, Leukemia Program and Phase I Development in Hematologic Malignancies, Duke Health, discusses the evolution of treatment in mantle cell lymphoma (MCL).

Similar to acute myeloid leukemia, the goal of therapy in MCL should be the key focus from treatment initiation. For example, a younger patient with limited comorbidities should be considered for curative-intent therapy or treatment with a time-limited regimen to elicit deep responses and prolonged progression-free survival, Erba says.

High-dose cytarabine-based therapies, such as the Nordic regimen known as maxi-CHOP, and autologous stem cell transplant could be considered for patients with MCL, Erba explains. Oral therapies, including BTK inhibitors, are also available options for patients with relapsed/refractory MCL or older patients who cannot tolerate intensive chemotherapy, Erba concludes.

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Dr. Kahl on the Potential Utility of Frontline CAR T-Cell Therapy in MCL – OncLive

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Brad S. Kahl, MD, discusses the potential utility of frontline CAR T-cell therapy in mantle cell lymphoma.

Brad S. Kahl, MD, professor of medicine, Department of Medicine, Oncology Division, Medical Oncology, Washington University School of Medicine in St. Louis, discusses the potential utility of frontline CAR T-cell therapy in mantle cell lymphoma (MCL).

CAR T-cell therapy has the potential to move into earlier lines of treatment, including the frontline setting, in MCL; however, longer follow-up is needed with CAR T-cell therapy in the relapsed/refractory setting before frontline clinical trials can be explored, Kahl says. Currently, CAR T-cell therapy is demonstrating high response rates at 12 and 18 months of follow-up in the relapsed/refractory setting, but it is unknown whether these responses will remain durable at 3 or 5 years.

Positive 3-year data in the relapsed/refractory setting could provide the clinical rationale to evaluate CAR T-cell therapy in the frontline setting, Kahl says. Pending these results, CAR T-cell therapy could replace autologous stem cell transplant as consolidative therapy or offer a standard option for patients with high-risk biologic features, such as TP53 mutations, Kahl concludes.

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Generation Bio to Present at European Society of Gene and Cell Therapy 2021 Annual Virtual Congress – Yahoo Finance

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CAMBRIDGE, Mass., Oct. 15, 2021 (GLOBE NEWSWIRE) -- Generation Bio Co. (Nasdaq: GBIO), a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases, today announced an oral presentation at the European Society of Gene and Cell Therapy (ESGCT) Annual Virtual Congress taking place October 19-22. The presentation will highlight preclinical advances from the companys retina therapeutic area.

We are excited to share our preclinical data demonstrating broad access to key cell types with our lipid nanoparticle developed for the retina, said Matthew Stanton, Ph.D., chief scientific officer of Generation Bio. Many inherited retinal diseases remain out of reach for viral-based gene therapies due to limited cargo capacity. We believe our non-viral delivery technology could overcome this barrier and expand the potential of our genetic medicine platform to treat more diseases.

The presentation will be streamed online for registered attendees on October 22, and a recording of the presentation will be made available for attendees for 30 days following the event.

Generation Bio will present:

About Generation BioGeneration 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.

Story continues

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

Contacts:

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

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

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

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Modern Treatment Standards Require State-of-the-Art Molecular Profiling – Cancer Network

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In my mind, the question is not who should get chemotherapy, but who can avoid chemotherapy in this day and age.

As more and more targeted therapy options emerge in the cancer space, investigators continue to see positive impacts on long-term outcomes. However, this wider, advanced, individualized range of treatment options that may be offered to patients requires more sophisticated molecular testing techniques.

In an interview with ONCOLOGY, Charu Aggarwal, MD, MPH, discussed this topic as it relates to her ongoing research, as well as how it may carry to other areas of oncology care outside of her area of expertise in the lung cancer space. She is the Leslye M. Heisler Associate Professor for Lung Cancer Excellence in the Department of Medicine at the University of Pennsylvanias Perelman School of Medicine in Philadelphia as well as co-chair for the 6th Annual International Congress on Immunotherapies in Cancer, hosted by Physicians Education Resource, LLC (PER).

Aggarwal spoke about how liquid biopsies, rather than invasive procedures, can help determine treatment prognosis. She also detailed how immunotherapy has evolved as a mainstay of treatment and how clinicians are now looking at adverse effects (AEs) as a positive sign of treatment efficacy.

A: Molecular genotyping is becoming extremely important in nonsmall cell lung cancer. At least 9 biomarkers1 must now be tested at initial diagnosis, and the gold standard for testing has been to use tissue-based testing. [However], its often a problem to get tissue because these biopsies are small and sometimes not enough tissue or not enough DNA [is present] on these samples. [So then] we asked, Could we complement our ability to test for these mutations using tissue alone by adding in plasma-based sequencing? We conducted a follow-up trial with about 300 patients here [at the University of Pennsylvania] and found that by adding plasma-based approaches, using 2 tubes of blood, we could get [results] relatively easier compared with tissue-based sequencing.2 We were able to increase our detection of molecular alterations from about 20% to about 36%a significant increase. This means that more patients were able to get targeted therapy, receive a drug based on their molecular profile, and have significant benefit. Patients were able to avoid chemotherapy or immunotherapy.

We are currently doing much more with liquid biopsies [and are] really looking at the dynamics of circulating tumor DNA [ctDNA], to guide whether patients are responding to treatment. If the ctDNA goes down, that gives us a sense, an indicator, that the therapy is working, [possibly] before we get a radiographic response, before I even get the CT scan. [Liquid biopsy] is an active area of research that I think will be extremely interesting.

A: Exactly. Thats the point: We can [check progress] in a minimally invasive way.

A: Lung cancer is among the leading cancer subtypes where liquid biopsies are being used. Thats because a significant amount of ctDNA is shed into the bloodstream in patients with advanced disease. [Also], lung cancer has so many different [molecular, actionable] subtypes that now have targetable drugs. We can say [to a patient], You have an EGFR mutation or You have a MET exon 14 [skipping] mutationIm going to give you a pill. There is more actionability in lung cancer than in other diseases. However, breast cancer, gastrointestinal cancer, and genitourinary cancer are all now [using] liquid biopsies and expanding the space to utilize it in the clinical setting.

A: I think we are getting there. Were not completely there, because we still need a few things from tissue samples. We can never characterize the cell type or the architecture of a tumor, which are still very necessary, with a liquid biopsy. Looking at tissue is still extremely important, no matter what. I think plasma or liquid biopsies will be essential to give us information about the rest of the tumor. In fact, it sometimes gives us a clearer picture of the heterogeneous nature of the tumor, so we can get a sense of the cells that may have more metastatic potential and may have a slightly different mutational profile. We can gather that [information] much better than we can with a single small biopsy.

A: The most obvious indication that [a treatment is working is] less tumor. However, were also looking at other things like methylation signatures, RNA sequencing, and changes in mutational profile over time that may help us eventually [determine how treatment is going].

A: We have learned a great deal about when to use targeted therapy in lung cancer. We need to know a patients molecular subtype. One way we [learn] that is by using both tissue and plasma sequencing, which is a must. Once we know the molecular subtype, the next question is how we utilize the information to guide therapy. In my mind, the question is not who should get chemotherapy, but who can avoid chemotherapy in this day and age. I feel that with the explosion of immunotherapy, we can now deliver immunotherapy safely with a survival benefit for most of our patients. There will always be a subset who dont get immunotherapy, but the vast majority of our patients can, and we use PD-L1 testing to determine which patients can get immunotherapy alone. Again, thats only for a small subset of patients; for [the rest, were still] using a combination of chemotherapy and immunotherapy.

A: The premise of immunotherapy is reactivating the immune system and harnessing the power of T cells during cancer treatment. We know that our T cells as well as our bodies are inherently programmed to fight cancer. However, cancer cells may express inhibitory molecules; these can then be inhibited using PD-L1 inhibitors, potentially creating the immune response again. Thats the premise: the immune activation thats inherent in the immune system to fight cancer.

A: Many guidelines now help us with managing irAEs in a stepwise fashion, including guidelines from the National Comprehensive Cancer Network, the Society for Immunotherapy of Cancer, and the American Society of Clinical Oncology. Id [like to] add that recent evidence suggests that the presence of irAEs in patients who receive immunotherapy may be related to better outcomes, depending on the grade of AEs. Preliminary data, at least, suggest that grade 2 and 3 AEs may be better in terms of predicting for an improved outcome to immunotherapy, which I think is very interesting. Its reminiscent of the old days when we used to look at things like rash from EGFR inhibitors [to] tell us that the drug is working, [and] also that they are more likely to see a response.

Financial Disclosure: The authors have no significant financial interest in or other relationship with the manufacturer of any product or provider of any service mentioned in this article.

1. NCCN. Clinical Practice Guidelines in Oncology. Nonsmall cell lung cancer, version 5.2021. Accessed September 2, 2021. https://bit.ly/3DGrtPb

2. Aggarwal C, Thompson JC, Black TA, et al. Clinical implications of plasma-based genotyping with the delivery of personalized therapy in metastatic nonsmall cell lung cancer.JAMA Oncol. 2019;5(2):173-180. doi:10.1001/jamaoncol.2018.4305

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The New England Journal of Medicine Publishes First-of-its-Kind Study on Cell-Based Quadrivalent Seasonal Influenza Vaccine (QIVc) Efficacy in…

Posted: at 2:03 am

SUMMIT, N.J., Oct. 14, 2021 /PRNewswire/ -- Seqirus, a global leader in influenza prevention, and a business of CSL Limited (ASX:CSL), today announced that The New England Journal of Medicine has published absolute efficacy data on the company's cell-based quadrivalent influenza vaccine (QIVc) from a randomized controlled trial (RCT) which met its primary endpoint.1 The study indicates that the seasonal influenza vaccine was effective and produced a sufficient immune response against influenza in children and adolescents 2 to <18 years of age over three influenza seasons in theSouthern (2017) and Northern (2017/18 and 2018/19) Hemispheres, compared to a non-influenza comparator.1 This represents the first absolute efficacy study of a cell-based influenza vaccine in children as young as two years of age.

"In this study, QIVc demonstrates absolute efficacy in children and adolescents, showing consistent benefit across three seasons and eight countries.1 This is particularly impactful giventhe disease burden in children as young as two years of age," said Jonathan Edelman, MD, Vice President, Clinical Development at Seqirus and study author. "These data add to a growing body of evidence supporting the fact that our differentiated, cell-based seasonal influenza vaccine can help provide effective protection against flu."

QIVc utilizes a cell-based influenza vaccine manufacturing process, an alternative to traditional egg-based manufacturing.2 Traditional egg-based vaccine production can cause the strain to mutate at several steps throughout the manufacturing process, which may lead to an antigenic mismatch between the circulating strains and the inactivated influenza strains contained within the seasonal influenza vaccine.2

Cell-based influenza vaccines are designed to produce an exact match to the World Health Organization (WHO)-selected influenza virus strains by avoiding egg-adapted changes, and therefore have the potential for greater vaccine effectiveness.2,3 Cell-based influenza vaccine technology may offer additional advantages over the standard influenza manufacturing process, including increased scalability and production speed in the event of an influenza pandemic.2

"Young children are at a higher risk than adults for serious influenza-related complications.4 We're particularly pleased with the results of this study because it supports the use of our differentiated, cell-based influenza vaccine technology as an effective means of influenza protection in children as young as two years old," said Gregg Sylvester, MD, Chief Medical Officer at Seqirus.

The results of this study supported the recent U.S. Food and Drug Administration (FDA) approval for an expanded age indication for use of QIVc in children 2 years of age.5 QIVc is marketed in the U.S. as FLUCELVAX QUADRIVALENT (Influenza Vaccine) and is currently under review by the FDA for an expanded age indication for children as young as six months of age.5

The Centers for Disease Control and Prevention (CDC) recommends annual seasonal influenza vaccination for everyone six months of age and older without contraindications as the best way to prevent seasonal influenza.6 It is estimated that more than 52,000 hospitalizations occurred in children younger than 18 years of age during the 2019/20 U.S. influenza season, and there were approximately over 434 influenza-related deaths in this age group.7

In the U.S., Seqirus operates a state-of-the-art cell-based manufacturing facility in Holly Springs, North Carolina, purpose-built in partnership with the Biomedical Advanced Research and Development Authority (BARDA) to increase cell-based vaccine manufacturing capacity and combat pandemic influenza threats.8 Last year, Seqirus announced plans to build a new, world-class cell-based manufacturing facility in Australia, which will be the only cell-based influenza vaccine manufacturing facility in the Southern Hemisphere.9

About the Study

This phase III/IV multi-center, randomized, observer-blind study was conducted across eight countries (Australia, Philippines, Thailand, Estonia, Finland, Lithuania, Poland, and Spain) over three influenza seasons Southern Hemisphere (2017) and Northern Hemisphere (2017/18 and 2018/19).1

The study was designed to demonstrate the efficacy and safety of QIVc in children 2 to <18 years of age, compared to a non-influenza comparator.1 A total of 4514 subjects (n= 2258 QIVc, n=2256 comparator (Menveo, meningococcal [Serogroup ACYW-135] conjugate vaccine)) were enrolled.1 The primary endpoint was the first occurrence of laboratory-confirmed influenza illness (by RT-PCR or viral culture) occurring between >14 days after last vaccination and the end of the influenza season.1 The influenza attack rate in the QIVc group was 175/2257 (7.8%; 6.5% to 10.2% over three seasons), compared with 364/2252 (16.2%; 15.2% to 17.4% over three seasons) cases in the control group.1

The efficacy of QIVc in children and adolescents against laboratory-confirmed influenza illness was 54.6% (95% CI 45.7 to 62.1), meeting the pre-specified endpoint for success and showing benefit across three seasons and eight countries.1

The safety profile of QIVc was comparable to the non-influenza comparator.1

About Seasonal Influenza

Influenza is a common, contagious seasonal respiratory disease that may cause severe illness and life- threatening complications in some people.10 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.10 Because transmission of influenza viruses to others may occur one day before symptoms develop and up to 5 to 7 days after becoming sick, the disease can be easily transmitted to others.10 Estimates from the CDC report that during the 2019/20 influenza season, there were an estimated 405,000 influenza-related hospitalizations in the U.S.7 The CDC recommends annual vaccination for individuals aged 6 months and older, who do not have any contraindications.6 Since it takes about two weeks after vaccination for antibodies to develop in the body that help protect against influenza virus infection, it is recommended that people get vaccinated before influenza begins spreading in their community.6 The CDC recommends that people get vaccinated by the end of October.6 For non-pregnant adults, getting vaccinated too early (for example, in July or August), should be avoided, unless there is concern that later vaccination may not be possible, as it can be associated with reduced protection against influenza infection later in the flu season.6

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

About CSL

CSL (ASX:CSL) is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat hemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL including our two businesses, CSL Behring and Seqirus provides life- saving products to more than 100 countries and employs more than 27,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For more information about CSL Limited, visit http://www.csl.com.

For more information visit http://www.seqirus.com and http://www.csl.com.

Intended Audience

This press release is issued from Seqirus USA Inc. in Summit, New Jersey, USA and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of Seqirus products.

Forward-Looking Statements

This press release may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements.

FLUCELVAX QUADRIVALENT (Influenza Vaccine)IMPORTANT SAFETY INFORMATION

What is FLUCELVAX QUADRIVALENT (Influenza Vaccine)?

FLUCELVAX QUADRIVALENT is a vaccine that helps protect people aged 2 and older from the flu. Vaccination with FLUCELVAX QUADRIVALENT may not protect all people who receive the vaccine.

Who should not get FLUCELVAX QUADRIVALENT?

You should not get FLUCELVAX QUADRIVALENT if you have had a severe allergic reaction to any of the ingredients in the vaccine.

Before receiving FLUCELVAX QUADRIVALENT, tell your healthcare provider about all medical conditions, including if you:

What are the most common side effects of FLUCELVAX QUADRIVALENT?

Additional side effects seen in children include:

These are not all of the possible side effects of FLUCELVAX QUADRIVALENT. You can ask your healthcare provider for more information and for advice about any side effects that concern you.

To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1855358-8966 or VAERS at 18008227967 or http://www.vaers.hhs.gov.

You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1800FDA1088.

Before receiving this vaccine, please see the full US Prescribing Information for FLUCELVAX QUADRIVALENT. The information provided here does not include all that is known about FLUCELVAX QUADRIVALENT. To learn more, talk with your healthcare provider or pharmacist.

FLUCELVAX QUADRIVALENT is a registered trademark of Seqirus UK Limited or its affiliates.

All other trademarks referenced herein are the property of their respective owners.

USA-QIVc-21-0085

MEDIA CONTACTMaria Tortoreto+1 (201) 248-5208[emailprotected]

REFERENCES

1 Nolan T, Fortanier AC, Leav B, et al. Efficacy of a Cell-CultureDerived Quadrivalent Influenza Vaccine in Children. N Engl J Med. DOI: 10.1056/NEJMoa2024848.

2 Centers for Disease Control and Prevention (CDC). (2021). Cell-Based Flu Vaccines. Retrieved from: https://www.cdc.gov/flu/prevent/cell-based.htm. Accessed September 2021.

3 Rajaram, S., Boikos, C., Gelone, et al. (2020). Influenza Vaccines: The Potential Benefits of Cell-Culture Isolation and Manufacturing. Therapeutic Advances in Vaccines and Immunotherapy. DOI: 10.1177/2515135520908121.

4 CDC. (2021). Flu & Young Children. Retrieved from: https://www.cdc.gov/flu/highrisk/children.htm. Accessed September 2021.

5 FLUCELVAX QUADRIVALENT (Influenza Vaccine) [package insert]. Holly Springs, NC: Seqirus Inc; 2021.

6 CDC. (2021). Who Needs a Flu Vaccine and When. Retrieved from: https://www.cdc.gov/flu/prevent/vaccinations.htm. Accessed September 2021.

7 CDC. (2021). Estimated Influenza Illnesses, Medical visits, Hospitalizations, and Deaths in the United States 20192020 Influenza Season. Retrieved from: https://www.cdc.gov/flu/about/burden/2019- 2020.html. Accessed September 2021.

8 This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract numbers HHSO10020060001F2C, HHSO100200700030C, HHSO100200900101C and HHSO100201200003I.

9 Data on file. (2020). Seqirus USA Inc.

10 CDC. (2021). Key Facts about Influenza (Flu). Retrieved from: https://www.cdc.gov/flu/about/keyfacts.htm. Accessed September 2021.

SOURCE Seqirus

https://www.seqirus.com/

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The New England Journal of Medicine Publishes First-of-its-Kind Study on Cell-Based Quadrivalent Seasonal Influenza Vaccine (QIVc) Efficacy in...

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FDA Approves Genentech’s Tecentriq as Adjuvant Treatment for Certain People With Early Non-Small Cell Lung Cancer – Business Wire

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SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for adults with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors express PD-L11%, as determined by an FDA-approved test.

Tecentriq is now the first and only cancer immunotherapy available for adjuvant treatment of NSCLC, introducing a new era where people diagnosed with early lung cancer may have the opportunity to receive immunotherapy to increase their chances for cure, said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. Todays landmark approval gives physicians and patients a new way to treat early lung cancer that has the potential to significantly reduce risk of cancer recurrence, after more than a decade with limited treatment advances in this setting.

Too many patients with early-stage lung cancer experience disease recurrence following surgery. Now, the availability of immunotherapy following surgery and chemotherapy offers many patients new hope and a powerful new tool to reduce their risk of cancer relapse, said Bonnie Addario, Co-founder and Chair, GO2 Foundation for Lung Cancer. With this approval, it is more important than ever to screen for lung cancer early and test for PD-L1 at diagnosis to help bring this advance to the people who can benefit.

The approval is based on results from an interim analysis of the Phase III IMpower010 study that showed treatment with Tecentriq following surgery and platinum-based chemotherapy reduced the risk of disease recurrence or death by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50-0.88) in people with Stage II-IIIA (UICC/AJCC 7th edition) NSCLC whose tumors express PD-L11%, compared with best supportive care (BSC). Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified. Fatal and serious adverse reactions occurred in 1.8% and 18%, respectively, of patients receiving Tecentriq. The most frequent serious adverse reactions (>1%) were pneumonia (1.8%), pneumonitis (1.6%), and pyrexia (1.2%).

The review of this application was conducted under the FDAs Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners. According to the FDA, collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions. Simultaneous applications were submitted to regulators in the United States, Switzerland, the United Kingdom, Canada, Brazil and Australia under Project Orbis. Additionally, the FDA reviewed and approved the supplemental application under its Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.

Tecentriq has previously shown clinically meaningful benefit in various types of lung cancer, with six currently approved indications in the U.S. In addition to becoming the first approved cancer immunotherapy for adjuvant NSCLC, Tecentriq was also the first approved cancer immunotherapy for front-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in advanced NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies. Tecentriq is available in three dosing options, providing the flexibility to choose administration every two, three or four weeks.

Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across different lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumor types.

About the IMpower010 study

IMpower010 is a Phase III, global, multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC/AJCC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomized 1,005 people with a ratio of 1:1 to receive either Tecentriq for 1 year (16 cycles), unless disease recurrence or unacceptable toxicity occurred, or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomized Stage II-IIIA and intent-to-treat (ITT) Stage IB-IIIA populations. Key secondary endpoints include overall survival (OS) in the overall study population, ITT Stage IB-IIIA NSCLC.

About lung cancer

According to the American Cancer Society, it is estimated that more than 235,000 Americans will be diagnosed with lung cancer in 2021. NSCLC accounts for 80-85% of all lung cancers and approximately 50% of patients diagnosed with NSCLC are diagnosed with early-stage (Stages I and II) or locally advanced (Stage III) disease. Today, about half of all people with early lung cancer still experience a cancer recurrence following surgery. Treating lung cancer early, before it has spread, may help prevent the disease from returning and provide people with the best opportunity for a cure.

About Tecentriq (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq U.S. Indications

Tecentriq is a prescription medicine used to treat adults with:

A type of lung cancer called non-small cell lung cancer (NSCLC).

A type of lung cancer called small cell lung cancer (SCLC).

It is not known if Tecentriq is safe and effective in children.

Important Safety Information

What is the most important information about Tecentriq?

Tecentriq can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. These problems can sometimes become severe or life threatening and can lead to death. Patients can have more than one of these problems at the same time. These problems may happen anytime during their treatment or even after their treatment has ended.

Patients should call or see their healthcare provider right away if they develop any new or worse signs or symptoms, including:

Lung problems

Intestinal problems

Liver problems

Hormone gland problems

Kidney problems

Skin problems

Problems can also happen in other organs.

These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq. Patients should call or see their healthcare provider right away for any new or worse signs or symptoms, including:

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if patients undergo transplantation either before or after being treated with Tecentriq. A healthcare provider will monitor for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider will check patients for these problems during their treatment with Tecentriq. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may also need to delay or completely stop treatment with Tecentriq if patients have severe side effects.

Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used alone include:

The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

Tecentriq may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.

These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq.

Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

Report side effects to Genentech at 1-888-835-2555.

Please see http://www.Tecentriq.com for full Prescribing Information and additional Important Safety Information.

About Genentech in cancer immunotherapy

Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system.

In addition to Genentechs approved PD-L1 checkpoint inhibitor, the companys broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies. For more information visit http://www.gene.com/cancer-immunotherapy.

About Genentech in lung cancer

Lung cancer is a major area of focus and investment for Genentech, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have five approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

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Ensoma Appoints Cell and Gene Therapy Pioneer Emile Nuwaysir, Ph.D., as Chief Executive Officer – Business Wire

Posted: at 2:03 am

BOSTON--(BUSINESS WIRE)--Ensoma, a gene therapy company advancing the future of medicine through precision in vivo engineering of blood and immune cells, today announced the appointment of Emile Nuwaysir, Ph.D., as president, chief executive officer and member of the companys board of directors. In conjunction with the CEO appointment, Paula Soteropoulos, executive chairman of Ensoma, will transition to the role of chairman of the board, and Kush M. Parmar, M.D., Ph.D., managing partner of 5AM ventures, will continue to serve as a member of the board.

Since launching Ensoma earlier this year, we have assembled a talented and diverse group of academic, scientific and clinical experts, initiated a strategic partnership with Takeda and have made significant progress on our platform and initial programs. Now, we are thrilled to welcome Emile to lead the team as we advance our platform and expand our strategic focus across multiple therapeutic areas ranging from rare genetic diseases to complex diseases of the immune system, such as oncology and autoimmunity disorders, said Ms. Soteropoulos. With more than 20 years of industry experience, a deep understanding of the gene and cell therapy landscape and as an entrepreneur with a track record for building successful life science companies from the ground up, Emile will be a tremendous asset to Ensoma as we seek to fully realize the power and promise of our platform to precisely edit and modify a patients own specific cells with a one-time in vivo curative medicine. We look forward to beginning our next chapter under Emiles leadership.

Dr. Nuwaysir is currently the chairman of the Alliance for Regenerative Medicine, an international advocacy organization comprised of 400+ member companies dedicated to advancing cell and gene medicines. He joins Ensoma from BlueRock Therapeutics, an independently operated subsidiary of Bayer Pharmaceuticals, where he was CEO and continues to serve as chairman of the companys board of directors. As the CEO of BlueRock from inception, he helped build a platform company at the intersection of cellular and genetic medicine, develop a pipeline of first-in-class therapeutic programs, and managed the companys acquisition and operation with Bayer. Prior to BlueRock, Dr. Nuwaysir served as president and chief operating officer of Cellular Dynamics International (CDI), A Fujifilm Company. He played a leading role in growing CDI and its stem cell therapy efforts from its inception, including its early efforts as a pre-revenue startup, to its successful IPO on Nasdaq and ultimate acquisition by Fujifilm. He was also president of Opsis Therapeutics Inc., CDI's retinal cell therapy subsidiary. Before CDI, Dr. Nuwaysir was the first employee of NimbleGen Systems, serving as a member of the senior management team that built a successful company and orchestrated a dual-track IPO process leading to the company's acquisition by Roche Diagnostics. After the acquisition of NimbleGen, Dr. Nuwaysir served as chief technical officer of the Roche NimbleGen subsidiary. Dr. Nuwaysir is also currently vice chairman of Invenra Inc., a multi-specifics antibody platform company he co-founded in 2011. He has held postdoctoral fellowships at the National Institutes of Health and the University of North Carolina at Chapel Hill. He holds a B.A. from the University of Delaware and a Ph.D. in molecular toxicology with a focus on oncology from the University of Wisconsin-Madison.

I am simply thrilled to join Ensoma. The company is poised to deliver on the full promise of genetic medicine, with the ability to precisely engineer the cells of the hematopoietic system through a single, simple, in vivo process, said Dr. Nuwaysir. The elegance of the platform, combined with its unprecedented payload capacity, will enable applications of genetic medicine that are simply undreamed of today. We will create an entire new class of smart immune cells with the power to provide cures for hundreds of genetic diseases, as well as complex diseases like cancer and autoimmunity. I look forward to joining the team and to the possibility of a brighter future for patients in need. I want to thank Paula and Kush for their vision and important commitment in launching the company and look forward to working with them in their continuing board roles.

About EnsomaEnsoma believes the future of medicine lies within us. Our Engenious gene therapy platform is the first to precisely engineer any or all hematopoietic and immune cells with a one-time, off-the-shelf in vivo treatment. Engenious therapies have an unmatched capacity to deliver all modern genetic modification tools and set a new standard for versatile cell programming and control across a range of complex diseases. Ensoma is supported by top-tier investors, a strategic collaboration with Takeda and a passionate team committed to a bold, global vision for gene therapy. Ensoma is based in Boston. For more information, visit http://www.ensoma.com.

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UAB researchers are part of a $3 million award to learn how to better treat lupus in Black patients – EurekAlert

Posted: at 2:03 am

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Credit: UAB

BIRMINGHAM, Ala. Nine out of 10 patients with systemic lupus erythematosus the autoimmune disease also known as SLE are females. Black women have the highest concentration of disease severity, and they are two to three times more likely to suffer SLE than are white women. The disease usually strikes during childbearing years, ages 15 to 45.

To help Black women with SLE, the University of Alabama at Birmingham and two other institutions have received a three-year, $3 million Global Team Science Award from the Lupus Research Alliance. The research will focus on better understanding this difficult disease, where patients often respond differently to the same treatment and vary widely in the severity of their symptoms.

Ignacio Sanz, M.D., chief of Rheumatology at Emory University School of Medicine, leads the multidisciplinary team. His Emory colleagues, together with research teams at UAB and the Medical University of South Carolina, or MUSC, will focus specifically on African American patients, identifying the characteristics of the B cells and plasma cells that create attacking antibodies in the development and progression of severe lupus. The project will define how the different characteristics of these cells correspond to patients responses to treatment.

A key to this research by UAB, Emory and MUSC is their access to a unique cohort of Black SLE patients from the American South, using large cohorts composed of rural and urban patients who receive care at the three institutions.

At UAB, this includes the SLE Clinic, which is enriched for severe patients from Alabamas rural Black Belt and from Birminghams urban communities. At Emory, this includes the Georgians Organized Against Lupus cohort, the largest community-based Black SLE cohort in the nation, with urban and rural Black Belt patients who have high poverty and disproportionately poor outcomes. At MUSC, 30 percent of the MUSC SLE Program patients are from the Gullah cohort, a group unique in their low white admixture, their genetic homogeneity and a double familial prevalence of lupus. The Gullah are Blacks who live in the Lowcountry of Atlantic states from Georgia to North Carolina, both on the coastal plain and on the Sea Islands.

SLE results from harmful antibodies made by a patients immune system. These can attack any part of the body, including kidneys, brain, heart, lungs, blood, skin and joints. B cells are precursors to plasma cells, the cells that produce the damaging antibodies. The SLE B cell signature is particularly accentuated in Black patients with severe disease, yet major gaps in knowledge to understand the different types of SLE clinical disease still persist.

The researchers say knowledge gained from these studies will greatly enhance understanding of SLE pathogenesis and differences in clinical manifestations, outcomes and therapeutic responses. Moreover, this knowledge will enable clinical investigators to more precisely design and evaluate clinical studies and standard-of-care treatments, with the ultimate goal of safer and more effective personalized treatments.

UAB investigators for the award, Linking different B cell types to lupus symptoms, progression and response to therapy, are Fran Lund, Ph.D., Alex Rosenberg, Ph.D., Winn Chatham, M.D., and Troy Randall, Ph.D., all researchers in the UAB Marnix E. Heersink School of Medicine.

Lund is the Charles H. McCauley Professor of Microbiology and founding director of the UAB Immunology Institute, a cutting-edge and interdisciplinary hub for faculty, researchers, clinicians, health policy experts and educators to advance the study of immunology and improve human health through immune-based therapies. Chatham, a professor of medicine and the Louis W. Heck Clinical Scholar in Rheumatology, is director of the UAB SLE Clinic. Randall, a professor of medicine, holds the Meyer Foundation William J. Koopman, M.D., Endowed Chair in Immunology and Rheumatology. Rosenberg is an associate professor of microbiology.

In addition to Sanz and the UAB investigators, the study includes five other researchers at Emory and two at MUSC.

This Lupus Research Alliance grant is one of two $3 million grants that form the first Global Team Science Awards, totaling $6 million, the largest-ever grant from the alliance.

The other award, Identifying differences in genetic makeup to stratify children with SLE into specific groups, went to researchers at Boston Childrens Hospital, Toronto Hospital for Sick Children, Brigham and Womens Hospital, and the Australian National University.

The Global Team Science Award embodies the Lupus Research Alliances strategic priorities of defining lupus heterogeneity, enabling patient stratification, and fostering collaborative global research and technology teams, said Teodora Staeva, Ph.D., chief scientific officer at the alliance. These first two projects, selected from among many compelling proposals, examine important underlying mechanisms of the autoimmune response and point the way to potential new treatment approaches.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Research Roundup: T-Cell Immune Response to COVID-19 Vaccines and More – BioSpace

Posted: at 2:03 am

Every week there are numerous scientific studies published. Heres a look at some of the more interesting ones.

T-Cell Immune Response to COVID-19 Vaccines and Natural Infections

Much of the discussions and news reports about immune responses to vaccines and COVID-19 revolve around antibody levels. Much less has been said about T-cells, which provide longer-term protection. Researchers atGladstone Institutesconducteda detailed T-cell survey before and after COVID-19 immunization, which they published ineLife. They concluded that the Pfizer-BioNTech and Moderna mRNA vaccines create long-term populations of T-cells that recognize multiple SARS-COV-2 virus variants. They also found key differences in the T-cell responses in people who had COVID-19 infections before vaccination compared to people who had never been infected.

Overall, our data support the idea that vaccines are eliciting a very robust T-cell response in healthy individuals, said Nadia Roan, senior author of the study and Gladstone Associate Investigator. But they also suggest there may be some ways to improve them further, by getting more of the vaccine-elicited T-cells to park themselves in the respiratory tract.

Antibodies produced by B-cells quickly recognize viruses, target them, and prevent infection by destroying the viruses. T-cells, however, identify and destroy cells that are already infected. Antibodies are better at stopping initial infection, but T-cells typically last longer after an initial infection or vaccine. At that point they are better at fighting off disease in its early stages, which prevents severe symptoms. But T-cells are very diverse and difficult to analyze. Some subsets respond differently to infected cells and behave differently, while others have different functions within the overall T-cell immune response.

One key finding was that in people who had not been previously infected, the T-cell responses become stronger in quantity and quality after the second dose of the vaccine. But in people who had previously had COVID-19, there was not much of a change between the first and second vaccine dose.

Blood Biomarkers Provide Warning Signs of Dementia

Investigators at theGerman Center for Neurodegenerative Diseases (DZNE)identifiedmolecules in the blood that potentially warn of impending dementia. The research study included several university hospitals across Germany. The biomarkers were based on measuring levels of microRNAs. They say that the technique isnt ready yet for practical use, but they hope to develop a simple blood test. MicroRNAs have regulatory properties, influencing protein production and metabolism. In tests in humans, mice and cell cultures, they found three microRNAs whose levels were linked to mental performance. The three microRNAs also influence neuro-inflammation and neuroplasticity, including the ability of neurons to establish connections with each other.

Stem Cell Population Essential for Bone Regeneration

Researchers at theUniversity of Tsukuba, Japan,identifieda subpopulation of mesenchymal stem cells that play a major role in bone healing. The stem cells are found in the bone marrow and express the marker CD73. When a bone fracture heals, it moves through a series of stages, including clotted blood forming at the fracture. This clot is replaced by fibrous tissue and cartilage, then by a hard bony callus. The bone is then remodeled, with regular bone replacing the hard callus. They found that the generation of the callus is critically dependent on recruiting MSCs from the surrounding tissue and bone marrow. They observed the CD73-positive MSCs migrating toward the fracture site and forming new cartilage and bone cells. When they grafted CD73-positive MSCs into the fracture, they noted enhanced healing processes.

Antiviral Molecule Prevents SARS-CoV-2 from Entering Cells

Scientists atWashington University School of Medicinein St. Louisdevelopeda compound that prevents the SARS-CoV-2 virus, which causes COVID-19, from entering cells. The compound is called MM3122 and has been studied in cell cultures and in mice. MM3122 targets a key human protein called transmembrane serine protease 2 (TMPRSS2), which coronaviruses use to enter and infect human cells. Once the virus attached onto a cell in the epithelia of the airway, the TMPRSS2 protein cuts the viral spike protein, which activates the spike protein to mediate fusion of the viral and cellular membranesstarting the infection process. In cell cultures, MM3122 protected cells from viral damage better than remdesivir,Gilead Sciences antiviral against COVID-19; and an acute safety assay in mice demonstrated that large doses of MM3122 given for seven days did not cause noticeable issues. The compound also was effective against SARS-CoV, the virus behind SARS, and MERS-CoV, the coronavirus that causes MERS. The researchers are now working with researchers at the NIH to test it in animal models of COVID-19. They are also working on an oral version of the injectable compound.

Specific Personality Traits Might Signal Pending Alzheimers

Researchers atFlorida State Universityfoundthat specific changes in the brain linked with Alzheimers disease are often visible earlier in people with personality traits associated with the disease. The research focused on two traits: neuroticism, or a predisposition for negative emotions, and conscientiousness, linked to a tendency to be careful, organized, goal-directed and responsible. They found that people with amyloid and tau deposits, proteins linked to Alzheimers disease in the brain, were identified in participants who scored higher in neuroticism levels and lower in conscientiousness. The study suggests that personality traits might help protect against Alzheimers and other brain diseases by delaying or preventing the neuropathology for people strong in conscientiousness and low in neuroticism.

Why We Overeat

Astudyfrom theUniversity of Washington School of Medicine/UW Medicinereported on the function of glutamatergic neurons in mice. These neurons communicate to the lateral habenula, a brain region associated with the pathophysiology of depression, and the ventral tegmental area, which is involved in motivation, reward and addiction. They found that when mice are eating, the neurons in the lateral habenula are more responsive than the neurons in the ventral tegmental area. They suggest that these neurons might play a bigger role in guiding feeding. In addition, they studied the influence of the leptin and ghrelin hormones, which are believed to regulate behavior via the mesolimbic dopamine system, part of the reward pathway. The research adds additional insight into satiety and why people or at least mice overeat.

We found these cells are not a monolithic group, and that different flavors of these cells do different things, said Garret Stuber, a joint UW professor of anesthesiology and pain medicine and pharmacology, the papers senior author.

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