Efforts at coronavirus vaccines and treatments abound in the Bay Area – San Francisco Chronicle

The frenetic search for the miracle that will rid the world of COVID-19 is branching out in a thousand directions, and a large part of the microbial treasure hunt is going on in the Bay Area, where major progress has been made in the 100 days since residents were ordered to shelter in place.

Scientists at universities, laboratories, biotechnology companies and drug manufacturers are combing through blood plasma taken from infected patients for secrets that will help them fight the disease.

The key is likely a super-strength antibody found in some patients. But researchers must first figure out how those antibodies work and how they can be harnessed and used to stop the many health problems associated with COVID-19, particularly acute respiratory distress syndrome, or ARDS, which has killed more people than any other complication connected to the disease.

Other developments showing promise include injections of mesenchymal stem cells, found in bone marrow and umbilical cords, that doctors are studying to battle inflammation caused by ARDS. And a steroid called dexamethasone reduced the number of deaths by halting the overreactive immune responses in seriously ill patients in the United Kingdom.

In all, more than 130 vaccines and 220 treatments are being tested worldwide.

What follows is a list of some of the most promising elixirs, medications and vaccines with ties to the Bay Area:

Monoclonal antibodies / Vir Biotechnology, San Francisco: Scientists at Vir and several institutions, including Stanford and UCSF, are studying monoclonal antibodies, which are clones of coronavirus-fighting antibodies produced by COVID-19 patients.

The idea is to utilize these neutralizing antibodies which bind to the virus crown-like spikes and prevent them from entering and hijacking human cells.

Only about 5% of coronavirus patients have these super-strength antibodies, and those people are believed to be immune to a second attack.

The trick for scientists at Vir is to identify these neutralizing antibodies, harvest, purify and clone them. If they succeed, the resulting monoclones could then be used to inoculate people and it is hoped give them long-term immunity against the coronavirus. The company recently signed a deal with Samsung Biologics, in South Korea, to scale up production of a temporary vaccine in the fall after clinical trials are complete.

Another monoclonal antibody, leronlimab, is being studied in coronavirus clinical trials by its Washington state drugmaker, CytoDyn. The companys chief medical officer is in San Francisco, and the company that does laboratory tests of leronlimab is in San Carlos.

Interferon-lambda / Stanford University: Doctors at Stanford are running a trial to see if interferon-lambda, which is administered by injection, helps patients in the early stages of COVID-19. Interferon-lambda is a manufactured version of a naturally occurring protein that has been used to treat hepatitis. Stanford doctors hope it will boost the immune system response to coronavirus infections.

Dr. Upinder Singh, a Stanford infectious-disease expert, said the trial has enrolled more than 50 patients and is halfway finished. We have noted that patients tolerate the drug very well, she said.

Mesenchymal stem cells / UCSF and UC Davis Medical Center: UCSF Dr. Michael Matthay is leading a study about whether a kind of stem cell found in bone marrow can help patients with ARDS. Matthay hopes that the stem cells can help reduce the inflammation associated with some of ARDS most dire respiratory symptoms, and help patients lungs to recover.

Matthay is aiming to enroll 120 patients in San Francisco, the UC Davis Medical Center in Sacramento and hospitals in a handful of other states. He said the trial, which includes a small number ARDS patients who dont have COVID-19, should have results within a year. So far 17 patients are enrolled in the trial, most of them in San Francisco.

Remdesivir / Gilead Sciences (Foster City): Remdesivir, once conceived as a potential treatment for ebola, was the first drug to show some promise in treating COVID-19 patients. The drug interferes with the process through which the virus replicates itself. A large study led by the federal government generated excitement in late April when officials said hospitalized patients who received remdesivir intravenously recovered faster than those who received a placebo.

A later study looking at dosage showed some benefit for moderately ill COVID-19 patients who received remdesivir for five days, but improvement among those who got it for 10 days was not statistically significant. Gilead, a drug company, recently announced that it will soon launch another clinical trial to see how remdesivir works on 50 pediatric patients, from newborns to teenagers, with moderate to severe COVID-19 symptoms. More than 30 locations in the U.S. and Europe will be involved in the trial, the company said.

Coronavirus crisis: 100 days

Editors note: Its been 100 days since the Bay Area sheltered in place, protecting itself from the coronavirus pandemic. What have we learned in that time? And what does the future hold for the region and its fight against COVID-19? The Chronicle explores the past 100 days and looks to the future in this exclusive report.

Favipiravir / Fujifilm Toyama Chemical (Stanford University): This antiviral drug, developed in 2014 by a subsidiary of the Japanese film company to treat influenza, is undergoing numerous clinical studies worldwide, including a Stanford University trial that began this month. Unlike remdesivir, it can be administered orally, so it can be used to treat patients early in the disease, before hospitalization is necessary.

Stanford epidemiologists want to see if favipiravir, which has shown promising results in other trials, prevents the coronavirus from replicating in human cells, halts the shedding of the virus and reduces the severity of infection. The Stanford study, the only outpatient trial for this drug in the nation, is enrolling 120 people who have been diagnosed with COVID-19 within the past 72 hours. Half of them will get a placebo. People can enroll by emailing treatcovid@stanford.edu.

Colchicine / UCSF (San Francisco and New York): The anti-inflammatory drug commonly used to treat gout flare-ups is being studied in the U.S. by scientists at UCSF and New York University. The drug short-circuits inflammation by decreasing the bodys production of certain proteins, and researchers hope that it will reduce lung complications and prevent deaths from COVID-19. About 6,000 patients are receiving colchicine or a placebo during the clinical trial, dubbed Colcorona, which began in March and is expected to be completed in September.

Selinexor / Kaiser Permanente: Kaiser hospitals in San Francisco, Oakland and Sacramento are studying selinexor, an anticancer drug that blocks a key protein in the cellular machinery for DNA processing, as a potential COVID-19 treatment. The drug has both antiviral and anti-inflammatory properties, and its administered orally, according to Kaisers Dr. Jacek Skarbinski. The trial aims to enroll 250 patients with severe symptoms at Kaiser and other hospitals that are participating nationwide.

VXA-COV2-1 / Vaxart, South San Francisco: The biotechnology company Vaxart is testing this drug to see if it is as effective at controlling COVID-19 as trials have shown it to be against influenza. VXA-COV2-1, the only potential vaccine in pill form, uses the genetic code of the coronavirus to trigger a defensive response in mucous membranes. The hope is that the newly fortified membranes will prevent the virus from entering the body.

Its the only vaccine (candidate) that activates the first line of defense, which is the mucosa, said Andrei Floroiu, Vaxarts chief executive, noting that intravenous vaccines kill the virus after it is inside the body. Our vaccine may prevent you from getting infected at all.

The drug was effective against influenza and norovirus in trials and appears to work on laboratory animals, Floroiu said. He expects trials of VXA-COV2-1 on humans to begin later this summer.

VaxiPatch / Verndari (Napa and UC Davis Medical Center): Napa vaccine company Verndari makes a patented adhesive patch that can deliver a vaccine instead of a shot. Now, the company is trying to make a vaccine for COVID-19 that they can administer through that patch. At UC Davis Medical Center in Sacramento, Verndari researchers are developing a potential vaccine that relies on the coronavirus spike-shaped protein. When injected into a person, the substance would ideally train their body to recognize the virus and fight it off without becoming ill.

A spokeswoman told The Chronicle that the companys preclinical tests have shown early, positive data in developing an immune response. Verndari hopes to move into the next phase of testing in the coming weeks and start clinical trials in humans this year.

If the vaccine is proved effective and safe, patients could receive it through the mail, according to company CEO Dr. Daniel Henderson. The patch would leave a temporary mark on the skin that patients could photograph and send to their doctor as proof they have taken the vaccine, Henderson has said.

Peter Fimrite and J.D. Morris are San Francisco Chronicle staff writers. Email: pfimrite@sfchronicle.com, jd.morris@sfchronicle.com Twitter: @pfimrite, @thejdmorris

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Efforts at coronavirus vaccines and treatments abound in the Bay Area - San Francisco Chronicle

New Preclinical Data Demonstrates Immune-Enhancing Effects of Triple I/O Combination Therapy with BeyondSpring’s Plinabulin – GlobeNewswire

June 23, 2020 08:00 ET | Source: BeyondSpring, Inc.

Research Presented at 2020 AACR Virtual Annual Meeting

The Triple I/O Combination of Plinabulin, Anti-PD-1 and Radiation Achieved a 100 Percent Complete Response in Anti-PD-1 Non-responsive Animal Model

Triple I/O Combination to Be Administered to Patients Who Failed I/O in Second Half of 2020

NEW YORK, June 23, 2020 (GLOBE NEWSWIRE) -- BeyondSpring (the Company or BeyondSpring) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology (I/O) therapies, today announced new preclinical research findings that indicate BeyondSprings lead asset, Plinabulin, enhances immuno-radiotherapy for cancer patients. The results of this preclinical study was highlighted in a poster presentation titled, Plinabulin, a microtubule destabilizing agent, improves tumor control by enhancing dendritic cell maturation and CD8 T cell infiltration in combination with immunoradiotherapy, at this years American Association for Cancer Research (AACR) Virtual Annual Meeting on June 22, 2020.

Based on these preclinical findings, including a 100% complete response of the triple I/O combination of Plinabulin, anti-PD-1, and radiation in a PD-1 antibody non-responsive model, the compound is being advanced toward a Phase 1 clinical trial in patients who failed or progressed on PD-1 / PD-L1 antibody treatments. Principal investigator Steven H. Lin,M.D., Ph.D., associate professor of radiation oncology at The University of Texas MD Anderson Cancer Center, presented the research data.

The experiments from my lab demonstrated that Plinabulin treatment in murine cancer models leads to activation of antigen-presenting dendritic cells, said Dr. Lin. The combination therapy with Plinabulin, anti-PD-1 therapy and radiation therapy further activated the immune system, resulting in increased T-cell activation, which is associated with increased tumor regressions.

Additional data highlights include:

The above data presentation is available on the Posters page of BeyondSprings website at: https://www.beyondspringpharma.com/conferences/list.aspx?lcid=3.

Peer-reviewed 2019 publications in Chem and Cell Reports demonstrated that Plinabulin is differentiated from all other tubulin-targeted agents through its binding site and kinetics and is among the most potent agents that induce dendritic cell maturation. Dendritic cells are key immune cell types in the activation of the immune system against cancer cells, but currently approved immuno-oncology agents, such as antibodies to PD-1, only take the brakes off of T-cells without activating antigen-presenting cells that stimulate T-cells to attack foreign proteins expressed by cancer cells.

We believe that the activation of dendritic cells is a key to unlocking the next boost to the efficacy of immuno-oncology agents, said Dr. James Tonra, BeyondSprings Chief Scientific Officer. Activated dendritic cells present foreign tumor antigens to T-cells to induce cancer-directed immune attacks. Thus, adding this critical step of dendritic cell activation in the immune cascade to the established effects of immune checkpoint inhibition therapies is expected to increase overall anti-cancer efficacy in the clinic. Our anti-cancer strategy was to activate dendritic cells and T-cells, in combination with checkpoint inhibition and to add onto the benefits of neoantigen generation and immune activation from radiotherapy, as Plinabulin serves as the key to reverse the tumor non-response to PD-1/PD-L1 antibodies. The data strongly indicates that this triple combination has enough potential to move into clinical testing to help patients who failed or had progressed on anti-PD-1/PD-L1 targeted therapy, a severely unmet medical need.

About BeyondSpring BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. BeyondSprings lead asset, first-in-class agent Plinabulin as an immune and stem cell modulator, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and two Phase 3 clinical programs in the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has strong R&D capabilities with a robust pipeline in addition to Plinabulin, including three immuno-oncology assets and a drug discovery platform using the ubiquitination degradation pathway. The Company also has a seasoned management team with many years of experience bringing drugs to the global market.

About Plinabulin Plinabulin, BeyondSprings lead asset, is a differentiated immune and stem cell modulator. Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN). The durable anticancer benefits of Plinabulin have been associated with its effect as a potent antigen-presenting cell (APC) inducer (through dendritic cell maturation) and T-cell activation (Chem and Cell Reports, 2019). Plinabulins CIN data highlights the ability to boost the number of hematopoietic stem / progenitor cells (HSPCs), or lineage-/cKit+/Sca1+ (LSK) cells in mice. Effects on HSPCs could explain the ability of Plinabulin to not only treat CIN but also to reduce chemotherapy-induced thrombocytopenia and increase circulating CD34+ cells in patients.

Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company's future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSprings most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Media Contacts Caitlin Kasunich / Raquel Cona KCSA Strategic Communications 212.896.1241 / 212.896.1276 ckasunich@kcsa.com / rcona@kcsa.com

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New Preclinical Data Demonstrates Immune-Enhancing Effects of Triple I/O Combination Therapy with BeyondSpring's Plinabulin - GlobeNewswire

[Herald Interview] Spinning cord blood into stem cell therapies – The Korea Herald

Medipost CEO Yang Yoon-sun (Lim Jeong-yeo/The Korea Herald)

Her journey as a professor of pathology at Samsung Medical Center to head of a cord blood stem cell research company at the age of 37 came with prejudices, challenges and pitfalls, but also with encouragement, conviction and immense potential.

Cord blood is that inside the umbilical cord that connects the baby and mother, and can be ethically, and legally, procured after a babys birth. Despite containing one of the most potent types of stem cell and possibilities for vast medicinal repurposing, cord blood has often been discarded due to a lack of technology to refine it, Yang said.

In 2000, the concept of processing raw cord blood for stem cell therapies was still in a nascent stage across the world.

Soon Yang came to realize that research on cord blood should be approached commercially rather than academically to fast-track the development of consequential treatments.

The conviction was supported by her colleagues, and further fostered by a nationwide boom in startups.

Yang met obstetricians and gynecologists nationwide to help persuade laboring mothers to donate the otherwise unusable blood.

Medipost humbly started out in a rented laboratory of a Doosan Group research facility in Yongin, Gyeonggi Province, on June 26, 2000.

The company soon got listed on Koreas tech-heavy secondary bourse Kosdaq in 2005. In 2019, the company posted roughly 45.8 billion won ($37.9 million) in revenue with a net loss of over 14.1 billion won.

Medipost now operates from a self-owned building with 14 levels in the biocluster of Pangyo, Seongnam in Gyeonggi Province. Some 200 full-time employees work for Medipost, with entities strewn in global locations such as the US, China and Japan.

It has seven subsidiaries, three of which are Medipost America, Shandong Orlife Pharmaceutical and Evastem Corp., located overseas in the US, China and Japan, respectively.

Medipost, the embodiment of Yangs visions, has three business pillars: its cord blood bank, cell therapy developments and health supplements.

The companys main revenue source is the cord blood bank, where over 259,000 children have their cord blood stored, with more being added. It roughly costs around 1.4 million won to store a vial containing cord blood for 15 years, and 4 million won to store it for a lifetime.

Celltree cord blood bank (Medipost)

Most recently, Winter Sonata actor Choi Ji-woo decided to store the cord blood of her first daughter, whom she gave birth to at age 45.

It was not always a smooth ride, as soon after the companys initial public offering, there broke out the ethical scandal of embryonic stem cell research that clouded the general perception of stem cell research in the public eye. More than once the companys revenue has taken a dive of 50 percent.

However, Yang has no regrets.

As for me, every step was an unexpected challenge and overcoming each hardship taught me to be prepared for anything to maintain business stability, Yang said in an interview with The Korea Herald.

Cord blood, Yang said, is an immune response-safe therapeutic insurance in case the children and their families face incurable diseases such as leukemia, refractory anemia, immune disorders, cerebral palsy, developmental disorders or various forms of cancer.

If the babys cord blood is used to treat the same baby, it would be called an autologous therapy. If used for another family member, that is an allogenic therapy.

Cartistem, an allogenic osteoarthritis treatment that was approved by the local Drug Ministry in 2012, is the next biggest contributor to Mediposts business growth, as well as a balm to the knee problems of seniors.

Celltree cord blood bank (Medipost)

Cartistem is a stem cell therapeutic agent for cartilage regeneration crafted from Mediposts pool of research-purpose cord blood. Once surgically applied to the affected region, the drug has been successful in triggering regrowth of knee cartilage in 98 percent of the 103 patients treated in clinical phase 3 trials.

Medipost counts over 16,000 patients who have so far benefited from the use of Cartistem in the eight years the drug has been in service. It is prescribed at some 550 hospitals here.

The therapy has currently finished clinical phase 1 and 2a trials in the US to launch there, and is pending phase 2 clinical trials in Japan with aims to start tests in July. As it would require a great volume of funding to carry out wide-scale clinical phase 3 trials in the US, it might be Japan where Cartistem launches first, Yang said.

SK Bioland, an SK Group subsidiary, in-licensed Cartistems indication for ankle joint inflammation at end-2019 to carry out clinical phase 3 trials and have full domestic rights to the drugs use for ankle therapy.

Other than Cartistem, Medipost has Pneumostem, Neurostem and SMUP-Cell injections under developments.

Pneumostem is a stem cell therapy for prematurely born babies lung fibrosis. Unlike adult lung fibrosis, which has numerous causes and is sometimes isolated, newborn babies lung problems have a singular cause and therefore a clearer path of tackling it.

Pneumostem is undergoing clinical phase 2 trials in Korea and has completed phase 1 and 2 clinical trials in the US. It has been designated by the US Food and Drug Administration and the European Medicines Agency as an orphan drug, granting it government assistance as it would otherwise prove unprofitable due to its limited scope, and it has the FDAs fast track designation. Once its efficacy is proved, it may attempt to expand Penumostems indications to other forms of lung inflammation, including COVID-19, Yang said.

Neurostem is a proposed Alzheimers disease stem cell therapy. It is believed to promote the degradation of beta-amyloid, and accumulation in the brain is believed to cause Alzheimers-type dementia. The pipeline has completed phase 1 and 2a clinical trials in Korea, and has been cleared for the FDAs phase 1 and 2 investigational new drug application.

SMUP-Cell, an injectable type innovative knee joint treatment, saves patients the trouble of undergoing intrusive surgery. Medipost has finished administrating the cell therapy to the first round of clinical phase 1 trials and has begun the five-year tracking of patients progress. If the drug makes it to commercial stage, it would be a groundbreaking solution for patients of joint inflammation who are in pain, but not at the stage yet to go under the knife.

At its basement in Pangyo, Medipost has enough space to install more cord blood tanks to last the next 20 years.

Our only goal should be to provide stem cell regenerative therapy to patients whose predicament previously had no life-extending solution. If we save one patient -- while to us it may just be one person, it is 100 percent to the patient themselves. That is our step-by-step approach, said Yang.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)

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[Herald Interview] Spinning cord blood into stem cell therapies - The Korea Herald

Children’s Hospital Los Angeles Ranked No. 1 Children’s Hospital in the Western U.S., No. 5 Nationally for Second Straight Year – Business Wire

LOS ANGELES--(BUSINESS WIRE)--Children's Hospital Los Angeles (CHLA) ranks again among the nations premier destinations for pediatric care, according to the U.S. News & World Report Best Children's Hospitals annual list released today.

CHLA not only retained its national No. 5 ranking in U.S. News Honor Roll of Best Childrens Hospitalswhich recognizes institutions with the most outstanding pediatric clinical careit continued its four-year streak of being the highest-scoring childrens hospital in the entire Western United States.

To make U.S. News & World Reports prestigious Best Childrens Hospitals Honor Roll, one must demonstrate the strongest achievements in clinical excellence, with a matchless team of expert, compassionate specialists committed to research and education as well as protocols that drive safety and quality and consistently lead to the best health outcomes for patients, says CHLA President and Chief Executive Officer Paul S. Viviano. "This honor affirms the work of every CHLA team member and our belief that when parents choose Childrens Hospital Los Angeles, they are choosing the best care for kids."

Every year, U.S. News scores nearly every major hospital and health system in the country and ranks them according to performance benchmarks, peer review, certifications, and other data provided by the hospital and third-party measurements of excellence. Children's hospitals are ranked separately from other facilities due to the specialized expertise, equipment and facilities required to care for infants, children and youth.

This year, U.S. News surveyed 118 pediatric medical centers, including hospitals that are freestanding or part of a larger institution. CHLA improved its ranking over last year in seven of the 10 pediatric specialty categories the survey considers, including a number two ranking for Neonatal Care. In all, the hospital earned top-10 recognition in seven of those categories:

CHLA has an organization-wide commitment to providing our patients the care they need no matter their circumstances, says CHLA Chief Medical Officer James Stein, M.D., MSc. "Our clinical teams often treat the most acute cases that are outside the scope or expertise of other childrens hospitals in California, and being named a Top-5 childrens hospital in the U.S. is a testament to the clinicians and staff who work every day to make sure each child receives the best care and experience possible.

Founded in 1901, Children's Hospital Los Angeles is a pediatric academic medical center built around its mission of creating hope and building healthier futures for children. Renowned for its world-class clinical care, leading-edge research and one of the largest and most successful pediatric training programs in the countryall while being the pediatric safety net hospital for the entire regionCHLA now sees more than 600,000 patient visits annually between its main hospital and five neighborhood care clinics.

CHLA physicians, nurses and clinical staff provide compassionate and lifesaving pediatric care for patients ranging from infants to young adults, hailing from all 50 states and more than 75 countries. Clinical care is led by physicians who are faculty members of the Keck School of Medicine of USC. Many of the hospital's achievements in care are made possible through a cohesive relationship between clinical experts at the bedside and the basic, translational, and clinical research conducted in The Saban Research Institute of CHLA.

In the past year, CHLA has had several notable achievements, including:

U.S. News & World Report works with research firm RTI International to develop its annual Best Children's Hospitals list, a collaboration between hospitals and the magazine to benchmark the performance of childrens hospitals for the benefit of parents and their children. The survey evaluates hundreds of data points, including patient survival and surgical complication rates; staffing, technology and special services; infection prevention and delivery of care; reputation among peer physicians nationwide (i.e. Where would the best pediatric specialists send their kids?); how involved parents are in their childrens care; and many other measurements of excellence.

U.S. News Media Group, parent of U.S. News & World Report, announced the 2020-21 hospital rankings online at 12:01 a.m. EDT on Tuesday, June 16. For additional information, please visit the Best Childrens Hospitals Honor Roll and specialty rankings page at usnews.com/childrenshospitals.

About Children's Hospital Los Angeles

Founded in 1901, Children's Hospital Los Angeles is ranked the top childrens hospital in California and fifth in the nation for clinical excellence with its selection to the prestigious U.S. News & World Report Honor Roll of childrens hospitals. Clinical care is led by physicians who are faculty members of the Keck School of Medicine of USC through an affiliation dating from 1932. The hospital also leads the largest pediatric residency training program at a freestanding childrens hospital of its kind in the western United States. The Saban Research Institute of Childrens Hospital Los Angeles encompasses basic, translational and clinical research conducted at CHLA. The hospitals Center for Global Health facilitates services for international patients from more than 75 countries. To learn more, follow us on Facebook, Instagram, LinkedIn and Twitter, and visit our blog for families (CHLA.org/blog) and our research blog (ResearCHLABlog.org).

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Children's Hospital Los Angeles Ranked No. 1 Children's Hospital in the Western U.S., No. 5 Nationally for Second Straight Year - Business Wire