Fate Therapeutics: UCSD patient gets 1st cancer treatment made from stem cells

A new form of cancer immunotherapy has been given to a UC San Diego Health patient in the first test of immune cells grown from stem cells.

The patient, Derek Ruff, is being treated for stage four colon cancer, which recurred after a decade in remission. The disease continued to progress despite chemotherapy and radiation, said UCSD’s Dr. Sandip Patel, who treated Ruff.

Ruff is getting infusions of what are called “natural killer” or NK cells, made by San Diego’sFate Therapeutics. Fate has worked closely with UCSD’s Dr. Dan Kaufman, an expert on these cells.

Ruff began getting multiple doses of NK cells in February. In early April, he said the immunotherapy hasn’t debilitated him like previous treatments.

“Before I got the first treatment, I was very apprehensive,” said Ruff, 52. “I had been through a lot of chemo, and chemo makes you feel really bad.”

It has yet to be determined if the NK cell treatment, called FT500, is working.

Fate is testing these NK cells in patients with advanced solid tumors, where a better-known cell therapy called chimeric antigen receptor, or CAR T cells, has shown limited benefit.

CAR T cells are genetically engineered to detect a specific molecular marker on the cancer cells. These cells have revolutionized cancer treatment, especially for blood cancers. Two approved treatments are available, Kymriah and Yescarta.

But the CAR T cells must be custom-made from the patient’s own cells, an expensive process that takes weeks. And they haven’t been extensively tested against solid tumors, such as Ruff’s.

Patel said he was particularly excited by the idea of treating solid tumors with NK cell therapies.

“Patients with solid tumors are the biggest population of patients that we see in aggregate, and are a major unmet need in terms of cellular immunotherapy,” Patel said.

FT500 is a first-of-kind product approved by the U.S. Food and Drug Administration for experimental use.

Unlike CAR T cells, which are custom-made from a patient’s own cells over a period of weeks, FT500 is produced in advance as an “off the shelf” treatment and doesn’t require immune matching. Due to economies of scale, “off-the-shelf” treatments are expected to cost less.

Fate starts with what are called induced pluripotent stem cells, or iPSCs. These are adult cells “reprogrammed” to resemble embryonic stem cells. These iPSCs are then matured into NK cells.

“This product is derived from a master bank of induced pluripotent stem cells that self-renew, and thus are able to continually make these NK cells,” Patel said. “If this works, patients can be treated en masse with these cells, given and administered like other drugs, but are living cellular products.”

More information on the trial can be found at clinicaltrials.gov by searching for the trial number, NCT03841110.

https://www.marketscreener.com/FATE-THERAPEUTICS-INC-14297698/news/Fate-Therapeutics-UCSD-patient-gets-first-cancer-treatment-made-from-stem-cells-28400216/

FDA pulls up Walmart, Kroger, others for selling tobacco to minors

The U.S. Food and Drug Administration (FDA) said on Friday it has sent letters to Walmart Inc, Kroger Co and 10 other convenience store chains for selling tobacco products to minors.

In the letters, dated April 5, the FDA asked the companies to submit a plan of action within 30 days, describing how they will address and mitigate illegal sales to minors.

The 10 other retail chains include Casey’s General Store, Family Dollar Stores, 7-Eleven Inc and retail stores run by Chevron Corp, Royal Dutch Shell Plc, Exxon Mobil Corp, Citgo, Marathon Petroleum, Sunoco LP, and BP Plc. (https://bit.ly/2Rf82Ve)

“We all share the important responsibility of keeping harmful and addictive tobacco products out of the hands of kids. Retailers in particular are on the frontlines of these efforts to reduce the health consequences of tobacco use and nicotine dependence,” the FDA said in the letter.

The FDA has rolled out a Youth Tobacco Prevention Plan as part of its push to discourage teens from smoking.

“The new retailer letters are part of #FDA’s continued actions as part of its Youth Tobacco Prevention Plan and the agency’s ongoing commitment to combat youth access to all tobacco products, including e-cigarettes,” FDA spokesperson Jennifer Rodriguez said on Twitter https://twitter.com/FDASpox/status/1116781622412685313.

In February, the regulator said it was taking action against certain retailers including Walgreen Boots Alliance for repeatedly flouting tobacco sale rules, including sale of cigars and menthol cigarettes to minors.

https://www.marketscreener.com/news/FDA-pulls-up-Walmart-Kroger-others-for-selling-tobacco-to-minors–28400217/?countview=0

Global health threat: Over 587 cases of deadly fungus reported, CDC says

At least 587 cases have been confirmed over the last few years of an emerging fungus infection, identified by U.S. health authorities as “a serious global health threat.”

Centered primarily in the New York City area, the Chicago area and New Jersey, Candida auris infections had spread to a dozen states by the end of February, the U.S. Centers for Disease Control and Prevention reported.

The fungus – also referred to as C. auris – is resistant to some or all antifungal medicines, which makes it harder to treat, the CDC says.

Found in hospitals and long-term care facilities, it can quickly lead to death in patients who have weakened immune systems or other underlying serious medical problems. More than one in three patients with an invasive infection of the fungus has died, the CDC said.

Of the 587 cases nationwide that the CDC confirmed citing February data, New York had 309, more than any other state. Illinois had confirmed 144 cases, the agency said.

New Jersey health officials reported Tuesday that over the last four years the state has 132 confirmed cases and another 22 that are considered probable.

“It’s taken us all by surprise,” said David S. Perlin, the chief scientific officer of the new Hackensack Meridian Health Center for Discovery and Innovation, in Nutley, New Jersey.

As former head of the Public Health Research Institute in Newark, Perlin published several studies in the last two years about diagnosing drug-resistant fungal infections, including C. auris.

“We don’t really know why globally this bug has burst on the scene all over the world.” he said. “We’re seeing it in hospitals – we have a problem obviously in New York and New Jersey, but we see it in Spain, the United Kingdom, South Africa, other places.”

C. auris spreads in hospitals and health care settings via surfaces, where it persists for days, and from person to person, he said. Those modes of transmission – and its persistence – are extremely unusual for fungal diseases.

What makes C. auris so deadly is that it is difficult to treat and often misidentified, the CDC says. Unlike bacterial infections, for which doctors have many antibiotics, fungal infections are treated by three main classes of drugs. However, some of the C. auris infections are resistant to all three.

Patients who have been hospitalized for long periods, those with a central venous catheter or other lines or tubes into their body or have previously taken antibiotics or antifungal medications are the most vulnerable to the fungus.

C. auris was first identified in 2009 in an ear infection in a Japanese woman, but the earliest known strain dates back to 1996 in South Korea, according to the New Jersey Department of Health. Since then, it has spread to at least 20 other countries.

The CDC alerted doctors in June 2016, asking them to report cases. Two months later, the first seven cases in the United States were reported, six of them dating from before the CDC’s notification.

An additional 1,056 patients have been “colonized” with the fungus, but did not show symptoms, the CDC said. They were identified through screenings in seven states where patients had become sick with the fungal infection.

There is still much to be learned about the fungus and how it spreads. One concern is that doctors may be promoting its spread inadvertently when they prescribe antifungal medication as a preventive medication for patients who have received an organ transplant or who are undergoing chemotherapy.

“It’s hard to eradicate from hospitals,” Perlin said. Most fungal pathogens die when they leave the body, but this one persists for days.

“A bulk of the work has to happen at the facilities,” said Tina Tan, the state epidemiologist for New Jersey. “They have to be aggressive in trying to implement good infection control to stem the spread.”

https://www.redding.com/story/news/health/2019/04/09/candida-auris-outbreak-deadly-fungus-infection-12-states-cdc-says/3417145002/

Anthem Down Nearly 7%, on Pace for Largest Percent Decrease Since July 2012

At 3 PM EST, Anthem, Inc. (ANTM) was at $257.24, down $19.05 or 6.89%

— Would be lowest close since Jan. 14, 2019, when it closed at $255.12

— On pace for largest percent decrease since July 25, 2012, when it fell 12.06%

— Currently down four of the past five days

— Currently down three consecutive days; down 11.33% over this period

— Worst three-day stretch since the three days ending July 26, 2012, when it fell 13.62%

— Down 10.36% month-to-date

— Down 2.05% year-to-date

— Down 18.96% from its all-time closing high of $317.42 on Feb. 26, 2019

— Traded as low as $249.57; lowest intraday level since Jan. 8, 2019, when it hit $241.18

— Down 9.67% at today’s intraday low; largest intraday percent decrease since July 25, 2012, when it fell as much as 13.29%

— Worst performer in the S&P 500 today

https://www.marketscreener.com/ANTHEM-INC-18740543/news/Anthem-Down-Nearly-7-on-Pace-for-Largest-Percent-Decrease-Since-July-2012-Data-Talk-28398661/

CDC investigating outbreak of E. coli, say ground beef may be source

The Centers for Disease Control and Prevention said that it, several states, and the U.S. Department of Agriculture’s Food Safety and Inspection Service are investigating a multistate outbreak of Shiga toxin-producing E. coli O103 infections. Preliminary information suggests that ground beef is the source of this outbreak. This investigation is ongoing. A total of 109 people infected with the outbreak strain of E. coli O103 have been reported from six states. Seventeen people have been hospitalized. No cases of hemolytic uremic syndrome, a type of kidney failure, have been reported. No deaths have been reported. Preliminary epidemiologic information suggests that ground beef is the source of this outbreak. At this time, no common supplier, distributor, or brand of ground beef has been identified. CDC is not recommending that consumers avoid eating ground beef at this time. Consumers and restaurants should handle ground beef safely and cook it thoroughly to avoid foodborne illness. At this time, CDC is not recommending that retailers stop serving or selling ground beef. Publicly traded companies in the space include Tyson Foods (TSN) and Hormel (HRL).

https://thefly.com/landingPageNews.php?id=2892129

Qiagen announces U.S. launch of therascreen FGFR Kit

Qiagen (QGEN) announced the U.S. launch of its therascreen FGFR RGQ RT-PCR Kit as a companion diagnostic to help guide the use of the newly approved FGFR kinase inhibitor, BALVERSA, developed by Janssen Biotech (JNJ). The test will aid in identifying patients with urothelial cancer whose tumors have certain alterations in the fibroblast growth factor receptor 3 gene. The U.S. Food and Drug Administration co-approved the new test with BALVERSA, as announced by Janssen.

https://thefly.com/landingPageNews.php?id=2892130

Fibrosis, Steatosis of the Liver Observed in Some Young Adults

A considerable proportion of young adults have fibrosis and steatosis of the liver, according to a study presented at The International Liver Congress 2019, held from April 10 to 19 in Vienna.

Kushala Abeysekera, M.B.B.S., from the University of Bristol in the United Kingdom, and colleagues examined the prevalence of nonalcoholic fatty liver disease among the young adults from the Avon Longitudinal Study of Parents and Children cohort. A total of 4,020 study participants had fibroscans.

The researchers found that 2.4 percent of the 3,128 individuals whose fibroscans were available for analysis had evidence of fibrosis and 0.3 percent had fibrosis evaluations equivalent to stage 4 fibrosis. There were correlations for alanine transaminase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT) with rising fibrosis score. Of the 3,277 scans that were eligible for analysis of steatosis, 20.8 percent of participants had steatosis and 10.1 percent had stage 3 steatosis. Significantly more steatosis was seen in women than men. There were correlations for increases in ALT, AST, and GGT with increasing controlled attenuated parameter (CAP) score. There was a positive association for CAP score with fibrosis score.

“We were concerned to find that, at only 24 years of age, one in five had steatosis and one in 40 had evidence of fibrosis, based on elastography results, in a group of largely asymptomatic, predominantly Caucasian young people,” Abeysekera said in a statement.

More Information

https://www.physiciansbriefing.com/gastroenterology-6/liver-disease-news-447/fibrosis-steatosis-of-the-liver-observed-in-some-young-adults-744802.html