With Adult Acne, You Are What You Eat

Dietary habits — particularly fats and carbs — were associated with risk of acne in adults, a French study found.
Looking at daily dietary records of nearly 25,000 individuals, consumption of one portion of fatty and sugary food per day was tied to a 54% higher odds of currently suffering from acne (adjusted odds ratio 1.54, 95% CI 1.09-2.16), Laetitia Penso, MSc, of the University of Paris in France, and colleagues reported in JAMA Dermatology.

In particular, drinking one glass of a sugary beverage a day was tied to moderately higher odds of current acne (aOR 1.18, 95% CI 1.01-1.38). And similarly, each daily glass of milk was tied to a bump in risk of current acne (aOR 1.12, 95% CI 1.00-1.25).
And just generally adhering to an “unhealthy” diet rich in energy-dense foods was associated with higher odds of currently suffering from acne (aOR 1.13, 95% CI 1.05-1.18).
These associations were dose-dependent as well:

• 5 glasses of milk/1 liter: aOR 1.76 (95% CI 1.00-3.05)
• 5 glasses of sugary beverages/1 liter: aOR 2.29 (95% CI 1.05-5.00)
• Complete meal of fatty and sugary products: aOR 8.38 (95% CI 1.54-47.02)

As for other notable offenders, consumption of carbohydrates (aOR 1.43, 95% CI 1.06-1.93), as well as saturated fatty acid intake (aOR 3.90, 95% CI 1.02-15.00), were also both tied to a significantly higher odds of currently having acne.
“Our results may support the hypothesis that the Western diet (rich in animal products and fatty and sugary foods) is associated with the presence of acne in adulthood,” Penso’s group wrote.

Part of the ongoing NutriNet-Santé study, this cross-sectional analysis pooled data on 24,452 adults in France who completed an online self-questionnaire including their experiences with acne in the past and present. Among these individuals, nearly half reported either having suffered from past or current acne. About 60% of this cohort was comprised of adults age 55 and older.
Participants also completed dietary intake assessments, which consisted of a series of 24-hour dietary recalls, each 6 months apart. Only individuals who completed at least three dietary recalls were included in the analysis.
Data were collected on average daily intake across several food groups, including fruit, vegetables, meat, fish, milk, dark chocolate, milk chocolate, refined cereals, snacks, and fast foods, as well as fatty and sugary products, in addition to nutrient intake of vitamins, zinc, fibers, carbohydrates, lipids, proteins, and saturated fatty acids.
The study’s findings don’t come as much of a surprise, said John Barbieri, MD, MBA, of the University of Pennsylvania in Philadelphia, in an accompanying editorial. “These findings are largely in line with prior observational studies suggesting an association between milk consumption and high glycemic-load diet with acne,” he wrote.

However, he pointed out that the study failed to take note of milkfat percentage or whey protein consumption in the data collection, which could hold further insight into these associations.
“[B]efore we can confidently make dietary recommendations for patients with acne, trials are needed to evaluate whether dietary interventions can improve or prevent acne and how the effect size of such interventions compares with other standard treatment modalities,” Barbieri concluded.

Disclosures

Penso and co-authors reported no disclosures.
Barbieri reported being supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health and partial salary support through a Pfizer Fellowship grant to the Trustees of the University of Pennsylvania.

Primary Source

JAMA Dermatology

Source Reference: Penso L, et al “Association Between Adult Acne and Dietary Behaviors: Findings From the NutriNet-Santé Prospective Cohort Study” JAMA Dermatol 2020; DOI: 10.1001/jamadermatol.2020.1602.

Secondary Source

JAMA Dermatology

Source Reference: Barbieri JS “Diet and Acne — Challenges of Translating Nutritional Epidemiologic Research Into Clinical Practice” JAMA Dermatol 2020; DOI: 10.1001/jamadermatol.2020.1601.

https://www.medpagetoday.com/dermatology/generaldermatology/86997

Genmab brings on Abbvie for bispecific boost

Abbvie pays handsomely to join the CD20 bispecific brawl, handing over $750m to Genmab for access to a project that is behind the competition.
Genmab has been promising a deal on its lead R&D project, epcoritamab, for some time now and today unveiled Abbvie as its new partner. The CD20-targeting bispecific sits in a field where Roche and Regeneron are ahead with similar agents, so the Danish biotech was always going to need help competing.
With its big presence in haematological cancers thanks to Imbruvica and Venclexta, partnering with Abbvie certainly makes sense. The deal terms point to the promise seen with bispecifics in this area: $750m up front and up to $3.2bn in milestones for Genmab, which also gets to keep a healthy portion of the profits should help epcoritamab make it to market.
The broad development and commercialisation deal also involves two other clinical-stage bispecifics and potentially four other projects down the road, so some of the fees will relate to progress elsewhere. A big proportion will be linked to epcoritamab, however, which Genmab will jointly market with Abbvie in the US and Japan.
Profits will be shared equally in these countries; elsewhere Genmab will receive 22-26% royalties. The terms are broadly similar for the other two projects: CD3 bispecifics targeting CD37, GEN3009, which is in a phase I trial; and 5T4, a target expressed on a wide variety of solid tumours. This is much earlier in development, with an IND having only just been filed.
On a call with investors this afternoon the deal was repeatedly described as a “50:50 partnership” and “transformational” by Genmab executives, although Abbvie’s management team are also probably hoping for pretty big things. The company has fired several blanks in oncology – think Rova-T and velaparib – and shares in the company opened up almost 2% today.
With an $18bn market cap Genmab can hardly be described as a small biotech anymore, though this valuation is largely thanks to a substantial rally over the past few months. The stock touched a record high in late May and has surged 64% so far this year, which probably explains a relatively muted response to the deal: shares were trading 5% higher on the news.
The bispecific promise
Highly encouraging response rates with Regeneron’s REGN1979 and Roche’s mosunetuzumab across various lymphomas have raised hopes that using a bispecific to hit CD20 might boost the effectiveness of this well established mechanism. The nearest term hope is that these agents might offer a more tolerable and convenient option than Car-T in later-stage settings.
While there are several CD20 bispecific projects in development, Roche and Regeneron are considered out in front. Both presented substantial data sets at Ash last year, which seems to show what REGN1979 gained in efficacy over mosunetuzumab, it lost in safety (Ash 2019 – Regeneron takes the bispecific baton and runs, December 10, 2019).
As a huge player in the CD20 space with Rituxan and Gazyva Roche should not be ruled out here, of course, but this is a race that is far from over.
Genmab presented the latest cut from an ongoing trial of epcoritamab at Asco this year, which appeared to show competitive efficacy. And on safety, which is more easily stacked up at this stage, epcoritamab certainly holds it own, with a much lower rate of more severe cytokine release seen, albeit in fewer patients to date.

CD20 bispecific safety comparison
	REGN1979 (Regeneron)	Mosunetuzumab (Roche)	Epcoritamab (Genmab/Abbvie)
N	110	270	58
CRS	59%	29%	57%
CRS grade 3-4	6.40%	1.10%	0%
CRS=cytokine release syndrome. Source: Ash 2019, Asco 2020.

Both Regeneron and Roche have already started much larger phase II programmes with their respective candidates, and on today’s call Genmab and Abbvie executives said they were keeping specific plans for epcoritamab “close to their chests”. While they acknowledged that they are behind, plans are afoot to catch up, they insisted, and hinted that a huge pivotal programme is on the cards.
A “Darzalex type development programme” should be expected, they revealed, involving multiple thousands of patients; combinations with Imbruvica and Venclexta are also likely. Considering that epcoritamab data in only 58 patients has been published to date, some might find this talk premature.
And of course if this comes to pass much of Genmab’s new-found wealth will be earmarked for such studies. However it is clear that in Abbvie a motivated and ambitious partner has been found.
https://www.evaluate.com/vantage/articles/news/deals/genmab-brings-abbvie-bispecific-boost

Nasdaq closes above 10,000 milestone, even as economy is in recession

The Nasdaq Composite Index closed at an important milestone for the first time on Wednesday, underscoring the rebound in technology-related stocks following the coronavirus rout that has helped to crystallize the view that parts of the stock market have entered a new bullish phase.
The rally for the tech-laden index comes after a series of fresh record closing highs for the index. A finish at or above 10,000 represents the fastest 1,000-point milestone for the Nasdaq COMP, +0.66%, 114 trading sessions, since the 49 sessions the index took to surge from 4,000 to 5,000 in 2000, according to data from Dow Jones Market Data.

The U.S. stock market, hit by an economy falling into recession as businesses were temporarily closed to combat the coronavirus pandemic, has staged a rapid rebound from its low in late March. The Nasdaq and its peer index, the Nasdaq-100, composed of the largest members of the Nasdaq Composite, is weighted heavily with technology businesses which have been viewed as more resilient to the COVID-19 pandemic that has rocked the economy and financial markets.
Check out a table of the milestones in the attached table:

The largest names by market value have helped to propel the recovery for the Nasdaq. Those companies include Facebook Inc. FB, -0.81%, Apple Inc. AAPL, +2.57%, Amazon.com Inc. AMZN, +1.79%, Netflix NFLX, +0.09% and Google parent Alphabet GOOG, +0.66% GOOGL, +0.86%.
To be sure, round numbers like 10,000 on the index aren’t necessarily significant for the market, but they can help to reflect growing upbeat sentiment, despite a number of risks that have confronted investors including the viral epidemic and civil unrest that erupted over the death of unarmed black man George Floyd in Minneapolis.

The Nasdaq closed on Wednesday at 10,020.35.
The Dow, which was first published 124-years ago, hit 10,000 in March 29, of 1999 as the tech sector was in the throws of the dot-com boom. The Nasdaq Composite, meanwhile, was first published in 1971, so its traverse above the 10,000 mark comes at a relatively brisk half-century clip.
Wednesday’s trading for the Nasdaq comes as the Federal Reserve said that it would do whatever its takes to support the economy and financial markets. Still, there are growing concerns that the rebound from the rout induced by COVID-19 has come too fast and too furiously, making the equity market more vulnerable to a sharp pullback.
The Dow Jones Industrial Average DJIA, -1.03% closed off 1% Wednesday, ending lower after it snapped a six-session rally on Tuesday, while the S&P 500 SPX, -0.53% finished off 0.5%.
Indeed, the economy has tumbled into such a deep recession that some forecasters predict up to a record 40% decline in gross domestic product on an annualized basis in the second quarter. In the first quarter, the economy contracted by 4.8%, one of the deepest declines on record.
The Fed on Wednesday said it doesn’t expect to lift short-term rates through the end of 2022. In a statement, the Fed said again it would use its “full range of tools” to support the economy.
https://www.marketwatch.com/story/nasdaq-on-the-verge-of-closing-at-psychological-milestone-at-10000-even-as-the-economy-is-in-recessionheres-how-we-got-here-2020-06-09

Expanded use of Vertex’s Kalydeco OK’d in Europe

The European Commission approves the use of Vertex Pharmaceuticals’ (NASDAQ:VRTX) Kalydeco (ivacaftor) in children with cystic fibrosis as young as six months old and weighing at least 5 kg who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

The product was previously approved for CF sufferers ages 18 and older with the R117H mutation, and in infants ages six months and older weighing at least 5 kg who have one of the following mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.

https://seekingalpha.com/news/3581804-expanded-use-of-vertexs-kalydeco-okd-in-europe

FDA OKs expanded emergency use of Quidel COVID-19 test

The FDA has amended its Emergency Use Authorization for Quidel’s (OTC:QDEL) rapid point-of-care Sofia SARS Antigen FIA test to allow it to be run on its automated Sofia Fluorescent Immunoassay Analyzer that can generate results in as little as 15 minutes.
https://seekingalpha.com/news/3581808-fda-oks-expanded-emergency-use-of-quidel-covidminus-19-test

FDA OKs emergency use of Illumina’s COVID-19 diagnostic test

The FDA has issued an Emergency Use Authorization for Illumina’s (NASDAQ:ILMN) COVIDSeq Test, a sequencing-based, in vitro diagnostic workflow enabling the detection of SARS-CoV-2.

The end-to-end workflow extends the options available for labs to scale diagnostic testing.

COVIDSeq uses upper respiratory specimens and delivers sample receipt to result in 24 hours using the NovaSeq 6000 Sequencing System.

The test currently has limited availability and is expected to be more broadly available this summer.

https://seekingalpha.com/news/3581810-fda-oks-emergency-use-of-illuminas-covidminus-19-diagnostic-test

Fulcrum Therapeutics to test losmapimod in COVID-19

Fulcrum Therapeutics (NASDAQ:FULC) has filed an IND with the FDA seeking sign-off for a late-stage clinical study evaluating lead drug losmapimod in hospitalized COVID-19 patients.

According to President & CEO Robert Gould, Ph.D., prior studies in other diseases showed the drug’s ability to reduce inflammatory proteins like IL-6 and C-reactive protein (CRP) that are associated with a poor prognosis.

On the working capital front, it has closed its $68.5M private placement of stock (~4M common shares at $17). Its current balance of quick assets should be sufficient to fund operations into Q1 2022.

Management hosted a conference call today at 8:30 am ET to discuss recent developments.

https://seekingalpha.com/news/3581828-fulcrum-therapeutics-to-test-losmapimod-in-covidminus-19