New York City is set for its reopening Monday — but there’ll be nothing grand about it.
A number of coronavirus-weary retailers — including Sephora, Coach,
Kate Spade and Stuart Weitzman — won’t be opening up, even though
in-store pickup or drop-off is OK.
“Phase 1 is only going to have a minor impact on retail and retail
employment,” said Stuart Applebaum, president of the 60,000-member
Retail, Wholesale and Department Store Union, referring to the state’s
four-phase reopening plan. “Most retail workers will remain unemployed.”
He said workers are “frightened” to come back to work over concerns
for their health as the city awakens from its coronavirus coma.
Tapestry Inc., the parent company of Coach, Kate Spade and Stuart
Weitzman, told Bloomberg News that it would wait longer to reopen its
shops in the Big Apple, despite having hundreds of stores already open
across the globe.
Business coalitions including the Fifth Avenue Association and Times
Square Alliance have no details as to which stores will reopen.
“For Times Square, we don’t expect too dramatic a difference from today,” said Times Square Alliance president Tim Tompkins.
Bloomingdale’s on East 60th Street and Macy’s in Herald Square will
open for curbside pickup next week, but reps for both stores warned, “We
are taking things day by day.”
Barnes & Noble is planning on a slow rollout, too, opening three shops on Monday and another three the following week.
Meanwhile, more than 33,500 non-essential construction sites — including real-estate and office construction — will come back online Monday in a boost to the workforce.
New York City is the last of the state’s 10 economic regions to open under Phase 1 of the four-phase plan. https://nypost.com/2020/06/05/inside-new-york-citys-not-so-grand-coronavirus-reopening/
Natera’s cancer blood test is couture, but Guardant’s pret-a-porter offering might sell better.
A growing number of companies are developing blood tests for cancer,
and many presented data at Asco or will do so at the upcoming AACR
meeting. But when assessing how these tests compare, particular
attention must be paid to the settings in which they are used.
Broadly, there are three: screening to detect early disease, recurrence monitoring, and tracking response to treatment. Here, Evaluate Vantage looks at two liquid biopsy developers, Guardant Health and Natera, which are taking very different strategic approaches.
Natera made its name with a test to detect foetal abnormalities using
circulating foetal DNA in the mother’s blood. It has adapted this
technology to pick up DNA shed by tumours into the patient’s blood, and
is focusing on detecting cancer recurrence in patients whose tumours
have been surgically removed. Its Signatera test is unlike any other in
development in that it is custom-made, using the excised cancer tissue
as a blueprint.
“We sequence the patient’s tumour,” says Alexey Aleshin, senior
medical director at Natera. “We then use that to design a bespoke assay
unique to each patient’s tumour that focuses on 16 of the most clonal or
truncal mutations.” Clonal mutations are those that occur early in the
tumour’s evolution and are consequently present in all the patient’s
cancer cells. Made to measure
This tumour-informed approach, as Natera calls it, is a pretty
involved process, but allows high levels of accuracy, Mr Aleshin says.
The test avoids picking up mutations that are not related to the tumour,
such as those that accrue in the bone marrow with age.
Exquisite accuracy is needed because of the postsurgical setting in which Signatera is used.
“In this space the patient’s cancer has been removed, so the levels
of circulating tumour DNA we need to detect are 0.01% up to maybe 1% at
the higher range,” Mr Aleshin says. This is one or two orders of
magnitude lower than the levels of ctDNA that tend to be seen in
advanced or even early-stage cancer patients who have not been treated
surgically. It allows the detection of minimal residual disease – the
cancer cells that remain after treatment and can cause relapse.
In a trial published last year,
in which Signatera was used to detect post-surgical disease recurrence
in breast cancer, suggested sensitivity and specificity of 89% and
100% respectively. Data presented at Asco suggested that the test identified patients at high risk of recurrence with near 100% specificity.
The intention here is to help doctors to decide whether to administer adjuvant chemotherapy. The ongoing Bespoke trial
is assessing whether Signatera can enable exactly this decision in
1,000 colorectal cancer patients. Results will not emerge for some
years.
Signatera is also used in Astrazeneca’s Columbia-2 study.
This is enrolling MRD-positive patients to examine whether the addition
of Imfinzi and various other therapies to adjuvant chemo can increase
cure rates.
Natera clearly believes that this personally tailored approach has
its advantages. But it also has a relatively high up-front cost, Mr
Aleshin acknowledges – though he adds that because it is used serially
to monitor response to treatment it becomes more economical over time.
It is sold as a lab-developed test in the US, and is also available
in Europe and beyond. Natera is working with the FDA for formal
approval. Off the peg
If Natera is focused on tailored tests, Guardant Health is chasing a
more one-size-fits-all approach. Or rather three sizes, as its chief
executive, Helmy Eltoukhy, explains.
“We’re one of the few liquid biopsy companies, maybe the only one,
that has active development programmes or products in each of the three
buckets of cancer care – early detection, cancer survivors in terms of
recurrence monitoring and adjuvant decision-making, and then the
late-stage market in terms of treatment selection,” he says.
Guardant’s Lunar-1 test is in the same setting as Signatera. The single-arm Pegasus trial
is looking at the feasibility of using Lunar-1 to guide the
post-surgical and post-adjuvant clinical management of colon cancer.
The phase II/III Cobra study
is more significant, evaluating whether using Lunar-1 in 1,400 subjects
with resected stage II colon cancer to help decide whether patients get
adjuvant chemotherapy improves recurrence-free survival.
Cobra will yield data in a couple of years, and its results in
particular could be extremely meaningful for Guardant – and, by
extension, for Natera.
Guardant also has the Lunar-2 programme, looking at screening for colon cancer. Data to be presented at AACR
this month show the test to have sensitivity of 90.3% and specificity
of 96.6%. These figures are pretty good, but with just 162 patients in
that cohort larger trials versus active control will be necessary before
the test is ready for prime time. Gold standard
“You have to compare to the existing standard of care,” Mr Eltoukhy
says. “It’s very difficult to get a physician to forgo use of a
guideline-recommended screening method, whether it’s a stool test,
colonoscopy, mammography, PSA, a low-dose CT scan, without seeing
head-to-head data with those specific modalities.”
That said, the company’s vast registrational Eclipse trial of Lunar-2 does not include a control group; any comparison with current screening would have to be against published data.
Guardant’s third liquid biopsy, Guardant360, is a pan-cancer assay to
help assign targeted therapy to late-stage patients. Data suggesting
that its use in detecting ARID1A mutations, found in around 11% of
colorectal tumours, could help oncologists decide whether to administer
Erbitux has a late-breaker slot at AACR. Studies in which the blood tests are used to guide treatment are vital, Mr Eltoukhy says.
“Prospective, randomised-control trials are the gold standard.
Anything retrospective means there may be some cherry-picking – there
may be some bias.” Guardant, unlike almost any other developer of cancer
blood tests, can afford to run these huge programmes because it is so
well funded. It floated in 2018, raising $273m
– still one of the 10 largest medtech IPOs in history. Its stock has
performed well, though the $315m equity offering it has just closed
knocked the shares slightly.
Guardant360 is already sold in the US as a lab-developed test, and is
the leading liquid biopsy in the US today, Mr Eltoukhy says, with
around 7,000 of the 10,000 oncologists in the US having ordered it.
Ultimately Guardant’s “tumour-naive” assays will likely sell better
than Natera’s tailored test. Guardant sold nearly 50,000 tests for
clinical use in 2019, plus more than 20,000 to pharma companies for use
in drug trials, with its revenues hitting $214m. Natera, and pretty much
all the other liquid biopsy developers, will have some catching up to
do. https://www.evaluate.com/vantage/articles/analysis/spotlight/how-best-develop-liquid-biopsy
The coronavirus pandemic hasn’t deterred investors of Atlas Venture, a
biotechnology-focused venture capital firm. On Friday, Atlas announced
its latest fund, which opened at the end of March, had closed with a
higher-than-expected yield of $400 million.
Atlas initially wanted to bring in $350 million from the fund, its 12th, according to partner Jason Rhodes.
But when the firm went out to fundraise, it was met with more than $1
billion in demand, which then pushed the fund toward a cap of $400
million. Rhodes said that the fresh money will be put into about 15
companies, and that his firm remains interested in areas such as
targeted cancer drugs, gene therapy and the central nervous system.
Atlas now joins Arch Venture, Flagship Pioneering and venBio
on the list of biotech venture firms and incubators that have closed
funds this year. Though considerably smaller than the billion-dollar
ones Arch and Flagship raised, Atlas’ fund completed in a little over
two months — and did so as COVID-19 disrupted the clinical research that’s vital for many young biotechs.
Yet, in spite of these disruptions, the pandemic’s impact on biotech
stocks was fleeting compared to the larger market. Venture-backed drug
companies have also continued to go public, which has kept firms and their investors optimistic about their ability to earn returns.
“While there are enormous parts of the broader economy … that have
been really adversely affected by the COVID-related lockdowns, biotech
is doing very well,” Rhodes said. “The fund flows are very strong by any
measure.”
Ned Pagliarulo / BioPharma Dive, market data
Atlas’ new fund could be reassuring to the biopharma venture
capitalists who feared the pandemic would make it harder to raise money
in 2020.
However, Rhodes said that the fund was backed almost entirely from
returning investors. As such, it doesn’t provide much clarity about
whether smaller firms conducting first-time funds will be able to find
cash as readily. In a recent interview, Bob Nelsen, managing director at
Arch, said he’d be surprised if any new, first-time funds raise money
this year.
For Atlas, the 12th fund adds to a string of activity from the last few years, which have been some of the best ever for biotech venture investing.
The firm closed its 11th fund three years ago, raking in $350 million.
Two years before that, in 2015, it raised $280 million through its 10th
fund. Atlas estimates it starts about 80% of the companies that receive
its investments, and so most of its fundraising goes into angel and seed
financing.
The firm also established in early 2019 a $250 million fund meant to
support its more advanced startups that had gotten to Series B or later
financing rounds.
Rhodes said these funds have performed “very well,” and pointed to
the continued interest from Atlas’ limited partners as evidence. He
noted that nine Atlas-backed biotechs have conducted initial public
offerings since 2018 and 15 were acquired since 2012. The list includes
Delinia, an autoimmune drug developer sold to Celgene for $300 million;
Rodin Therapeutics, a brain drug developer sold to Alkermes for $100
million; and Akero Therapeutics, a metabolic disease drug developer that
raised $98 million through a 2019 IPO.
Venture firms and their advisors generally expect biotech
acquisitions to continue, given that large pharmaceutical companies need
to refill their pipelines after years of shifting research priorities.
They’re also cautiously optimistic that the public markets will remain
excited about the scientific breakthroughs going on in biotech.
“It used to be that it wasn’t even like a boom-and-bust cycle,” said
Rhodes, who has worked in biotech since the 1990s. “You would have these
very occasional IPOs, and I always thought of it as raining in the
desert.”
“We’re now in a world where we’re regularly having whatever the
number is, 30 or more IPOs per year,” he said. “That reflects the
maturation of the biotech capital markets … and is just a very positive
thing for kind of innovation aspects of an economy.” https://www.biopharmadive.com/news/atlas-venture-biotech-fund-400-million/579254/
A judge ruled in favor of Teva
Pharmaceuticals Industries Ltd., and against Opiant Pharmaceuticals Inc.
and Emergent Biosolutions Inc., in a patent dispute related to Narcan
spray, Bloomberg Law reported Friday.
–Opiant shares fell 35% to $7.57 after hours, while Emergent was down 14% to $75. Teva rose 1.6% to $13.05
Legend Biotech, a Nanjing, China-based developer of cell therapies for cancer, is raising just over $420 million in an initial public offering, announcing Friday the pricing of 18.4 million shares at $23 apiece.
The biotech upsized the offering, or priced shares higher than it
had originally planned, a signal of high demand for an IPO. Its total
haul easily eclipses the year’s previous top IPOs, and marks the largest
initial offering in the sector since Danish firm Genmab’s offering in
July 2019.
Legend’s offering comes right after a multiple myeloma cell therapy it developed and licensed to Johnson & Johnson produced more encouraging results
at the American Society of Clinical Oncology’s yearly meeting. It was
also one of three biotech IPOs to price Thursday, which put the sector ahead of its 2019 pace despite economic disruption from the pandemic.
Legend Biotech, a subsidiary of Hong Kong firm GenScript, has become
increasingly known in U.S. biotech circles since cutting a deal with
Johnson & Johnson two and a half years ago.
In the December 2017 agreement,
J&J paid $350 million in upfront cash to acquire rights to a cell
therapy for multiple myeloma that had just turned heads at the year’s
biggest cancer meeting months earlier. The data set Legend’s CAR-T
treatment up to be a contender in an increasingly competitive race to
bring the cutting edge technology to multiple myeloma, a persistent and
deadly cancer of the bone marrow.
Since that time, Legend’s program has emerged as the primary
competitor to another CAR-T treatment from Bristol Myers Squibb and
partner Bluebird bio. In May, the FDA rejected an approval application
for the two companies’ cell therapy, known as ide-cel. Bluebird and
Bristol plan to resubmit their filing by the end of July, however, and
European regulators have since begun reviewing the product as well. That
keeps the two ahead of Legend and J&J, but their lead has narrowed.
In the meantime, Legend’s cell therapy, termed JNJ-4528 by J&J,
has continued to impress. The most updated results from an early stage
study, delivered at ASCO last month, showed that all 29 patients in the
trial — people who had failed several prior therapies — had responded to
treatment, and 25 of them had no trace of cancer after a median of 11.5
months of follow-up time. The results make JNJ-4528 “a major competitor
in relapsed/refractory multiple myeloma,” SVB Leerink analyst Mani
Foroohar wrote recently.
J&J plans to file the drug for approval in the U.S. in the second
half of this year, Craig Tendler, J&J’s vice president of oncology
clinical development, said in a recent interview. An application for approval in Europe is also expected this year, according to a regulatory filing from Legend.
Legend has now parlayed its success into the largest U.S. biotech IPO
of 2020, far outpacing the $274 million raised by Revolution Medicines
earlier this year. The IPO is the top initial biotech stock offering in
the U.S. since Danish antibody developer Genmab got roughly $580 million
in 2019. Legend’s haul could grow, as well, since underwriters have the
option to buy another 2,763,750 shares at the IPO price.
The cash will help Legend advance other CAR-T therapies for
additional blood cancers and solid tumors. Three of those programs are
in early testing in China, and all of them are “autologous” treatments,
meaning they are genetically engineered from the cells of cancer
patients in a lengthy, complex procedure.
Aside from the upfront check, Legend has gotten an additional $110
million in cash from J&J, and could get another $1.24 billion in
future payments if JNJ-4528 continues to progress.
Legend was one of three biotechs to price their first U.S. stock
offerings on Thursday, along with Applied Molecular Transport and
Calliditas Therapeutics. Another, Lantern Pharma, was expected to price
Thursday. There have now been 18 biotech IPOs in 2020, versus 17 by this
point in 2019. Another eight offerings, however, quickly followed
before the end of June 2019. https://www.biopharmadive.com/news/legend-biotech-ipo-car-t-multiple-myeloma/579291/
Japanese industrial conglomerates Hitachi Ltd and Toshiba Corp will join with Miraca Holdings
to increase production of antigen-based coronavirus tests, aiding in
the country’s effort to screen more people for the new virus.
The alliance will double production of Miraca subsidiary Fujirebio’s
testing kits, which received government approval in May, to 400,000 a
week, the three companies said in a joint statement on Friday.
A new plant to make the kits will be established in Hokkaido
prefecture, Japan’s northern island, and will start operations by
December.
Larger output of antigen tests, designed for rapid detection of the
virus, will help Japan do more surveillance of the virus. Japan is far
behind many industrialised nations in testing for the virus, which
critics say obscures the true scale of infection.
“We believe we can contribute in providing a system that enables
prompt testing should second and third waves come,” a Miraca spokeswoman
said.
Antigen tests scan for proteins found on or inside a virus, and
typically test a sample taken from the nasal cavity using swabs. The
tests can detect the virus quickly but produce false negatives at a
higher rate than the currently dominant polymerase chain reaction (PCR)
tests.
It takes about 10 to 30 minutes to get a result with Fujirebio’s
palm-sized antigen test kit, Miraca said, compared with four to six
hours for a PCR test. Miraca does not disclose the false negative rate
for the kits.
In a rare partnership, Hitachi will provide engineering know-how,
while Toshiba will offer facilities. Fujirebio currently produces test
kits at a plant in southern Japan.
The coronavirus has infected more than 6.6 million people and killed
about 391,000 around the world. Japan has had about 17,000 infections
and 910 known deaths to date. https://www.marketscreener.com/MIRACA-HOLDINGS-INC-6494293/news/Hitachi-Toshiba-Miraca-to-set-up-factory-for-coronavirus-antigen-tests-30725830/
Telehealth giant Amwell is reportedly preparing to go public on the
heels of raising almost $200 million in funding amid widespread
enthusiasm for telehealth.
The 14-year-old vendor confidentially filed for an IPO earlier this
week, hiring Goldman Sachs and Morgan Stanley to lead the deal, according to CNBC. The IPO could take place in September, CNBC sources say.
An Amwell spokesperson declined to confirm or deny reports of an IPO
to Healthcare Dive, but the timing would be good for the company amid
surging demand for virtual care and lowered regulatory barriers brought
on by the COVID-19 pandemic.
Rumors have bubbled for months that Boston-based Amwell was exploring
an IPO as more patients look to receive low-acuity medical care in the
home amid the pandemic, sparking a seismic shift in healthcare delivery.
The company has seen a 1,000% increase in video visits due to
COVID-19, but it’s closer to 3,000% to 4,000% in some cases, Amwell CEO
Roy Schoenberg told Healthcare Dive earlier this year.
The vendor in May raised $194 million
in a Series C funding round to build out its telehealth offerings,
bringing its total funding to $711 million across eight rounds. Major
investors include Anthem, Philadelphia-based Jefferson Health and
Japanese pharma Takeda.
Along with rebranding from “American Well” to Amwell in early March,
the company has introduced new offerings amid the pandemic, including
one for physician practices with fewer than 100 doctors, a national COVID-19 response program and COVID-specific workflows.
Its clients include 240 health systems, including giants like
Cleveland Clinic, Salt Lake City-based Intermountain Healthcare and
NewYork-Presbyterian, and 55 health plans including 36,000 employers.
Telehealth providers have been struggling to meet patient demand as
more and more healthy individuals look to screen symptoms and connect
with doctors without going to an office or hospital, where they could
spread or potentially contract COVID-19. The Trump administration has
pared back restrictions to telehealth since March, also bolstering
sustained growth in the sector.
Though coping with a flood of patients hasn’t been cheap,
digital health players have seen their stock prices soar. Shares of
rival Teladoc, which went public in 2015, are up almost 90% since the
end of 2019, while remote monitoring and chronic care management company
Livongo has doubled its stock price.
Some analysts expect telehealth use to flag in the second half of
2020 if the coronavirus loses steam, but others maintain tailwinds could
persist for the next 12 to 18 months at least, until a vaccine is
widely available, giving digital care players plenty of time to saturate
the market.
Up to $250 billion of healthcare spend could be digitized, according to consultancy McKinsey
— roughly a fifth of all estimated Medicare, Medicaid and commercial
outpatient, office and home health spending for 2020. In comparison, the
sum annual revenues of all U.S. telehealth companies were estimated at
$3 billion prior to the pandemic. https://www.healthcaredive.com/news/amwell-files-for-ipo-report/579290/
