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/
Tenet is preparing for potential lawsuits from patients claiming they
caught the coronavirus at one of its hospitals. A New York nursing
union is suing hospitals claiming inadequate protection for workers on
the front lines.
Providers are grappling with a host of novel legal concerns like
these as they treat patients amid the COVID-19 pandemic, leading them to
seek protections from various levels of government.
From decisions over what qualifies as elective surgery to navigating
near-daily CMS updates and fears of doctors claiming unsafe working
conditions, doctors and hospitals have little precedent to go on.
“This is such an unknown area,” Damaris Medina, co-chair of the life
sciences practice at law firm Buchalter, told Healthcare Dive. “It’s
really hard to predict what’s going to happen in terms of litigation.”
Hospitals and physician groups are taking unprecedented economic hits
and many have furloughed or laid off staff as they try to weather the
storm. That could leave them even more unprepared for legal issues that
arise, as they almost inevitably will.
“It’s just a horrible, difficult situation, and there’s not a lot of
easy answers here,” Douglas Grimm, healthcare practice co-leader at
Arent Fox, told Healthcare Dive. “I’m not sure we’ve experienced
something like this before. In fact, I know we haven’t.”
Potential immunities
Provider groups are pushing Congress to include some immunity for
those treating COVID-19 patients in relief legislation. The four bills
signed into law so far have only extended protections for medical
volunteers.
It could be an uphill battle. The last bill approved in the
Democratic-controlled House, panned by Republicans in the Senate and the
president, does not include any immunity language.
Senate Majority Leader Mitch McConnell and fellow Republicans have
said they want future legislation to provide broad-based liability
protections to businesses that could face lawsuits from employees or
customers who say they became infected with COVID-19 on their premises.
McConnell opposes other provisions in the Democrats’ bill such as
extending enhanced unemployment insurance and additional direct payments
to citizens.
Mike Stinson, vice president of government relations and public
policy for the Medical Professional Liability Association, which
represent liability insurance providers and supportsthe creation of federal legislationproviding a form of immunity, contends the idea has broad support.
“Right now, I think there’s fairly unanimous consent that liability
protections for healthcare providers are necessary and appropriate,” he
said. “We’re not hearing a lot of pushback on that, depending on what
the scope is going to be.” https://www.healthcaredive.com/news/covid-19-creates-thicket-of-legal-concerns-for-providers/578764/
After vaccines and antiviral approaches to tackling the Covid-19
pandemic, it’s time for antibodies to take their turn in the spotlight.
This week Lilly seized the lead in this space, starting the first
clinical trial of an antibody designed to treat the novel coronavirus.
LY-CoV555, derived from a deal with Abcellera, targets Covid-19’s
Spike protein, meaning that unlike projects aiming to reduce the
infection’s complications it takes direct aim at the virus itself. While
at present this is the only clinical-stage antibody against Covid-19,
it will not retain this monopoly for long.
The Spike protein-targeting approach is similar to that of several of
Lilly’s competitors. The protein is present on the virus surface, and
the virus uses it to dock with the Ace2 receptor on target cells,
allowing it to be internalised and infect.
The next project into the clinic with this mechanism could come from
Vir’s partnership with Glaxosmithkline, which has so far identified two
lead MAbs. Also keenly awaited are a multi-antibody cocktail from
Regeneron, and a project under way at Astrazeneca, all of which could be
studied in patients within the next few months.
The hope is that these antibodies can prevent the virus docking, or
hit another part of it that leads to antibody-mediated destruction.
The last two are noteworthy because they are based in part on plasma
derived from patients who have recovered from Covid-19 infection. This
approach, it might be surmised, could provide a broader range of
targets, some of which might provide a more efficient way of targeting
the virus than hitting the Spike protein.
Selected antibodies and related biologicals in development for Covid-19
Note: excludes anti-IL6, anti-GM-CSF and other MAbs not directly targeting Covid-19.
The Spike protein is also used as the target for most of the
industry’s vaccine approaches seeking to prime the immune system, and
indeed Regeneron has suggested that REGN-COV2 could also have a
prophylactic role.
And there are other biologicals already in clinical development, such
as MAbs against cytokines, GM-CSF and angiopoietin 2, but these are not
considered here as they aim to treat the effects of Covid-19, such as
cytokine elevations and respiratory complications, rather that the virus
itself. Design
Though many projects have the same target in common, there is additional variability in antibody structure.
For instance, while most are based on IgG, a tie-up between Atreca,
Beigene and IGM Biosciences is looking at those derived from IgM and
IgA, which, the companies argue, have more binding domains and hence
greater binding power than IgG.
A separate tie-up Vir has with Xencor looks to develop MAbs with an
engineered Fc domain to give an extended half-life, and a similar
thinking lies behind the so-called Darpins in development by Molecular
Partners.
There are also bispecific approaches and fusion proteins, for
instance SI-F019, in development by Systimmune, a private US group
focusing on MAbs, bispecifics and antibody-dug conjugates. This combines
two proteins each mimicking Ace2, aiming to take up the relevant
binding sites on Covid-19 and prevent its interaction with the
endogenous Ace2 receptor.
While many companies are making claims about the superiority of their
respective approaches, these are of course all based on animal or in vitro data, and no comparison will be possible until the first clinical trials read out.
After Lilly’s clinical study, primarily testing safety,
pharmacokinetics and pharmacodynamics, the designs of competitor trials
will be watched with interest. https://www.evaluate.com/vantage/articles/news/trial-results/here-come-anti-covid-antibodies
