Top Stories for Week of August 10, 2020

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Pfizer to help manufacture Gilead’s remdesivir for COVID-19.

Pfizer Inc. (NYC) on Friday said it inked a multiyear agreement to make COVID-19 treatment remdesivir for developer Gilead Sciences Inc. (Foster City CA), which is under pressure to increase tight supplies of the antiviral drug. Gilead is aiming to make enough of the drug by the end of the year to treat more than two million COVID-19 patients and agreed to send nearly all of its remdesivir supply to the US through September, Reuters reports.

But hospital staffers and politicians have complained about difficulties in gaining access to the drug, which is one of only two to have demonstrated an ability to help hospitalized COVID-19 patients in formal clinical trials. There are also fears of shortages outside the US. Gilead said its manufacturing network for the drug had grown to more than 40 companies in North America, Europe and Asia to add capacity.

Earlier last week, a bipartisan group of US state attorneys general urged the federal government to allow other companies to make Gilead’s remdesivir, to increase its availability and lower the price of the antiviral drug. Pfizer will provide contract manufacturing services through its McPherson, KS, plant, the drugmaker said. It was not immediately clear if Pfizer would supply only the US market.

Pfizer has helped other drugmakers manufacture their products before. It makes Epipen emergency allergy treatments through its Meridian Medical Technologies business and also operates a contract manufacturer called Center One. Pfizer, with Germany’s BioNTech SE (Mainz), is also rushing to develop a vaccine against the coronavirus.

Separately, according to Johns Hopkins Medical, as of Saturday, Aug. 8, there were over 19.4 million COVID-19 global cases confirmed, and some 723,000 deaths. Confirmed cases in the US totaled 5 million with nearly 162,000 deaths. Both of the US figures comprise 26% and 22%, respectively, of the global totals. The US death toll is more than twice as high as that of the country with the second-highest death rate, Brazil. That South American country has reported more than 57,600 deaths, according to Johns Hopkins’s global case count. Leaders in both countries have continued to downplay the severity of coronavirus.

COVID-19 Addenda: More than 160,000 people have died from the coronavirus pandemic in the US, nearly a quarter of the global total, according to a Reuters count on Friday, as the country debates whether schools are ready to reopen in coming weeks. The country recorded 160,003 deaths and 4.91 million cases, the highest caseload in the world. Public health experts have voiced concern for weeks that Americans in some quarters were resisting wearing masks and maintaining safe social distances. Coronavirus deaths are rising in 23 states and cases are rising in 20 states, according to a Reuters analysis of data the past two weeks compared with the prior two weeks. On a per-capita basis, the US ranks 10th highest in the world for both cases and deaths.

A new poll finds just 31% trust Trump on coronavirus. That’s fewer than 1 in 3 Americans who said they trust President Trump on the coronavirus pandemic, according to new polling from NBC News. The NBC News-SurveyMonkey weekly tracking poll found 58% of Americans do not trust the president on the pandemic, compared to 31% who say they do trust him. By comparison, 51% of adults said they trust statements on the virus by Anthony Fauci, the nation’s top infectious diseases specialist. A larger majority, 55%, said they trust the Centers for Disease Control and Prevention (CDC) on the virus. Twenty-nine percent of Americans said they distrust Fauci on the virus, while 32% said they do not trust the CDC. (Ref: The Hill)

FDA Commissioner Stephen Hahn attempted once again to reassure the public about FDA standards on vaccine approval. Amid growing concerns that Americans–especially the most vulnerable populations–will hesitate to get a COVID-19 vaccine, Hahn is appealing to the public directly in an attempt to assuage any worries. “No matter what, only a safe, effective vaccine will get our approval,” reads the title of his op-ed published in the Washington Post. The unusual move highlights the intense spotlight now cast on FDA regulators.

Once Phase 3 results are out, they will be (as Hahn puts it) the final arbiters of whether a vaccine is indeed safe and effective enough to be given to large populations. Hahn reiterated the previously disclosed threshold for authorization or approval: Any candidate would need to show that it prevents the disease or its severity in at least 50% of people who are vaccinated–a standard he called reasonable given the pandemic.

The state of New York, which includes the nation’s largest school district in New York City, on Friday authorized reopening schools, as long as cases remain stable and schools undertake proper COVID-19 infection control procedures. New York City’s school system has more than one million students; city officials had previously said they hoped to reopen on a so-called hybrid model, with children attending in person up to three days per week and via remote learning the other days.

“Every region is well below our COVID infection limit, therefore all school districts are authorized to open,” Gov. Andrew Cuomo (D) wrote in a tweet. “If the infection rate spikes, the guidance will change accordingly.”

Cuomo added that school districts are required to submit their plans to the state’s departments of health and education for review, which includes contact tracing plans, their district’s plans.

For a world crippled by the coronavirus, deliverance hinges on a vaccine. But in the US, where nearly 5 million people have been infected and over 162,000 have died, the promise of that vaccine is impeded by a perplexing epidemic that long preceded COVID-19: obesity. Scientists know that vaccines engineered to protect the public from influenza, hepatitis B, tetanus and rabies can be less effective in obese adults than in the general population, leaving them more vulnerable to infection and illness. There is little reason to believe, obesity researchers say, that COVID-19 vaccines will be any different, Medscape reports. More than 107 million American adults are obese.

And UK biotech Oxford Nanopore Technologies Ltd. has launched a portable test that can detect both COVID-19 and seasonal flu viruses in saliva or swabs in a little over an hour. The quick output of Oxford Nanopore’s test, called LamPORE, is expected to be a huge improvement on existing polymerase chain reaction (PCR) tests, considered the gold standard in confirming COVID-19 cases, which typically take about a day to produce results and only look for a single pathogen, says

“The advent of new, faster tests could help considerably, provided that we are able to get accurate tests to where they are most needed,” Billy Palmer, a senior fellow at the UK health think tank Nuffield Trust, said.

Regeneron says antibody cocktail prevents and treats COVID-19 in animals; Q2 results also brighten future.

Regeneron Pharmaceuticals Inc. (Tarrytown NY) COVID-19 antibody cocktail has moved into the next stage of testing, the company announced last week. REGN-COV2 is being studied in both the treatment and prevention of COVID-19 and its symptoms. The treatment portion is moving into the Phase 2/3 stage while the prevention study is entering Phase 3. In a call with investors reporting second quarter financials, Regeneron executives elaborated on these topics, saying the company is conducting four overall trials for the cocktail.

The four trials separately involve: hospitalized COVID-19 patients; an ambulatory study in outpatient COVID-19 diagnoses; individuals whose household contacts have become infected; and healthy volunteers. Regeneron hopes to have data available by the end of September, and NIAID is jointly running the study regarding household transmission.

Regeneron CEO Leonard Schleifer discussed how the product can provide passive immunization in light of recent data on antibody cocktails possibly proving more effective than vaccines.

“In the setting of until there’s a vaccine, if this comes first that would be great,” Schleifer said. “But even after this vaccine, there will be many people who are not vaccinated or whose vaccination effects wore off and they got ill or even if they were vaccinated, they didn’t get enough of a response.”

Early last month, Regeneron received $450 million in BARDA funding to help cover bulk delivery of the cocktail beginning in the late summer.

In stark contrast to many drugmakers registering second-quarter declines, Regeneron pulled off a 24% revenue increase on the strength of Eylea and Dupixent sales, as well as a US government supply deal for its COVID-19 antibodies. Eye med Eylea brought in $1.11 billion in second-quarter US sales, a 4% year-over-year decline as a result of COVID-19, but still beat expectations lowered by pandemic frustrations. Ophthalmology is among the therapy areas suffering most from COVID-19 lockdowns, as evident in a 25% sales drop that one Eylea rival–Novartis AG and Roche Holding AG’s Lucentis—recorded for Q2. But Eylea outperformed the overall anti-VEGF field with continued share gains.

Novavax touts latest positive snapshot of early-stage COVID-19 vaccine.

A potential COVID-19 vaccine from the biotech company Novavax Inc. (Gaithersburg MD) showed a promising immune response in a small, early trial, but not without a high rate of mostly mild side effects. The results, published last week, are the latest encouraging sign in the global effort to develop a vaccine for the novel coronavirus. But the Novavax data, much like results recently published by Moderna Inc. (Cambridge MA) and AstraZeneca PLC (London), are too preliminary to draw any conclusions about how well the vaccine might protect against COVID-19, experts said.

“It’s a small number of people in each arm, and the study wasn’t designed to demonstrate efficacy, which are the standard caveats for a Phase 1 trial,” said Edward Belongia, an epidemiologist and vaccine researcher at the Marshfield Clinic Research Institute in Wisconsin. “Having said that, it looks very promising–at least as promising if not more so than the other vaccines we’ve looked at.”

The data were published on a preprint server, meaning they have not yet been peer-reviewed, STAT News explained.

Novavax enrolled about 130 healthy volunteers in its trial and gave them either a placebo or one of four escalating doses of its vaccine. Everyone who received the vaccine developed neutralizing antibodies against SARS-CoV-2, which may help prevent infection. The best responses came from volunteers who received two injections of Novavax’s vaccine three weeks apart, plus an adjuvant meant to boost its effects. After 35 days, those participants had neutralizing antibody levels that, on average, were roughly four times higher than what was seen in a group of 32 patients who had recovered from the disease. About 80% of those volunteers had side effects at the site of injection, including pain and tenderness. More than 60% had other side effects, mostly headaches, muscle pain, and fatigue. Most reactions were mild or moderate. All of the reactions resolved after a few days, and none was life-threatening.

Whether the vaccine’s demonstrated effect on neutralizing antibodies will protect people from COVID-19 remains unclear. Scientists are still mapping out the underlying mechanisms that drive immunity to SARS-CoV-2. It’s also impossible to directly compare Novavax’s product, NVX-CoV2373, against other vaccines in development, said Kathryn Edwards, scientific director of the Vanderbilt Vaccine Research Program in Nashville, TN. Novavax shares closed the week up 19% at $170.29.

IPO Sector: Checkmate Pharmaceuticals Inc., a clinical stage immuno-oncology biotech developing therapies for solid tumors, raised $75 million by offering 5 million shares at $15, within the range of $14 to $16. Checkmate initially filed for an IPO on July 17, then raised its maximum offering price to $92 million in an amended S-1 filing. The immuno-oncology biotech is investigating its drug CMP-001 across multiple cancers, including melanoma and head and neck squamous cell carcinoma (HNSCC), and says it will use the funds to advance clinical trials. CMP-001 uses the immune system to its advantage, directing activated anti-tumor T cells to attack both the injected tumor and tumors throughout the body. It’s been tested on more than 200 melanoma patients to date, and based on clinical data, the company believes “there is an opportunity for CMP-001 to be developed as a differentiated immuno-oncology therapy,” according to the S-1 filing. Checkmate lists on the Nasdaq under the symbol “CMPI.” BofA Securities, Jefferies and BMO Capital Markets acted as lead managers on the deal. Shares closed the week off 7% at $14.

Elsewhere, Acutus Medical Inc., which manufactures devices for electrophysiological mapping to treat arrhythmias, raised $159 million by offering 8.8 million shares at $18, the high end of the range of $16 to $18. The company offered 1.5 million more shares than anticipated. Certain existing shareholders indicated on $45 million of the IPO (28% of the deal). At pricing, the company commands a fully diluted market value of $509 million. The company’s diverse product portfolio includes its foundational product, the AcQMap imaging and mapping system. Early versions have been available in the US since May 2018 and in Western Europe since July 2016, though it fully commenced the launch of its commercial-grade console and software products in the 1Q20. Acutus Medical was founded in 2011 and booked $4 million in revenue for the 12 months ended March 31, 2020. Acutus Medical lists on the Nasdaq under the symbol “AFIB.” J.P. Morgan, BofA Securities and William Blair acted as lead managers on the deal. Shares closed the week up 49% at $26.79.

PainReform Ltd., a Phase 2 Israeli biotech developing therapies for post-operative pain relief, announced terms for its IPO. The Herzliya, Israel-based company plans to raise $23 million by offering 2.6 million shares at a price range of $8 to $10. At the midpoint of the proposed range, PainReform would command a fully diluted market value of $82 million. The company’s lead candidate and first product, PRF-110, is based on the local anesthetic ropivacaine, targeting the post-operative pain relief market. In a small 15 patient Phase 2 proof-of-concept trial for herniorrhaphy, PRF-110 provided substantial pain reduction for up to 72 hours post-op. The company plans to initiate two Phase 3 trials for PRF-110 soon after the closing of this offering. PainReform was founded in 2007 and plans to list on the Nasdaq under the symbol “PRFX.” Maxim Group LLC and Joseph Gunnar are the joint bookrunners on the deal.

Oak Street Health Inc., which operates primary care health facilities for Medicare patients in the Midwest, raised $328 million by offering 15.6 million shares at $21, above the upwardly revised range of $19 to $20. The company originally planned to offer the same number of shares at $15 to $17 before increasing the range. At pricing, the company commands a fully diluted market value of $5.0 billion. The company employs 260 primary care providers and 54 health centers, in 13 markets across eight states, which provided care for approximately 85,000 patients as of March 31, 2020. The Chicago-based firm was founded in 2012 and booked $641 million in revenue for the 12 months ended March 31, 2020. It lists on the NYSE under the symbol “OSH.” J.P. Morgan, Goldman Sachs, Morgan Stanley, William Blair and Piper Sandler acted as lead managers on the deal. Shares closed the week up 86% at $39.

Freeline Therapeutics Inc., a Phase 1/2 biotech developing gene therapies for hemophilia and rare diseases, raised $159 million by offering 8.8 million shares at $18, the high end of the range of $16 to $18. The Stevenage, UK-based company offered 1.5 million more shares than anticipated. At pricing, Freeline Therapeutics commands a fully diluted market value of $636 million. Its AAV gene-therapy treatments target hemophilia A and B, Fabry disease, and Type 1 Gaucher disease. The biotech’s lead candidate, FLT180a, is currently in a Phase 1/2 trial for hemophilia B. IPO funds will propel the company’s pipeline, including Phase 1/2 trials for FLT180a and FLT190, a potential drug to treat Fabry disease. Freeline Therapeutics lists on the Nasdaq under the symbol “FRLN.” J.P. Morgan, Morgan Stanley, Evercore ISI and Wedbush PacGrow acted as lead managers on the deal. Shares closed the week unchanged at $18.

And ARYA Sciences Acquisition III Corp., the third healthcare-focused blank check company formed by Perceptive Advisors, raised $130 million by offering 13 million shares at $10. Unlike an ordinary SPAC, the company did not offer units with warrants attached. In March, Arya I merged with biotech Immatics in a $252 million deal. Cerevel Therapeutics merged with Arya II in July, expecting to raise about $445 million to develop its pipeline. The company is led by Chairman Joseph Edelman, founder of Perceptive. The team’s first SPAC, ARYA Sciences Acquisition, completed its acquisition of Immatics Biotechnologies in July 2020. ARYA Sciences Acquisition III lists on the Nasdaq under the symbol “ARYA.” Jefferies and Goldman Sachs acted as lead managers on the deal. Shares closed the week up 4% at $10.44.

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