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Monday, June 15, 2020

U of Illinois to test Moderna’s COVID-19 vaccine in older, minority populations

The University of Illinois at Chicago will conduct a study of Moderna’s experimental COVID-19 vaccine, focusing on older patients and minority groups, which are at high risk of infection, the Chicago Sun-Times reported.
The trial, part of the federal government’s Operation Warp Speed, will include at least 1,000 people and is set to begin July 9. At least 400 people will be 65 or older, and researchers are hoping to test a large number of African American and Latino residents, both groups that are at a high risk of infection and death. They’re also hoping to test people working in warehouses and manufacturing sites, places with high risk of the virus spreading.
Researchers aim to determine if the vaccine is effective in preventing COVID-19 and severe COVID-19 illness, according to the Sun-Times.
The trial is scheduled to last two years, but researchers said that if the vaccine proves to be effective by the end of this year or in early next year, it could be approved for use in 2021.
Study participants will be given a shot at the beginning of the trial and another a month later, with half receiving the vaccine and half receiving a placebo.
UIC is one of several sites in the U.S. that will test Moderena’s vaccine, and more than 30,000 people are expected to enroll in the trials, the Sun-Times reported.
https://www.beckershospitalreview.com/pharmacy/u-of-illinois-to-test-moderna-s-covid-19-vaccine-in-older-and-minority-populations.html

Stocks rise after Fed expands stimulus

Stocks erased earlier losses and rose Monday, after the Federal Reserve said it would begin purchasing individual corporate bonds as part of its emerging lending program to inject liquidity into the virus-stricken economy.
Earlier in the session, the Dow was off as many as 762 points, or 3%, as investor jitters over rising coronavirus cases in key parts of the country stirred up an extension of last week’s pullback in equities.
Last week, stocks posted their first weekly loss in a month, with a steep selloff on Thursday comprising much of the weekly decline. The plunge, which came on the heels of a more than 40% run-up in the S&P 500 since March, came after new data showed rising coronavirus case and hospitalization counts in states that were among the first to reopen businesses, and after the Federal Reserve last week delivered a grim forecast for near-term economic activity.
Market participants continued to eye coronavirus cases across the country for signs of resurgences. New cases in the densely populated state of Florida grew faster than the past week’s average as of Sunday’s tally, according to Bloomberg data, and Washington State Department of Health issued a report warning of statewide increases in the virus.
In New York, the daily coronavirus death toll came in at 23 as of Sunday, or the lowest since the pandemic began and well below the near 800 per day at the outbreak’s peak in early April. Governor Andrew Cuomo, however, flagged that more than 25,000 complaints had been filed over violations of social distancing standards, and Cuomo warned he would tighten restrictions if businesses and individuals did not comply with the phased reopening process.
Still, some analysts maintained that geographies that have been slower to reopen including the Northeast, were less at risk of a renewed flare-up in cases, given their more protracted original lockdowns.
“We are not worried that the renewed lockdowns we expect in parts of Arizona, Texas, the Carolinas, Arkansas, and perhaps others, will be required elsewhere,” Ian Shepherdson, chief economist for Pantheon Macroeconomics, said in a note. “Far more people have been sick in the densely populated Northeast and Midwest than in most of the South, and lockdowns in major cities have been very long and painful.”
“Accordingly, we’re expecting people in the Northeast and Midwest to be much more cautious about maintaining social distancing, and to be more willing to wear masks in stores, on public transportation and at leisure facilities,” he added.
Meanwhile, White House economic director Larry Kudlow during CNN’s “State of the Union” on Sunday downplayed economic concerns posed by potential new waves of the coronavirus, saying, “There’s a very good chance you are going to get the V-shaped recovery,” and asserting growth would pick back up in the second half of the year. The remarks contrasted with some of the more cautionary outlooks from officials including Federal Reserve Chair Jerome Powell, who last week underscored the ongoing uncertainty created by the pandemic.
Kudlow also said the current $600-per-week unemployment payment paid out to some Americans who had lost their jobs during the pandemic as part of Washington’s sweeping coronavirus relief plan would end on schedule at the end of July, calling the program “a disincentive” for people to return to work.
Later this week, market participants are poised to receive new economic data on the retail trade and manufacturing sectors, which many economists believe will affirm an at least slight pick-up in activity from the doldrums of April.
Stocks rose and the Dow added more than 200 points, after the Federal Reserve said it will purchase individual corporate bonds that meet their criteria under the central bank’s Secondary Market Corporate Credit Facility. Previously, the Fed had been purchasing just exchange-traded funds under this facility.
The new program will include an index “made up of all the bonds in the secondary market that have been issued by U.S. companies that satisfy the facility’s minimum rating, maximum maturity, and other criteria. This indexing approach will complement the facility’s current purchases of exchange-traded funds,” the Fed said in a statement.
https://finance.yahoo.com/news/stock-market-news-live-june-15-2020-222141593.html

Germany stakes its claim over Curevac

The German government will not get exclusive access to Curevac’s Covid-19 vaccine as part of its 23% stake purchase, the company insists.
Perhaps there was some truth behind reports of a strategic Covid-19 vaccine deal between the Trump administration and the German biotech company Curevac, resoundingly denied three months ago. The German government has bought a 23% stake in the mRNA researcher for €300m ($338m), it was revealed today.
The investment is not tied to any sort of exclusive access or supply arrangement over Curevac’s Covid-19 vaccine candidate, the company’s finance director, Pierre Kemula, told Evaluate Vantage. However it seems likely that alarm at the highest levels at the implications of such an arrangement – real or otherwise – had helped persuade the German government into this move.
“When Covid-19 appeared we had meetings with the government and said we could do with some support,” Mr Kemula said. The investment was “triggered by Covid, but it is not related to Covid directly”.
He did not rule out deals that might involve access in the future – for example when it comes to figuring out how to fund the large and expensive trials that will be required to test the company’s vaccine candidate thoroughly. For now, however, the government will remain a large shareholder, but with not have a board seat or a say over the company’s strategic direction.
Curevac’s mRNA-based vaccine candidate is poised to start trials in healthy volunteers. Speculation that the company’s former chief executive had talked about an exclusive supply agreement with the US sparked uproar in Germany back in March, and upheaval at the company (Crisis, what crisis? Curevac denies everything, March 17, 2020)
Long-term thinking
The €300m investment, which will be made via the country’s state-owned development bank, Kreditanstalt für Wiederaufbau, is a first for Germany. Partly it has been driven by a realisation that the country’s healthcare sector needs supporting; this has not “shined as brightly” as other parts of the economy, Mr Kemula said.
The money will be used to support Curevac’s research into various disease areas, but it seems clear that the German government is thinking both long and short term here. In a press release on the deal a German minister acknowledges that the Covid-19 pandemic has made securing medical supply chains a national security issue.
What the deal says about Curevac’s valuation is another question. The terms put the company’s worth at €1.3bn. This sounds low: an earlier financing was said to have been done at a $1.7bn valuation, and the market caps of mRNA peers Moderna and Biontech are substantially higher.
Mr Kemula declined to discuss what the company might be worth, but pointed out that its lead project, a prostate cancer vaccine, failed in early 2017. Such an event would certainly knock a valuation, although the subsequent revival in interest in mRNA would surely have helped Curevac to recover since then.
Either way, the company’s majority shareholder, the serial German biotech investor Dietmar Hopp, apparently supports the new financing. His 80% stake will be diluted accordingly.
As a decades-long and very generous backer of the country’s biotech scene Mr Hopp has always exhibited an ability to look long term. And, from his point of view, welcoming a deep-pocketed new partner to the party on generous terms could pay dividends in the future.
https://www.evaluate.com/vantage/articles/news/deals/germany-stakes-its-claim-over-curevac

ADA 2020 – Medtronic leads Insulet, but things could change

Medtronic’s newest closed-loop system posts decent pivotal data, but Insulet and Abbott are waiting in the wings.
This weekend’s data on the latest iteration of Medtronic’s artificial pancreas look good enough to secure US approval. The question is whether the MiniMed 780G controls patients’ blood sugar as well as rival technologies, and could thus allow Medtronic to slow the decline of its market share.
And today’s US market clearance of the long-awaited next generation of Abbott’s continuous glucose monitor ups the ante. The FreeStyle Libre 2 is one of the most effective blood sugar sensors available and also one of the cheapest, and could soon be available as part of a closed-loop system with Insulet’s Omnipod 5 insulin pump, impressive data on which also emerged on Friday.
Medtronic’s 780G was CE marked last week, but must still prove its worth to the US regulator. In the pivotal trial, data from which were presented at the virtual annual meeting of the American Diabetes Association on Friday, the device allowed type 1 diabetes patients’ blood sugar levels to remain in the safe range of 70-180mg/dl 75% of the time.
The trial had no control group, but all study subjects had previously been using either Medtronic’s earlier version of the system, the MiniMed 670G, or a different sensor-augmented pump. Comparing patient’s achievements at the end of the study with their baseline stats gives an indication of sorts of the 780G’s performance.
The patients did improve; unfortunately many of the improvements were marginal. Perhaps the most positive finding was that the amount of time the participants were happy to leave their device in auto mode jumped from 33% to 95%. In the pivotal trial of the 670G this was 87%, though likely lower in real life. Stifel analysts say this is a critical improvement over the 670G.
Minimed 780G pivotal data
  Baseline Trial results
Time in range 68.8% 74.5%
Time in auto mode 33.4% 94.8%
Time in hypoglycaemia 4.1% 2.8%
Time in hyperglycaemia 34.1% 27.7%
Average A1C 7.5% 7.0%
Source: ADA 2020 Presentation.
The time in range is better than seen with some other artificial pancreas technologies, but not by much. The combination of Tandem Diabetes Care’s t:slim X2 insulin pump with Dexcom’s G6 continuous glucose monitor kept patients in range 71% of the time. And this system does not require patients to test their blood sugar with daily fingersticks for calibration, whereas Medtronic’s system requires maybe four or five of these each day.
Another rival technology whose performance must be considered is Insulet’s Omnipod 5. Formerly called the Omnipod Horizon, this insulin pump is intended to work with glucose sensors from Abbott and Dexcom – including the former’s newly available Freestyle Libre 2 (Collaborative diabetes tech on the Horizon, February 20, 2020).
The pivotal trial of the Omnipod 5 was halted in March to allow Insulet to correct a flaw in the software that could have caused the system to deliver the wrong quantity of insulin, though at the time no adverse events had been reported due to this issue. The trial resumed just over a week ago and ought to report towards the end of this year.
The ADA data come from a small, single-arm study. In 18 adults, time in range improved from 66% at baseline to 73%; in the 18 children in the trial this jumped from 51% at baseline to 65%. Patients had the device in auto mode 97% of the time, which Stifel analysts called “very impressive”.
Better and cheaper
If Insulet’s system can repeat this kind of performance in its pivotal trial approval, a planned launch in the first half of next year, is all but assured. Following that, a combination closed-loop system incorporating Abbott’s CGM is intended to follow.
The first version of the Freestyle Libre is the bestselling CGM in the US thanks in large part to its relative cheapness. Abbott said today that the Libre 2 will be sold at the same price as its forerunner, preserving this advantage, but it also has potentially best-in-class accuracy, and a paediatric indication. This label could meaningfully expand Abbott’s market in the US when the device is launched in late summer.
By the time any an artificial pancreas incorporating Omnipod 5 and Libre 2 reaches market, the 780G will likely have already been on sale for a year or more. Medtronic must make the most of this, because on current showing it does not have the technological edge.
https://www.evaluate.com/vantage/articles/news/trial-results/ada-2020-medtronic-leads-insulet-things-could-change

Provention Bio up 11% on positive teplizumab data

Provention Bio (PRVB +10.6%) is up on a 4x surge in volume in reaction to follow-up data from a Phase 2 study, “At Risk” TN-10, evaluating teplizumab for preventing/delaying the onset of type 1 diabetes (T1D) in relatives of type 1 diabetics deemed “at very high risk” of developing the condition.
Results showed that a single 14-day course of teplizumab significantly delayed the onset of T1D in presymptomatic patients by a median of three years compared to placebo.
In addition, declines in C-peptide levels (reductions indicate destruction of insulin-producing beta cells in the pancreas) in treated patients stabilized than reversed, suggesting possible restoration of insulin production by these cells.
Treatment with teplizumab resulted in 54% less risk of progressing to insulin-dependent T1D compared to placebo.
No new safety signals were observed.
The company expects to complete its U.S. marketing application in Q4.
Teplizumab is a CD3-targeted monoclonal antibody designed to slow the loss of insulin-producing beta cells in the pancreas while preserving beta cell function as measured by C-peptide.
https://seekingalpha.com/news/3583109-provention-bio-up-11-on-positive-teplizumab-data

COVID-19 cuts at least 10 states’ tax revenue by 30%

At least 10 U.S. states will see their tax collections shrink by more than 30% due to the COVID-19 pandemic, say researchers at Arizona State and Old Dominion universities.
On average, states’ tax revenue will fall ~20%, economists say.
New York’s tax collections are projected to fall 40% and Maine’s is expected to decline 39.7%; Hawaii, Maine, and California round out the top five in terms of COVID-19 impact.
Meanwhile, Congress is deadlocked over whether it should send more cash to states.
The researchers figure that a one percentage-point increase in employment translates to a 1.56% pp rise in tax revenue; they reverse-engineered the number using state unemployment-insurance claims as of June 5 to calculate the average 20% tax revenue impact of the pandemic.
The states or districts expected to experience revenue declines of 4% or less are Alaska; Washington, DC; and South Dakota.
ETFs: NAC, PZC, PCK, PCQ, NRK, BNY, NKX, NXJ
https://seekingalpha.com/news/3583114-covidminus-19-cuts-least-10-states-tax-revenue-30

Biotech week ahead, June 15

Biotech stocks came under pressure along with the broader market in the week ended June 12, as a worsening pandemic situation and its impact on the economy led to an across-the-board sell-off in the global markets.
The week kickstarted with the rumor of a big-ticket acquisition. AstraZeneca plc AZN 2.18% reportedly approached Gilead Sciences, Inc. GILD 0.52% with a bid, although experts and analysts shrugged off the possibility of a deal materializing.
The FDA promptly approved Viela Bio Inc’s VIE 3.65% drug for treating neuromyelitis optica spectrum disorder.
More importantly, five biopharma companies debuted on Wall Street, raising a combined $983.25 million. The week also witnessed virtual presentations at key conferences such as the European Hematology Association Congress.
Here are the key catalysts for the unfolding week.
Conferences
  • The Endocrine Society’s ENDO Online 2020: June 8-22
  • 25th Edition of the European Hematology Association, or EHA, Annual Congress held in virtual format: June 11-21
  • American Academy of Dermatology, or AAD, Virtual Meeting Experience: June 12-14
  • The American Diabetes Association, or ADA, 80th Scientific Sessions – Virtual: June 12-16
  • The World Federation of Hemophilia, or WFH, Virtual Summit: June 14-19

PDUFA Dates

The FDA is scheduled to give its verdict on Merck & Co., Inc.’s MRK 2.92% Keytruda as a monotherapy option for unresectable or metastatic solid tumors, with tissue tumor mutational burden-high. (Tuesday)
Ultragenyx Pharmaceutical Inc RARE 0.47% and its Japanese partner Kyowa Kirin have a tryst with the FDA, as the agency is set to rule on hypophosphatemia treatment candidate burosumab. (Thursday)
The regulatory agency will also decide on Epizyme Inc’s EPZM 8.47% regulatory application for label expansion for tazemetostat, this time for follicular lymphoma. (Thursday)
Nabriva Therapeutics PLC – ADR NBRV 17.42% is knocking at the FDA altar for the second time for its investigational antibiotic contepo for treating complicated urinary tract infection. Late May, the company hinted at the decision being delayed due to the FDA requiring to inspect facilities of third-party manufacturers in Europe (Friday)
Evoke Pharma Inc EVOK 12.13% has a PDUFA date for its Gimoti to treat women with acute and recurrent diabetic gastroparesis. (Friday)

Adcom Meetings

FDA’s Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee will consider through teleconferencing the SP 2577 presentation by Salarius Pharmaceuticals Inc SLRX 15.36% and marizomib, presentation by Celgene, a subsidiary of Bristol-Myers Squibb Co BMY 2.84%. SP 2577 is being evaluated for the treatment of relapsed/refractory patients with Ewing sarcoma and marizomib for multiple myeloma.
The FDA said the subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate.

Clinical Readouts/Presentations

ProQR Therapeutics N.V. PRQR 3.05% will make a virtual presentation of data from the Phase 1/2 trial of intravitreal sepofarsen, an antisense oligonucleotide, in Leber congenital amaurosis 10 due to p.Cys998X mutation in the CEP290 gene. The data is to be shared via a video presentation through the Association for Research in Vision and Ophthalmology. (available online from Monday)
Sanofi SA SNY 0.46% is scheduled to host a virtual scientific session to present data from the Phase 3 COMET trial of investigational enzyme replacement therapy avalglucosidase alfa in patients with late-onset Pompe disease. (Tuesday)
Catalyst Biosciences Inc CBIO 5.49% is due to present at the WFH virtual summit Phase 2a data for factor IX levels of a daily subcutaneous prophylaxis treatment regimen of dalcinonacog alfa in hemophilia B.

Earnings

  • Centogene NV CNTG 0.52% (Monday, before the market open)
  • BioNano Genomics Inc BNGO 2.71% (Thursday, after the close)
  • Urovant Sciences Ltd UROV 0.36% (Thursday, after the close)

IPOs

Royalty Pharma, which buys royalties for late-stage and commercial drugs, has filed to offer 70 million shares in an initial public offering at an estimated price range of $25-$28. The company has applied for listing its shares on the Nasdaq under the ticker symbol RPRX.

IPO Quiet Period Expiry

Inari Medical Inc NARI 0.39%
https://www.benzinga.com/general/biotech/20/06/16244480/the-week-ahead-in-biotech-fda-decisions-in-the-cards-for-merck-epizyme-evoke-and-ultragenyx