Covid-19 roundup: Italy death toll of­fi­cial­ly tops Chi­na; US com­pa­ny plans roll out of at-home spec­i­men col­lec­tion kits

In a first, Chi­na re­port­ed on Thurs­day that there were no new lo­cal­ly-trans­mit­ted coro­n­avirus cas­es for the first time since the pan­dem­ic be­gan, while Pres­i­dent Trump im­plied treat­ments to fight the coro­n­avirus scourge were ap­proved and/or just around the cor­ner, on­ly to be po­lite­ly cor­rect­ed by FDA chief Stephen Hahn, who un­der­scored da­ta on safe­ty and ef­fi­ca­cy were still to come. As of Fri­day, glob­al cas­es hit 244,500.

→ Eu­rope is no longer just the epi­cen­ter of the coro­n­avirus pan­dem­ic — the death toll in Eu­rope’s worst-hit coun­try, Italy, has of­fi­cial­ly sur­passed the to­tal fa­tal­i­ties in Chi­na, where the virus orig­i­nat­ed last year. Ital­ian deaths stand at 3,405 ver­sus Chi­na’s 3,245, al­though the re­li­a­bil­i­ty of the da­ta emerg­ing from Chi­na has been ques­tioned.

Mar­cel­lo Na­tali, who ap­peared in a TV in­ter­view be­fore his Covid-19 di­ag­no­sis to show how bad­ly stretched the health care sys­tem had be­come for doc­tors on the front lines in Italy, died on Wednes­day iso­lat­ed and alone in an in­ten­sive care unit. He had been work­ing with san­i­tiz­er and a face mask, but re­port­ed­ly with­out gloves. “They have run out,” he told Eu­ronews late in Feb­ru­ary. “Cer­tain­ly, we were not pre­pared to face this sit­u­a­tion.”

→ Al­though more than 108,000 tests have been done so far in the Unit­ed States, ac­cord­ing to the Covid Track­ing Pro­ject, de­mand still far out­strips sup­ply and pri­vate en­ter­prise is work­ing up a fren­zy to en­hance pro­duc­tion and plug gaps.

Ear­li­er this week, at-home lab test­ing com­pa­ny Ever­ly­well un­veiled that it had de­vel­oped an at-home spec­i­men col­lec­tion kit with tele­health di­ag­no­sis for Covid-19, which will be avail­able to con­sumers start­ing Mon­day. Once re­quest­ed on­line by con­sumers ex­pe­ri­enc­ing symp­toms, sam­ples can be col­lect­ed at home. Each test costs $135 — at no prof­it to Ever­ly­well — and will be cov­ered by par­tic­i­pat­ing HSA and FSA providers. There is an ini­tial sup­ply of 30,000 tests, but the com­pa­ny plans to shore up its ca­pac­i­ty to cater to a quar­ter of a mil­lion peo­ple week­ly.

Sep­a­rate­ly on Thurs­day, di­ag­nos­tics com­pa­ny Lab­Corp said it was ahead of sched­ule in the num­ber of tests it can per­form per day — as of Fri­day, it can of­fer 20,000 Covid-19 tests/day.

→ The in­ter­est in mR­NA tech­nol­o­gy has ex­plod­ed as com­pa­nies like Mod­er­na and Cure­Vac har­ness it to com­bat the new coro­n­avirus. Now, a Russ­ian com­pa­ny is the lat­est biotech to make its for­ay in­to the field with three vac­cine op­tions, al­though it is well be­hind some of the oth­er ef­forts. The com­pa­ny, BIO­CAD, an­tic­i­pates kick­ing off an­i­mal stud­ies by late April.

Var­i­ous tri­als are test­ing the promise of a host of an­tivi­rals: Gilead‘s remde­sivir; the HIV drug cock­tail of lopinavir and ri­ton­avir; lopinavir and ri­ton­avir plus in­ter­fer­on-be­ta; and the an­ti­malar­i­al drug chloro­quine. Now, Ger­many’s Mer­ck KGaA has do­nat­ed a sup­ply of in­ter­fer­on be­ta-1a, brand­ed Rebif, to the French In­sti­tut Na­tion­al de la San­té et de la Recherche Médi­cale (IN­SERM) for use in a clin­i­cal tri­al.

→ Af­ter Pres­i­dent Trump on Thurs­day im­plied a decades-old malar­ia drug — chloro­quine phos­phate — was sanc­tioned by the FDA to fight the new coro­n­avirus, re­ports emerged that late last year the drug’s mak­er Ris­ing Phar­ma­ceu­ti­cals dou­bled the price of the com­pound, but has now re­stored the orig­i­nal price tag as the virus en­velops much of the globe. (End­points Link).

Apart from Bay­er — which on Thurs­day said it would do­nate 3 mil­lion tablets of its ver­sion of chloro­quine phos­phate — My­lan and Te­va al­so com­mit­ted to do­nat­ing a chloro­quine com­pound (hy­drox­y­chloro­quine sul­fate) to the Unit­ed States, as the po­ten­tial of the drug to fight coro­n­avirus is in­ves­ti­gat­ed.

→ An­oth­er drug­mak­er’s clin­i­cal tri­al work has been de­railed by the coro­n­avirus pan­dem­ic. Gas­troin­testi­nal dis­ease-fo­cused Phath­om Phar­ma­ceu­ti­cals pressed pause on en­roll­ment in two tri­als, in line with the Amer­i­can So­ci­ety for Gas­troin­testi­nal En­doscopy’s rec­om­men­da­tions on lim­it­ing en­do­scopies, which are re­quired in both clin­i­cal tri­als.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

A small, ob­scure biotech just won big with their IPO. In this mar­ket. Are you kid­ding me?

How could a small, largely unknown biotech that emerged from stealth mode just months ago with early-stage cancer programs jump onto Wall Street in the middle of a Force 5 financial hurricane and sail through with a $165 million IPO?

And what does that mean for the rest of the industry waiting to see just how much damage global lockdowns will wreak on clinical development?

The biotech is a company called Zentalis. The crew there nabbed an $85 million crossover round late last year — notably waiting 5 years before waving the numbers around to attract attention, according to my read of a FierceBiotech story. Perceptive joined in, but the syndicate was not in general the kind of marquee affair that gets tongues wagging.

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Bob Nelsen at the Milken Institute Global Conference on April 29, 2019 in Beverly Hills, California. (Photo by Michael Kovac/Getty Images)

ARCH chief Bob Nelsen has $1.5B to prove 2 sim­ple points: ‘We’re in the most in­no­v­a­tive time ever’ and in­vestors are stay­ing

ARCH co-founder and managing director Bob Nelsen has a well known yen for the home run swing, betting big on potentially transformative meds and tech and the biotech teams he helps bring together. He thrives and bleeds on the cutting edge. And now Nelsen and the ARCH group have debuted 2 big funds to prove that this is the time for the best of biotech to shine — deadly pandemic be damned.

Two new funds, ARCH Venture Fund X and ARCH Venture Fund X Overage, gathered a combined $1.46 billion. And that’s a record. ARCH Venture Fund IX and ARCH Venture Fund IX Overage closed in 2016 with a combined $1.1 billion. ARCH Venture Fund VIII and ARCH Venture Fund VIII Overage closed in 2014 with a combined $560 million.

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In­vest­ing in the time of coro­n­avirus: the good, the bad and the hope­ful, as biotech VC firms close funds worth $3B

Apart from disrupting biopharma R&D and regulatory timelines, the coronavirus pandemic has inevitably ravaged financial markets and eroded investor risk appetite. Investing in the time of coronavirus feels reckless, but if biotech venture funds are any indication, the time is ripe.

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GSK vac­cine chief heads for AIDS vac­cine ini­tia­tive; Pfiz­er en­lists Sue Desmond-Hell­mann to its board of di­rec­tors

→ Rip Ballou, who until very recently led vaccine research and development at GlaxoSmithKline, is joining the International AIDS Vaccine Initiative (IAVI) to lead its USAID-funded ADVANCE program. The program uses a network of researchers and institutions in Africa to help develop a vaccine for HIV. Ballou had worked at GSK since 2010 and has led global vaccine R&D since 2015. Prior to that he held posts at the Bill & Melinda Gates Foundation, a different post at GSK, Medimmune, and Walter Reed Army Institute of Research.  IAVI is led by Mark Feinberg, the former CSO of Merck Vaccines. 

Ahead of US IPO, Leg­end Biotech adds $150M, top-tier in­vestors to back CAR-T pipeline

Last month Nanjing Legend Biotech revealed that it sees, and was quietly planning for, a future as a public company in the US, separate but still tied to its former parent, Chinese CRO GenScript. It’s evidently a vision that enticed investors, drawing marquee names for a pre-IPO round.

The Series A fetched a whopping $150.5 million from Hudson Bay Capital Management, Lilly Asia Ventures, Vivo Capital, RA Capital Management and JJDC, the venture arm of J&J. The pharma giant has helped fund Legend’s CAR-T work with the $350 million upfront payment it handed over to partner on the lead BCMA program.

Covid-19 roundup: Mod­er­na CEO Stéphane Ban­cel be­comes a bil­lion­aire; No­var­tis, In­cyte pitch Jakafi PhI­II to tack­le se­vere cas­es

You can now add Moderna CEO Stéphane Bancel to the list of biotech billionaires.

Since investors began to understand the full scope of the coronavirus outbreak in late February, cash has flushed out of much of the stock market and into the handful of companies leading the fight for drugs and vaccines. That’s meant hundreds of millions for Moderna, the Flagship-backed company that emerged early as the world’s first best hope for a Covid-19 vaccine.

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J&J gives pi­o­neer­ing stem cell biotech its first Big Phar­ma deal, part­ner­ing on iP­SC CAR-T and CAR-NK

Late last summer, one of the earliest stem cell therapy companies got two government decisions in the span of three weeks: The USPTO granted them a patent for iPSC-derived CAR-T cells, and then the FDA cleared them for their first-in-human CAR-NK trial.

Yesterday, the two technologies landed them an up-to $3.1 billion deal.

Fate Therapeutics and J&J announced a global collaboration that will pay Fate $100 million upfront and a trove of potential milestones to develop multiple CAR-T and CAR-NK therapies. It’s the first Big Pharma partnership Fate has announced in their 13-year existence and the largest, although at least one longtime follower thought they could have landed more.

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FDA re­ports short­age of se­da­tion drug used for putting Covid-19 pa­tients on ven­ti­la­tors

The FDA on Thursday updated its list of drugs in shortage to include the sedation drug midazolam, which along with other sedatives is being used to treat COVID-19 patients requiring mechanical ventilation.

The updated listings for five manufacturers note an increased demand for midazolam and may just be the beginning of what’s to come for other sedation drugs too.

Michael Ganio, senior director of pharmacy practice and quality at the American Society for Health-System Pharmacists, told Focus via email: “We have multiple reports of increases in purchases and utilization of sedatives like midazolam, fentanyl, and propofol to treat COVID-19 patients who require mechanical ventilation.”

Drug dis­cov­ery in the age of coro­n­avirus

Developing new drugs is incredibly hard. That’s why, despite superhuman efforts from the industry, we’re still looking at 12-18 months minimum before we can realistically hope for a vaccine for Covid-19, and probably months before there’s a proven viable drug treatment.

But our increasing ability to begin to industrialize the drug discovery and development process through an engineering approach means that we have more hope for speeding up this process than ever before — and not just to defeat coronavirus, but to benefit the development of all new medicines in the future.