Covid-19 roundup — Re­gen­eron zooms in on cock­tail; BioN­Tech shares sky­rock­et on quick Pfiz­er al­liance

On the morn­ing af­ter the Bay Area or­dered res­i­dents of six coun­ties to “shel­ter in place” amid vary­ing lev­els of lock­down around the world, here are the lat­est in­dus­try up­dates:

— Lead­ing the hunt for an­ti­bod­ies that can neu­tral­ize the coro­n­avirus that caus­es Covid-19, Re­gen­eron said it’s as­sem­bled a large pool of can­di­dates — hun­dreds of an­ti­bod­ies — from which it will se­lect two to make a “cock­tail treat­ment.” While the an­ti­bod­ies are be­ing se­lect­ed, the com­pa­ny will get its Ve­lociMab plat­form in place to pre­pare cell lines for clin­i­cal-scale pro­duc­tion. Re­gen­eron en­vi­sions en­ter­ing hu­man stud­ies in a cou­ple months, with a goal to pro­duce “hun­dreds of thou­sands of pro­phy­lac­tic dos­es per month” by the end of sum­mer. All of this comes a lit­tle over a month af­ter Re­gen­eron first threw its name in­to the coro­n­avirus R&D hat. Fol­low­ing this same ap­proach has led the biotech to an Ebo­la reg­i­men that best­ed three oth­er treat­ments. In ad­di­tion to de­vel­op­ing an­ti­bod­ies that can serve both as treat­ment and as a pro­phy­lax­is be­fore peo­ple are ex­posed to SARS-CoV-2 (an ap­proach Vir is al­so tak­ing), Re­gen­eron has al­so rushed its IL-6 drug Kez­vara — ap­proved for arthri­tis — in­to a late-stage tri­al test­ing its abil­i­ty to tack­le the lung in­flam­ma­tion that re­sults from the vi­ral in­fec­tion.

Ash­leigh Palmer

— Al­most a year ago Proven­tion Bio be­gan what Jef­frey Blue­stone called the “re­al hard work” on the res­ur­rect­ed di­a­betes drug teplizum­ab, dos­ing the first pa­tient with new­ly di­ag­nosed type 1 di­a­betes with the an­ti-CD3 an­ti­body. The work has just got­ten hard­er as the Covid-19 pan­dem­ic is forc­ing the biotech to tem­porar­i­ly pause ran­dom­iz­ing and treat­ing new pa­tients — while those cur­rent­ly tak­ing the ther­a­py com­plete their course. This de­lay, though, does not hin­der Proven­tion’s plan to wrap up its rolling BLA sub­mis­sion for the at-risk pop­u­la­tion by the end of the year. That was part­ly sup­port­ed by Phase II da­ta sug­gest­ing teplizum­ab de­layed di­a­betes di­ag­noses for pa­tients who ap­pear poised to de­vel­op the dis­ease. The Phase III PRO­TECT study was de­signed to see if the drug could help pa­tients who al­ready have di­a­betes — such as to low­er their de­pen­dence on in­sulin. “Our de­ci­sion was not based on any study-re­lat­ed COVID-19 in­fec­tions or oth­er safe­ty events, but rather a pre­pon­der­ance of cau­tion re­lat­ing to the on­go­ing pan­dem­ic, and our con­cern for the well-be­ing of re­cent­ly di­ag­nosed T1D pe­di­atric pa­tients and their care­givers,” CEO Ash­leigh Palmer said in a state­ment. “The de­mands on med­ical in­sti­tu­tions and their clin­i­cians dur­ing this un­prece­dent­ed glob­al cri­sis were al­so a main con­sid­er­a­tion in this de­ci­sion.”

— Shut­downs are be­com­ing more com­mon, and they’ve been fill­ing the BioTwit­ter chan­nel:

— In the year of coro­n­avirus, there’s no time to dot every i and cross every t in a bio­phar­ma deal. Ear­ly Tues­day Pfiz­er and BioN­Tech $BN­TX were ready to hitch up on one of the big mes­sen­ger RNA vac­cine pro­grams aimed at the dev­as­tat­ing spread of Covid-19. And they made it clear they were rolling ahead of any for­mal sig­na­tures on a fi­nal con­tract. Qui­et­ly re­vealed just days ago, BioN­Tech says that BNT162 should be ready to go in the clin­ic by the end of next month. It fol­lows a lead­ing mR­NA ef­fort from Mod­er­na as well as a hur­ry-up project from Cure­Vac, where the re­volv­ing door at the CEO suite is spin­ning. The col­lab­o­ra­tion work starts now, with a plan to uti­lize mul­ti­ple R&D sites across both com­pa­nies in the US and Ger­many, where BioN­Tech is based. They ex­pect to fi­nal­ize the de­tails of their part­ner­ship in the next few weeks. If there are any ba­sics in the let­ter of agree­ment, they’re not talk­ing about it yet. In the mean­time, BioN­Tech’s shares rock­et­ed up 55%.

— In the spir­it of do­na­tions, Bio­gen said its phil­an­thropic arm has com­mit­ted $10 mil­lion to sup­port Covid-19 re­lief ef­forts in the US and around the world. “We are deeply af­fect­ed by the im­pact of COVID-19 glob­al­ly and we un­der­stand the crit­i­cal im­por­tance of ac­cess to test­ing and oth­er ma­te­ri­als to sup­port health­care providers,” said CEO Michel Vounatsos, who’s now pre­sid­ing over the hard­est-hit drug­mak­er in the in­dus­try. A strat­e­gy meet­ing held at Boston Mar­riott Long Wharf has led to the in­fec­tion of 100 Bio­gen staffers and their house­hold con­tacts in Mass­a­chu­setts, where a to­tal of 197 cas­es have been re­port­ed as of Mon­day af­ter­noon — and that’s not count­ing oth­er lo­cal trans­mis­sion. In ad­di­tion to pro­vid­ing med­ical equip­ment and sup­plies to Part­ners Health­Care and sup­port­ing two lo­cal hos­pi­tals in their front line work, Bio­gen’s funds will al­so go to­ward ex­pend­ing test­ing op­tions, eas­ing the strains on med­ical sys­tems, of­fer­ing train­ing and se­cur­ing ac­cess to ne­ces­si­ties like food in places such as North Car­oli­na, where at least five Bio­gen staffers have been test­ed pos­i­tive af­ter at­tend­ing the lead­er­ship gath­er­ing.

— Amid warn­ings that peo­ple who get mild symp­toms of Covid-19 and re­cov­er are dri­ving the spread of the dis­ease, sci­en­tists at the Uni­ver­si­ty of Min­neso­ta are turn­ing their fo­cus to this par­tic­u­lar pop­u­la­tion. They are launch­ing a new clin­i­cal tri­al to see if an old malar­ia drug — chloro­quine or hy­drox­y­chloro­quine — is a bet­ter post-ex­po­sure pro­phy­lax­is than the cur­rent stan­dard of care: ob­ser­va­tion. The tri­al will en­roll 1,500 in­di­vid­u­als who have had ex­po­sure to a Covid-19 case with­in 3 days, name­ly ei­ther health­care work­ers of house­hold con­tacts. The Uni­ver­si­ty of Ox­ford is plan­ning a sim­i­lar study with 10,000 par­tic­i­pants in May. Clin­i­cians in Chi­na and Aus­tralia have re­port­ed en­cour­ag­ing re­sults treat­ing Covid-19 pa­tients with chloro­quine.

— Chi­nese sci­en­tists may now be­gin test­ing a sub­unit vac­cine de­vel­oped by the Acad­e­my of Mil­i­tary Med­ical Sci­ences in col­lab­o­ra­tion with CanSi­no Bi­o­log­ics. The Hong Kong-list­ed com­pa­ny said its can­di­date us­es a repli­ca­tion-de­fec­tive ade­n­ovirus type 5 as a vec­tor to ex­press the spike pro­tein on SARS-CoV-2. It’s al­so be­gun pre-screen­ing of healthy vol­un­teers in an­tic­i­pa­tion of the tri­al, which was green­light­ed Mon­day night. CanSi­no has pre­vi­ous­ly worked with Wei Chen, the se­nior bio­engi­neer cred­it­ed with lead­ing the re­search work, on Chi­na’s first Ebo­la vac­cine.

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

Ven­ture Cap­i­tal as a Strate­gic Part­ner: Fu­el­ing In­no­va­tion be­yond Fi­nance

The average level of investment required for a biotech start-up to succeed is increasing every year, elevating the pressure even further on venture capital to make smart financial investments. Financial investment alone, however, does not always guarantee that exciting innovations can be transformed into real businesses that make a meaningful difference to patients.

Beyond just capital

At Astellas Venture Management (AVM) – a wholly-owned venture capital organization within Astellas, headquartered in the San Francisco Bay Area – capital is just one of the ingredients we offer to add value to our biotechnology investments and partnerships. We generally take a strategic investor approach for companies in our invested portfolio, providing access to expertise, technology and/or resources in addition to the injection of finance. An equity investment from AVM can include access to Astellas’ research and development (R&D) capabilities and expertise, and a global network of partner academic institutions and biotechnology companies, to help advance and accelerate the start-up’s innovation.

UP­DAT­ED: Ver­tex joins Mer­ck, Pfiz­er — re­vamp­ing multi­bil­lion-dol­lar tri­al strat­e­gy as biotech R&D crum­bles

You can add Pfizer, Merck and — as we found out Friday morning — Vertex to the growing list of pharma giants hitting the pause button on a range of clinical trials. But not everyone in R&D is getting a red light.

Vertex says that it’s doing its best to keep working its pipeline strategy, coming up with a plan “to enable virtual clinic visits and home delivery of study drug to ensure study continuity and medical monitoring, and to facilitate study procedures.”

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Covid-19 roundup: In­ter­cept, blue­bird and a grow­ing list of biotechs feel the pain as pan­dem­ic man­gles FDA, R&D sched­ules

Around 100 staffers at Boston area hospitals have now tested positive for Covid-19, spotlighting the growing risk that the pandemic will sideline many of the most essential workers in healthcare as caseloads peak in the US and around the globe. With more than 3,400 deaths, Spain has become the latest country to surpass the official death count attributed to the new coronavirus in China, where the outbreak originated. As of Thursday morning, confirmed global cases had crossed 470,000 and the death count eclipsed 21,000.

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Af­ter crit­ics lam­bast­ed Gilead for grab­bing the FDA's spe­cial rare drug sta­tus on remde­sivir, they're giv­ing it back

Two days after Gilead won orphan drug status for remdesivir as a potential treatment for Covid-19, they’re handing it back.

The company was slammed from several sides after Gilead reported that the FDA had come through with the special status, which comes with 7 years of market exclusivity, the waiver of FDA fees and some tax credits as well. Typically, everyone who can get orphan status lands it without much of a fuss, but Democratic presidential candidate Bernie Sanders, Public Citizen and other consumer groups were outraged.

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Mod­er­na CEO Stéphane Ban­cel out­lines a short path for emer­gency use of a coro­n­avirus vac­cine

NIAID director Anthony Fauci has left no doubts that it takes 12 to 18 months to get a new vaccine tested and in commercial use, in the best of circumstances. But in times of a global emergency — like these — maybe there’s another, faster route to follow.

In an SEC filing on Tuesday, Moderna $MRNA staked out a record-setting pathway to getting their mRNA vaccine into the frontline of the healthcare response as early as this fall. The SEC filing notes that CEO Stéphane Bancel told Goldman Sachs that an emergency use approval could allow the vaccine to go to healthcare workers and certain individuals in a matter of months — presumably provided the NIH sees the safety and efficacy data they would need from the Phase I.

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Caught in a Covid-19 mael­strom, Eli Lil­ly locks down clin­i­cal tri­als as multi­bil­lion-dol­lar R&D ops de­rail

The Covid-19 pandemic has derailed Eli Lilly’s $6 billion R&D operations.

The pharma giant reported Monday morning that it has decided to hit the brakes on most new study starts and pause enrollment for most ongoing studies. Lilly adds that it is continuing dosing for ongoing studies, “but with study-by-study consideration.”

The pandemic has severely disrupted healthcare systems around the globe, says Lilly, making it difficult or impossible to conduct studies at many research sites. And there’s no timeline for when it expects to get back on track.

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As share buy­backs come un­der scruti­ny, what's in store for the bio­phar­ma in­dus­try?

Stock buybacks are not to be permitted for companies that will be bailed out in the coronavirus stimulus package, Congressional leaders have signaled. To what degree the biopharma industry has relied on buybacks for earnings growth in recent years, and if the trend continues, are the big questions as scrutiny into the practice heightens and balance sheets weaken with the coronavirus pandemic wreaking havoc on global economies.

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A Sin­ga­pore VC rais­es $200M for a new round, but will Covid-19 pre­vent it from rais­ing the rest?

A top Singaporean biotech venture fund is nearly halfway toward its largest ever fund, but in a sign of what could be in store for VCs amid a global economic freeze, said they could face headwinds raising the other half.

Vickers Venture Partners has secured $200 million out of a targeted $500 million for its 6th fund, first announced in early 2018. They’ve given themselves 13 months to complete the financing, Vickers founder Finian Tan told Deal Street Asia, but the financial frost settling amid the Covid-19 pandemic could slow efforts.

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Strug­gling Unum ex­ecs are ready to con­sid­er a sale, merg­er or any deal that comes its way

Unum $UMRX is working its way through a survival plan of sorts.

After getting hit with a trio of FDA holds in its brief public history and triggering its second pivot to a new lead drug program while laying off 60% of the staff, the troubled penny stock biotech Unum Therapeutics has hatched new plans to secure financial backing while lining up a go-forward strategy for the company.

First, Lincoln Park Capital Fund has agreed to buy up to $25 million of the long-suffering stock, as Unum directs. And the executive team — led by CEO Chuck Wilson — has put everything on the table for consideration: a sale, acquisition, merger, licensing deal, you name it. The ACTR707 program, meanwhile, is being formally wrapped up — their second failed lead program.