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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.

South Korean Olympic table tennis team player Lee Sang-su receiving the first dose of the Pfizer/BioNTech Covid-19 coronavirus vaccine in Seoul (Chung Sung-Jun/Pool Photo via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech do­nate their vac­cine to the Tokyo Olympics; No­vavax, Pfiz­er/BioN­Tech vac­cines ap­pear to be less ef­fec­tive against vari­ants

The long-delayed 2020 Olympics in Tokyo will feature gymnast Simone Biles in what is likely her last Summer Games, and skateboarder Nyjah Huston in what will be his first. But the players with the most impact on the games could be Pfizer and BioNTech. After a meeting between Pfizer CEO Albert Bourla and Japan’s Prime Minister Yoshihide Suga, a plan has been outlined to donate doses of their Covid-19 vaccine for the Olympic Games.

Biden ad­min­is­tra­tion backs a po­lar­iz­ing pro­pos­al to waive IP for all Covid-19 vac­cines

In a surprise U-turn, the Biden administration said Wednesday that it will support a proposal at the World Trade Organization to temporarily waive intellectual property protections on Covid-19 vaccines.

The proposal, backed by South Africa and India at the WTO, seeks to help developing countries with limited vaccine supplies. The US and Europe historically opposed the proposal, saying IP should be protected because it incentivizes new drug and vaccine development.

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