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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Troy Wilson, Kura CEO

FDA lifts par­tial hold on Ku­ra's Phase Ib AML pro­gram as biotech re­dou­bles mit­i­ga­tion ef­forts

Kura Oncology is clear to resume studies for its early-stage leukemia program after the FDA lifted a clinical hold Thursday afternoon.

Regulators had placed the hold on a Phase Ib study of KO-539, an experimental oral treatment for some genetic subsets of acute myeloid leukemia last November after a patient died while taking the drug. Kura expects to begin enrolling patients again imminently, CEO Troy Wilson told Endpoints News.

A Sen­ate bill wants to even an 'un­lev­el play­ing field' for do­mes­tic, for­eign in­spec­tion drop-ins amid back­log

Amid geopolitical tensions between the US and China, two Republican senators are calling for a bill that would aim to strike a balance on domestic and foreign inspection requirements from the FDA.

Sens. Mike Braun (R-IN) and Joni Ernst (R-IA) have penned a bill called the Creating Efficiency in Foreign Inspections Act. It contains a bit of rhetoric, highlighting “communist China” not once, but twice in the release, but states that the goal is to even the playing field between foreign and American manufacturers.

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