Covid-19 roundup: Till­man Gern­gross inks deal to bring an­ti­body can­di­date to In­dia; At FDA's re­quest, mR­NA vac­cine mak­ers will ex­pand tri­als for chil­dren ages 5-11

A week af­ter it was re­port­ed that In­dia’s Covid-19 death toll could be in the mil­lions, an­ti­body leg­end Till­man Gern­gross has inked a deal to de­vel­op Ada­gio’s lead can­di­date for the treat­ment and pre­ven­tion of the virus in south­ern Asia.

Ada­gio is join­ing hands with Bio­con Bi­o­log­ics to man­u­fac­ture and com­mer­cial­ize a treat­ment based on ADG20 in In­dia and “se­lect emerg­ing mar­kets,” the com­pa­nies an­nounced on Mon­day. Un­der the agree­ment, Ada­gio will pro­vide Bio­con with ma­te­ri­als and know-how to make the ther­a­py, in­clud­ing da­ta from on­go­ing Phase II/III tri­als and (if all goes well) ac­cess to its po­ten­tial EUA pack­age.

The fi­nan­cial terms of the deal weren’t dis­closed.

Till­man Gern­gross

ADG20 is cur­rent­ly in two Phase II/III tri­als: one for the treat­ment of non-hos­pi­tal­ized Covid pa­tients, and one for the pre­ven­tion of Covid-19. Back in May, Ada­gio of­fered a first peek at ear­ly Phase I da­ta, which sug­gest­ed a sin­gle dose of­fered broad­ly neu­tral­iz­ing ac­tiv­i­ty com­pa­ra­ble to peak titers re­port­ed from the mR­NA vac­cines.

“As a com­pa­ny, it is our be­lief that the phar­ma­ceu­ti­cals in­dus­try has a hu­man­i­tar­i­an re­spon­si­bil­i­ty to serve pa­tients who are in need,” Ki­ran Mazum­dar-Shaw, ex­ec­u­tive chair­per­son at Bio­con, said in a state­ment. “We had looked at dozens of po­ten­tial mol­e­cules, and up­on re­view­ing the ADG20 da­ta, we were con­vinced this was a dif­fer­en­ti­at­ed an­ti­body with the po­ten­tial to ad­dress not on­ly to­day’s virus and vari­ants, but fu­ture SARS-like virus­es as well.”

Ki­ran Mazum­dar-Shaw

In April, Ada­gio snagged $336 mil­lion as part of a Se­ries C round led by RA Cap­i­tal to ad­vance the an­ti­body through the STAMP tri­al for the treat­ment of high-risk, mild to mod­er­ate Covid pa­tients.

“Im­por­tant­ly, Bio­con’s ex­ten­sive man­u­fac­tur­ing ca­pa­bil­i­ties will en­able large scale pro­duc­tion, mak­ing this po­ten­tial­ly life-sav­ing drug broad­ly avail­able to mil­lions of peo­ple who oth­er­wise would not have ac­cess to this type of ther­a­py,” Gern­gross said. — Nicole De­Feud­is 

At FDA’s re­quest, mR­NA vac­cine mak­ers will ex­pand tri­als for chil­dren ages 5-11

In an ef­fort to track rare side ef­fects, Pfiz­er-BioN­Tech and Mod­er­na will ex­pand clin­i­cal tri­als for chil­dren to as young as 5 years old, the New York Times re­port­ed Mon­day.

The mea­sure is to de­tect side ef­fects such as heart in­flam­ma­tion prob­lems that ap­pear in vac­ci­nat­ed peo­ple un­der 30. There’s not yet a time­line for when pe­di­atric vac­cines will be­come avail­able, though at a meet­ing in Ohio last week, Pres­i­dent Joe Biden promised that emer­gency au­tho­riza­tion is com­ing soon.

Both com­pa­nies have been in­struct­ed by the FDA that the pe­di­atric stud­ies are not big enough nor broad enough to de­tect rare side ef­fects, in­clud­ing my­ocardi­tis and peri­cardi­tis, the in­flam­ma­tion of the heart mus­cle or the lin­ing around the heart.

The push comes as schools around the coun­try are set to open in the next two months.

An­oth­er 3,000 chil­dren be­tween the ages of 5 and 11 years old will join the tri­al at the FDA’s re­quest. Mod­er­na start­ed re­cruit­ing pa­tients in March, while the Times says that Pfiz­er is on a faster timetable than Mod­er­na and could be able to meet the FDA’s re­quest and still file for emer­gency use au­tho­riza­tion in chil­dren by the end of Sep­tem­ber. Pfiz­er has pre­vi­ous­ly said that it ex­pects to have re­sults for the youngest age group — 6 months to 2 years old — by Oc­to­ber or No­vem­ber. — Josh Sul­li­van

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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