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1. Special report: Meet 20 extraordinary women who are supercharging biopharma R&D
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'We're in': Roche and Genentech join forces on a multibillion-dollar discovery pact with a brash AI upstart
3. AstraZeneca grabs PhIII ATTR drug from Ionis — infusing $200M cash into struggling partner
4. Richard Lerner, antibody pioneer and longtime president of Scripps Research, dies at 83
5. Merck pumps the brakes on two more PhIII trials for its lead anti-HIV drug
6. Icelandic billionare's biosimilar company raises $450M, preps for Nasdaq launch with SPAC merger
7. London AI-focused BenevolentAI going public in Europe via $438M SPAC deal
8. Acadia touts late-stage win for its Rett syndrome drug, edging out a lead against its competitors
9. Covid-19 roundup: Plant-based shot proves safe, 71% efficacious in PhIII; Bourla expects antiviral to launch this month
10. Can a new European biotech make an ADC better than Padcev? Investors are putting up almost $100M to find out
11. Always busy, Gary Glick recruits OrbiMed in a massive $218M Series A for enigmatic data science biotech
12. WHO recommends against the use of convalescent plasma for Covid-19
13. Klick Health hands out $100 bills in annual holiday greeting that’s turned into default recruiting tool
14. Apple Tree Partners leaps across the pond to launch a UK biotech looking to crack the secrets of dendritic cells
15. Digital clutter threatens pharma-to-physician relationships in shift to next era of communications
16. Transpacific AI biotech makes its Series A debut — putting $86M in the bank
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vTv Therapeutics cuts 65% of employees in shakeup; Freenome bags $300M in Series D to expand multiomics platform
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Kyle Blankenship
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I'm proud to say our annual Women in Biopharma R&D report is finally out in the world. This was a team effort and something that means a great deal for everyone here. Please note that senior editor Amber Tong and editor Nicole DeFeudis will be hosting our WIB live event starting at 2 p.m. ET. Register here — you won't want to miss it!

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Kyle Blankenship
Managing Editor, Endpoints News
@ka_blankenship
1
by Endpoints Staff

Even though many bio­phar­ma lead­ers have come to­geth­er in re­cent years to ad­dress its gen­der gap, the con­sen­sus is clear: We still have a long way to go.

Com­pa­nies this year were 2.5 times more like­ly than last year to have a di­ver­si­ty and in­clu­sion pro­gram in place, ac­cord­ing to a re­cent BIO sur­vey, but women are still large­ly ab­sent from ex­ec­u­tive roles. Get­ting women to en­ter the in­dus­try isn’t the prob­lem — stud­ies show that they rep­re­sent just un­der half of all biotech em­ploy­ees around the world. But climb­ing through the ranks can be chal­leng­ing, as women still re­port fac­ing stereo­types, and, un­for­tu­nate­ly, ha­rass­ment.

The sec­ond year of the pan­dem­ic has co­in­cid­ed with a stark spot­light on some of these is­sues. In an era where par­ent­ing is vis­i­ble just out­side the Zoom frame, or­ga­ni­za­tions are rec­og­niz­ing how the bur­den of un­paid care of­ten falls dis­pro­por­tion­ate­ly on women in a house­hold. At the same time, both com­pa­nies and aca­d­e­m­ic in­sti­tu­tions have tak­en dras­tic steps to ad­dress sex­u­al ha­rass­ment, oust­ing promi­nent em­ploy­ees in the wake of ac­cu­sa­tions and in­ves­ti­ga­tions sub­stan­ti­at­ing those claims.

End­points News has cov­ered each of those news sto­ries ex­ten­sive­ly. But be­yond the re­al-time de­vel­op­ments, we want­ed to dig deep­er and tell the sto­ries of those who made it to the top de­spite the odds — the chal­lenges they faced, the peo­ple who helped them over­come those hur­dles, the ways they're giv­ing back now, and the di­rec­tion they think the in­dus­try ought to go.

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2

Over the past cou­ple of years, the top ex­ecs at Roche and Genen­tech have inked a flur­ry of deals align­ing the glob­al pair with sev­er­al of the new play­ers that have emerged in the boom­ing AI and ma­chine learn­ing world. That strat­e­gy was su­per­charged in the spring of 2020 by their de­ci­sion to re­cruit Aviv Regev out of the com­pu­ta­tion­al world she oc­cu­pied at the Broad. And to­day they’re tak­ing that com­pu­ta­tion­al ap­proach in R&D to a whole new lev­el.

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Brett Monia, Ionis CEO
3
by Amber Tong

As­traZeneca is pluck­ing an­oth­er an­ti­sense drug out of Io­n­is’ pro­lif­ic pipeline.

Pay­ing $200 mil­lion in cash, As­traZeneca has inked a de­vel­op­ment and com­mer­cial­iza­tion deal around eplon­ter­sen — the Phase III TTR amy­loi­do­sis drug for­mer­ly known as IO­N­IS-TTR-LRX. On top of the up­front and $485 mil­lion worth of con­di­tion­al pay­ments to fol­low reg­u­la­to­ry ap­provals, the phar­ma gi­ant is promis­ing $2.9 bil­lion in sales-re­lat­ed mile­stones should the drug reach megablock­buster sta­tus, plus roy­al­ties.

The deal marks a much-need­ed boost for Io­n­is, which has been strug­gling to re­al­ize CEO Brett Mo­nia’s vi­sion of trans­form­ing the biotech from one that’s heav­i­ly fo­cused on R&D to a com­mer­cial com­pa­ny ca­pa­ble of pulling drugs past the fin­ish line.

Back in April, Io­n­is re­vealed plans to lay off 70% of the staffers at Akcea — the com­pa­ny that it orig­i­nal­ly spun out to mar­ket its ex­ist­ing drugs and de­vel­op late-stage can­di­dates for lipid dis­or­ders but lat­er re­ab­sorbed — af­ter de­cid­ing to en­list So­bi as a com­mer­cial part­ner in Eu­rope. The com­pa­ny al­so said the re­struc­tur­ing would al­low it to fo­cus on high pri­or­i­ty pro­grams. A few weeks lat­er, it scrapped an in-house cys­tic fi­bro­sis pro­gram in the wake of a clin­i­cal set­back.

One of those pri­or­i­ty pro­grams was eplon­ter­sen. A lig­and-con­ju­gat­ed an­ti­sense, the drug tar­gets transthyretin, the same pro­tein blocked by Io­n­is’ ap­proved drug Tegse­di.

It is cur­rent­ly in Phase III clin­i­cal tri­als for AT­TR car­diomy­opa­thy and AT­TR polyneu­ropa­thy. Un­der their new al­liance, Io­n­is will be re­spon­si­ble for man­u­fac­tur­ing eplon­ter­sen through­out the stud­ies and the sub­se­quent process qual­i­fi­ca­tion, with As­traZeneca set to take over on com­mer­cial sup­ply.

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Richard Lerner (Scott Audette/AP Images)
4
by Josh Sullivan

Richard Lern­er, the es­teemed bio­chemist who pi­o­neered a new way to de­vel­op mon­o­clon­al an­ti­bod­ies and led Scripps Re­search In­sti­tute to promi­nence, has passed away.

A spokesper­son for Scripps told the San Diego Union-Tri­bune that Lern­er died of can­cer in his La Jol­la home. He was 83 years old.

Among oth­er things, Lern­er's lab was known for de­vis­ing a new tech­nique for cre­at­ing an­ti­bod­ies — de­ployed as can­cer treat­ments as well as in im­munol­o­gy and dis­ease re­search — one that the New York Times called a “ma­jor ad­vance in biotech­nol­o­gy." It led to com­pa­nies mak­ing mAbs a thou­sand times faster, more ac­cu­rate­ly, at a low­er cost. That foun­da­tion­al re­search ce­ment­ed the dis­cov­ery of Hu­mi­ra, which went on to be­come the world’s best-sell­ing treat­ment.

Lern­er was trained at Stan­ford, and served as the di­rec­tor and pres­i­dent of Scripps from 1987 un­til 2012. In that time, the in­sti­tu­tion es­tab­lished a Flori­da cam­pus, start­ed a bi-coastal grad­u­ate school and climbed its way to the top-10 grad­u­ate pro­grams of its kind in the US.

“We felt we were with him on a non-stop ad­ven­ture,” Paul Shim­mel, a pro­fes­sor of mol­e­c­u­lar med­i­cine at Scripps, said in an obit­u­ary. “Like pi­o­neers of the old west, who would trans­form med­ical re­search and its as­so­ci­at­ed grad­u­ate ed­u­ca­tion.”

As a man­ag­er, Lern­er had an eye for star re­searchers, fa­mous­ly re­cruit­ing Bar­ry Sharp­less, who went on to win the No­bel Prize. Two oth­er sci­en­tists with ties to Scripps — Ben­jamin List, a for­mer post­doc­tor­al re­searcher for Lern­er — and Ar­dem Pat­apout­ian, who is cur­rent­ly with Scripps, were award­ed No­bel Prizes this fall.

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5
by Zachary Brennan

Af­ter tri­al in­ves­ti­ga­tors flagged a drop in im­mune cell counts that an ex­ter­nal com­mit­tee de­ter­mined was re­lat­ed to treat­ment last month, Mer­ck has been paus­ing HIV-re­lat­ed Phase II and III tri­als ever since.

On Mon­day, the bio­phar­ma com­pa­ny an­nounced it's paus­ing en­roll­ment in two of its Phase III tri­als eval­u­at­ing its lead­ing an­ti-HIV drug can­di­date, which is the once-month­ly, oral is­la­travir.

"At the rec­om­men­da­tion of the ISL PrEP ex­ter­nal da­ta mon­i­tor­ing com­mit­tee (eDMC), Mer­ck is paus­ing en­roll­ment for the IM­POW­ER 22 and IM­POW­ER 24 tri­als while the com­pa­ny con­ducts fur­ther analy­ses of these and oth­er on­go­ing stud­ies," the com­pa­ny said in a state­ment. "In­formed by the rec­om­men­da­tions of the PrEP eDMC, Mer­ck is im­ple­ment­ing ad­di­tion­al mon­i­tor­ing mea­sures for study par­tic­i­pants, in­clud­ing in­creas­ing the fre­quen­cy of to­tal lym­pho­cyte and CD4+ T-cell as­sess­ments."

Mizuho Se­cu­ri­ties was­n't fazed by the paus­es, as it told in­vestors yes­ter­day, "The pause, in our view, is not un­ex­pect­ed as MRK works through the clin­i­cal pro­file of is­la­travir to de­ter­mine the true risk pro­file of the drug. Our fore­cast re­mains un­changed at this time based on our mod­est view on is­la­travir fran­chise over­all."

Ear­li­er last month, Mer­ck paused a Phase II study that first sound­ed the alarm, dubbed IMAG­INE-DR, which was test­ing the once-week­ly com­bi­na­tion of MK-8507, a non-nu­cle­o­side re­verse tran­scrip­tase in­hibitor, and is­la­travir, an in­ves­ti­ga­tion­al nu­cle­o­side re­verse tran­scrip­tase translo­ca­tion in­hibitor. The phar­ma gi­ant and part­ner Gilead al­so said they paused en­roll­ment of a sep­a­rate study us­ing one of the in­ves­ti­ga­tion­al com­pounds from Mer­ck’s so­lo tri­al, out of an abun­dance of cau­tion.

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Róbert Wessman, Alvotech chairman and founder
6
by Zachary Brennan

As Ice­landic bil­lion­aire Róbert Wess­man tries to take down Ab­b­Vie's megablock­buster Hu­mi­ra in court, he's al­so tak­ing his biosim­i­lar up­start to the big time with a $2.25 bil­lion SPAC merg­er, Nas­daq launch and $450 mil­lion raise an­nounced ear­ly Tues­day.

While Wess­man­'s Alvotech has not won FDA ap­proval for any of its biosim­i­lar can­di­dates yet, the com­pa­ny was the first to file with the FDA for ap­proval of its high-con­cen­tra­tion Hu­mi­ra biosim­i­lar and to have suc­cess­ful­ly con­duct­ed a switch­ing study in sup­port of a high­ly-cov­et­ed in­ter­change­abil­i­ty des­ig­na­tion. But oth­er com­pa­nies like Am­gen, Boehringer In­gel­heim and Pfiz­er have since caught up ahead of the launch­es of their own Hu­mi­ra biosim­i­lar com­peti­tors in 2023.

“So when those biosim­i­lar com­pa­nies en­ter in 2023, we ex­pect that on­ly 10% of Hu­mi­ra sales in the US – around 15 to 16 bil­lion, on­ly 10% will be 50 mg. We, on the oth­er hand, were the first to get fil­ing ac­cep­tance of the high­er con­cen­tra­tion, so we can fo­cus on 90% of the mar­ket when we come out,” Wess­man pre­vi­ous­ly told End­points News.

But the high­er con­cen­tra­tion ver­sion of a Hu­mi­ra biosim­i­lar may be a moot point, as BI said in a re­cent cit­i­zen pe­ti­tion to FDA that the agency has yet to weigh in on:

In Boehringer In­gel­heim’s view, these biosim­i­lar prod­ucts, in­clud­ing Cyl­te­zo, should be con­sid­ered to have the same ‘strength’ as the cor­re­spond­ing OC and HC ver­sions of Hu­mi­ra be­cause they con­tain the same to­tal drug con­tent per con­tain­er (e.g., 40 mg), re­gard­less of the vol­ume of ex­cip­i­ents.

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7
by Paul Schloesser

AI biotech Benev­o­len­tAI is go­ing pub­lic in the Nether­lands, and it de­cid­ed to go the SPAC route as part of one of the largest merg­ers in Eu­rope to date.

The AI biotech is join­ing with a SPAC known as Odyssey, launched by in­vest­ment banker broth­ers Michael and Yoel Za­oui. And when it clos­es ear­ly next year and lists on Eu­ronext in Am­s­ter­dam, the merg­er will al­low Benev­o­len­tAI to raise more than $430 mil­lion — and go pub­lic with more than $1 bil­lion in val­ue, which should last the biotech for the next few years.

Be­fore trans­ac­tion costs, Benev­o­len­tAI will re­ceive the more than $330 mil­lion raised by Odyssey when it list­ed back in Ju­ly, as well as more than $150 mil­lion in the form of a pri­vate in­vest­ment in pub­lic eq­ui­ty from ex­ist­ing back­ers such as Sin­ga­pore’s Temasek, As­traZeneca, and health in­vest­ing spe­cial­ists Al­ly Bridge, just to name a few.

"The com­bi­na­tion with Odyssey will al­low us to scale our vi­sion and am­bi­tion of unit­ing pur­pose­ful tech­nol­o­gy and cut­ting-edge sci­ence to dis­cov­er life-chang­ing med­i­cines," said Benev­o­len­tAI's CEO Joan­na Shields in a state­ment.

Now, the funds will be used to ac­cel­er­ate Benev­o­len­tAI's work on drug de­vel­op­ment and add to its clin­i­cal pipeline — which cur­rent­ly has more than a dozen pro­grams and is spear­head­ed by a can­di­date for atopic der­mati­tis. That can­di­date is cur­rent­ly in Phase I tri­als.

Cir­cling back to As­traZeneca: The British phar­ma and Benev­o­len­tAI have long col­lab­o­rat­ed be­fore, start­ing back in 2019. Cur­tesy of Benev­o­len­tAI's plat­form, Back in Jan­u­ary As­traZeneca added its first AI-dis­cov­ered drug tar­get to its port­fo­lio, go­ing af­ter chron­ic kid­ney dis­ease.

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8
by Kyle Blankenship

Rare neu­ro­log­i­cal dis­or­ders have long proved dif­fi­cult for drug de­vel­op­ers, with huge R&D bud­gets and com­mer­cial plans of­ten go­ing bust at the very last minute. Now, Aca­dia Phar­ma is tout­ing a win for its late-stage can­di­date in Rett syn­drome, which could help juice its com­peti­tors' ef­forts as well.

Aca­di­a's trofine­tide hit its co-pri­ma­ry end­points in Phase III study in 187 girls and young women with the rare neu­ro­log­i­cal dis­ease Rett syn­drome, which im­pacts be­tween 6,000 and 9,000 US pa­tients and is of­ten mis­di­ag­nosed as autism, cere­bral pal­sy or non-spe­cif­ic de­vel­op­men­tal de­lay, the com­pa­ny said Tues­day.

The drug best­ed place­bo on two met­rics judged by a pa­tien­t's care­giv­er and physi­cian, re­spec­tive­ly, called the Rett Syn­drome Be­hav­iour Ques­tion­naire and the Clin­i­cal Glob­al Im­pres­sion–Im­prove­ment (CGI-I) as­sess­ment. Both as­sess­ments de­ter­mined im­prove­ments in pa­tients' symp­toms over the 12-week du­ra­tion of the study.

On the RS­BQ as­sess­ment, pa­tients' scores dropped an av­er­age of 5.1 points ver­sus a 1.7-point de­crease in the con­trol (p=0.0175). Mean­while, the CGI-I test showed a 3.5-point change for pa­tients in the trofine­tide arm ver­sus 3.8 for place­bo (p=0.003).

Tak­ing home a late-stage win in Rett syn­drome is a good look for Aca­dia, and in­vestors cheered the news with the com­pa­ny's stock ACAD trad­ing at just above $20 ear­ly Tues­day, up rough­ly 5% from Mon­day's clos­ing price.

Aca­dia now plans to take its da­ta in front of the FDA by the mid­dle of next year, with a pre-NDA meet­ing sched­uled for the first quar­ter, it said. Trofine­tide has re­ceived fast track des­ig­na­tion from the agency and would be el­i­gi­ble for pri­or­i­ty re­view.

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9
by Zachary Brennan

Que­bec-based Med­ica­go and its ad­ju­vant part­ner Glax­o­SmithK­line said Tues­day that their plant-based Covid-19 vac­cine can­di­date proved to be 71% ef­fi­ca­cious against all vari­ants of SARS-CoV-2 in a Phase III tri­al of more than 24,000 adults in Cana­da, the US, UK, Mex­i­co, Ar­genti­na and Brazil.

In ad­di­tion to show­ing 75% ef­fi­ca­cy against the Delta vari­ant specif­i­cal­ly, the com­pa­nies al­so said the vac­cine proved to be gen­er­al­ly safe, with no se­ri­ous ad­verse events re­port­ed and re­ac­to­genic­i­ty gen­er­al­ly be­ing mild to mod­er­ate. The re­sults mean that a reg­u­la­to­ry sub­mis­sion will be filed with Health Cana­da im­mi­nent­ly, they said.

Like its mR­NA coun­ter­parts, the Med­ica­go/GSK vac­cine is two dos­es, with each dose pro­vid­ed 21 days apart.

"These are en­cour­ag­ing re­sults giv­en da­ta were ob­tained in an en­vi­ron­ment with no an­ces­tral virus cir­cu­lat­ing. The glob­al COVID-19 pan­dem­ic is con­tin­u­ing to show new facets with the cur­rent dom­i­nance of the Delta vari­ant, up­com­ing Omi­cron, and oth­er vari­ants like­ly to fol­low," Thomas Breuer, GSK's glob­al Covid-19 ad­ju­vant­ed vac­cines lead, said in a state­ment. "The com­bi­na­tion of GSK's es­tab­lished pan­dem­ic ad­ju­vant with Med­icago's plant-based vac­cine tech­nol­o­gy has sig­nif­i­cant po­ten­tial to be an ef­fec­tive, re­frig­er­a­tor-sta­ble op­tion to help pro­tect peo­ple against SARS-CoV-2."

GSK is al­so still work­ing with Sanofi and SK bio­science to de­vel­op ad­ju­vant­ed, pro­tein-based vac­cines, which are now in Phase III tri­als, as well as with Cure­Vac, to joint­ly de­vel­op a next-gen mR­NA vac­cine, with the po­ten­tial to ad­dress emerg­ing vari­ants in one vac­cine.

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10
by Max Gelman

A new Eu­ro­pean biotech has put to­geth­er a near­ly $100 mil­lion Se­ries A, and its lead pro­gram is go­ing af­ter a tar­get re­cent­ly val­i­dat­ed by the FDA.

Emer­gence Ther­a­peu­tics raised €87 mil­lion in its first big raise Tues­day, good for rough­ly $97.8 mil­lion, com­ing out of stealth with a plan to tack­le an­ti­body-drug con­ju­gates. The first pro­gram up is set­ting its sights on nectin-4, the tar­get for Astel­las and Seagen’s Pad­cev drug, which gained full FDA ap­proval for urothe­lial can­cers this past sum­mer.

CEO Jack Elands said the com­pa­ny got its start af­ter work­ing with re­searchers at the Uni­ver­si­ty of Mar­seille Can­cer Re­search Cen­ter to de­vel­op the lead can­di­date.

“We start­ed think­ing about what we ac­tu­al­ly need to do in or­der to out­per­form Pad­cev, be­cause we did­n't want to just blind­ly de­vel­op , we re­al­ly want­ed to de­vel­op some­thing that was marked­ly bet­ter,” Elands told End­points News.

He added: “We're now in a phase where we just have to ex­e­cute rapid­ly and with high qual­i­ty, and the abil­i­ty to raise this Se­ries A is go­ing to en­able us to do that.”

The pro­gram in ques­tion is known as ETx-22, and Emer­gence is pin­ning its high hopes here. By sharp­en­ing the mes­sage that re­searchers want to tack­le nectin-4, Elands is all but de­clar­ing his com­pa­ny can de­vel­op a Pad­cev suc­ces­sor.

There are scant hard da­ta to go on so far, as Emer­gence has on­ly con­duct­ed pre­clin­i­cal work for the can­di­date to this point. The biotech is pre­dict­ing, how­ev­er, ETx-22 will prove less tox­ic than oth­er nectin-4 AD­Cs, al­low­ing for high­er dos­ing and greater ef­fi­ca­cy.

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11
by Max Gelman

Gary Glick is back at it again, found­ing yet an­oth­er biotech com­pa­ny. And by the sheer size of its first raise, this may be the biggest one yet.

Glick has as­sem­bled what he calls an all-star ros­ter and re­cruit­ed one of the biggest health­care in­vestors in Or­biMed to put to­geth­er a mas­sive $218 mil­lion Se­ries A for his newest ven­ture, Odyssey Ther­a­peu­tics. The launch, an­nounced Tues­day morn­ing and co-led by SR One Cap­i­tal Man­age­ment, comes not three months af­ter Glick sold First Wave Bio to Azur­Rx for $229 mil­lion.

But Glick has had Odyssey on his mind since at least ear­ly this year, first craft­ing the vi­sion back in March with co-founder David Pom­pli­ano, with whom Glick did his post­doc at Je­re­my Knowles’ Har­vard lab. Liken­ing Odyssey to one of his ear­li­er com­pa­nies, IFM Ther­a­peu­tics, Glick said the new biotech is plac­ing a sim­i­lar bet on en­sur­ing the best peo­ple are in­volved.

“What's oc­cur­ring at Odyssey is just some­thing on a much larg­er scale, with a con­sid­er­able amount more depth in many of those sort of drug dis­cov­ery dis­ci­plines,” Glick tells End­points News. “The fi­nanc­ing al­lows us to sup­port not on­ly a larg­er num­ber of pro­grams, but quite a bit of tech­nol­o­gy de­vel­op­ment and in­te­gra­tion to cre­ate the plat­form.

“It’s a recipe for suc­cess that's worked across all my com­pa­nies,” he added.

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12
by Zachary Brennan

The World Health Or­ga­ni­za­tion said late to­day that it's not rec­om­mend­ing the use of con­va­les­cent plas­ma as a treat­ment for Covid-19 for mild or se­vere cas­es, but some U.S. ex­perts dis­agree with the rec­om­men­da­tions and say there are pa­tients who can ben­e­fit from the plas­ma of those who've re­cov­ered from Covid-19.

The rec­om­men­da­tion is in­formed by a re­view of 16 RCTs and a "meta-analy­sis on an­ti­bod­ies and cel­lu­lar ther­a­pies for covid-19," the WHO said, adding in a state­ment:

De­spite its ini­tial promise, cur­rent ev­i­dence shows that it does not im­prove sur­vival nor re­duce the need for me­chan­i­cal ven­ti­la­tion, and it is cost­ly and time-con­sum­ing to ad­min­is­ter. As such, the WHO makes a strong rec­om­men­da­tion against the use of con­va­les­cent plas­ma in pa­tients with non-se­vere ill­ness, and a rec­om­men­da­tion against its use in pa­tients with se­vere and crit­i­cal ill­ness, ex­cept in the con­text of a ran­domised con­trolled tri­al (RCT).

The WHO wrote in the BMJ that, "Most im­por­tant­ly, giv­en there was no ben­e­fit demon­strat­ed in any of the crit­i­cal or im­por­tant out­comes for non-se­vere covid-19, the GDG did not see any jus­ti­fi­ca­tion for the re­sources (in­clud­ing time and cost) that would be as­so­ci­at­ed with ad­min­is­tra­tion of con­va­les­cent plas­ma."

The an­nounce­ment builds on re­cent­ly pub­lished da­ta show­ing that while con­va­les­cent plas­ma has proven to be gen­er­al­ly safe, it al­so failed to show signs of ef­fi­ca­cy in some large RCTs of out­pa­tients, in­clud­ing on mor­tal­i­ty in a UK tri­al of those hos­pi­tal­ized with Covid, pub­lished in The Lancet in May, and an­oth­er for out­pa­tients in Au­gust in the New Eng­land Jour­nal of Med­i­cine.

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13
by Beth Snyder Bulik

What would you do with $100 and the sim­ple in­struc­tion to “spread joy?" That’s what phar­ma and health­care agency Klick Health asked its em­ploy­ees as part of its an­nu­al hol­i­day greet­ing for clients, friends and fu­ture re­cruits.

More than 600 Klick­sters, as the agency folks call them­selves, took up the chal­lenge. For each per­son who signed up, Klick sent a box with a roy­al blue agency brand­ed scarf, cards and a $100 bill. Each per­son filmed them­selves open­ing the box, start­ing out on their “joy” mis­sions and their re­cip­i­ents’ re­ac­tions.

The smart­phone videos were then com­piled in­to a three-minute “#Spread­Joy” hol­i­day video, a process that chief cre­ative of­fi­cer Rich Levy said took about three weeks. While the an­nu­al greet­ing is a pop­u­lar tra­di­tion in­side the com­pa­ny, it al­so serves as a de­fault re­cruit­ing tool with mil­lions of views and al­most every in­ter­vie­wee men­tion­ing they’d seen one of the videos. The 2020 an­i­mat­ed video clocked 4.8 mil­lion views while 5.9 mil­lion watched the last pre­vi­ous live-shot video in 2019.

“When you start get­ting that num­ber of views, every­one sees it and every­one re­mem­bers it. I think peo­ple like them be­cause they show what the com­pa­ny stands for, and peo­ple want to work for com­pa­nies that match their per­son­al val­ues,” Levy said.

In the video, some Klick em­ploy­ees hand big tips to wait­ers or baris­tas, while oth­ers gift the mon­ey to bus dri­vers, cross­ing guards and kind neigh­bors.

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14
by Kyle Blankenship

Once large­ly a mys­tery to re­searchers, the far-flung realm of cells in the im­mune sys­tem has emerged as a fruit­ful sand­box for drug de­vel­op­ers. A new UK biotech is lean­ing on re­search in­to the grow­ing role of den­drit­ic cells in spurring im­mune re­spons­es, and US ven­ture firm Ap­ple Tree Part­ners is bankrolling its ear­ly ef­forts.

Lon­don-based Aden­dra Ther­a­peu­tics launched Tues­day with $53 mil­lion from found­ing in­vestor ATP and re­search out of the Fran­cis Crick In­sti­tute look­ing to lever­age new in­sights in­to how den­drit­ic cells sic preda­to­ry T cells on­to tu­mors — and their role in dri­ving au­toim­mune dis­ease.

Lever­ag­ing re­search out of the lab of Cae­tano Reis e Sousa, Aden­dra starts life with cut­ting-edge re­search in­to den­drit­ic cells un­der its belt and a hefty pay­check to boot.

Reis e Sousa, who helped kick­start the com­pa­ny as sci­en­tif­ic co-founder, point­ed to den­drit­ic cell­s' dual role in both tak­ing pieces of for­eign bod­ies and pre­sent­ing them to T cells for iden­ti­fi­ca­tion but al­so act­ing as T cell­s' "on-off" switch. New­er re­search has al­so point­ed to those cell­s' role in "goad­ing" pro­longed T cell ac­ti­va­tion, which means den­drit­ic cells not on­ly turn T cells on or off but al­so tell them how long to en­gage their tar­get.

"It's not just about trig­ger­ing it but al­so about con­tin­u­ing to push the re­sponse for­ward," he told End­points News. "That is im­por­tant par­tic­u­lar­ly in the con­text of au­toim­mu­ni­ty when you ac­tu­al­ly want to in­ter­rupt that cy­cle. You can think of it as a ther­a­peu­tic tar­get where you can ef­fec­tive­ly try and block these pos­i­tive sig­nals com­ing from the den­drit­ic cells, there­by break­ing the cy­cle that is lead­ing to con­tin­u­al ac­ti­va­tion of those T cells."

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15
by Beth Snyder Bulik

Phar­ma com­pa­nies have more dig­i­tal doors to doc­tors than ever be­cause of the Covid-19 pan­dem­ic, but health­care providers think many can do bet­ter.

While 86% of HCPs rec­og­nize that phar­ma com­pa­nies are more con­sid­er­ate of their needs now, al­most two-thirds (65%) al­so say at least one phar­ma has “spammed” them with dig­i­tal con­tent in the past year. And 64% agree that the vol­ume of dig­i­tal con­tent from phar­ma com­pa­nies is too much, ac­cord­ing to the Ac­cen­ture study set for re­lease Mon­day.

“There’s great op­por­tu­ni­ty here, but al­so great cau­tion to be had,” Suzy Jack­son, man­ag­ing di­rec­tor in Ac­cen­ture’s life sci­ence prac­tice, said. “The an­swer is not quan­ti­ty, but qual­i­ty, and mak­ing sure you’re cut­ting through the noise. And if you do so, we’re show­ing that you get re­ward­ed for that.”

That re­ward? More time and at­ten­tion from doc­tors. Time, in fact, is some­thing most HCPs have more of to­day. About three-fourths re­port­ed drops in pa­tient num­bers over the past year, con­sis­tent across spe­cial­ties, in­clud­ing on­col­o­gy (76%), im­munol­o­gy (78%), car­di­ol­o­gy (72%) and gen­er­al prac­tice (73%).

The good news for phar­ma is that more free time – and bet­ter com­mu­ni­ca­tions – trans­lates to more ac­cess with 88% twice as like­ly to meet with a phar­ma rep if it were sim­i­lar to their best in­ter­ac­tions. When ques­tioned fur­ther, they agreed they would be more open to meet­ing oth­ers in the com­pa­ny, open emails and lis­ten to mes­sages from that com­pa­ny ver­sus oth­ers.

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16
by Paul Schloesser

With the rush of AI per­me­at­ing the biotech in­dus­try, an­oth­er AI play­er is com­ing out well-or­ga­nized and flush with cash. METiS Ther­a­peu­tics an­nounced this morn­ing that it suc­cess­ful­ly put $86 mil­lion in the bank, thanks to a Se­ries A.

Two in­vest­ment firms con­nect­ed to the Chi­nese gov­ern­ment (Peo­ple's In­sur­ance Com­pa­ny of Chi­na and Chi­na Life In­sur­ance Com­pa­ny) led the fi­nanc­ing round — and were joined by Se­quoia Cap­i­tal Chi­na, 5Y Cap­i­tal and sev­er­al oth­er in­vestors.

"To­day’s news rep­re­sents the first of many sig­nif­i­cant mile­stones that we will be ac­com­plish­ing through­out the next year," METiS CEO Chris Lai said in a state­ment.

The biotech, found­ed back in 2017 and with 70 em­ploy­ees in both Chi­na and in Cam­bridge, MA, plans to triple its US-based em­ploy­ees with­in the next 12 months.

Af­ter its found­ing, METiS part­nered with XtalPi, a Cam­bridge AI-fo­cused R&D com­pa­ny — where the biotech got seed fund­ing and in­cu­bat­ed for a time be­fore spin­ning out in ear­ly 2020.

So where is this Se­ries A mon­ey go­ing? The $86 mil­lion will be used to ad­vance the com­pa­ny’s pipeline, METiS said, along with con­tin­ued de­vel­op­ment of its AI drug dis­cov­ery and de­liv­ery plat­form, along the lines of RNA ther­a­peu­tics, gene ther­a­pies and small mol­e­cules. Con­cern­ing how far it'll last the com­pa­ny? The com­pa­ny re­mained mum on the top­ic, on­ly say­ing "$86 mil­lion will take them through mul­ti­ple mile­stones and val­ue in­flec­tion points."

And while it is still ear­ly in the com­pa­ny's his­to­ry, the com­pa­ny told End­points in an email that they do have some­thing in mind for ini­tial tar­gets: "or­phan dis­eases, CNS, au­toim­mune sys­tems and nephrol­o­gy," they said.

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News Briefing: Quick hits from the biopharma web
17
by Paul Schloesser

vTv Ther­a­peu­tics has de­cid­ed to chop down its work­force by al­most two-thirds.

The High Point, NC biotech an­nounced Mon­day that it would piv­ot and now pri­or­i­tize its lead pro­gram, the oral glu­cok­i­nase ac­ti­va­tor TTP399, as it gears up for Phase III piv­otal tri­als.

The drug was grant­ed break­through ther­a­py des­ig­na­tion af­ter show­ing a 40% re­duc­tion in hy­po­glycemic episodes com­pared to place­bo, and back in Oc­to­ber vTv an­nounced pos­i­tive re­sults in a study show­ing no in­creased risk for ke­toaci­do­sis, a se­vere com­pli­ca­tion of di­a­betes.

And be­cause of that shift, vTv is un­der­go­ing the mas­sive re­struc­tur­ing, in­clud­ing cut­ting the work­force, adding "sev­er­al con­sul­tants" and paus­ing de­vel­op­ment on an­oth­er drug — a PDE4 in­hibitor for pso­ri­a­sis.

"It is al­ways dif­fi­cult to re­struc­ture but this al­lows us to fo­cus on TTP399 and our fu­ture growth," said vTv CEO and pres­i­dent Deepa Prasad. "We con­tin­ue to en­gage with the FDA to map out a clear and pos­i­tive path for­ward on our Phase 3 piv­otal stud­ies with the goal of im­prov­ing qual­i­ty of life for pa­tients man­ag­ing this chron­ic, bur­den­some dis­ease."

On­col­o­gy-fo­cused Freenome rais­es $300M in Se­ries D round

South San Fran­cis­co's Freenome to­day an­nounced a mas­sive Se­ries D haul this morn­ing, bring­ing in $300 mil­lion and push­ing Freenome's to­tal fund­ing to over $800 mil­lion since 2014.

This round of fi­nanc­ing was led by Per­cep­tive Ad­vi­sors and Pe­ter Kolchin­sky's RA Cap­i­tal Man­age­ment, joined by ex­ist­ing in­vestors Ar­tis Ven­tures, Kaiser Per­ma­nente, No­var­tis and Ridge­back Cap­i­tal Man­age­ment. And with this kind of fund­ing, there were sev­er­al new in­vestors that tagged along: Lo­gos Cap­i­tal and Pure Vi­da In­vest­ments, to name two.

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