Soros, Gates back medtech's move in­to a 'so­cial en­ter­prise'; Ag­ing an­ti-re­jec­tion drug earns fresh ap­proval

George Soros and Bill Gates are team­ing up to buy out a British di­ag­nos­tics com­pa­ny.

The pair and their foun­da­tions will spend about $41 mil­lion to trans­form Mo­log­ic in­to a “So­cial En­ter­prise” aimed at ex­pand­ing ac­cess to state-of-the-art med­ical tech­nol­o­gy, the com­pa­ny an­nounced Mon­day. Launched in 2003, Mo­log­ic comes from the fa­ther-and-son team of Mark and Paul Davis, the lat­ter of whom helped cre­ate one of the first at-home preg­nan­cy tests.

“Mo­log­ic’s tran­si­tion in­to a so­cial en­ter­prise is a de­lib­er­ate, log­i­cal and nat­ur­al step for a com­pa­ny fo­cused on de­liv­er­ing af­ford­able di­ag­nos­tics and biotech­nol­o­gy to places that have been left un­der­served by the re­lent­less pur­suit of prof­i­teer­ing,” Mark Davis, who al­so serves as CEO, said in a state­ment. — Max Gel­man

An­ti-re­jec­tion drug gets FDA OK for lung trans­plants

An an­ti-re­jec­tion drug pre­vi­ous­ly used to pre­vent or­gan re­jec­tion in pa­tients with liv­er, kid­ney and heart trans­plants has been ap­proved by the FDA for lung trans­plant pa­tients as well on Fri­day.

Pro­graf was ap­proved for use in com­bi­na­tion with oth­er im­muno­sup­pres­sant drugs. The ap­proval marks the first and on­ly for a drug to pre­vent re­jec­tion of a lung trans­plant.

Ap­proval was grant­ed based on a non-in­ter­ven­tion­al, fit-for-pur­pose study us­ing re­al-world da­ta. Da­ta were col­lect­ed on all US lung trans­plants, and da­ta from ran­dom­ized con­trolled tri­als of Pro­graf in oth­er set­tings pro­vid­ed con­fir­ma­to­ry ev­i­dence, the FDA said.

“A dra­mat­ic im­prove­ment in out­comes was ob­served among lung trans­plant pa­tients re­ceiv­ing Pro­graf as part of their im­muno­sup­pres­sion med­ica­tions com­pared to the well-doc­u­ment­ed nat­ur­al his­to­ry of a trans­plant­ed drug with no or min­i­mal im­muno­sup­pres­sive ther­a­py,” the press re­lease from the FDA said.  — Josh Sul­li­van

As­traZeneca pneu­mo­nia can­di­date tar­get­ed in li­cens­ing deal

Aridis Phar­ma­ceu­ti­cals will ex­clu­sive­ly li­cense As­traZeneca’s late-stage pneu­mo­nia an­ti­body can­di­date su­vra­tox­um­ab.

Su­vra­tox­um­ab, which re­cent­ly fin­ished a Phase II tri­al, will com­ple­ment Aridis’ own Phase III pneu­mo­nia pro­gram for AR-301. Both can­di­dates tar­get the S. au­reus strain.

As part of the deal, As­traZeneca will be­come a share­hold­er in Aridis and will re­tain fu­ture “first-to-ne­go­ti­ate” rights for li­cens­ing the pro­gram.

In that Phase II test, su­vra­tox­um­ab re­duced the rel­a­tive risk of pneu­mo­nia by 32% in 196 pa­tients with a 47% re­duc­tion in the over-65 pop­u­la­tion. The drug was al­so as­so­ci­at­ed with a sub­stan­tial re­duc­tion in du­ra­tion of care need­ed at the ICU and hos­pi­tal. — Kyle Blanken­ship

Ra­tio­nal de­sign for pro­tein degra­da­tion? Aus­tri­an deep learn­ing start­up takes a stab

For all the promis­es of PRO­TACs and mol­e­c­u­lar glues as a class, there re­mains lots of room for im­prove­ment on how in­di­vid­ual pro­tein de­graders are dis­cov­ered.

Christo­pher Trum­mer

That’s ac­cord­ing to Christo­pher Trum­mer, a for­mer bioin­for­mat­ics con­sul­tant who no­ticed, while do­ing con­tract re­search for a va­ri­ety of bio­phar­ma com­pa­nies, that there was re­al­ly no ra­tio­nal ap­proach to de­sign­ing mol­e­cules that can grab tar­gets and tag them for dis­pos­al. Iden­ti­fy­ing the right ones was al­ways a tri­al and er­ror af­fair.

“Typ­i­cal­ly if you do some brute force meth­ods, high through­put screen­ing — even if you part­ner with [what are con­sid­ered] the cheap­est CROs, right — you would end up in at least half a mil­lion or a mil­lion for screen­ing, in the PRO­TAC area, maybe 2,000, 3,000 com­pounds, some­thing like that,” he said. “So it is very very cost­ly.”

To­geth­er with his friend Jakob Ho­hen­berg­er, who has a back­ground in tech, Trum­mer be­gan ex­plor­ing a so­lu­tion steeped in deep learn­ing. The re­sult was Celeris Ther­a­peu­tics, whose Celeris One soft­ware promis­es to pre­dict pro­tein-pro­tein in­ter­ac­tions and dock­ing specif­i­cal­ly for ap­pli­ca­tions in tar­get­ed pro­tein in­ter­ac­tions.

Jakob Ho­hen­berg­er

It was enough to draw in­quiries from Big Phar­ma and biotech com­pa­nies, Trum­mer said, one of which has al­ready agreed to a part­ner­ship.

The team of 15 is cur­rent­ly based in Aus­tria. While Celeris plans to keep a pres­ence here — and grow even big­ger by build­ing a wet lab lat­er this year — Trum­mer, the CEO, plans to move to Sil­i­con Val­ley soon to be clos­er to in­vestors as well as sci­en­tists and po­ten­tial part­ners.

True to its Eu­ro­pean roots, though, Celeris has kept its fund­ing mod­est. Af­ter APEX Med­ical brought their pre-seed fund­ing to €1.6 mil­lion ($1.89 mil­lion), the biotech is tar­get­ing €5 mil­lion for the seed round.

“We gen­uine­ly be­lieve that these ma­chine learn­ing based sim­u­la­tions will stream­line the way ear­ly stage drug de­vel­op­ment is per­formed and even­tu­al­ly will ben­e­fit all over the world,” Gor­don Eu­ller, gen­er­al part­ner at APEX, wrote in an email.

The goal, ul­ti­mate­ly, is to op­er­ate like the cash-rich AI play­er Ex­sci­en­tia, which is lend­ing its tech­nol­o­gy to clients but al­so pur­su­ing in-house dis­cov­ery and de­vel­op­ment. — Am­ber Tong

Opi­oid al­ter­na­tive starts PhII tri­al in bunionec­to­my and ab­domino­plas­ty surgery

Ver­tex has kicked off a Phase II proof-of-con­cept study in acute pain af­ter bunionec­to­my surgery, the com­pa­ny an­nounced Mon­day. It will start a Phase II study of pain fol­low­ing ab­domino­plas­ty surgery in the com­ing weeks.

Car­men Boz­ic

The ran­dom­ized, dou­ble-blind­ed, place­bo-con­trolled stud­ies will eval­u­ate its se­lec­tive NaV1.8 in­hibitor VX-548, and in­clude a hy­drocodone bitar­trate/ac­eta­minophen ref­er­ence arm. The small mol­e­cule has shown to re­duce neu­ro­path­ic pain and mus­cu­loskele­tal pain in pre­vi­ous clin­i­cal tri­als. If Ver­tex hits on VX-548, it could pro­vide a po­tent, non-ad­dic­tive al­ter­na­tive to opi­oids.

“NaV1.8 is a ge­net­i­cal­ly and phar­ma­co­log­i­cal­ly val­i­dat­ed tar­get and we are ex­cit­ed about the po­ten­tial for VX-548 as a new class of ef­fec­tive pain treat­ments with­out the lim­i­ta­tions of cur­rent ther­a­pies, in­clud­ing the ad­dic­tive po­ten­tial of opi­oids,” EVP Car­men Boz­ic said in a press re­lease.

Re­sults from the study are ex­pect­ed by Q1 of 2022. — Josh Sul­li­van

French biotech PEP-Ther­a­py ex­pands Se­ries A round

A few months af­ter clos­ing its $3.4 mil­lion Se­ries A round, Paris-based PEP-Ther­a­py has in­vestors reach­ing a lit­tle deep­er in­to their wal­lets.

PEP-Ther­a­py has reeled in an­oth­er $3 mil­lion in a Se­ries A ex­pan­sion, bring­ing its to­tal haul to $6.4 mil­lion. The com­pa­ny’s work­ing on what it calls Cell Pen­e­trat­ing & In­ter­fer­ing Pep­tide (CP&IP) tech­nol­o­gy, de­signed to pen­e­trate cells and specif­i­cal­ly block rel­e­vant in­tra­cel­lu­lar pro­tein-pro­tein in­ter­ac­tions. Its lead can­di­date PEP-010 is cur­rent­ly in a Phase Ia/b tri­al for ad­vanced sol­id tu­mors.

“We are de­light­ed to have com­plet­ed this fi­nanc­ing round via an at­trac­tive bal­ance of di­lu­tive and non-di­lu­tive funds from new high qual­i­ty and di­ver­si­fied in­vestors who will bring ex­per­tise and new in­sights to sup­port our de­vel­op­ment,” CEO An­toine Pre­stat said in a state­ment. — Nicole De­Feud­is 

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

New Charles River Laboratories High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. (Charles River)

Charles Riv­er Lab­o­ra­to­ries to start cell and gene ther­a­py man­u­fac­tur­ing at UK site in Sep­tem­ber

While Massachusetts-based Charles River Laboratories has been on an acquisition spree, they are not against planting their flag. The latest move by the company sees them crossing the pond to establish a manufacturing site in the UK.

The company on Tuesday opened its cell and gene therapy manufacturing center at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. The expansion follows Charles River’s acquisition of Cognate BioServices and Cobra Biologics in 2021 for $875 million. Cognate is a plasmid DNA, viral vector and cell therapy CDMO.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”

#Can­nes­Lions2022: Con­sumer health ex­ecs call on agen­cies to in­volve pa­tients in cre­ative process

CANNES — When Tamara Rogers joined GSK back in 2018, “science was king and R&D were the gods.” Now the global chief marketing officer of consumer healthcare wants to make room for another supreme being: the consumer.

As health and wellness becomes more relevant to consumers amid the pandemic, four health-focused executives called on marketers to involve patients in their creative process in a panel discussion at the Cannes Lions advertising creativity festival.

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