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 

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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FTC pulls re­main­ing case against Ab­b­Vie; New EU clin­i­cal tri­als sys­tem com­ing in 2022; Abing­worth bets big on CymaBay

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.

UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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Alan Hirzel, Abcam

Drug sup­pli­er Ab­cam brings a long­time col­lab­o­ra­tor in house as part of $340M buy­out pact

BioVision has supplied Abcam with research tools since 1999, and now the two are making it official as part of a merger unveiled Monday.

Abcam will buyout BioVision as part of a $340 million acquisition deal to bring aboard the supplier’s biochemical and cell-based assays for biological research, as well as recombinant proteins, antibodies and enzymes.

The deal will give Abcam control of BioVision’s portfolio and allow for both the expansion of research existing areas of focus such as oncology, neuroscience and epigenetics and preparation to expand into new products. As a part of the deal, Abcam will develop and supply products and services to NKY, the previous owner of BioVision and receive support for ongoing development and commercialization of in vitro diagnostic products.