Alexis Borisy (file photo)

EQRx and Ex­sci­en­tia, a pair of self-styled dis­rup­tors, team up to over­turn the drug pric­ing ap­ple cart

The biotech in­dus­try has seen no short­age of in­no­va­tion in re­cent years, but in one area — drug pric­ing — the field has been any­thing but in­no­v­a­tive. Now, two brash star­tups tak­ing dif­fer­ent roads to up­set the drug pric­ing mod­el will part­ner up to cre­ate a sort of “su­per-dis­rup­tor.”

EQRx and UK-based AI spe­cial­ist Ex­sci­en­tia will team up on a dis­cov­ery-through-com­mer­cial­iza­tion col­lab­o­ra­tion the part­ners hope will work bet­ter than the sum of its parts to bring cheap­er med­i­cines to pa­tients faster, the com­pa­nies said Thurs­day.

As part of the deal, Ex­sci­en­tia will pick up dis­cov­ery du­ties through IND while EQRx will han­dle de­vel­op­ment and com­mer­cial­iza­tion. Fi­nan­cial terms of the deal were not dis­closed.

EQRx, helmed by Blue­print co-founder Alex­is Borisy, has made its name on tar­get­ing drug mar­kets with­out any mean­ing­ful price com­pe­ti­tion with a com­mer­cial strat­e­gy of di­rect­ly un­der­cut­ting its com­peti­tors. Its first tar­get is PD-1, which de­spite sev­en drugs on the mar­ket hasn’t seen a sin­gle play­er try a dis­count­ing strat­e­gy to un­der­cut those drugs’ no­to­ri­ous­ly high list prices.

Late last month, EQRx and part­ner CStone read out late-stage da­ta show­ing their PD-1 drug sug­e­mal­imab hit its pri­ma­ry end­point of pro­gres­sion-free sur­vival as a con­sol­i­da­tion ther­a­py for pa­tients with stage III non-small cell lung can­cer whose dis­ease hasn’t pro­gressed af­ter con­cur­rent or se­quen­tial chemora­dio­ther­a­py.

The GEM­STONE-301 study fol­lowed up re­sults from GEM­STONE-302, which test­ed sug­e­mal­imab against place­bo in Stage IV NSCLC. That Phase III study, with re­sults pre­sent­ed last year, was al­so a win, and tak­en to­geth­er the da­ta “set the stage” for reg­u­la­to­ry fil­ings.

Ex­sci­en­tia, for its part, has tout­ed its work in bring­ing the first “AI-dis­cov­ered” mol­e­cule to hu­man tri­als, a process the com­pa­ny says can sig­nif­i­cant­ly cut down de­vel­op­ment time and low­er the bench­mark R&D es­ti­mate of $2.6 bil­lion for any new drug on av­er­age.

An­drew Hop­kins

Whether Ex­sci­en­tia’s mol­e­cules are ac­tu­al­ly “AI-dis­cov­ered” — the com­pa­ny’s plat­form crunch­es tri­al da­ta to nar­row down its dis­cov­ery search — is up for de­bate, the com­pa­ny has earned some se­ri­ous in­vestors in its mis­sion. In April, Ex­sci­en­tia scored a $225 Se­ries D round as well as a $300 mil­lion eq­ui­ty in­vest­ment from Soft­Bank Vi­sion Fund 2 with back­ing from a range of blue-chip in­vestors.

In a con­ver­sa­tion with End­points News, Ex­sci­en­tia CEO An­drew Hop­kins said the EQRx col­lab­o­ra­tion be­gan from a se­ries of im­promp­tu talks with Borisy about the com­pa­nies’ mis­sion state­ments.

“There’s a re­al chem­istry be­tween the two teams, and I think it fits down to a very sim­i­lar phi­los­o­phy and mis­sion be­tween the two com­pa­nies,” he said. “Once we start­ed talk­ing about what Ex­sci­en­tia was de­vel­op­ing, how our tech­nol­o­gy had val­i­dat­ed it­self, then we could see a re­al syn­er­gy be­tween what Ex­sci­en­tia wants to achieve with what EQRx’s mis­sion is.”

The key to the col­lab­o­ra­tion is pa­tient ac­cess, Hop­kins said, and pric­ing is a key road­block there. The com­pa­nies take two sep­a­rate ap­proach­es — EQRx on the com­mer­cial end and Ex­sci­en­tia in dis­cov­ery — but com­bined, they think they can cut costs across the R&D chain and open pricey, cut­ting-edge ther­a­pies up for a broad­er, glob­al pa­tient pool than may nor­mal­ly have been able to af­ford them.

“For us, it’s the whole con­cept of in­creas­ing the ac­cess of in­no­v­a­tive med­i­cines to a wider range of pa­tients,” he said.

Hop­kins was mum on what mile­stones for this deal will look like and didn’t dis­close any lead tar­gets or mol­e­cules. It’s ear­ly days, he said, but Ex­sci­en­tia’s speedy dis­cov­ery process could be­gin churn­ing out drugs soon­er than you think.

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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Stéphane Bancel, AP Images

Mod­er­na takes on a low-risk pact with CAR-T play­er Au­to­lus for mR­NA-based can­cer drugs

Moderna’s Covid-19 vaccine has transformed the once-backwater biotech into one of the most highly valued drugmakers in the world in the span of a year. But what does the future hold for Moderna’s star turn? A small-scale discovery pact could offer a clue.

Moderna will hold exclusive rights to four mRNA-based immuno-oncology candidates using proprietary binding tech from Autolus, a biotech best known for its work on “off-the-shelf” CAR-T therapies, the partners said Monday.

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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Ipsen con­tin­ues its shop­ping spree with a $1B-plus deal for Ex­i­cure's next-gen oligonu­cleotides

Ipsen has been on a deal-making spree the last few weeks, shelling out more than a billion dollars in two separate deals to work on a mid-stage levodopa-induced dyskinesia (LID) candidate and a preclinical BAX inhibitor in several cancers. But on Monday, the company inked its largest collaboration deal yet.

Ipsen is putting down $20 million upfront and up to $1 billion in biobucks for exclusive options to two of Exicure’s discovery-stage spherical nucleic acid (SNA) treatments for Huntington’s disease and Angelman syndrome.

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

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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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