The dis­rup­tors at EQRx have their eyes on the PD-(L)1 mar­ket — tee­ing up $150M cash to grab 2 back­bone ther­a­pies from Chi­na

EQRx is pay­ing top dol­lar to bring a pair of PD-(L)1 drugs in­to its port­fo­lio of fast-fol­low ther­a­pies, of­fer­ing $150 mil­lion up­front in what could shape up to be a $1.3 bil­lion al­liance with Chi­na’s CStone.

As ear­ly as 2017 Cel­gene had bet on a made-in-Chi­na PD-1 via its pact with BeiGene, quick­ly fol­lowed by Ar­cus as the sec­ond check­point wave was loom­ing; more re­cent­ly Eli Lil­ly im­port­ed long­time part­ner In­novent’s PD-1 in a $1 bil­lion deal. All are div­ing in­to a space now dom­i­nat­ed by Mer­ck’s Keytru­da fran­chise, where six oth­er play­ers are try­ing to catch up by carv­ing out their own nich­es — and more are on their way to tap in­to the var­i­ous I/O pair­ings an­chored by a PD-(L)1. But none so far has quite shared EQRx’s ex­plic­it mis­sion to dis­rupt the multi­bil­lion-dol­lar mar­ket by of­fer­ing a low­er cost op­tion.

With sev­en drugs al­ready ap­proved, though, one has to won­der: Why hasn’t there been more com­pe­ti­tion on price? And what makes EQRx think it can make any dif­fer­ence?

“That’s a re­al­ly in­ter­est­ing ques­tion, isn’t it? In most in­dus­tries that’s what you’d ex­pect,” Alex­is Borisy, co-founder and CEO, told End­points News. “There’s a lot of an­swers to it[…] It’s a very com­plex set of in­ter­ac­tions, the net re­sult of which has been spi­ral­ing ever high­er prices in our in­dus­try.”

The promise at EQRx, as Borisy and Melanie Nal­licheri wide­ly pitched at this year’s JP Mor­gan con­fab, is not just to de­vel­op drugs against known tar­gets more ef­fi­cient­ly — but al­so set a new mod­el for how the in­dus­try brings drugs to mar­ket.

Frank Jiang

A Sanofi vet who spent sev­er­al years in New Jer­sey be­fore mov­ing back to Shang­hai, CStone CEO Frank Jiang is clear­ly a big fan of what Borisy is build­ing at EQRx in terms of sell­ing drugs and paving a path to adop­tion, even though the de­tails won’t be pub­lic for an­oth­er year or two.

“Many of those things are con­fi­den­tial but when you look in­to it, these are re­al­ly trans­form­ing the way that we do the busi­ness, like nor­mal busi­ness,” Jiang told in­vestors on a call. “Their in­no­v­a­tive mod­el can po­si­tion them, put both sug­e­mal­imab and PD-1 com­pet­i­tive­ly against the ex­ist­ing al­ter­na­tive ther­a­pies in many of the largest health­care glob­al mar­kets by hav­ing strate­gic col­lab­o­ra­tions with pay­ers and health sys­tems.”

Aside from scor­ing cash to in­vest in what he calls CStone’s pipeline 2.0, Jiang not­ed that his R&D team will be able to tag along as EQRx plots glob­al tri­als for var­i­ous com­bi­na­tion ther­a­pies uti­liz­ing CS1003 as a back­bone.

The CStone deal is no­tably larg­er than the oth­er two EQRx has dis­closed so far: Li­cens­ing the CDK4/6 in­hibitor le­ro­ci­clib from G1 Ther­a­peu­tics took $20 mil­lion up­front and $290 mil­lion in mile­stones, while the li­cense for Han­soh Phar­ma’s EGFR-tar­get­ed al­moner­tinib is val­ued at around $100 mil­lion.

Yet sug­e­mal­imab is al­so ar­guably high­er pro­file, hav­ing scored break­through ther­a­py des­ig­na­tion from the FDA just days ago for re­lapsed or re­frac­to­ry ex­tra­n­odal nat­ur­al killer/T-cell lym­phoma. CStone has re­peat­ed tout­ed it as a po­ten­tial best-in-class drug, post­ing some en­cour­ag­ing Phase III da­ta in non-small cell lung can­cer this sum­mer.

While a Third Rock part­ner, Borisy al­so co-found­ed Blue­print Med­i­cines, a CStone part­ner that’s con­tributed three clin­i­cal as­sets to the pipeline. And that’s giv­en him a front row seat in how Jiang does his busi­ness.

“The qual­i­ty of the da­ta that they gen­er­ate and the qual­i­ty of the team is ab­solute­ly ex­cel­lent,” he said.

Hav­ing launched with a time­line to bring its first med­i­cine to mar­ket by 2025, Borisy added that his crew is now ahead of the orig­i­nal sched­ule, with mul­ti­ple drugs slat­ed for ap­proval in the next hand­ful of years.

With the deal — which cov­ers world­wide rights ex­cept in the re­gion known as Greater Chi­na — CStone has now ful­ly sold all rights to the PD-L1 drug sug­e­mal­imab. In a li­cens­ing pact un­veiled last month, Pfiz­er bagged Chi­na com­mer­cial­iza­tion rights by buy­ing up $200 mil­lion worth of CStone stock.

The Chi­nese biotech, though, re­tains rights to de­vel­op the PD-1 in­hibitor CS1003 in main­land Chi­na, Tai­wan, Hong Kong and Macau.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.