Alexis Borisy and Melanie Nallicheri (EQRx)

Fast fol­low: EQRx en­gi­neers $410M-plus worth of deals to CDK4/6, EGFR drugs

Alex­is Borisy and Melanie Nal­licheri have giv­en the world a first glimpse at the mar­kets they want to dis­rupt, as EQRx un­veils the li­cens­ing of two drugs that it’s now rush­ing to de­vel­op and com­mer­cial­ize — at a promised steep dis­count to ri­vals.

Both le­ro­ci­clib from G1 Ther­a­peu­tics and al­moner­tinib from Han­soh Phar­ma are what EQRx dubs “fast fol­low” med­i­cines, with the same tar­gets as ap­proved can­cer drugs.

The G1 deal, which pits them against Pfiz­er and Eli Lil­ly in the CDK4/6 space, in­volves an up­front pay­ment of $20 mil­lion and mile­stones adding up to $290 mil­lion. EQRx has ex­clu­sive rights to the drug in the US, Eu­rope, Japan and all oth­er re­gions ex­clud­ing the Asia-Pa­cif­ic (where Genor has staked a claim).

For Han­soh, deal val­ue is ap­prox­i­mate­ly $100 mil­lion be­tween up­front pay­ments and de­vel­op­ment and reg­u­la­to­ry mile­stones for ex-Chi­na world­wide rights to an EGFR ty­ro­sine ki­nase in­hibitor that’s al­ready OK’d in Chi­na. The deal al­so in­clud­ed undis­closed com­mer­cial mile­stones.

“These are not our first pro­grams, they are the first that are be­ing dis­closed,” Borisy told End­points News, adding they dis­closed them be­cause the part­ners are pub­lic com­pa­nies. “We’re very ex­cit­ed about these two pro­grams, we think they’re ab­solute­ly great pro­grams … but it’s not our first nor on­ly.”

He de­clined to name how many they’ve li­censed so far: “We will come out when we’re ready.”

San­dra Horn­ing

They are, how­ev­er, the first con­crete ex­am­ples of how the ex­ecs are go­ing about achiev­ing the lofty mis­sion they blast­ed at the bio­phar­ma world at EQRx’s Jan­u­ary launch. Borisy, a for­mer ven­ture cap­i­tal­ist at Third Rock, set out with ex-Foun­da­tion Med­i­cine CBO Nal­licheri to prove that com­pe­ti­tion, not reg­u­la­tion, is the way to bring down sky high drug prices that they ad­mit need to be reined in. Pe­ter Bach, the di­rec­tor of Memo­r­i­al Sloan Ket­ter­ing’s Cen­ter for Health Pol­i­cy and Out­comes and an out­spo­ken crit­ic of the sta­tus quo in US drug pric­ing, joined as a co-founder along­side for­mer Roche CMO San­dra Horn­ing.

They had $200 mil­lion to be­gin. The plan, ac­cord­ing to CEO Borisy, was to have their first drug on the mar­ket with­in 5 years and nine more by 2030.

EQRx didn’t delve in­to de­tails about their de­vel­op­ment plan, but not­ed that le­ro­ci­clib is cur­rent­ly in two Phase I/II tri­als, one in com­bi­na­tion with ful­ves­trant for pa­tients with ER+, HER-2 breast can­cer, and an­oth­er in EGFRm non-small cell lung can­cer. As for al­moner­tinib, it’s al­ready avail­able in Chi­na as sec­ond-line ther­a­py for metasta­t­ic EGFR T790M mu­ta­tion-pos­i­tive non-small cell lung can­cer. An on­go­ing Phase III tests it head-to-head with Ires­sa, a first-gen EGFR TKI.

Borisy said the com­pa­ny had start­ed with a list of 50 drug tar­gets, then whit­tled to the first 25, then the first 10. CDK4/6 and EGFR stood out be­cause of the sheer size of the mar­ket and the cost of the drugs cur­rent­ly avail­able. Both Pfiz­er and Eli Lil­ly charge around $13,000 for their CDk4/6 in­hibitors Ibrance and Verzenio.

“We said we’ll be heav­i­ly fo­cused on on­col­o­gy and in­flam­ma­to­ry dis­or­ders, and we said that be­cause that’s where we have re­al sig­nif­i­cant bur­den of those ex­tra­or­di­nar­i­ly high-priced drugs and the scale of those drugs,” Borisy said. “CDK4/6 and EGFR — these are two of the largest drug cat­e­gories out there.”

Over the past months, Borisy and Nal­licheri — who serves as pres­i­dent and COO — grew the team out to more than 50 and still plans to hire more.

Even as the na­tion grap­ples with “the largest health­care chal­lenge of our time,” they not­ed, peo­ple still get di­ag­nosed with can­cer and pay­ing for treat­ments re­mains a chal­lenge for many. The re­al­i­ty ren­ders EQRx’s so­cial con­tract more im­por­tant than ever:

Amidst the back­drop of a na­tion­al health­care cri­sis, our in­dus­try has demon­strat­ed the speed and tenac­i­ty that un­der­scores how ef­fi­cient we can all be if we sim­ply put our col­lec­tive minds to solv­ing a prob­lem.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Eric Shaff (Seres)

Af­ter a 4-year so­journ, a strug­gling mi­cro­bio­me pi­o­neer claims a break­out PhI­II come­back. And they're tak­ing it straight to the FDA

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Levi Garraway, Roche CMO (Source: Genentech)

UP­DAT­ED: FDA hands out a quick OK for po­ten­tial SMA block­buster ris­diplam, giv­ing Genen­tech and Roche a chance to chal­lenge ri­vals on the price

US regulators handed Roche and Genentech a big win Friday afternoon, one that has market-shaping potential for its high-priced rivals from Novartis and Biogen.

The FDA has green-lit the companies’ spinal muscular atrophy drug risdiplam, which will be marketed as Evrysdi in the US, for use in patients two months and older. It’s the first SMA drug that can be taken orally, as Biogen’s Spinraza is injected into the spine while Novartis’ Zolgensma is a gene therapy.

Moncef Slaoui, Getty Images

When will it end? Big Phar­ma's top vac­cine ex­pert at OWS of­fers a speedy time­line for a Covid-19 vac­cine — ei­ther be­fore or right af­ter the elec­tion

Moncef Slaoui hasn’t started making plans for his summer vacation next year. But he offers high odds that all Americans will be able to do that in the not too distant future.

In an interview with a pair of sympathetic podcasters at the conservative American Enterprise Institute, Slaoui provides an education to listeners on how any drug or vaccine can be sped through trials. And he leaves the door wide open to the notion that the leading vaccine developers can demonstrate efficacy and safety in a compelling fashion as early as October — or as late as the end of this year.