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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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UCB buys its way to epilep­sy show­down with Jazz with $1.9B Zo­genix ac­qui­si­tion

Zogenix’s epilepsy drug Fintepla may only have brought in around $100 million of sales in its first year, but UCB clearly believes it can go much, much higher.

The Belgian pharma has inked a $1.9 billion deal to buy out Zogenix, paying $26 per share in cash and offering a contingent value right worth $2 more per share if Fintepla lands an extra EU approval by the end of 2023.

But even the upfront marks a 72% premium to California-based Zogenix’s shares, which were trading just north of $15 on Tuesday.

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