Andrew Hopkins, Exscientia CEO

UP­DAT­ED: Bris­tol My­ers ex­pands Cel­gene-era deal with Ex­sci­en­tia, tak­ing its AI R&D en­gine to the next step

One day af­ter tak­ing a shot on an an­ti-TIG­IT bis­pe­cif­ic from Agenus, Bris­tol My­ers Squibb is still in a deal­mak­ing mood.

For Wednes­day’s chas­er, Bris­tol My­ers is re­turn­ing to a com­pa­ny that had teamed up with Cel­gene be­fore its ac­qui­si­tion in 2019. That biotech is Ex­sci­en­tia, and they’ve scored an ex­pand­ed deal with Bris­tol My­ers to fur­ther build on its ar­ti­fi­cial in­tel­li­gence ca­pa­bil­i­ties less than a month af­ter a mas­sive Se­ries D fi­nanc­ing.

The up­dat­ed col­lab­o­ra­tion calls for “up to” a $50 mil­lion up­front pay­ment to the Ox­ford, UK-based biotech, along with $125 mil­lion in “near to mid-term” mile­stones, the com­pa­nies said in a re­lease. Oth­er mile­stones for reg­u­la­to­ry and com­mer­cial as­pects can bring the to­tal val­ue of the deal past $1.2 bil­lion.

Much like the orig­i­nal deal, the ex­pan­sion will cov­er three new projects, Ex­sci­en­tia CEO An­drew Hop­kins told End­points News. The part­ner­ship al­so al­lows the pair an op­tion to go in­to even fur­ther projects, he added. In­di­ca­tions will cov­er pri­mar­i­ly on­col­o­gy and im­munol­o­gy but can cov­er any dis­ease with­in those um­brel­las.

Over the last few years, AI deals have be­gun grab­bing a big­ger foothold through­out the bio­phar­ma in­dus­try. Sev­er­al biotechs have al­so popped up promis­ing to speed up the drug de­vel­op­ment process through ma­chine learn­ing and oth­er AI-fo­cused mod­els, in­clud­ing play­ers like in­sil­i­co, De­n­ovio and Gen­e­sis.

Bris­tol My­ers has made these types of AI plays be­fore, sign­ing on to work with Con­cer­to HealthAI in March 2019 to do just that. They al­so part­nered with ma­chine-learn­ing start­up In­sitro in Oc­to­ber 2020 to po­ten­tial­ly find new ways to cre­ate drugs for ALS.

And As­traZeneca an­nounced in Feb­ru­ary it added the first tar­get gen­er­at­ed by AI to its port­fo­lio, com­ing out of a col­lab­o­ra­tion with the Lon­don-based com­pa­ny, Benev­o­len­tAI. That deal fo­cused on iden­ti­fy­ing and val­i­dat­ing a new way to at­tack chron­ic kid­ney dis­ease.

Ex­sci­en­tia is no stranger to wheel­ing and deal­ing, hav­ing scored sev­er­al ma­jor col­lab­o­ra­tions be­fore its first ma­jor fi­nanc­ing round about a year ago. The biotech net­ted part­ner­ships with a host of Big Phar­mas in­clud­ing Bay­er, Roche, Sanofi and Glax­o­SmithK­line, not lim­it­ing their plat­form to one area: The deals ranged from car­di­ol­o­gy and on­col­o­gy to psy­chi­atric and meta­bol­ic dis­eases.

Those deals al­so fol­lowed a team-up with Sum­it­o­mo Dainip­pon Phar­ma for an ex­per­i­men­tal pill in ob­ses­sive com­pul­sive dis­or­der, which the pair claim was the first AI-de­vel­oped drug to en­ter the clin­ic when it be­gan Phase I in ear­ly 2020.

But back in May 2020, Ex­sci­en­tia be­gan hit­ting the gas in rais­ing cap­i­tal, net­ting a $60 mil­lion Se­ries C to more than dou­ble their pre­vi­ous round from 2018. The Se­ries C was ul­ti­mate­ly ex­pand­ed this past March when Black­Rock pushed its to­tal to $100 mil­lion, and Ex­sci­en­tia quick­ly raised an­oth­er $525 mil­lion in late April — a raise that in­clud­ed a $252 Se­ries D round, plus a $300 mil­lion eq­ui­ty in­vest­ment by Soft­Bank.

“Tech­no­log­i­cal­ly we see our goal is to solve drug de­sign and to then use that tech to then scale how we de­liv­er high-qual­i­ty, pre­ci­sion-en­gi­neered drugs in­to the clin­ic,” Hop­kins told End­points. “The more projects we run, the more our sys­tem learns and the bet­ter it gets. There is a di­rect cor­re­la­tion of learn­ing by do­ing.”

The biotech has al­so con­tin­ued to tout what it says are the first-ever ex­per­i­men­tal drugs to hit the clin­ic. In the vein of its OCD pill, Ex­sci­en­tia said in April that its AI-de­signed mol­e­cule for im­muno-on­col­o­gy is the first such com­pound to reach in-hu­man test­ing in that area as well.

This ar­ti­cle has been up­dat­ed to in­clude com­ment from Ex­sci­en­tia CEO An­drew Hop­kins.

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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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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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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Troy Wilson, Kura CEO

FDA lifts par­tial hold on Ku­ra's Phase Ib AML pro­gram as biotech re­dou­bles mit­i­ga­tion ef­forts

Kura Oncology is clear to resume studies for its early-stage leukemia program after the FDA lifted a clinical hold Thursday afternoon.

Regulators had placed the hold on a Phase Ib study of KO-539, an experimental oral treatment for some genetic subsets of acute myeloid leukemia last November after a patient died while taking the drug. Kura expects to begin enrolling patients again imminently, CEO Troy Wilson told Endpoints News.

A Sen­ate bill wants to even an 'un­lev­el play­ing field' for do­mes­tic, for­eign in­spec­tion drop-ins amid back­log

Amid geopolitical tensions between the US and China, two Republican senators are calling for a bill that would aim to strike a balance on domestic and foreign inspection requirements from the FDA.

Sens. Mike Braun (R-IN) and Joni Ernst (R-IA) have penned a bill called the Creating Efficiency in Foreign Inspections Act. It contains a bit of rhetoric, highlighting “communist China” not once, but twice in the release, but states that the goal is to even the playing field between foreign and American manufacturers.

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