Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia tees up an IPO for its AI drug dis­cov­ery plat­form, like­ly not will­ing to set­tle for just $100M

The biotech IPO mar­ket awoke from its sum­mer hi­ber­na­tion on Fri­day morn­ing with a small AD­HD drug de­vel­op­er seek­ing a mod­est raise, but late Fri­day night saw an­oth­er com­pa­ny file its SEC pa­per­work, one that will like­ly shoot for the stars.

Ex­sci­en­tia, the UK-based AI out­fit with bold claims about its plat­form, sub­mit­ted its F-1 on Fri­day, pen­cil­ing in an ini­tial $100 mil­lion raise es­ti­mate. That fig­ure will al­most cer­tain­ly end up much high­er, as Ex­sci­en­tia has spent most of 2021 rack­ing up huge fundrais­ing sums thanks to a Se­ries C ex­ten­sion head­ed by Black­Rock, and an up to $525 mil­lion Se­ries D that in­clud­ed a $300 mil­lion eq­ui­ty in­vest­ment from Soft­Bank.

AI biotechs have proven large­ly suc­cess­ful at drum­ming up hype around their tech­nol­o­gy, and Ex­sci­en­tia is no dif­fer­ent. Promis­ing to cut down on the lengthy process that is drug de­vel­op­ment by months, if not years, Ex­sci­en­tia will seek to join one of its main com­peti­tors in Re­cur­sion on Nas­daq.

Both com­pa­nies claimed to be the first to put an AI-de­vel­oped drug in­to the clin­ic. Re­cur­sion did so in Ju­ly 2019, even though CEO Chris Gib­son read­i­ly con­ced­ed the pro­gram orig­i­nal­ly came out of Dean Li’s lab at Mer­ck.

Ex­sci­en­tia fol­lowed up with its an­nounce­ment in Jan­u­ary 2020, though its can­di­date — de­vel­oped in part­ner­ship with Sum­it­o­mo Dainip­pon — emerged af­ter the pair syn­the­sized 350 com­pounds and test­ed them in a lab be­fore de­cid­ing on one to move for­ward. Whether ei­ther pro­gram tru­ly came from AI is large­ly be­side the point, how­ev­er, as both biotechs con­tin­ue to en­list ma­jor part­ners and sig­nif­i­cant in­vest­ment.

In par­tic­u­lar, Ex­sci­en­tia ex­pand­ed a Cel­gene-era deal with Bris­tol My­ers Squibb in May, one that could see more than $1.2 bil­lion paid out when all is said and done. The biotech fol­lowed that up with a small ac­qui­si­tion for the mol­e­cule-screen­ing biotech All­cyte in June, and less than two weeks lat­er joined forces with EQRx.

Fol­low­ing its own mas­sive fundrais­ing rounds, Re­cur­sion went pub­lic in April to the tune of a $436.4 mil­lion raise, a fig­ure that could prove a use­ful barom­e­ter for Ex­sci­en­tia’s Nas­daq am­bi­tions. There’s al­so the ma­chine learn­ing biotech in­sitro, which hasn’t an­nounced plans to go pub­lic just yet but raked in $400 mil­lion in a Se­ries C this past March.

Though it helped Sum­it­o­mo ad­vance two ad­di­tion­al pro­grams in­to Phase I, one of which brought about Ex­sci­en­tia’s “first AI” claims, the biotech has just one in-house can­di­date in hu­man stud­ies: an A2a re­cep­tor an­tag­o­nist co-de­vel­oped with Evotec. This can­di­date en­tered the clin­ic in April, and Ex­sci­en­tia plans to fun­nel a good chunk of its IPO raise to­ward the pro­gram.

The biotech hasn’t spec­i­fied how it plans to divvy up its new cash, on­ly list­ing the “de­vel­op­ment” of its plat­form and the in-house com­pound as the main ben­e­fi­cia­ries. There will al­so be $70 mil­lion set aside for Ex­sci­en­tia’s Gates Foun­da­tion-part­nered pan­dem­ic pre­pared­ness pro­gram.

As the cal­en­dar ap­proach­es the fourth quar­ter, the biotech IPO mar­ket re­mains on pace to eclipse last year’s record raise of $16.5 bil­lion. Through near­ly nine months, the sec­tor has com­bined to raise near­ly $13 bil­lion per the End­points News tal­ly, and two more biotechs in DiCE Ther­a­peu­tics and Tyra Bio­sciences are ex­pect­ed to land nine-fig­ure rais­es lat­er this week.

Pass­ing 2020’s fig­ure may ul­ti­mate­ly re­quire an end-of-year boost, giv­en the slow­down of pric­ings over the sum­mer. If Ex­sci­en­tia comes any­where close to Re­cur­sion’s to­tal, the in­dus­try may be well on its way to an­oth­er phe­nom­e­nal IPO year.

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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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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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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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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CEO Lex Rovner (64x Bio)

A George Church spin­out fight­ing the vi­ral vec­tor bot­tle­neck in cell and gene ther­a­py lands $55M

A synthetic biology company spun out of George Church’s lab is set to tackle the gene therapy manufacturing bottleneck, and it just landed $55 million in a Series A financing round to do so.

64x Bio comes out of the Harvard Department of Genetics. CEO Lex Rovner and her team — which right now, sits around 10 people — are looking to tackle a key hurdle for major companies: manufacturing cell and gene therapies.