The lat­est health­care SPAC comes in at $200M with a laser fo­cus on ar­ti­fi­cial in­tel­li­gence

A new health­care SPAC is ex­pect­ed to price dur­ing Fri­day’s ses­sion, and it’s one that wants to take ad­van­tage of the in­dus­try’s buzzi­est sec­tor.

The blank check com­pa­ny will make a $200 mil­lion de­but on Nas­daq, com­ing to the pub­lic mar­ket on the backs of Stan­ley Cap­i­tal fundrais­ing. This SPAC is not on­ly tar­get­ing life sci­ences, but life sci­ences com­pa­nies with a spe­cif­ic fo­cus on ar­ti­fi­cial in­tel­li­gence. One need not look past the name as ev­i­dence — Health­care AI Ac­qui­si­tion Corp.

Ac­cord­ing to the S-1 fil­ing, the SPAC is aim­ing to tar­get com­pa­nies “with high AI readi­ness and tech­no­log­i­cal trans­for­ma­tion po­ten­tial.” The pri­ma­ry fo­cus will be in the US and Eu­rope in op­er­a­tions “where the ad­di­tion­al in­te­gra­tion of an AI or au­toma­tion so­lu­tion can cre­ate in­cre­men­tal trans­for­ma­tion­al val­ue.”

Si­mon Cot­tle

Led by Stan­ley Cap­i­tal’s found­ing part­ners Si­mon Cot­tle and Patrick Hargutt, the SPAC team be­lieves such val­ue can be found in any of three sec­tors in health­care. The first two deal less with drug R&D but re­main tan­gen­tial: with­in the S-1, the team lays out how AI will blos­som in clin­i­cal tri­al soft­ware and health­care IT.

But the com­pa­ny lays out most of its de­tails re­gard­ing the third area — out­sourced phar­ma­ceu­ti­cal ser­vices, such as CROs and CMOs. The S-1 lays out how such out­sourc­ing has trend­ed up in the last sev­er­al years, cit­ing a BCC Re­search es­ti­mate say­ing this ser­vices mar­ket will grow to $266 bil­lion by 2025.

“The out­sourc­ing typ­i­cal­ly oc­curs at all stages of the val­ue chain from dis­cov­ery, R&D, med­ical af­fairs, com­mer­cial­iza­tion and man­u­fac­tur­ing. We will fo­cus on the last three sub­sec­tors of the val­ue chain,” the S-1 reads.

It’s an area where AI-cen­tered com­pa­nies have al­ready tried tak­ing ad­van­tage. In 2019, Atom­wise teamed up with Charles Riv­er on an AI al­liance, and In­sil­i­co — which could be on the heels of go­ing pub­lic it­self af­ter a $255 mil­lion megaround in June — signed a deal with WuXi AppTec as one of its ear­ly moves back in 2018.

In­vest­ment in­to AI- and da­ta sci­ence-fo­cused com­pa­nies has rock­et­ed up else­where as well, and ear­li­er this week se­r­i­al en­tre­pre­neur Gary Glick launched his newest biotech in Odyssey Ther­a­peu­tics, which is plac­ing a huge em­pha­sis on da­ta sci­ence. Though much re­mains un­known about the biotech’s R&D op­er­a­tions, about a third of Odyssey’s rough­ly 100 em­ploy­ees are da­ta sci­en­tists.

SPACs, mean­while, con­tin­ue rais­ing boat­loads of cash de­spite a much more tur­bu­lent mar­ket space than ear­li­er this year. Al­though 2021 saw sev­er­al SPAC deals in the first six to eight months of the year, last month Flag­ship’s Va­lo Health and a Khosla Ven­tures SPAC sur­pris­ing­ly called off their re­verse merg­er, cit­ing “mar­ket con­di­tions.”

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Dominic Borie, Kyverna Therapeutics CEO

Well-con­nect­ed, Gilead-backed biotech gets an­oth­er stack of cash to pur­sue CAR-Ts for au­toim­mune dis­ease

Almost exactly two years after its debut at the 2020 JP Morgan confab — and on the heels of a new partnership with the gene editing experts at Intellia — a Gilead-backed, autoimmune disease-focused startup has returned to the well with a clearer outline of just what it plans to do with its CAR-T platform.

Kyverna brought in $85 million in its oversubscribed Series B, the company announced Wednesday. Northpond Ventures led the round, and Westlake Village BioPartners, Vida Ventures, Gilead and Intellia all contributed as well.

Bahija Jallal, Immunocore CEO

BREAK­ING: FDA hur­ries up a quick ap­proval for the world's first TCR -- af­ter a 14-year R&D trek

Over the 14 years since Immunocore was spun out of MediGene in a quest to develop a gamechanging cancer med, the biotech has raised record sums and undergone a major shakeup on a long roller coaster ride of valuations for investors. But they survived and thrived and today they’re popping the champagne corks to celebrate an FDA approval of their first TCR drug.

Immunocore flagged the FDA’s green light for tebentafusp Wednesday morning by highlighting a series of firsts.

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Days af­ter Gilead yanks PI3K drug, In­cyte with­draws NDA for its own PI3K — say­ing con­fir­ma­to­ry tri­als would take too long

The FDA’s intensifying scrutiny on accelerated approvals isn’t just putting pressure on drugmakers with marketed products. It is also subtly reshaping the regulatory dynamics.

Case in point: Incyte announced late Tuesday that it has made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.

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Dan O'Day (Getty Images)

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Brian Thomas, Metagenomi CEO

Gen 2: Berke­ley spin­out lands $175M megaround to keep it on the cut­ting edge of the boom­ing gene-edit­ing field

The big bucks keep pumping into the gene-editing field.

This morning Metagenomi, allied with one of the biggest names in the mRNA field with a company DNA that includes the ubiquitous Jennifer Doudna, is showing off a $175 million B round that will pay for a rapid swelling of its staff in pursuit of some of the cutting-edge tech that keeps this field in the spotlight. And they’re aligning themselves with some major industry players with an eye on the clinic while getting behind some startups to help expand the work into new fields.

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