Joanna Shields, BenevolentAI CEO (Photo by: Andreas Gebert/picture-alliance/dpa/AP Images)

Lon­don AI-fo­cused Benev­o­len­tAI go­ing pub­lic in Eu­rope via $438M SPAC deal

AI biotech Benev­o­len­tAI is go­ing pub­lic in the Nether­lands, and it de­cid­ed to go the SPAC route as part of one of the largest merg­ers in Eu­rope to date.

The AI biotech is join­ing with a SPAC known as Odyssey, launched by in­vest­ment banker broth­ers Michael and Yoel Za­oui. And when it clos­es ear­ly next year and lists on Eu­ronext in Am­s­ter­dam, the merg­er will al­low Benev­o­len­tAI to raise more than $430 mil­lion — and go pub­lic with more than $1 bil­lion in val­ue, which should last the biotech for the next few years.

Be­fore trans­ac­tion costs, Benev­o­len­tAI will re­ceive the more than $330 mil­lion raised by Odyssey when it list­ed back in Ju­ly, as well as more than $150 mil­lion in the form of a pri­vate in­vest­ment in pub­lic eq­ui­ty from ex­ist­ing back­ers such as Sin­ga­pore’s Temasek, As­traZeneca, and health in­vest­ing spe­cial­ists Al­ly Bridge, just to name a few.

“The com­bi­na­tion with Odyssey will al­low us to scale our vi­sion and am­bi­tion of unit­ing pur­pose­ful tech­nol­o­gy and cut­ting-edge sci­ence to dis­cov­er life-chang­ing med­i­cines,” said Benev­o­len­tAI’s CEO Joan­na Shields in a state­ment.

Olivi­er Brandi­court

Now, the funds will be used to ac­cel­er­ate Benev­o­len­tAI’s work on drug de­vel­op­ment and add to its clin­i­cal pipeline — which cur­rent­ly has more than a dozen pro­grams and is spear­head­ed by a can­di­date for atopic der­mati­tis. That can­di­date is cur­rent­ly in Phase I tri­als.

Cir­cling back to As­traZeneca: The British phar­ma and Benev­o­len­tAI have long col­lab­o­rat­ed be­fore, start­ing back in 2019. Cur­tesy of Benev­o­len­tAI’s plat­form, Back in Jan­u­ary As­traZeneca added its first AI-dis­cov­ered drug tar­get to its port­fo­lio, go­ing af­ter chron­ic kid­ney dis­ease.

Fur­ther, Benev­o­len­tAI and As­traZeneca have been work­ing on de­vel­op­ing drugs for id­io­path­ic pul­monary fi­bro­sis as part of the two-year-long col­lab­o­ra­tion.

Two new board ap­point­ments were al­so an­nounced along with the merg­er. The for­mer Natix­is In­vest­ment Man­agers CEO and SPAC co-CEO Jean Ra­by and for­mer Sanofi CEO Olivi­er Brandi­court will join Benev­o­len­tAI’s board once the merg­er is com­plete.

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.

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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Michael Egholm, Standard BioTools president and CEO (IsoPlexis)

Eli Cas­din co-leads $250M in­fu­sion in­to mi­croflu­idics play­er that land­ed NIH fund­ing for Covid-19 test­ing

In about 17 months, Fluidigm has gone from working with sharks to Vikings.

The South San Francisco-based company, which landed NIH money in a Shark Tank-style program for Covid-19 testing, announced that it will take on an investment worth $250 million from Casdin Capital and Viking Global Investors. It will also rebrand, and call itself Standard BioTools. The investment will help the company focus on the highest growth areas of discovery and development and expand its CRO and CMO service providers. Right now, the company’s customer reach is limited to basic research, it said.

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