Generate co-founder Molly Gibson and CEO Mike Nally

Flag­ship's ma­chine learn­ing start­up Gen­er­ate bags $370M in lat­est round with plans for a big hir­ing spree

As the fu­ture of ma­chine learn­ing and AI promis­es to make ma­jor break­throughs in drug de­vel­op­ment, a suite of star­tups is look­ing to scale their own com­pet­ing ro­bot brain trusts. An am­bi­tious start­up out of Flag­ship Pi­o­neer­ing’s in­cu­ba­tor un­cloaked last year with its own spin in that arms race — and now it’s primed and ready for a ma­jor ex­pan­sion in the com­ing years.

Gen­er­ate Bio­med­i­cines has closed a gi­ant $370 mil­lion Se­ries B from found­ing in­vestor Flag­ship as well as Alas­ka Per­ma­nent Fund, Al­ti­tude Life Sci­ence Ven­tures, ARCH Ven­ture Part­ners, and funds and ac­counts ad­vised by T. Rowe Price As­so­ci­ates, the com­pa­ny said.

Gen­er­ate, which de­buted in late 2020, is Flag­ship’s shot at us­ing ma­chine learn­ing ad­vances to change the game in the de­vel­op­ment of pro­tein ther­a­peu­tics, with the com­pa­ny promis­ing much faster de­vel­op­ment times and dis­cov­ery suc­cess rates. It’s a mod­el be­ing tried else­where from com­pa­nies like Ex­sci­en­tia and In­sil­i­co, but Gen­er­ate sets it­self apart with its fo­cus on pro­tein se­quenc­ing and the goal to pro­duce de no­vo bi­o­log­ics.

Since launch, Gen­er­ate has been hard at work crunch­ing da­ta through its sys­tem in an at­tempt to give it the broad­est pos­si­ble plat­form for dis­cov­ery. Now, the com­pa­ny is ready to great­ly ex­pand its “wet lab” and bi­ol­o­gy ca­pa­bil­i­ties, CEO Mike Nal­ly told End­points News, and that will spell a huge hir­ing spree for the com­pa­ny as well as new cor­po­rate digs in the Somerville, MA area and an­oth­er site in An­dover.

Cur­rent­ly op­er­at­ing with a work­force of around 80, Gen­er­ate is plan­ning to make the quan­tum leap to 500 em­ploy­ees over the course of the next two years while al­so mov­ing in­to two new fa­cil­i­ties in the com­ing weeks and months. The An­dover site will be used to ex­pand the biotech’s range in struc­tur­al bi­ol­o­gy, in­clud­ing a big in­vest­ment in cryo­genic elec­tron mi­croscopy (cryo-EM), a cut­ting-edge tech­nique used to de­ter­mine the struc­ture of pro­teins.

The im­me­di­ate goal is to move past the work of the past two years, pri­mar­i­ly prov­ing Gen­er­ate’s plat­form could pro­duce high­er bind­ing affin­i­ty pro­teins from pre­cur­sor ref­er­ence bi­o­log­ics, in­to the realm of de­vel­op­ing pro­tein drugs from scratch us­ing pro­pri­etary da­ta learn­ing, Gen­er­ate’s chief strat­e­gy and in­no­va­tion of­fi­cer and co-founder Mol­ly Gib­son told End­points.

“Since in­cep­tion, we’ve set out to an­swer this ques­tion whether we can pro­gram pro­teins at the DNA lev­el, and what we’ve done over the past year is take those first in­sights … re­al­ly show that at scale and push pro­grams for­ward,” Gib­son said. “We’ve shown that we’ve been able to make sig­nif­i­cant ad­vances over where we start­ed cre­at­ing these ma­chine learn­ing al­go­rithms us­ing pub­lic da­ta.”

Now, the team said it will be ready to start churn­ing out pre­clin­i­cal can­di­dates by the end of the year with some of those pro­grams ex­pect­ed to hit hu­man tri­als as ear­ly as 2023.

As the clin­ic moves clos­er, the Gen­er­ate team is keep­ing a close eye on the po­ten­tial for strate­gic part­ner­ships giv­en the po­ten­tial breadth of its plat­form’s ca­pa­bil­i­ties. Those strate­gic part­ner­ships, more in the line of sub­stan­tial R&D team-ups, are a key part of the com­pa­ny’s BD strat­e­gy mov­ing for­ward, Nal­ly said, which the com­pa­ny will have to lever­age with its own in-house work.

“The re­al­i­ty is … we can pro­duce far more than we can con­sume so we want to make sure we com­ple­ment our ex­per­tise in pro­tein en­gi­neer­ing with oth­ers’ dis­tinct ca­pa­bil­i­ty in ar­eas like dis­ease-area bi­ol­o­gy, man­u­fac­tur­ing and clin­i­cal de­vel­op­ment,” Nal­ly said. “Ul­ti­mate­ly there’s a huge in­vest­ment across biotech and phar­ma in un­der­stand­ing tar­get bi­ol­o­gy so we think if there’s an ap­pro­pri­ate task, this tech­nol­o­gy may be able to ad­dress it in a way that very few oth­er tech­nolo­gies can.”

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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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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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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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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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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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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