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.”

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.