Doug Williams ups the ante at Co­di­ak Bio to $168.5M in a dri­ve to first hu­man study

When Doug Williams ex­it­ed his role as R&D chief at Bio­gen a cou­ple of years ago to run his own start­up, he made the leap based on the promise that some of the ven­ture play­ers in biotech were buy­ing in­to a whole new ap­proach to com­pa­ny cre­ation.

Shoe­string bud­gets were be­ing re­placed with com­pa­ny launch plans that dwarfed the old VC mod­el. And a tra­di­tion­al fo­cus on one or two as­sets shift­ed to a com­mit­ment to pricey pipeline con­struc­tion.

“For me,” Williams tells me, “part of what was the rea­son to coax me out of a pret­ty good day job at Bio­gen was not on­ly the in­ter­est around tech­nol­o­gy ma­tur­ing to where it looked like a plat­form tech­nol­o­gy, but hav­ing suf­fi­cient funds to keep your head down to make it work, with­out a need to im­me­di­ate­ly raise small tranch­es.”

Says Williams: “It is the new mod­el.”

That “new mod­el” in ven­ture in­vest­ing just de­liv­ered a $76.5 mil­lion round for Co­di­ak Bio­Sciences, bring­ing Williams’ to­tal raise to $168.5 mil­lion in two years.

Not sur­pris­ing­ly, the syn­di­cate be­hind Co­di­ak in­cludes Arch and Flag­ship, which have been seed­ing a grow­ing slate of these en­ter­prise class up­starts. In this case, Williams is now bankrolled in­to 2020 as he moves his first pro­gram to an IND in about a year as he starts to bring his head up in a high-stakes move to the clin­ic.

The plat­form that Williams and his staff of 48 are build­ing — a struc­ture de­signed to de­liv­er mul­ti­ple ther­a­peu­tics for it­self and the in­dus­try part­ners that he wants to bring on board now — fo­cus­es on the sci­en­tif­ic un­der­stand­ing the com­pa­ny’s in­tel­lec­tu­al founders formed of the way the hu­man body re­lies on ex­o­somes as a kind of cel­lu­lar freight ser­vice, car­ry­ing pay­loads of nu­cle­ic acids, pro­teins, small mol­e­cules and more through the var­i­ous road­blocks your body us­es to check the spread of threat­en­ing sub­stances.

By hi­jack­ing the sys­tem, Co­di­ak is look­ing to cre­ate a whole new way to drug the cur­rent­ly un­drug­gable. And their first ef­fort will be to jump on board these nanopar­ti­cles with an siR­NA tar­get­ing KRAS that has shown promise in a va­ri­ety of mod­els for pan­cre­at­ic can­cer.

Not long af­ter the com­pa­ny launch, Williams brought in Jan Löt­vall from Göte­borg Uni­ver­si­ty as chief sci­en­tist. It was Löt­vall who did some of the pi­o­neer­ing lab work — along with re­search at MD An­der­son — that demon­strat­ed a decade ago how ex­o­somes could trans­fer nu­cle­ic acids be­tween cells.

“It got peo­ple to re­think how they might be use­ful to de­liv­er com­plex pay­loads,” says Williams, who was one of the first in a group of Bio­gen ex­ecs like CEO George Scan­gos (Vir) and Steve Holtz­man (Deci­bel) to jump ship and head back in­to the biotech are­na to start their own com­pa­nies.

Now he has the mon­ey to see if it can work in hu­mans the way the sci­ence sug­gests it can. In ad­di­tion to Flag­ship and Arch, the syn­di­cate be­hind Co­di­ak in­cludes Fi­deli­ty Man­age­ment and Re­search Com­pa­ny, the Alas­ka Per­ma­nent Fund and Alexan­dria Ven­ture In­vest­ments, with new in­vestors in­clud­ing Qatar In­vest­ment Au­thor­i­ty, Box­er Cap­i­tal of the Tavi­s­tock Group, Sirona Cap­i­tal, EcoR1 Cap­i­tal, and Cas­din Cap­i­tal.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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Winselow Tucker, Eli Lilly's new Loxo unit chief commercial officer

Eli Lil­ly plucks a new com­mer­cial chief from Bris­tol My­ers in man­age­ment shuf­fle as HR chief re­tires

Eli Lilly has found a new chief commercial officer from among the ranks at Bristol Myers Squibb, as it says farewell to its longtime head of human resources Stephen Fry.

Fry announced on Thursday his plans to retire after more than 35 years with Lilly. He’ll vacate his seat as SVP of human resources and diversity at the end of the year, and current Loxo CCO Eric Dozier is slated to take his place. As a result, BMS’ Winselow Tucker is joining the team as Loxo CCO at the end of the month.

Simba Gill, Evelo Biosciences CEO

Sim­ba Gill heads back to Flag­ship af­ter sev­en-year run as Evelo CEO

Evelo Biosciences is on the hunt for a new CEO, with its founding chief Simba Gill switching to the chairman post to free up time for his new gig at Evelo’s incubator, Flagship Pioneering.

Gill will trade in his former Flagship title of venture partner with the higher-up role of executive partner, after originally joining in 2015. He’ll serve as CEO of Evelo until his successor is chosen, and at Flagship his priorities will be counseling and supporting the venture firm’s portfolio companies.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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