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.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.