Lau­ra Shawver hits the ground run­ning, scout­ing new in­vestors for tiny Syn­thorx

Syn­thorx doesn’t make the news a lot. But when it does, it makes sure peo­ple pay at­ten­tion.

The syn­thet­ic bi­ol­o­gy start­up came out with two big an­nounce­ments this week: Lau­ra Shawver is tak­ing its helm as CEO, pres­i­dent and di­rec­tor; sci­en­tif­ic founder Floyd Romes­berg has pub­lished a pa­per in Na­ture dis­cussing how a se­mi-syn­thet­ic or­gan­ism can trans­late DNA with two ad­di­tion­al bases (X and Y) in­to nov­el pro­teins.

“You can’t do an IPO or a big ven­ture raise with a part-time CEO boot­strapped across three or four com­pa­nies,” Jay Lichter of Aval­on Ven­tures, which backs the com­pa­ny, told End­points News on Mon­day. “The tech has had a ma­jor in­flec­tion, and as a re­sult we need full-time A-team tal­ent to run the com­pa­ny.”

Shawver, a well-known ex­ec who led Cleave Bio­sciences through two siz­able rounds of fund­ing, steps right up to the task. She is al­ready think­ing about tak­ing the first pro­grams in­to clin­i­cal de­vel­op­ment, as well as seek­ing part­ner­ships where Syn­thorx can help tweak ther­a­peu­tics us­ing new pro­tein can­di­dates the com­pa­ny calls “Syn­thorins.”

“It’s not very of­ten that one gets to par­tic­i­pate in some­thing that is po­ten­tial­ly game-chang­ing for ther­a­peu­tics and like­ly will — this plat­form tech­nol­o­gy will be uti­lized for years to come,” she told End­points.

She de­cid­ed to take the job af­ter meet­ing with Romes­berg, the Scripps re­searcher who first came up with the way to in­cor­po­rate new DNA com­po­nents in E. Coli genes. That led to the in­cep­tion of the com­pa­ny in 2014.

Over break­fast at La Jol­la — near one of Shawver’s fa­vorite surf spots — they talked about the sci­ence and its ap­plic­a­bil­i­ty on ther­a­peu­tics.

“I was con­vinced pret­ty quick­ly ac­tu­al­ly,” she said.

Giv­en the waves that Romes­berg’s pa­per made, that’s per­haps not sur­pris­ing. The ad­di­tion­al base pair can, in prin­ci­ple, en­code for an ex­tra 152 nov­el amino acids that can make pro­teins with unique phar­ma­co­log­i­cal prop­er­ties. That’s a big leap from the cur­rent 20.

The com­pa­ny is not talk­ing specifics out­side of its lead pro­gram in in­ter­leukin-2, a dou­ble-edged sword of an an­ti-can­cer drug. But Shawver con­firmed that it is cur­rent­ly fo­cused on on­col­o­gy and au­toim­mune dis­eases.

Mar­cos Mil­la

Its 14 staffers, in­clud­ing SVP of re­search and Janssen vet Mar­cos Mil­la, whom Shawver de­scribes as a “drug hunter,” have been hard at work teas­ing out where ex­act­ly the non-nat­ur­al amino acids should – and shouldn’t – go. In the case of IL-2, by plac­ing non-nat­ur­al amino acids in spe­cif­ic lo­ca­tions, Shawver said, the plat­form tech­nol­o­gy can tune up ef­fi­ca­cy and tune down the tox­i­c­i­ty.

“There’s on­ly a few places that ac­tu­al­ly tune the phar­ma­col­o­gy the way we need it to … so this has been a metic­u­lous task that they have un­der­tak­en,” Shawver ex­plained.

For Shawver, mov­ing from Cleave to Syn­thorx al­so meant leav­ing her home in San Fran­cis­co and re­turn­ing to her oth­er home in San Diego.

“One of the great things about biotech is that we all move on­to oth­er jobs from time to time, and that cre­ates our net­work that we uti­lize in our next jobs,” she said.

With two FDA-ap­proved drugs un­der her belt, her pre­vi­ous ex­pe­ri­ence has giv­en her much to uti­lize.

“They have got­ten very far down the path with very lit­tle cash, it is time to do a more sig­nif­i­cant fi­nanc­ing so we can take this to clin­i­cal de­vel­op­ment,” she said.


Im­age: Lau­ra Shawver.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Sanofi/Re­gen­eron mus­cle ahead of a ri­val No­var­tis/Roche team, win first ap­proval in key rhi­nos­i­nusi­tis field

Re­gen­eron and their part­ners at Sanofi have beat the No­var­tis/Roche team to the punch on an­oth­er key in­di­ca­tion for their block­buster an­ti-in­flam­ma­to­ry drug Dupix­ent. The drug team scored an ac­cel­er­at­ed FDA ap­proval for chron­ic rhi­nos­i­nusi­tis with nasal polyps, mak­ing this the first such NDA for the field.

An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.

Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

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Two biotech uni­corns swell pro­posed IPOs, eye­ing a $600M-plus wind­fall

We’ve been wait­ing for the ar­rival of Bridge­Bio’s IPO to top off the wave of new biotech of­fer­ings sweep­ing through Nas­daq at the end of H1. And now we learn that it’s been sub­stan­tial­ly up­sized.

Ini­tial­ly pen­ciled in at a uni­corn-sized $225 mil­lion, the KKR-backed biotech has spiked that to the neigh­bor­hood of $300 mil­lion, look­ing to sell 20 mil­lion shares at $14 to $16 each. That’s an added 5 mil­lion shares, re­ports Re­nais­sance Cap­i­tal, which fig­ures the pro­posed mar­ket val­u­a­tion for Neil Ku­mar’s com­pa­ny at $1.8 bil­lion.

No­var­tis holds back the copy­cat brigade's at­tack on its top drug fran­chise — for now

A fed­er­al judge has put a gener­ic chal­lenge to No­var­tis’ block­buster mul­ti­ple scle­ro­sis drug Gilenya on hold while a patent fight plays out in court.

Judge Leonard P. Stark is­sued a tem­po­rary in­junc­tion ear­li­er this week, forc­ing My­lan, Dr. Red­dy’s Lab­o­ra­to­ries and Au­robindo Phar­ma to shelve their launch plans to al­low the patent fight to pro­ceed. He ruled that al­low­ing the gener­ics in­to the mar­ket now would per­ma­nent­ly slash the price for No­var­tis, even if it pre­vails. 

Top an­a­lyst finds a sil­ver lin­ing in Ab­b­Vie’s $63B Al­ler­gan buy­out — but there’s a catch

Af­ter get­ting beat up on all sides from mar­ket ob­servers who don’t much care for the lat­est mega-deal to ar­rive in bio­phar­ma, at least one promi­nent an­a­lyst now is start­ing to like what he sees in the num­bers for Ab­b­Vie/Al­ler­gan.

But it’s go­ing to take some en­cour­age­ment if Ab­b­Vie ex­ecs want it to last.

Ab­b­Vie’s mar­ket cap de­clined $20 bil­lion on Tues­day as the stock took a 17% hit dur­ing the day. And SVB Leerink’s Ge­of­frey Porges can see a dis­tinct out­line of an up­side af­ter re­view­ing the fun­da­men­tals of the deal.

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While Ako­rn works to re­vive its for­tunes, the FDA hits it with an­oth­er warn­ing let­ter

Ako­rn just can’t dig it­self out of its hole.

The spe­cial­ty gener­ic drug­mak­er has re­ceived yet an­oth­er warn­ing let­ter from the FDA this year. With­out dis­clos­ing any specifics, the Lake For­est, Illi­nois-based drug­mak­er on Wednes­day said the US reg­u­la­tor had is­sued the let­ter, cit­ing an in­spec­tion of its Som­er­set, New Jer­sey man­u­fac­tur­ing fa­cil­i­ty in Ju­ly and Au­gust of 2018. The com­pa­ny’s shares $AKRX dipped about 1.7% to $4.65 be­fore the bell.