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.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

Zachary Hornby. Boundless

'A fourth rev­o­lu­tion in can­cer ther­a­pies': ARCH-backed Bound­less Bio flash­es big check, makes big­ger promis­es in de­but

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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