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.

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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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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Teresa Graham, incoming Roche Pharmaceuticals CEO

In­com­ing Roche CEO builds out his top team, tap­ping Genen­tech vet to lead phar­ma di­vi­sion

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

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.

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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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.