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.

Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Randy Schatzman, Bolt CEO (Bolt Biotherapeutics)

Bolt Bio­ther­a­peu­tics nabs $93.5M to push Provenge in­ven­tor's new idea deep­er in the clin­ic

A cancer-fighting concept from the inventor of the first cancer vaccine is nearing prime time, and its biotech developer has received a significant new infusion of cash to get it there.

Bolt Biotherapeutics announced a $93.5 million Series C round led by Sofinnova Investments and joined by more than 9 others, including Pfizer Ventures and RA Capital Management. That money will go toward pushing the San Francisco biotech’s platform of innate immune-boosting warheads through its first trial on metastatic solid tumors and into several more.

Josh Cohen, Justin Klee

Armed with pos­i­tive ALS da­ta, Amy­lyx scores $30M in fresh fund­ing to com­plete Alzheimer's PhII

Four years after announcing themselves to the biotech world with a new idea for drugging neurodegeneration, backing by the late Henri Termeer and $5 million from Morningside Venture, the young entrepreneurs at Amylyx are back for round 2.

Morningside continued to lead the $30 million Series B, with participation from unnamed investors. Having celebrated a topline Phase II win for its lead program in amyotrophic lateral sclerosis, Amylyx expects the cash to fund talks with regulators as well as a separate trial for the same drug in Alzheimer’s — for which they had just finished enrolling.

Days af­ter In­ter­cept re­jec­tion, Akero surges on ‘un­prece­dent­ed‘ NASH da­ta

A year and a half after scoring a $70 million Series B and a top Gilead executive as CEO, Akero Therapeutics has announced new data on their NASH drug. And with the field still reeling from a surprise FDA rejection this week, the news was enough to send their stock surging.

Akero had already said in March that its lead drug had beaten placebo in its Phase II trial, reducing liver fat by 14% in the highest dose group compared to 0.3% in placebo, according to MRI scans. But although NASH is an obesity-related condition and results from fatty buildup in the liver, the real immediate question for any therapy is whether it can resolve the fibrosis and inflammation that results from that buildup. Those data require biopsying the patients, a longer and more invasive process that was further complicated by a pandemic.