Nim­bus picks 4 pre­clin­i­cal tar­gets for the next chap­ter of its pi­o­neer­ing com­pu­ta­tion­al drug dis­cov­ery work

Big name part­ner­ships were crit­i­cal for Nim­bus Ther­a­peu­tics’ first decade. With a head-turn­ing $1.2 bil­lion — $600 mil­lion of which were paid with­in months — deal from Gilead and a re­turn­ing cus­tomer in Cel­gene, the biotech emerged as a pro­lif­ic pi­o­neer of com­pu­ta­tion­al chem­istry and struc­ture-based drug dis­cov­ery while the in­dus­try went through a seis­mic shift in its think­ing of the role that al­go­rithms play in en­gi­neer­ing new ther­a­pies.

Jeb Keiper

As the sec­ond of the ini­tial batch of pro­grams en­ter the clin­ic, Nim­bus is un­veil­ing the head­ings that will de­fine what it calls its sec­ond chap­ter.

Their team of 20-plus sci­en­tists has iden­ti­fied four new tar­gets — AMP­Kβ2, CTPS1, Cbl-b and WRN — which they have been prob­ing with aca­d­e­m­ic col­lab­o­ra­tors and ex­perts at Schrödinger. And this time around, they plan to keep all four in-house for at least a lit­tle longer, fo­cus­ing on re­cruit­ing new staffers and friend­ly re­searchers rather than buy­ers.

At the same time, Nim­bus has dropped its STING ef­forts af­ter a slew of biotechs reached for it and came up emp­ty.

“One of the com­pli­ments we’ve been paid by our peers in the broad­er drug dis­cov­ery and de­vel­op­ment com­mu­ni­ty has been in our abil­i­ty to se­lect re­al­ly in­ter­est­ing tar­gets that are quite com­pelling,” Jeb Keiper — the for­mer BD chief who took over as CEO from Don Nichol­son less than two years ago — told End­points News. “We care a lot about be­ing able to do that.”

Aside from the usu­al sus­pects in tar­get se­lec­tion, such as ge­net­ic val­i­da­tion and med­ical need, Nim­bus zoomed in­to ones for which a se­lec­tive, struc­ture-based ap­proach is par­tic­u­lar­ly help­ful, CSO Pe­ter Tum­mi­no said.

Pe­ter Tum­mi­no

In AMPK (AMP-ac­ti­vat­ed pro­tein ki­nase), that means find­ing ac­ti­va­tors se­lec­tive for the β2 sub­unit, which could trans­late in­to a bet­ter safe­ty pro­file as meta­bol­ic drugs. Sim­i­lar­ly, the chal­lenge in CTP is to find com­pounds se­lec­tive for the S-1 iso­form. Cbl-b (Cbl pro­to-onco­gene B) is an E3 ubiq­ui­tin lig­ase — a nat­ur­al pro­tein de­grad­er — that’s gar­nered at­ten­tion from both small com­pa­nies like Nurix and big ones like Roche. Fi­nal­ly, the goal with WRN (Wern­er syn­drome ATP-de­pen­dent he­li­case) is to come up with a new treat­ment op­tion for tu­mors vul­ner­a­ble to dis­rup­tions in DNA re­pair.

“What isn’t new is we’re look­ing for small mol­e­cule agents,” he said.

Al­though these are tar­gets of high in­ter­est, he added, much is still un­known about their struc­tures, and Nim­bus is work­ing with lead­ing bi­ol­o­gists to elu­ci­date them with tech­niques like cryo-EM and crys­tal­log­ra­phy.

These are “not things you can sim­ply out­source to con­tract re­search groups,” Keiper added. “You re­al­ly are do­ing fun­da­men­tal aca­d­e­m­ic dis­cov­ery work.” That’s the kind of spe­cial sauce — mix­ing dyed in the wool drug dis­cov­ery vet­er­ans with com­pu­ta­tion­al ex­perts — that Nim­bus be­lieves will keep it go­ing for many years more.

Janet Woodcock (AP Images)

Janet Wood­cock to be act­ing FDA com­mis­sion­er while Biden team fi­nal­izes nom­i­nee — re­ports

Janet Woodcock is set to be the most powerful person at the FDA in less than a week.

The veteran regulator and longtime director of the Center for Drug Evaluation and Research has been tapped as acting commissioner of the FDA, according to reports by BioCentury’s Steve Usdin and Pink Sheet’s Sarah Karlin-Smith.

The appointment was requested by the incoming Biden team, Karlin-Smith added, as they sort out the nomination of a permanent successor to Stephen Hahn — whose one-year tenure has been defined by Covid-19.

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Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

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Steve Harr (L) and Hans Bishop

Paint­ing by the num­bers, Sana founders carve up a gi­ant uni­corn-sized IPO — for a biotech that has­n't quite made it to the clin­ic

Sana Biotechnology is one of those startups that was sketched in on the chalkboard day one in the shape of a unicorn.

A giant unicorn.

And from the numbers the cell therapy 2.0 play spelled out in their S-1 $SANA, it’s clear that the company founders — led by a pair of major VCs aligned with some high-profile industry figures — are hunting a big chunk of that value for themselves.

The raise they penciled in — $150 million — isn’t likely what they actually have in mind, and it doesn’t do justice to the size of their ambitions.

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CEO Brett Monia (Ionis)

Can Brett Mo­nia push Io­n­is be­yond Spin­raza?

For 30 years, Brett Monia struggled as one of Ionis’ top scientists to get their antisense technology to work. Now, as CEO, he’s trying to use it to turn Ionis into one of the industry’s biggest biotechs.

Monia, one of the handful of young scientists who in 1989 followed Stanley Crooke across the country from SmithKline (now GSK) in Philadelphia to found Ionis in Northern California, replaced Crooke as CEO last January. By then, they had proven antisense, an RNA-based method for manipulating gene expression, could work dramatically well in at least some instances, transforming spinal muscular atrophy with the Biogen-partnered blockbuster Spinraza.

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David Kessler in April 2009 (Eric Risberg/AP Images)

Covid-19 roundup: Hack­ers start re­leas­ing 'ma­nip­u­lat­ed' Covid-19 vac­cine docs; Ex-FDA com­mish David Kessler to re­place Mon­cef Slaoui as Op­er­a­tion Warp Speed chief — re­port

There’s a new twist on the EMA Covid-19 hacking story.

Friday the European agency put out the 5th in a series of statements about the hackers who broke into their system, noting that some of the information on vaccines that was gleaned in the attack is showing up online — altered to raise questions about the Covid-19 vaccines now in use.

This included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines. Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.

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Terry Rosen, Arcus CEO

Gilead part­ner Ar­cus earns an­a­lyst­s' plau­dits for ear­ly pan­cre­at­ic can­cer da­ta that 'ex­ceed­ed ex­pec­ta­tion­s'

Arcus’ small molecule CD73 inhibitor for pancreatic cancer got a standing ovation from analysts who said preliminary data “exceeded expectations”— making waves in a field that’s seen little progress in several years and proving the candidate could be worth the hundreds of millions Gilead provided upfront in a deal that included more than a billion dollars for opt-in rights and milestones.

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News brief­ing: Five Prime fi­nal­izes PhI­II plans for gas­tric can­cer; AI di­ag­nos­tics-fo­cused Paige ex­pands staff

Five Prime Therapeutics has finalized a plan to take their comeback gastric cancer drug into late-stage studies.

The South San Francisco-based biotech released full Phase II data for bemarituzumab on Friday, which Five Prime said in November met all of its pre-specified efficacy endpoints in a topline readout. Now, the company is announcing it plans to launch a Phase III trial for the program in 2021. Following November’s readout, the future of bemarituzumab had not yet been finalized.

Peter Thiel, Getty (Photographer: Kiyoshi Ota/Bloomberg)

Pe­ter Thiel's psy­che­delics-fo­cused ATAI ac­quires ma­jor­i­ty stake in Recog­ni­fy and its lead schiz­o­phre­nia can­di­date

Billionaire Peter Thiel has made significant and sometimes controversial pushes into life sciences over the past few years, and one of his startups out of Berlin has made a new acquisition less than two months after achieving unicorn status.

ATAI Life Sciences purchased a majority stake Tuesday in Recognify Life Sciences, a company focused on developing treatments for cognitive impairment associated with schizophrenia. The financial terms of the deal weren’t disclosed, but the acquisition follows up a $125 million Series C in November co-led by Thiel, leading to a post-money valuation of about $1 billion for ATAI.

Cog­nate dou­bles man­u­fac­tur­ing ca­pac­i­ties in Mem­phis, Eu­rope, as de­mand for cell and gene ther­a­pies sky­rock­ets

The marketplace for gene and cell manufacturing therapeutics continues to be scorching.

Cognate BioSciences, a leading CDMO specializing in gene and cell therapy technologies, announced plans Friday that will double its total manufacturing capacities at sites in both the US and Europe — in direct response to a “great demand of commercial capacity within the biologics industry.”

The company provided most details for its US expansion, which will take place at its current headquarters in Memphis, Tennessee near the Memphis International Airport — crucial, it said, as Memphis is one of the world’s busiest cargo airports. Cognate will add two separate facilities totaling 250,000-square-feet: a GMP distribution center to manage global supply chain needs, and a third site for commercial manufacturing.