News brief­ing: Nestlé whips up re­search col­lab­o­ra­tion with new­ly-un­veiled Flag­ship up­start; Mar­i­anne De Backer joins Kro­nos board

Flag­ship Pi­o­neer­ing tapped in­to a va­ri­ety of trendy R&D themes when it of­fi­cial­ly de­buted Sen­da Bio­sciences a few months ago, most promi­nent­ly its fo­cus on the mi­cro­bio­me, com­pu­ta­tion­al bi­ol­o­gy and cel­lu­lar in­ter­ac­tions. And while it’s all still in its in­fan­cy, the founders clear­ly elicit­ed some high-pro­file at­ten­tion from a ma­jor play­er which strad­dles the line be­tween food and med­i­cine.

Nestlé Health Sci­ence has part­nered with Sen­da on one of its ini­tial slate of R&D fo­cus­es, align­ing it­self with the biotech on meta­bol­ics, with a fo­cus on some big tar­gets, in­clud­ing obe­si­ty and glycemia.

Ac­cord­ing to Sen­da, they’ve gen­er­at­ed the pre­clin­i­cal an­i­mal da­ta need­ed to demon­strate that this new ap­proach of theirs can spur weight loss and glu­cose clear­ing. Now Nestlé will help en­gi­neer a move in­to the clin­i­cal sphere with hu­man stud­ies.

Nestlé proved with its Aim­mune buy­out that it is will­ing to go big in­to biotech when it finds the right op­por­tu­ni­ty. But this new deal is be­ing an­nounced with­out a biobuck to its name — all terms are be­ing kept on the qt.

But each re­tains own­er­ship where it counts. Nestlé holds the glob­al com­mer­cial rights to any nu­tri­tion­al prod­uct that can be de­vel­oped, while Sen­da is keep­ing rights to any ther­a­peu­tic that can be ad­vanced. — John Car­roll

Mar­i­anne De Backer joins Kro­nos Bio board

Long­time J&J vet and cur­rent Bay­er busi­ness chief Mar­i­anne De Backer is join­ing a new board.

Kro­nos Bio an­nounced Tues­day that De Backer has been ap­point­ed to the com­pa­ny’s board of di­rec­tors. The move comes about three months af­ter Kro­nos went pub­lic with an im­pres­sive $287.5 mil­lion IPO.

De Backer isn’t the on­ly promi­nent name with Big Phar­ma ex­pe­ri­ence at the com­pa­ny. 30-year Gilead R&D vet­er­an Nor­bert Bischof­berg­er has been run­ning the show at Kro­nos since the com­pa­ny launched in 2018.

De Backer’s “sig­nif­i­cant ex­pe­ri­ence in forg­ing and man­ag­ing strate­gic part­ner­ships cou­pled with her broad busi­ness and com­mer­cial acu­men and strong sci­ence back­ground will be valu­able as the com­pa­ny con­tin­ues to grow,” Bischof­berg­er said in a state­ment.

The biotech was mak­ing plen­ty of moves in re­cent months, hav­ing ac­quired en­tosple­tinib — which was shelved when Bischof­berg­er still worked at Gilead — as well as an­oth­er SYK in­hibitor, lan­raplenib. — Max Gel­man

Ger­man gene ther­a­py biotech grabs $10M plus to ad­vance to­ward clin­ic 

A Ger­man biotech that’s been work­ing on a new gene ther­a­py ap­proach aimed at turn­ing “tis­sues or or­gans that need to be treat­ed in­to fac­to­ries for lo­cal pro­duc­tion of ther­a­peu­tic pro­teins” has raised a new round aimed at get­ting them in­to a hu­man study.

GeneQuine Bio­ther­a­peu­tics GmbH grabbed more than $10 mil­lion — which in­cludes a loan com­bined with in­vest­ment cash — from a syn­di­cate of in­vestors in­trigued by its plat­form tech, which re­lies on helper-de­pen­dent ade­n­ovi­ral — HDAd — vec­tors, to do the work.

Their lead pro­gram:

GQ-303, cur­rent­ly at pre­clin­i­cal stage, is an HDAd vec­tor ex­press­ing the pro­tein pro­teo­gly­can 4 for lo­cal treat­ment of OA (os­teoarthri­tis). Pro­teo­gly­can 4 (al­so known as lu­bricin) has been shown to have a dual mech­a­nism of ac­tion in OA: 1) a bio­me­chan­i­cal ef­fect due to its lu­bri­cat­ing prop­er­ties, and 2) ef­fects on mol­e­c­u­lar path­ways lead­ing to sup­pres­sion of pain, in­flam­ma­tion and car­ti­lage de­gen­er­a­tion.

Paci­ra Bio­Sciences led the raise, which in­clud­ed High-Tech Grün­der­fonds,  Noshaq SA and Sa­mum Ver­mö­gensver­wal­tungs GmbH. — John Car­roll

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Chris Gibson (Photo By Vaughn Ridley/Sportsfile for Web Summit via Getty Images)

Re­cur­sion founders gin for­tunes as IPO back­ers show­er $436M on one of the biggest boasts in AI -- based on some very small deals

In the AI drug development world, boasting often comes with the territory. Yet few can rival Recursion when it comes to claiming the lead role in what company execs like to call the industrialization of drug development, with promises of continued exponential growth in the number of drugs it has in the pipeline.

On Friday, the Salt Lake City-based biotech translated its unicorn-sized boasts into a killer IPO, pricing more than 24 million shares at the high end of its range and bringing in $436 million — with a large chunk of that promised by some deep-pocket backers.

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Seagen gets Au­gust PDU­FA for Pad­cev ex­pan­sions; Adap­tate pulls in new cash for gam­ma delta T cell an­ti­bod­ies

Seagen is riding the wave of two new priority reviews straight to the FDA.

The Bothell, WA-based biotech and their partners at Astellas announced Monday that two supplemental BLAs for Padcev had been accepted by US regulators. FDA has set Aug. 17 as the PDUFA date for the reviews.

“With our recent regulatory submissions, we intend to provide the highest level of clinical evidence supporting Padcev use — overall survival data from a randomized Phase III trial — and expand availability in multiple countries where there is unmet medical need,” said Astellas oncology chief Andrew Krivoshik.

UP­DAT­ED: New Kaiser analy­sis shows how lim­it­ing price ne­go­ti­a­tions to tar­get­ed drugs may bet­ter fo­cus up­com­ing leg­is­la­tion

As Congress considers whether to adopt sweeping new legislation to lower prescription drug prices across the board, the Kaiser Family Foundation is out with a new report on Monday showing how a more targeted approach on a subset of drugs might be a more efficient way to save government funds.

“This analysis shows that Medicare Part D and Part B spending is highly concentrated among a relatively small share of covered drugs, mainly those without generic or biosimilar competitors,” wrote Juliette Cubanski, deputy director of the program on Medicare policy at KFF, and Tricia Neuman, SVP of KFF. “Focusing drug price negotiation or reference pricing on a subset of drugs that account for a disproportionate share of spending would be an efficient use of administrative resources, though it would also leave some potential savings on the table.”

Tillman Gerngross (Adagio)

Till­man Gern­gross' Covid-19 an­ti­body moon­shot scores $336M with the help of new ace CFO. Is an IPO next?

Less than a year into its existence, serial biotech entrepreneur Tillman Gerngross’ antibody play Adagio has raced ahead into a pivotal trial for its lead drug for Covid-19 on the back of some very promising preclinical data. Now, crossover investors led by Peter Kolchinsky at RA are rolling up the Brinks truck — and that could spell an IPO in the offing for Adagio.

Adagio has bagged $336 million as part of a Series C round led by RA Capital to advance lead single-shot antibody ADG20 through a pivotal Phase I/II/III trial for the treatment of mild to moderate Covid-19 patients at high risk of infection, the biotech said Monday.

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When is a drug re­al­ly a de­vice? Court knocks down FDA ap­peal in try­ing to sort that grey area

It’s always a surprise when a court has to step in to tell the FDA that it erred in performing one of its main duties: classifying whether a medical product is drug or a device.

But that’s what the US Court of Appeals for the District of Columbia did on Friday, making clear to the world’s top drug regulator that Genus Medical Technologies’ contrast agent barium sulfate (also known as Vanilla SilQ) should not be considered a drug, as the FDA had said, but a medical device.

Q1: A flood of in­vestor cash drove biotech's num­bers to new record highs, and the tor­rent of cash is mov­ing up­stream fast

If you thought biotech was booming last year, wait until you get a load of the numbers from Q1 2021.

On virtually every level, with one exception, the money engine was working around the clock in the first 3 months of this year. Venture capital has reached such a fever peak that the average B round now weighs in at an average mega-weight value of $100 million. The money flow is also finding its way to the mouth of the R&D river, where discovery work now merits the big bucks instead of cautionary seed funds.

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Jami Rubin (EQRx)

Ja­mi Ru­bin, once fa­bled for grilling bio­phar­ma ex­ecs, de­camps to head fi­nance at drug pric­ing dis­rupter

As Goldman Sachs’ top pharmaceutical analyst, Jami Rubin was known for asking the tough questions. Now, as she takes the lead on EQRx’s mission to rewrite the rules of drug pricing, we’ll see how good her answers are.

Rubin made the jump to biotech on April 5, becoming EQRx’s new CFO, the company said Monday. She’s coming from PJT Partners, where she’s been a partner providing strategic guidance for biotech and pharmaceutical companies for the last couple years. With EQRx’s recent $500 million Series B round in the books, it wouldn’t be a surprise if she was already lining up a public debut.

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Ben Carson (Evan Vucci, AP Images)

UP­DAT­ED The doc­tor is in: Trump in­sid­er Ben Car­son joins NASH play­er Galectin as a 'spe­cial con­sul­tant,' part-time spokesman

In the few short months since President Donald Trump left office, his former department heads are reportedly having a difficult time finding employment. But for Ben Carson, Trump’s former housing secretary, that’s not a problem anymore after biotech came calling.

Carson, a former GOP presidential candidate and erstwhile HUD head, has joined Galectin Therapeutics as a “special consultant” the biotech hopes will help raise its profile and provide an entrée to key business partnerships, the company said Monday.