CEO Mark McKenna (Prometheus Biosciences)

Prometheus Bio is ready for its close-up shot, fol­low­ing a $130M round to back IBD drugs now head­ed to the clin­ic

A lit­tle over a year ago, Take­da lined up a deal to col­lab­o­rate with a low-pro­file San Diego up­start called Prometheus Bio­sciences on a string of new drugs for in­flam­ma­to­ry bow­el dis­ease. The phar­ma play­er tossed an undis­closed up­front and up to $420 mil­lion in mile­stones to get the al­liance start­ed.

These days, pre­clin­i­cal deals are com­mon, mile­stones are hazy mark­ers of fi­nan­cial health and the pact didn’t get a lot of at­ten­tion. But that ob­scu­ri­ty should start to dis­si­pate this week.

To­day, Prometheus, which had been cre­at­ed by the ac­qui­si­tion of Prometheus Labs by Pre­ci­sion IBD, is show­ing off a whop­ping $130 mil­lion raise from some fa­mil­iar biotech in­vestors jump­ing in to stretch the run­way at the 4-year-old pre­clin­i­cal biotech out in­to 2023, when CEO Mark McKen­na is promis­ing to have 3-4 IBD drugs ei­ther in the clin­ic or IND ready. The first of those clin­i­cal pro­grams is slat­ed to be­gin in a mat­ter of weeks, putting McKen­na’s team on track to their first round of hu­man da­ta.

Spun out of Cedars-Sinai Med­ical Cen­ter, the com­pa­ny built a con­sid­er­able por­tion of its sci­en­tif­ic foun­da­tion around the work of Stephan Tar­gan, an IBD spe­cial­ist who found­ed the IBD Cen­ter at the med­ical cen­ter some 28 years ago.

“We lever­aged this big da­ta set built over 20 years to iden­ti­fy new tar­gets in IBD and de­vel­op com­pan­ion di­ag­nos­tics for the drugs,” says McKen­na, cit­ing 20,000 sam­ples in the da­ta bank. Us­ing bioin­for­mat­ics tech, they have been work­ing on spot­light­ing tar­get­ed ther­a­peu­tics that can do bet­ter — in a much more durable fash­ion — than the cur­rent gen­er­a­tion of IBD drugs.

Their lead pro­gram — PRA023 — is an an­ti-TL1A an­ti­body. But they’re not alone. Pfiz­er has a sim­i­lar pro­gram. But McKen­na has am­bi­tions to build a broad pipeline around IBD.

“We be­lieve we can put out a new tar­get every year,” he tells me.

You may re­call that McKen­na spent a 4-year stretch fo­cused on Bausch sub Sal­ix Phar­ma­ceu­ti­cals, where he won ku­dos for the turn­around work he ac­com­plished there. Once seen as a pos­si­ble suc­ces­sor to Bausch chief Joe Pa­pa, he now wants to take this new com­pa­ny all the way through to com­mer­cial­iza­tion. And Pa­pa has joined his board at Prometheus, watch­ing the work from a front-row seat.

It was Prometheus chair­man Tachi Ya­ma­da, a leg­end in the biotech busi­ness, who reached out to McKen­na to see if he would be in­ter­est­ed in run­ning Prometheus, af­ter watch­ing his work at Sal­ix.

Ya­ma­da, no doubt, al­so played a role in bring­ing to­geth­er a large syn­di­cate of in­vestors.

Even­tide As­set Man­age­ment and RTW In­vest­ments led the round with a slate of new in­vestors: Per­cep­tive Ad­vi­sors, Cor­morant Cap­i­tal, Cowen Health­care In­vest­ments, Point72 As­set man­age­ment and Irv­ing In­vestors. Then there are the ex­ist­ing in­vestors: As­cend Glob­al In­vest­ment Fund, Cedars-Sinai Med­ical Cen­ter and Nestlé SA. Joy Ghosh of Even­tide As­set Man­age­ment and Adam Stone of Per­cep­tive Ad­vi­sors will be join­ing the Prometheus board to watch over their in­vest­ments.

They’re back­ing a com­pa­ny that has grown to 125 staffers, in a mar­ket that might sug­gest they’re think­ing about an IPO.

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.

(Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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Covid-19 man­u­fac­tur­ing roundup: Mary­land looks to grow biotech ca­pac­i­ty with $400M check; Rus­sia lands sec­ond Sput­nik V part­ner this week

A Maryland real estate project has added three new biotech-focused manufacturing and research buildings to an office park to keep up with demand created by the pandemic, the Washington Business Journal reported.

The Milestone Business Park — located off of I-270 in Germantown, MD — will see the new buildings and a total of 532,000 square feet as the campus rebrands to Milestone Innovation Park.

Saurabh Saha at Endpoints News' #BIO19

On the heels of $250M launch, Centes­sa barges ahead with an IPO to fu­el its 10-in-1 Medicxi pipeline

Francesco De Rubertis made no secret of IPO plans for Centessa, his 10-in-1 legacy play. Barely two months later, the S-1 is in.

The hot-off-the-press filing depicts the same grand vision that the longtime VC touted when he did the rounds in February: Take the asset-centric mindset that he’s been preaching at Medicxi over the years, and roll up a bunch of biotech upstarts, with unrelated risk profiles, into 1 pharma company that can carry on the development at scale.

Steffen Schuster, ITM CEO

Ra­dio­phar­ma re­mains hot as Ger­many's ITM rais­es $109M to ad­vance neu­roen­docrine can­cer pro­gram

The world of radiopharmaceuticals has been heating up over the last few years, and Thursday saw another company focused on the field pull in a new nine-figure raise.

Germany’s ITM, or Isotopen Technologien München, scored a $109 million round of loan financing to push forward its precision oncology pipeline and fund late-stage development for its lead program. As part of the agreement, the loan will convert to shares in the event of future financial or corporate transactions, ITM said.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.