Boehringer In­gel­heim adds sec­ond AI part­ner in a month

Three weeks af­ter sign­ing a deal with one AI-fo­cused biotech, Boehringer In­gel­heim is adding an­oth­er.

The Ger­man phar­ma has an­nounced a part­ner­ship with BERG, the da­ta analy­sis and Bayesian AI com­pa­ny found­ed over a decade ago by re­al es­tate bil­lion­aire Carl Berg. Berg will use its com­put­er and wet lab plat­form to in­ves­ti­gate in­flam­ma­to­ry dis­eases, most no­tably at­tempt­ing com­ing up with caus­es, bio­mark­ers, drug tar­gets and drugs for in­flam­ma­to­ry bow­el dis­ease and Crohn’s dis­ease.

Niv­en Narain

“The bi­ol­o­gy be­hind these dis­eases are still not well un­der­stood,” BERG CEO Niv­en Narain told End­points News, not­ing that it can still be dif­fi­cult to dis­tin­guish Crohn’s from IBD. The plat­form will try “to de­mys­ti­fy the bi­o­log­i­cal trig­ger points.”

For Boehringer, the deal comes not long af­ter they inked a deal with In­sil­i­co, the com­pa­ny that pro­voked both en­thu­si­as­tic and deeply skep­ti­cal head­lines last Sep­tem­ber af­ter pub­lish­ing a Na­ture Biotech­nol­o­gy pa­per ex­plain­ing how they de­signed a drug can­di­date mol­e­cule in 21 days. In in­ter­views, Narain is quick to dis­tance BERG from the hype that has sur­round­ed ma­chine learn­ing-fo­cused biotech star­tups, not­ing that Berg em­ploys a wet lab, gen­er­ates their own da­ta, has brought a pair of their own drugs in­to the clin­ic, and us­es a math­e­mat­i­cal ap­proach dis­tinct from ma­chine learn­ing.

“We’re a bi­ol­o­gy com­pa­ny,” Narain said. “We use AI as a tool.”

BERG, though, found­ed in 2006, was among the ear­ly  biotechs to promise that their plat­form can make the drug dis­cov­ery faster, cheap­er, and more ef­fi­cient — the now ubiq­ui­tous and yet un­sub­stan­ti­at­ed claim of the AI biotech world. And they are far from alone in hav­ing a wet lab or gen­er­at­ing their own da­ta.

The com­pa­ny’s ap­proach in­volves tis­sue sam­ples from pa­tients with and with­out dis­ease, sub­ject­ing the cells to dif­fer­ent con­di­tions and wring­ing as much da­ta as pos­si­ble from them: ge­nomics, pro­teomics, metabolomics, lipidomics, and oth­ers. The com­pa­ny then us­es Bayesian AI, a math­e­mat­i­cal method to de­duce causal­i­ty.

With Boehringer, BERG will an­a­lyze tis­sues for a host of ac­tion­able da­ta. That in­cludes bio­mark­ers to di­ag­nose in­flam­ma­to­ry dis­eases ear­ly, to in­di­cate which drugs are most like­ly to work in which pa­tients, and to de­cide what drugs to give to pa­tients who have failed an ear­ly med­ica­tion. Longer term, the hope is to find new drugs.

“This is fur­ther along than just the ba­sic re­search,” Narain said. “There could be ac­tion­able in­sights that come out of this project.”

It’s the third Big Phar­ma part­ner­ship for the com­pa­ny. They have al­so worked with As­traZeneca on Parkin­son’s Dis­ease, help­ing lead to one drug now in lead op­ti­miza­tion, Narain said, and with Sanofi on in­fluen­za and dengue fever vac­cines. They just com­plet­ed a Phase II tri­al on their in­ter­nal pan­cre­at­ic can­cer can­di­date.

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.

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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Noubar Afeyan (Sebastien Micke/Paris Match/Contour by Getty Images)

As Mod­er­na rose, Flag­ship cashed in for $1.4B — with a lot more wealth still re­main­ing

For nearly a decade, Flagship poured record-setting levels of cash into Moderna, even as they faced setbacks on early programs and skeptics wondered whether the company’s science could ever match its hype.

Now that the science has delivered, Flagship is cashing in.

Over the last 13 months, since the World Health Organization declared a pandemic, Flagship has sold off Moderna shares worth $1.4 billion. The sales, first reported by Forbes, came as the Cambridge biotech’s shares soared from just under $20 per share on Jan. 3, 2020, to $169.50 when markets opened Thursday.

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Bay­er plots a ma­jor facelift at Berke­ley cam­pus, un­cork­ing a 30-year, $1.2B plan to dri­ve cell and gene ther­a­pies

Bayer first set roots in Berkeley back in 1974, when it was still operating as Miles Labs. The site has pumped out three hemophilia A treatments for distribution worldwide; but now, as the pharma continues its cell and gene therapy push, it has something bigger in mind.

Bayer is planning a 30-year revamp at the campus, which includes 918,000 square feet in new buildings and double the jobs, according to a report by the Bay Area Council Economic Institute.

LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

The Leukemia and Lymphoma Society has tapped 5 new early-stage projects to back with up to $10 million each in fresh investments. The 5 biotechs are:

— Caribou, headed by Rachel Haurwitz and co-founded by Jennifer Doudna, is working on next-gen, off-the-shelf CAR-Ts to replace the patient-derived cells now in use.

— The LLS supported NexImmune’s IPO, helping fund its work on nanoparticles that can gin up an immune response directed at cancer cells. The biotech has 2 projects now in Phase I trials.

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.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

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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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.