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.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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FDA ap­proves the third NSOMD drug in 18 months as Roche/Genen­tech beefs up its port­fo­lio of drugs for neu­ro­log­i­cal dis­or­ders

There were no FDA approved treatments for neuromyelitis optica spectrum disorder at the start of 2019. Now, as of Friday, there are three.

The latest entrant to the market is the Roche/Genentech drug satralizumab after US regulators gave it the thumbs up late Friday. An IL-6 inhibitor, the drug joins Alexion’s Soliris and AstraZeneca spinout Viela Bio’s Uplizna. The annual cost of satralizumab — which will hit the market as Enspryng — will be $190,000 for 13 doses, a Genentech spokesperson said, though the first year of treatment requires 15 doses and cost about $220,000.

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Franz-Werner Haas, CureVac CEO

UP­DAT­ED: On the heels of a snap $1B raise, Cure­Vac out­lines plans to seek emer­gency OK for Covid-19 vac­cine -- shares rock­et up

CureVac is going from being one of the quietest players in the race to develop a new vaccine to fight the worst public health crisis in a century to a challenger for the multibillion-dollar market that awaits the first vaccines to make it over the finish line. Typically low-key at a time of brash comments and incredibly ambitious development timelines from the leaders, CureVac now is jumping straight into the spotlight.

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Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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US gov­ern­ment re­port­ed­ly be­gins prepar­ing for Covid-19 chal­lenge tri­als. Are they eth­i­cal?

Controversial human challenge trials for potential Covid-19 vaccines reportedly have a new booster — the US government.

Scientists working for the government have begun manufacturing a strain of the novel coronavirus that could be used in such studies, Reuters reported Friday morning. The trials would enroll healthy volunteers to be vaccinated and then intentionally infected with a weakened coronavirus.

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Trevor Martin (Mammoth)

Eye­ing in-vi­vo edit­ing, Mam­moth li­cens­es Jen­nifer Doud­na’s new CRISPR en­zyme

Last month, Jennifer Doudna revealed in Science a new, “hyper-compact” CRISPR enzyme that was half the size of traditional CRISPR enzymes and could, she suspected, offer a new, more versatile tool for gene editing.

Now, the University of California-Berkeley has licensed that enzyme, known as Casφ, exclusively to a biotech startup she and two former students set up three years ago: Mammoth Biosciences. It’s the second new CRISPR protein Mammoth has licensed from Doudna’s lab, after they licensed Cas14 in 2019.

Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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