Ramy Farid, Schrödinger CEO (Schrödinger)

Bris­tol My­ers fronts new Schrödinger al­liance with $55M up­front, ex­pand­ing pre­ci­sion on­col­o­gy pro­file

Bris­tol My­ers Squibb has a new R&D part­ner, one to which they’re pay­ing a pret­ty pen­ny to use their dis­cov­ery plat­form.

The phar­ma com­pa­ny is dol­ing out $55 mil­lion up­front to Schrödinger $SD­GR to work on up to five small mol­e­cules, with the po­ten­tial for $2.7 bil­lion in mile­stone pay­ments. Schrödinger’s ini­tial tar­gets in­clude HIF-2 al­pha and SOS1/KRAS for a type of kid­ney can­cer and KRAS-dri­ven can­cers, re­spec­tive­ly.

Mon­day’s news was greet­ed well by in­vestors, as Schrödinger shares ticked up rough­ly 10% in ear­ly trad­ing.

With­in the col­lab­o­ra­tion’s 8-K, Schrödinger got in­to the nit­ty grit­ty of the mile­stones. The com­pa­ny can re­ceive up to $585 mil­lion per on­col­o­gy tar­get, with $360 mil­lion for R&D and reg­u­la­to­ry mile­stones and $225 mil­lion for com­mer­cial mile­stones. For neu­rol­o­gy and im­munol­o­gy tar­gets, BMS’s pay­ments could max out at $482 mil­lion — $257 mil­lion on the R&D and reg­u­la­to­ry side, with an­oth­er $225 mil­lion for com­mer­cial­iza­tion mile­stones.

Schrödinger can al­so re­ceive roy­al­ties rang­ing from the mid-sin­gle dig­its to low-dou­ble dig­its.

The com­pa­ny’s dis­cov­ery plat­form proved the im­pe­tus for such a deal, which CEO Ramy Farid stressed to End­points News is not one of the many ma­chine learn­ing or AI-based tech­nolo­gies that have tak­en the biotech world by storm. Rather, Schrödinger’s plat­form cre­ates physics-based mol­e­c­u­lar sim­u­la­tions that can pre­dict how mol­e­cules and com­pounds will bind to pro­teins be­fore even step­ping foot in the wet lab.

And since there’s no AI in­volved, Schrödinger doesn’t have to spend time train­ing their mod­el to rec­og­nize and de­tect a drug’s po­ten­tial affin­i­ty. Farid says the com­pa­ny can sim­u­late a com­pound’s en­tire chem­i­cal space, or the pool of its po­ten­tial el­e­men­tal com­bi­na­tions, which can to­tal up to 10 to the pow­er of 50 dif­fer­ent struc­tures.

“For ex­am­ple when you want to build an AI, let’s say to de­tect cats in pho­tographs, you feed the mod­el a bunch of pic­tures of cats … physics-based meth­ods do not do that at all, there is no train­ing set,” Farid said, adding lat­er, “This is the rea­son why AI doesn’t work re­li­ably. That space is so enor­mous that it’s im­pos­si­ble to gen­er­ate a train­ing set that can cap­ture all of it.”

Karen Akin­sanya

Though Schrödinger isn’t close to test­ing any­thing in an­i­mals, let alone hu­mans, they’ll be work­ing on the two ini­tial tar­gets for the fore­see­able fu­ture, as the part­ner­ship runs for four years. Once the pro­grams in the deal get to the IND-en­abling stage, Schrödinger will hand off de­vel­op­ment to BMS, R&D chief Karen Akin­sanya said. Schrödinger will re­tain un­lim­it­ed ac­cess to its plat­form.

For BMS, the deal fits in­to a trend of ex­pand­ing their im­muno-on­col­o­gy ef­fort through R&D part­ner­ships since its big-mon­ey ac­qui­si­tion of Cel­gene. The com­pa­ny spent $475 mil­lion in Au­gust for con­trol of Drag­on­fly’s ex­tend­ed half-life cy­tokine DF6002, a mono­va­lent IL-12 im­munoglob­u­lin Fc fu­sion pro­tein de­signed to fire up a tar­get­ed im­mune re­sponse.

A week lat­er, BMS bought out a small biotech called For­bius whose pipeline of TGF-be­ta in­hibitors matched their on­col­o­gy deal pro­file. The terms of that trans­ac­tion weren’t dis­closed, though For­bius’ un­re­lat­ed as­sets were spun out in­to an­oth­er com­pa­ny.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.