CEO Evan Feinberg (Boris Feldman)

A Genen­tech-part­nered Vi­jay Pande fa­vorite nabs $52M to ad­vance an AI pipeline

Evan Fein­berg could have picked a bet­ter time to launch his AI biotech, Gen­e­sis. He an­nounced a $4.1 mil­lion round last No­vem­ber; by March, South San Fran­cis­co, Cal­i­for­nia was un­der lock­down.

Still, a year lat­er, he can look back at his ear­ly tenure with a cer­tain de­gree of sat­is­fac­tion.

“To see the things we’ve ac­com­plished, all from my couch?” Fein­berg told End­points News. “It’s re­al­ly bizarre.”

As with most ear­ly-stage biotechs, it’s dif­fi­cult to ver­i­fy pre­cise­ly what they’ve ac­com­plished, but Gen­e­sis Ther­a­peu­tics has man­aged to check some key box­es: They’ve ex­pand­ed the team from 5 mem­bers to 12. In Oc­to­ber, James Sabry and Aviv Regev at Genen­tech tapped them to help dis­cov­er new mol­e­cules. And with some in­ter­nal proof-of-con­cept da­ta to show in­vestors, they an­nounced to­day a $52 mil­lion Se­ries A round to help them land more big-name part­ners and ad­vance an in­ter­nal pipeline of small mol­e­cule drugs.

The round was led by Rock Springs, with old pals at An­dreessen Horowitz and Fe­li­cis Ven­tures, among oth­ers, chip­ping in.

Gen­e­sis be­longs to a raft of biotechs now try­ing to use ma­chine learn­ing and neur­al net­works to sift through bil­lions of small mol­e­cules and find the best ones to hit a giv­en tar­get. The $52 mil­lion raise is a size­able start­ing round, al­though not out of step with the cash that has re­cent­ly be­gun to flow in­to the space; Atom­wise, ar­guably the flashiest name in the field, re­cent­ly raised a $123 mil­lion Se­ries B.

Atom­wise and oth­ers have al­so no­tably at­tract­ed crit­i­cism for over-hyp­ing what their al­go­rithms can do and how quick­ly they can speed up drug de­vel­op­ment.

Vi­jay Pande

Fein­berg and a16z’s Vi­jay Pande, who men­tored Fein­berg when he was a grad­u­ate stu­dent at Pande’s Stan­ford lab, have sought to dis­tin­guish them­selves by point­ing to the team that has been as­sem­bled. It’s not just soft­ware en­gi­neers, Fein­berg said, but al­so dyed-in-the-wool med­i­c­i­nal chemists — the tra­di­tion­al hu­man al­go­rithms of drug dis­cov­ery — such as CSO Pep­pi Pr­a­sit, a Ver­sant ad­vi­sor and vet­er­an of Mer­ck and Ami­ra Phar­ma­ceu­ti­cals, and VP Nick Scott, an­oth­er Ami­ra vet­er­an.

“They don’t re­al­ly have pa­tience for the sort of neb­u­lous claims that of­ten pro­lif­er­ate in the com­pu­ta­tion­al space,” Fein­berg said. “They want to see da­ta, they want to see ex­per­i­ments in the lab­o­ra­to­ry ver­i­fy­ing com­pu­ta­tion­al pre­dic­tions be­ing use­ful for re­al drug tar­gets, oth­er­wise it’s just not in­ter­est­ing to them.”

Fein­berg al­so points to their al­go­rithms, the ba­sis of which has been pub­lished in promi­nent chem­istry jour­nals, and which he says has im­proved sub­stan­tial­ly over the past years.

The com­pa­ny is one of just a hand­ful in the AI small mol­e­cule space look­ing to build an in­ter­nal pipeline. For now, what those can­di­dates are and what they will tar­get re­main en­tire­ly un­der wraps.

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.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Yanay Ofran (L) and Anat Binur (Ukko)

Leaps by Bay­er backs a pro­tein en­gi­neer­ing start­up tak­ing on Aim­mune — and Nestlé — in peanut al­ler­gy

Little capsules of peanut powder drove Nestlé’s $2.6 billion buyout of Aimmune. Now, with $40 million in new funding, a fledgling biotech is promising to bring a more sophisticated version of that protein therapy that can go much, much further.

Ukko’s goal is two-pronged — with the initial products spanning therapeutic and food — but it’s grounded in the same protein engineering platform, co-founder and CEO Anat Binur told Endpoints News.

As tar­get­ed ther­a­pies get ever more pre­cise, Deer­field un­veils $50M bet on an Har­vard pro­fes­sor's chem­istry in­sights

Behind the seemingly simple concept of targeted cancer therapies is the drug developer’s headache that the target is always changing. Each generation of kinase inhibitors may be ostensibly hitting the same oncogene, but in addition to blocking the wildtype oncogene, they must now also address the mutations that have developed along the way, spurring resistance to current drugs.

The more those target kinases evolve, too, the more they could resemble off-target kinases you don’t want to bind. So each iteration requires more selectivity — sometimes down to differences of a few atoms.

Vincent Sandanayaka (file photo)

UP­DAT­ED: Ex-MD An­der­son chief De­Pin­ho is help­ing launch an­oth­er biotech — and he's stick­ing with fa­mil­iar ground

Years after co-founding SINE-focused Karyopharm and stirring up controversy at MD Anderson, Ronald DePinho is helping uncloak a new biotech targeting solute carrier transporter proteins — and Karyopharm’s former head of chemistry is leading the charge.

Nirogy Therapeutics emerged from stealth mode on Tuesday with a $16.5 million Series A round and plans to hit the clinic by 2022. The financing should be enough to carry the startup’s lead program, a small molecule lactate transport inhibitor, through Phase I, CEO Vincent Sandanayaka said.

As­traZeneca scores new goal on the pipeline front, adding its first AI-gen­er­at­ed tar­get to the port­fo­lio

As more and more biopharmas develop artificial intelligence platforms, the drug discovery process is being reshaped to fit new goals on cutting down the prodigious amount of time, energy and money that go into a drug program. Now one of the most ambitious players in the drive to improve on ROI, AstraZeneca, is marking a milestone on that front by adding the first target generated by AI to its portfolio.

Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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