James Sabry (Roche)

Roche's James Sabry inks his sec­ond AI deal in back-to-back pacts — this time part­ner­ing Genen­tech with Stan­ford spin­out Gen­e­sis Ther­a­peu­tics

Less than a week af­ter Roche joined forces with Dyno Ther­a­peu­tics to de­vel­op gene ther­a­pies us­ing ar­ti­fi­cial in­tel­li­gence, its gi­ant sub­sidiary Genen­tech is hop­ping on the AI band­wag­on with a dif­fer­ent play­er.

Genen­tech has inked a deal with Stan­ford spin­out Gen­e­sis Ther­a­peu­tics to har­ness its AI pow­er for drug de­vel­op­ment and dis­cov­ery. Gen­e­sis is get­ting an up­front pay­ment and mile­stones, but the com­pa­nies are keep­ing the de­tails un­der wraps for now. The Burlingame, CA-based biotech al­so stands to earn fu­ture roy­al­ties on any ap­proved Genen­tech drugs that come from the deal.

Us­ing AI tech­nol­o­gy, Gen­e­sis is able to make “ul­tra-fast and ac­cu­rate pre­dic­tions” of a com­pound’s po­ten­cy, se­lec­tiv­i­ty, tox­i­c­i­ty and more, CEO Evan Fein­berg told End­points News. “That helps us get them pre­pared for clin­i­cal tri­als more quick­ly, and with a more op­ti­mal com­pound,” he said.

Evan Fein­berg

“We are screen­ing any­where from mil­lions to bil­lions of com­pounds in sil­i­co at each stage, from hit iden­ti­fi­ca­tion through hit-to-lead, lead op­ti­miza­tion and can­di­date se­lec­tion,” he added lat­er.

The biotech was formed out of Stan­ford Uni­ver­si­ty’s Pande Lab in 2019, where Fein­berg co-in­vent­ed Po­ten­tial­Net — a neur­al net­work de­signed to pre­dict pro­tein−lig­and bind­ing and mol­e­c­u­lar prop­er­ties. The com­pa­ny is backed by An­dreessen Horowitz, and touts Ami­ra Phar­ma­ceu­ti­cals’ founder and long­time Ver­sant ad­vi­sor Pep­pi Pr­a­sit as its act­ing CSO, with Alex­ion founder Leonard Bell along for the ride as chair­man of the board.

Gen­e­sis seeks to use AI to de­vel­op can­di­dates with “su­pe­ri­or se­lec­tiv­i­ty,” thus lim­it­ing side ef­fects, which Fein­berg said “is what this is all about.” The CEO said he’s had four sig­nif­i­cant leg surg­eries in the last 10 years, one of which left a pe­riph­er­al nerve per­ma­nent­ly dam­aged.

“I’ve had first-hand ex­pe­ri­ence with most or many neu­ro­mus­cu­lar, mus­cu­loskele­tal-re­lat­ed drugs that have re­al­ly bad side ef­fects. So I… feel very per­son­al­ly com­mit­ted to cre­at­ing a phar­ma­copoeia that has bet­ter qual­i­ty of life for pa­tients,” he said.

Pep­pi Pr­a­sit

The deal ar­rives right on the heels of Aviv Regev’s ar­rival as the new head of re­search at gRED. Regev has been a star at the Broad, work­ing in her high­ly spe­cial­ized field of com­pu­ta­tion­al bi­ol­o­gy. And she’s ex­pect­ed to play a big role at Genen­tech adding to their strengths in ar­ti­fi­cial in­tel­li­gence and ma­chine learn­ing.

In its col­lab­o­ra­tion with Dyno, Roche’s Spark team will work on im­prov­ing AAV vec­tors. Dyno de­signs, tests and val­i­dates the vec­tors, while part­ners add their pay­loads and work on new de­vel­op­ment pro­grams. James Sabry, glob­al head of Roche Phar­ma Part­ner­ing, said the deal will “bring us added abil­i­ty to go to AAV 2.0.” AI and ma­chine learn­ing, he added, are “no longer things of the fu­ture when it comes to drug dis­cov­ery.”

“AI can help un­lock the next gen­er­a­tion of in­no­v­a­tive ther­a­pies for pa­tients in need of ad­di­tion­al op­tions. We are ex­cit­ed to work with Gen­e­sis’ team to dis­cov­er med­i­cines cur­rent­ly out of reach us­ing con­ven­tion­al meth­ods,” Sabry said in a state­ment.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

Peter Marks (Greg Nash/Pool via AP)

Even FDA's Pe­ter Marks is wor­ried about the com­mer­cial vi­a­bil­i­ty of gene and cell ther­a­pies

When bluebird bio’s gene therapy to treat beta thalassemia won European approval in 2019, the nearly $2 million per patient price tag for the potential cure seemed like a surmountable hurdle.

Fast forward two years later, and bluebird has withdrawn Zynteglo, the beta thal drug, along with the rest of its gene therapy portfolio from Europe, which the company said is generally unwilling to pay a fair price for the treatment.

Pri­cy in­halers re­main ex­pen­sive due to de­vice tweaks that keep com­peti­tors at bay, re­searchers find

New research published in Health Affairs today highlights the way in which the FDA’s inhaler regulations have rewarded incremental adjustments to older products, thereby enabling companies to skirt around cheaper competition.

A DC appeals court clerk and researchers from Harvard and the University of Calgary dug through all the patents and regulatory exclusivities granted to inhalers approved by the FDA between 1986 and 2020, finding that of the 62 inhalers approved, 53 (or 85%) were brand-name products, with a median of 16 years of protection from generic competition.