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.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

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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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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An Endpoints Zoom meeting; and the email header employees will see if your company is a Premium subscriber

What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Fast on Glax­o­SmithK­line's heels, Au­rinia wins OK to steer a sec­ond lu­pus nephri­tis drug straight to the mar­ket

GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.

Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.

Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Kimberly Smith, ViiV R&D chief (ViiV Healthcare)

Af­ter sting­ing FDA set­back, Glax­o­SmithK­line's Vi­iV fi­nal­ly notch­es US ap­proval for long-act­ing HIV in­jec­tion

GlaxoSmithKline’s HIV unit ViiV was dealt a stinging loss back in late 2019 when the FDA slammed the brakes on its application for a once-monthly injection based on manufacturing issues. Now, with that roadblock in the rearview, ViiV has finally made good on its promise to change the HIV game.

The FDA on Thursday approved ViiV’s Cabenuva (cabotegravir and rilpivirine) as a long acting, once-monthly therapy for HIV-positive adults who are virologically suppressed and on a stable antiviral regimen.