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.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Covid-19 man­u­fac­tur­ing roundup: Mary­land looks to grow biotech ca­pac­i­ty with $400M check; Rus­sia lands sec­ond Sput­nik V part­ner this week

A Maryland real estate project has added three new biotech-focused manufacturing and research buildings to an office park to keep up with demand created by the pandemic, the Washington Business Journal reported.

The Milestone Business Park — located off of I-270 in Germantown, MD — will see the new buildings and a total of 532,000 square feet as the campus rebrands to Milestone Innovation Park.

Noubar Afeyan (Sebastien Micke/Paris Match/Contour by Getty Images)

As Mod­er­na rose, Flag­ship cashed in for $1.4B — with a lot more wealth still re­main­ing

For nearly a decade, Flagship poured record-setting levels of cash into Moderna, even as they faced setbacks on early programs and skeptics wondered whether the company’s science could ever match its hype.

Now that the science has delivered, Flagship is cashing in.

Over the last 13 months, since the World Health Organization declared a pandemic, Flagship has sold off Moderna shares worth $1.4 billion. The sales, first reported by Forbes, came as the Cambridge biotech’s shares soared from just under $20 per share on Jan. 3, 2020, to $169.50 when markets opened Thursday.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Bay­er plots a ma­jor facelift at Berke­ley cam­pus, un­cork­ing a 30-year, $1.2B plan to dri­ve cell and gene ther­a­pies

Bayer first set roots in Berkeley back in 1974, when it was still operating as Miles Labs. The site has pumped out three hemophilia A treatments for distribution worldwide; but now, as the pharma continues its cell and gene therapy push, it has something bigger in mind.

Bayer is planning a 30-year revamp at the campus, which includes 918,000 square feet in new buildings and double the jobs, according to a report by the Bay Area Council Economic Institute.

LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

The Leukemia and Lymphoma Society has tapped 5 new early-stage projects to back with up to $10 million each in fresh investments. The 5 biotechs are:

— Caribou, headed by Rachel Haurwitz and co-founded by Jennifer Doudna, is working on next-gen, off-the-shelf CAR-Ts to replace the patient-derived cells now in use.

— The LLS supported NexImmune’s IPO, helping fund its work on nanoparticles that can gin up an immune response directed at cancer cells. The biotech has 2 projects now in Phase I trials.