Skirt­ing a group of pi­o­neers, Gilead part­ners with gene-edit­ing up­start Pre­ci­sion Bio in hunt to cure hep B

Hav­ing al­ready found a pain­less cure for he­pati­tis C, Gilead has now set its sights on an­oth­er cure for he­pati­tis B. And they’ve steered around the most promi­nent gene-edit­ing play­ers in the field to part­ner up Durham, NC-based Pre­ci­sion Bio­Sciences just a cou­ple of months af­ter the biotech raised an im­pres­sive $110 mil­lion mega-crossover round.

Gilead said this morn­ing it has seed­ed their col­lab­o­ra­tion with Pre­ci­sion with $445 mil­lion in mile­stones, avoid­ing any men­tion of an up­front in the an­nounce­ment. 

What brought them in?

Derek Jantz

Pre­ci­sion has been work­ing with a new gene edit­ing tech that it be­lieves can of­fer a best-in-class ap­proach to ge­net­ic surgery, us­ing a syn­thet­ic en­zyme called the ARC nu­cle­ase that can be cal­i­brat­ed to rec­og­nize spe­cif­ic DNA se­quences in a gene. In­ter­est­ing­ly, Gilead al­so avoid­ed Ed­i­tas, CRISPR and In­tel­lia — the high pro­file troi­ka that launched with new CRISPR/Cas9 tech — in part­ner­ing with Sang­amo ear­ly this year on a gene-edit­ing ap­proach to off-the-shelf CAR-T drugs.

Gilead, a high­ly at­trac­tive de­vel­op­ment part­ner with a yen for big sci­ence, has been un­der­go­ing a brain drain this year. Its CEO John Mil­li­gan and chair­man John Mar­tin are head­ed out the door. CMO An­drew Cheng just left to run a start­up com­pa­ny and R&D chief Nor­bert Bischof­berg­er left ear­li­er to make his own tran­si­tion to the pri­vate drug de­vel­op­ment world.

Through it all, though, it seems de­ter­mined to keep the pres­sure on HIV — its main­stay — and vi­ral he­pati­tis af­ter cur­ing hep C and earn­ing bil­lions of dol­lars in a wind­fall, on­ly to see the mar­ket start to evap­o­rate. Since then the com­pa­ny has al­so jumped in­to CAR-T with a pi­o­neer­ing ther­a­py.

Pre­ci­sion, mean­while, has ex­hib­it­ed all the signs of a biotech lin­ing up for an IPO. Now that it has a big de­vel­op­ment part­ner to boast about, it would ap­pear that the busi­ness plan sec­tion of the S-1 should be ready to roll.

“Gilead’s cure-based ap­proach to he­pati­tis B is com­pre­hen­sive and ex­cit­ing,” not­ed Pre­ci­sion chief sci­en­tif­ic of­fi­cer Derek Jantz in a state­ment. “Pre­ci­sion is pleased that ini­tial stud­ies with our AR­CUS plat­form have es­tab­lished an im­por­tant role for genome edit­ing in their HBV pro­gram. This is an ex­cel­lent ap­pli­ca­tion for our tech­nol­o­gy, which has made no­table progress to­ward ther­a­peu­tic in vi­vo edit­ing in rel­e­vant mod­els over the last year.”

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

UP­DAT­ED: Feds clear the road for J&J to start de­liv­er­ing mil­lions of dos­es of their Covid-19 vac­cine — but frets linger about run­ner-up sta­tus

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

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