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.”

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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The race to de­vel­op Covid-19 drugs and vac­cines is on — here’s what’s hap­pen­ing in the UK

Weeks away from the results of ongoing US and China trials testing its experimental antiviral remdesivir, Gilead is going to trial the failed Ebola drug in a small group of coronavirus patients in England and Scotland. The United Kingdom is also home to a range of other therapeutic efforts, as the pandemic rages on across the globe.

On Tuesday, Southampton, UK-based startup Synairgen kicked off a mid-stage placebo-controlled study testing its experimental drug, SNG001 — an inhaled formulation of interferon-beta-1a — that has previously shown to be safe and effective in improving lung function in asthma patients with a respiratory viral infection in a pair of Phase II trials.

‘There was a grow­ing weari­ness’: Rush­ing against a pan­dem­ic clock, As­pen Neu­ro­sciences se­cures $70M Se­ries A

Just before Christmastime, Howard Federoff got a tip from Washington: There was a new virus in China. And this one could be bad.

News report of the virus had not yet appeared. Federoff, a neuroscientist, was briefed because years before, he was vetted as part of a group — he didn’t give a name for the group — to consult for the US government on emerging scientific issues. His day job, though, was CEO of Aspen Neurosciences, a Parkinson’s cell therapy startup that days before had come out of stealth mode and gave word to investors they were hoping to raise $70 million. That, Federoff realized, would be difficult if a pandemic shut down the global economy.

FDA puts pe­di­atric aGVHD drug on pri­or­i­ty re­view lane — will they go vir­tu­al with the ad­comm?

Despite worries about regulatory delays due to new work arrangements under Covid-19, the FDA appears intent to go full speed ahead with its everyday work, not only granting priority review to a stem cell therapy for acute graft versus host disease but also plotting an advisory committee meeting for it.

With a PDUFA date of September 30, the journey of the drug — remestemcel-L, or Ryoncil — could shed light on the agency’s capacity to facilitate drug development unrelated to Covid-19.

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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Covid-19 roundup: Trump push­es his new fa­vorite, untest­ed drug; CRISPR out­lines crip­pling im­pact of Covid-19

President Trump has a new favorite Covid-19 drug.

After a conversation with Japanese Prime Minister Shinzo Abe, Politico reports, the president is pressuring the FDA to issue emergency use authorization for favipiravir, a flu drug that showed glimpses of success in China but remains unproven and carries a list of worrying side effects. The push comes after a week-plus in which the White House touted a potentially effective but unproven malaria medication despite the concerns of scientific advisors such as NIAID director Anthony Fauci. And Trump ally Rudy Giuliani has been talking up unproven cell therapy efforts on Twitter.

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