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As­traZeneca bets cau­tious­ly on on­colyt­ic virus dis­cov­ery pro­gram, out­lin­ing $13M deal with Trans­gene

Mount­ing a pre­lim­i­nary ef­fort to catch up with oth­er phar­ma gi­ants in the on­colyt­ic virus space, As­traZeneca has found a part­ner in France’s Trans­gene.

In the deal, the biotech — which is al­ready al­lied with Bris­tol-My­ers Squibb and Pfiz­er/Mer­ck KGaA on com­bi­na­tion pro­grams with its in-house ther­a­peu­tic vac­cines — will come up with five new armed on­colyt­ic vac­cinia virus can­di­dates. As­traZeneca is start­ing small with $10 mil­lion up­front and just $3 mil­lion in pre­clin­i­cal suc­cess mile­stones, but promis­es an undis­closed li­cense fee for each clin­i­cal can­di­date they ul­ti­mate­ly de­cide to co-de­vel­op.

Can dif­fer­ences in ge­nom­ic im­mune sys­tem sig­na­tures de­tect lung can­cer be­fore it takes hold?

There’s as­pirin for col­orec­tal can­cer and statins for car­dio­vas­cu­lar dis­ease, but for the lead­ing cause of can­cer deaths glob­al­ly — lung can­cer — there’s no tool in the doc­tor’s ar­se­nal to ar­rest or pre­vent the fa­tal dis­ease (apart from smok­ing ab­sti­nence). But a new study sug­gests ge­nom­ic im­mune sys­tem dis­par­i­ties may play a cru­cial role in the de­vel­op­ment of lung can­cer, set­ting the stage for fresh ther­a­peu­tics that could arm the im­mune sys­tem to bet­ter fight can­cer­ous cells from an­chor­ing in the lungs.

How bio­phar­ma com­pa­nies use NIH and vice ver­sa

An ar­gu­ment has been brew­ing on Capi­tol Hill and else­where that boils down to the the­o­ry that US tax­pay­ers are fronting bil­lions of dol­lars’ worth of pub­lic re­search that trans­lates in­to ear­ly-stage prod­ucts that are lat­er sold to com­pa­nies, go on to win FDA ap­proval and then reap mil­lions or bil­lions in sales, al­though the gov­ern­ment nev­er sees a dime of those earn­ings.

With the help of a new Con­gres­sion­al Re­search Ser­vice (CRS) re­port pub­lished Fri­day and some oth­er ma­te­ri­als, Fo­cus can break down what’s hap­pen­ing.
1. Do tax­pay­ers pay for bil­lions in re­search?
Yes. In FY 2018, the Na­tion­al In­sti­tutes of Health (NIH) had a bud­get of more than $34 bil­lion to sup­port more than 300,000 sci­en­tists and re­search per­son­nel work­ing at over 2,500 in­sti­tu­tions across the US and abroad. And from FY 1998 to FY 2003, Con­gress dou­bled the NIH bud­get. The to­tal NIH ap­pro­pri­a­tion for FY 2019 is $39 bil­lion.
2. Does NIH re­search trans­late in­to ear­ly-stage prod­ucts?
Some­times. And here’s where the quan­tifi­ca­tion of NIH’s work gets tricky.

Penn sci­en­tists cor­rect ge­net­ic flaw in mice fe­tus­es, ex­pand­ing in utero CRISPR reach to lung dis­eases

Re­mem­ber when re­searchers ap­plied CRISPR to ed­it genes of mice fe­tus­es while they are still in the womb, spar­ing them from death by liv­er dis­ease? The same team from the Uni­ver­si­ty of Penn­syl­va­nia has now test­ed the same idea — al­beit with a dif­fer­ent tech­nique — in ge­net­ic lung dis­eases.

In the bur­geon­ing world of gene edit­ing spawned by CRISPR, in utero treat­ment can be seen as a mid­point be­tween ear­ly em­bryo edit­ing (which pass­es the ge­net­ic al­ter­ations to fu­ture gen­er­a­tions) and edit­ing af­ter birth, which can be too late for pa­tients with cer­tain lethal dis­eases.

Vi­iV's Dova­to wins speedy US ap­proval with PRV, em­pow­er­ing GSK to mus­cle in­to Gilead­'s HIV em­pire

GSK’s Vi­iV is poised to take a bite out of Gilead’s HIV em­pire, af­ter its dual HIV reg­i­men — Dova­to — se­cured FDA ap­proval on Mon­day, af­ter the British drug­mak­er sub­mit­ted its mar­ket­ing ap­pli­ca­tion with a pri­or­i­ty re­view vouch­er (PRV) last Oc­to­ber, en­abling a speedy re­sponse from the US reg­u­la­tor.

Dova­to is an im­prove­ment over GSK’s ex­ist­ing two-drug reg­i­men Ju­lu­ca, which does not in­clude a nu­cle­o­side ana­log re­verse tran­scrip­tase in­hibitor or a ‘nuke.’ This fam­i­ly of drugs are used to thwart an en­zyme called re­verse tran­scrip­tase, which is used by the HIV virus to make copies of it­self in­side a healthy cell.

Rat study sug­gests Al­ler­gan's failed an­ti­de­pres­sant ra­pastinel may work as opi­oid ad­dic­tion treat­ment

Last month, when Al­ler­gan’s $AGN once-tout­ed pipeline star ra­pastinel crashed and burned a slate of piv­otal de­pres­sion stud­ies, it looked like the ex­per­i­men­tal mod­u­la­tor of the NM­DA re­cep­tor would be shroud­ed in a cloak of in­vis­i­bil­i­ty — but re­searchers may have found a way to res­cue the ex­per­i­men­tal drug by re­pur­pos­ing it as a treat­ment for opi­oid de­pen­dence.

In the Unit­ed States, the cri­sis of opi­oid abuse, mis­use and over­dose — from pre­scrip­tion painkillers, hero­in, and syn­thet­ic opi­oids such as fen­tanyl — has reached epi­dem­ic pro­por­tions, caus­ing 130 deaths every day, ac­cord­ing to NIH es­ti­mates. Once in with­draw­al, ad­dicts are left to cope with a myr­i­ad of symp­toms in­clud­ing anx­i­ety, ag­i­ta­tion, sleep prob­lems, mus­cle aches, run­ny nose, sweat­ing, nau­sea, vom­it­ing, di­ar­rhea and opi­oid crav­ings.

The case of the miss­ing PD-L1: UCSF sleuths de­vise a new ‘tu­mor cell vac­cine’ and a check­point strat­e­gy that could sur­prise you

It will come as no surprise to anyone watching the I/O market boom that PD-1/L1 drugs may be amazingly effective, but for only about 1 in 4 patents. In certain types of cancer, it’s much worse.

That 1 in 4 ratio has created a multibillion-dollar business — virtually overnight in biopharma terms. But it has focused an amazing amount of attention on the other 3 who are missing out.

Starting from that premise, a team of investigators at UCSF wanted to find out why some cancer cells had less of the PD-L1 protein that are displayed on the cell surface and used to cloak themselves from an immune response.

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Jeff Be­zos teams with Bill Gates to fund new and bet­ter ways to di­ag­nose Alzheimer’s

The world’s wealth­i­est man is chip­ping in­to a new fund from one of the oth­er rich­est men on the plan­et to fi­nance a hunt for new, bet­ter and cheap­er ways to di­ag­nose Alzheimer’s.

E-tail mogul Jeff Be­zos — along­side his es­tranged wife MacKen­zie — added $15 mil­lion to the $35 mil­lion Bill Gates helped put to­geth­er for the di­ag­nos­tics work be­ing done by the Alzheimer’s Drug Dis­cov­ery Foun­da­tion.

Bel­gian biotech found­ed by Uni­ver­si­ty of Tori­no team nabs $23.5 mil­lion in Se­ries A round

Hav­ing spent more than two decades re­search­ing bi­ol­o­gy of the he­pa­to­cyte growth fac­tor (HGF), Pao­lo Michieli and his team at the Uni­ver­si­ty of Tori­no, Italy forged a col­lab­o­ra­tion with Nether­lands-based biotech Argenyx to cre­ate AgomAb Ther­a­peu­tics in 2017. On Wednes­day, the Bel­gian firm scored a €21 mil­lion (about $23.5 mil­lion) in­jec­tion for its slate of undis­closed pre­clin­i­cal pro­grams.

HGF — a pro­tein se­cret­ed by mes­enchy­mal cells — has long been stud­ied for its role in cell pro­lif­er­a­tion, sur­vival, motil­i­ty and dif­fer­en­ti­a­tion. It is un­der­stood to pro­mote wound heal­ing as well as tis­sue re­gen­er­a­tion in a num­ber of pre­clin­i­cal mod­els, chief Tim Knot­nerus said in an in­ter­view with End­points News.

The top 20 pre­clin­i­cal biotech deals ranked by cash up­front re­veals 3 big play­ers — and some ma­jor league stinkers

Novartis’s decision to pay up to $1.6 billion for a late preclinical program — setting aside that first dosing in a healthy volunteer trial on Friday — is remarkable for several reasons. But one of the standouts is the amount of cash involved: $310 million upfront.

Discovery and preclinical deals are best known for back-ending the money in milestones, limiting the amount of financial risk in an industry where preclinical rates of success can be extraordinarily lean. If you never make it into Phase II, well, the major league players usually arrange to take a modest hit without wondering if anyone will hold them to task for it.

Novartis joined some rare company in moving a substantial part of the deal money to cash. We asked DealForma chief Chris Dokomajilar to run the preclinical numbers, which you’ll find for licensing and M&A deals combined in a top 20 and then split into two lists of their own.

Three biopharma companies dominate the list of high rollers. Novartis makes the top 20 three times, alongside matching records as a buyer for Bristol-Myers Squibb and Celgene, which are being mashed together in a buyout that will permanently alter the landscape on preclinical risk taking.

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