NICE fails to en­dorse Roche's Tecen­triq for breast can­cer; Eli­cio clos­es fi­nanc­ing round with $33M

→ UK’s cost-ef­fec­tive­ness watch­dog NICE is not back­ing Roche‘s PD-L1 check­point in­hibitor Tecen­triq (known chem­i­cal­ly as ate­zolizum­ab), in an­oth­er blow to the Swiss drug­mak­er who re­vealed the drug wasn’t strong enough to score ap­proval in blad­der can­cer at the ES­MO con­fer­ence last week­end. NICE’s draft guid­ance, how­ev­er, per­tains to the im­munother­a­py’s use in ad­vanced breast can­cer in com­bi­na­tion with the chemother­a­py nab-pa­cli­tax­el.

“How­ev­er, there was no tri­al da­ta di­rect­ly com­par­ing ate­zolizum­ab plus nab-pa­cli­tax­el with oth­er treat­ments cur­rent­ly used at this stage – week­ly pa­cli­tax­el and do­c­etax­el -and the com­mit­tee felt that the com­pa­ny’s analy­sis in­di­rect­ly com­par­ing these treat­ments was un­re­li­able and lacked va­lid­i­ty,” NICE re­view­ers said.

→ Penn-al­lied Tmu­ni­ty — which is run by No­var­tis $NVS vet Us­man “Oz” Azam and bagged a $100 mil­lion mega-round last year — has part­nered with Chil­dren’s Hos­pi­tal of Philadel­phia to ad­vance a glyp­i­can 2 (GPC2) CAR-T ther­a­py for the treat­ment of neu­rob­las­toma (a rare can­cer that af­fects the de­vel­op­ing ner­vous sys­tem). “The ther­a­py al­so has ex­pan­sion po­ten­tial in medul­loblas­toma and small cell lung can­cer, among sev­er­al oth­er pe­di­atric and adult can­cers that ex­press an abun­dance of the GPC2 pro­tein on their cell sur­face.” Fi­nan­cial de­tails have not yet been dis­closed.

→ Dar­rell Irvine co-found­ed Eli­cio Ther­a­peu­tics — fo­cused on am­phiphile im­munother­a­pies — has closed its Se­ries B with $33 mil­lion. The com­pa­ny says that the fi­nanc­ing will ad­vance Eli­cio’s pipeline, in­clud­ing its am­phiphile mKRAS vac­cine, ELI-002 — which tar­gets sev­en KRAS mu­ta­tions that dri­ve 99% of all KRAS-dri­ven can­cers. In­vestors for the round in­clud­ed Clal Biotech­nol­o­gy In­dus­tries, Liv­zon Phar­ma­ceu­ti­cal Group and Efung Cap­i­tal.

Back in Au­gust at the Amer­i­can Vet­er­ans Na­tion­al Con­ven­tion, Don­ald Trump tout­ed the ben­e­fits of Spra­va­to for de­pres­sion, and or­dered the VA to get as much of the prod­uct as it could —  and sug­gest­ed its mak­er J&J $JNJ should of­fer it to vet­er­ans for free. To­day, J&J’s Janssen an­nounced the sub­mis­sion of an sN­DA to the FDA for a new in­di­ca­tion for Spra­va­to for the rapid re­duc­tion of de­pres­sive symp­toms in adult pa­tients with ma­jor de­pres­sive dis­or­der (MDD) who have ac­tive sui­ci­dal ideation with in­tent.

In June, Enan­ta Phar­ma­ceu­ti­cals $EN­TA put to­geth­er plans for a new RSV study in adult pa­tients af­ter post­ing pos­i­tive da­ta in a Phase IIa study test­ing its drug, EDP-938. Enan­ta plans to ini­ti­ate a Phase IIb clin­i­cal study of EDP-938 in adult out-pa­tients with RSV by the end of 2019.

Goldfinch Bio — fo­cused on de­vel­op­ing treat­ments and med­i­cines for kid­ney dis­eases — has inked a li­cense agree­ment with Take­da for world­wide rights to a pre­clin­i­cal, pe­riph­er­al­ly-re­strict­ed cannabi­noid re­cep­tor 1 (CB1) mon­o­clon­al an­ti­body. Fi­nan­cial terms have not yet been dis­closed. Goldfinch Bio plans to file an IND for the CB1 in­hibitor, re­named GFB-024, in the sec­ond half of 2020.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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As­traZeneca gains EU nod for di­a­betes triple; Am­gen and Duke launch re­al-world PC­SK9 ob­ser­va­tion­al study

→ Weeks after winning EU approval to start marketing dapagliflozin as Forxiga, AstraZeneca has racked up another OK for a triplet combo involving the SGLT2 diabetes drug. Named Qtrilmet, the pill combines Forxiga with the DPP-4 inhibitor Onglyza (saxagliptin) and the bedrock drug metformin in a modified-release format. That 3-in-1 approach proved superior in reducing average blood glucose levels to a number of other dual combinations across 5 Phase III trials, including Forxiga plus metformin, Onglyza with metformin, or glimepiride with metformin.

Five drugs, in­clud­ing two No­var­tis ther­a­pies, win EMA en­dorse­ment

As is custom, an EMA panel on Friday issued its weekly recommendations on marketing applications submitted by drug developers. This week, the agency backed the use of five new therapies — including two Novartis drugs — but issued no negative reviews.

Novartis’ S1P drug for relapsing forms of multiple sclerosis (MS) drug, Mayzent (known chemically as siponimod), which was approved by the FDA in March — has been given the nod by the EMA. The Swiss drugmaker already sells its other MS drug, Gilenya, in both regions.

Atom­wise's X-37 spin­out gets $14.5 mil­lion to launch AI dis­cov­ery ef­forts

The folks behind Atomwise’s spinout X-37 like to think in cosmological metaphors, and you can think of their AI drug development model as probes sent into space from a central station. That station just got $14.5 million in Series A funding from DCVC Bio, Alpha Intelligence Capital and Hemi Ventures to back those missions.

X-37 uses Atomwise’s AI platform to identify drug targets and – unlike the parent company, which largely sticks to computers  – bring those into a wet lab and preclinical testing.  In addition to AI professionals, it’s led in by part by drug developers from Velocity Pharmaceutical Development.

Ab­bott Lab­o­ra­to­ries CEO Miles White pass­es ba­ton down to suc­ces­sor; Lon­za CEO Marc Funk hits the ex­it

→ Abbott Laboratories has named a successor to CEO Miles White after he announced that he was stepping down in March after 21 years of service. Robert Ford, the company’s COO and president, will take the helm. Ford is known for his work in the $25 billion merger between St. Jude Medical into Abbott in January 2017. White will remain with the company as executive chairman of the board. 

→ After snapping up Novartis’ Swiss facility, Novartis Center of Excellence, in July, Lonza has announced that their CEO, Marc Funk, is hitting the exit for “personal reasons.” Funk has been the CEO of the company for less than a year — brought onto the company back in March. In the meantime, chairman Albert Baehny will serve as interim CEO. 

BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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