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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.