Are­na takes a big step down the come­back trail with PhII suc­cess, shares rock­et up

A year af­ter new Are­na $AR­NA CEO Amit Mun­shi be­gan a painful makeover in­volv­ing deep staff cuts and a deal to even­tu­al­ly of­fload its rights to a dis­ap­point­ing weight drug, the com­pa­ny is mak­ing the case that it’s on track with a new drug for pul­monary ar­te­r­i­al hy­per­ten­sion.

Af­ter the mar­ket closed on Mon­day, Are­na said its PAH drug ra­linepag scored on a key end­point in a Phase II study of the dis­ease, send­ing its shares rock­et­ing up more than 40%. Com­par­ing the drug against a place­bo, in­ves­ti­ga­tors re­port­ed a suc­cess on pul­monary vas­cu­lar re­sis­tance. Their con­clu­sion:

Ra­linepag im­proved me­di­an PVR by 163.9 dyn.s.cm-5 from base­line com­pared to a 0.7 dyn.s.cm-5 wors­en­ing from base­line in the place­bo arm (P=0.02). Pa­tients treat­ed with ra­linepag had a 29.8% im­prove­ment in PVR com­pared to the place­bo arm (P=0.03) and a 20.1% im­prove­ment in PVR com­pared to base­line.

The drug will now shift in­to Phase III as Are­na con­tin­ues down what it hopes is a come­back trail. The biotech was one of three de­vel­op­ers to score on an ap­proval for a weight loss drug sev­er­al years ago. But Belviq proved to be a flop on the mar­ket. Ei­sai owns it all now.

Their top clin­i­cal pro­gram is for etrasi­mod (APD334), which Mun­shi de­scribes as the “sec­ond S1P mod­u­la­tor be­hind Re­cep­tos (ozan­i­mod),” bought out by Cel­gene for more than $7 bil­lion. Phase II da­ta is due in late 2017. Ra­linepag (ADP811) will de­liv­er mid-stage da­ta on pul­monary ar­te­r­i­al hy­per­ten­sion lat­er in the year. And their cannabi­noid 2 re­cep­tor ag­o­nist for Crohn’s pain wraps the in-house pipeline. Nelotanserin, a 5-HT2A in­verse ag­o­nist, is part­nered with Ax­o­vant for de­men­tia a”The pos­i­tive out­come of this Phase II tri­al in a con­tem­po­rary PAH pa­tient pop­u­la­tion is an im­por­tant mile­stone in the de­vel­op­ment of ra­linepag for the treat­ment of pa­tients suf­fer­ing from this griev­ous ill­ness,” not­ed Are­na chief med­ical of­fi­cer Pre­ston Klassen. “It is ex­cit­ing to see the pos­i­tive non­clin­i­cal phar­ma­co­log­i­cal pro­file trans­lat­ing in­to po­ten­tial­ly the first oral prosta­cy­clin ther­a­py that may ap­proach con­sis­tent ther­a­peu­tic lev­els with­out the com­plex­i­ty of par­enter­al (IV) ther­a­py. These da­ta give us con­fi­dence to move ex­pe­di­tious­ly to­ward a Phase 3 clin­i­cal pro­gram.”

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

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected 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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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.

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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New safe­ty da­ta ex­pose po­ten­tial weak­ness as Pfiz­er's abroc­i­tinib takes on Dupix­ent in eczema

Last September, when Pfizer celebrated positive data from a second Phase III study of abrocitinib, many watchers applauded the efficacy but were still waiting to see whether the JAK1 inhibitor is “safe enough to be a formidable competitor to Dupixent,” the clear leader in the atopic dermatitis field. The full slate of safety data are now out and, according to one analyst, the answer is: probably not.

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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