Su­per­nus bags ear­ly-stage CNS drug for $15M up­front in re­newed epilep­sy R&D ef­forts

A few years in­to mar­ket­ing their two epilep­sy drugs, the neu­rol­o­gy and psy­chi­a­try ex­perts at Su­per­nus Phar­ma are go­ing back to the draw­ing board with a new as­set.

Su­per­nus $SUPN is pay­ing $15 mil­lion up­front to ac­quire Bis­cayne Neu­rother­a­peu­tics and their Phase I pro­gram, with de­vel­op­ment and sales mile­stones to­talling $73 mil­lion and $95 mil­lion re­spec­tive­ly. A low sin­gle dig­it roy­al­ty would al­so be due should the drug ever reach the mar­ket.

While the num­bers are small, it’s a con­sid­er­able win for Mi­a­mi-based Bis­cayne Neu­rother­a­peu­tics, which spun out of Bis­cayne Phar­ma less than two years ago with $3 mil­lion in fund­ing.

Steven Schachter

Their epilep­sy treat­ment — now called SPN-817 — is a syn­thet­ic form of hu­perzine A, a sup­ple­ment with roots in Chi­nese med­i­cine that peo­ple some­times take for mem­o­ry im­pair­ment. It in­hibits the acetyl­cholinesterase en­zyme, there­by reg­u­lat­ing a neu­ro­trans­mit­ter re­spon­si­ble for send­ing sig­nals to mus­cles called acetyl­choline.

“In ad­di­tion to its pow­er­ful an­ti­seizure ac­tiv­i­ty in pre­clin­i­cal mod­els of se­vere epilep­sy, BIS-001 has ex­hib­it­ed the cog­ni­tion-en­hanc­ing prop­er­ties seen with oth­er AChE drugs, but with much bet­ter cen­tral ner­vous sys­tem and sys­temic tol­er­a­bil­i­ty and safe­ty than cur­rent­ly avail­able agents,” Steven Schachter, a Har­vard pro­fes­sor who co-found­ed Bis­cayne, said at its launch. “At a min­i­mum, we are op­ti­mistic it will be de­void of the detri­men­tal ef­fects on cog­ni­tion seen with many ex­ist­ing antiepilep­tic drugs.”

Jack Khat­tar

Su­per­nus has a long way to go in prov­ing that op­ti­mism — and a num­ber of ri­vals to con­tend with. GW Phar­ma scored the very first cannabis-de­rived drug ap­proval weeks ago to treat Dravet syn­drome, the ex­act form of rare pe­di­atric epilep­sy that Su­per­nus plans to start with. Zo­genix is lin­ing up with their pitch for the same in­di­ca­tion with a ther­a­py backed by a slate of pos­i­tive Phase III da­ta.

But it’s al­so had some time to nav­i­gate the epilep­sy mar­ket with their ex­tend­ed re­lease pills Ox­tel­lar XR (ox­car­bazepine) and Tro­k­en­di (top­i­ra­mate), with which SPN-817 will be a “strong strate­gic fit” ac­cord­ing to CEO Jack Khat­tar.

The pri­or­i­ty now is to de­vel­op an ex­tend­ed re­lease oral dosage for the drug, while fin­ish­ing up a proof-of-con­cept in adult pa­tients with re­frac­to­ry com­plex par­tial seizures.

Oth­er pro­grams in Su­per­nus’ pipeline tar­get AD­HD, bipo­lar dis­or­der, and de­pres­sion.

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.

Bris­tol-My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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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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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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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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