Part­nered with No­var­tis, tiny Ca­dent jumps out of stealth with $40M round for its CNS pipeline

A small Cam­bridge, Mass­a­chu­setts-based com­pa­ny is hop­ing its bet on CNS drugs us­ing a well es­tab­lished phar­ma­ceu­ti­cal ap­proach — al­losteric mod­u­la­tors — will ce­ment its place as a biotech pow­er­house in the years to come. Ca­dent Ther­a­peu­tics — cur­rent­ly a 9-per­son team — has al­ready found a part­ner in No­var­tis $NVS.

The com­pa­ny is work­ing on treat­ments for move­ment and cog­ni­tive dis­or­ders us­ing al­losteric mod­u­la­tors, from which some of the biggest neu­ro­science prod­ucts, such as Xanax and Am­bi­en, have been de­vel­oped. On Thurs­day, Ca­dent said it had emerged “out of stealth mode” by an­nounc­ing a $40 mil­lion Se­ries B round of fund­ing, led by Cowen Health­care In­vest­ments and At­las Ven­ture. In­vestors such as Qim­ing Ven­ture Part­ners and No­var­tis In­sti­tutes for Bio­med­ical Re­search al­so par­tic­i­pat­ed in the round, which will be used to shep­herd two of the com­pa­ny’s ex­per­i­men­tal drugs in­to three Phase II tri­als.

Ca­dent is us­ing al­losteric mod­u­la­tors – which func­tion some­what like dim­mer switch­es – to tar­get ion chan­nels that are es­sen­tial to neu­ronal ac­tiv­i­ty. The biotech’s move­ment dis­or­ders pro­gram is fo­cused on the SK chan­nel – which reg­u­lates the amount of potas­si­um that en­ters a cell –  for the treat­ment of es­sen­tial tremor (ET) and spin­ocere­bel­lar atax­ia (SCA). Mean­while, Ca­dent’s sec­ond pro­gram is cen­tered on cog­ni­tive dis­or­ders. It em­ploys the use of al­losteric mod­u­la­tors to reg­u­late the the NM­DA re­cep­tor, which has been shown to play a crit­i­cal role in cog­ni­tion and de­pres­sion.

Bob Dagher

“We have both fla­vors of the NM­DA re­cep­tor, we can turn it up in the case of cog­ni­tive im­pair­ment, and we can turn it down, in the case of de­pres­sion,” chief Michael Cur­tis told End­points News. 

Ca­dent’s de­pres­sion pro­gram is part­nered with No­var­tis $NVS, so the Swiss drug­mak­er is tasked with com­pet­ing with Sage $SAGE, Al­ler­gan $AGN, John­son & John­son $JNJ and oth­ers in the de­pres­sion space, he added. With­out delv­ing in­to specifics, Cur­tis said the No­var­tis deal gen­er­ates non-di­lu­tive fund­ing for Ca­dent.

In the case of pos­i­tive al­losteric mod­u­la­tors for the NM­DA re­cep­tor, Ca­dent is tar­get­ing cog­ni­tive im­pair­ment as­so­ci­at­ed with schiz­o­phre­nia. What sets the com­pa­ny apart, ac­cord­ing to Cur­tis, is the use of an EEG (elec­troen­cephalo­gram) — that mea­sures brain elec­tri­cal ac­tiv­i­ty — as a bio­mark­er. An EEG deficit is be­lieved to be di­rect­ly re­lat­ed to NM­DA re­cep­tor hy­po-ac­tiv­i­ty, but us­ing this mea­sure as a bio­mark­er was pre­vi­ous­ly not a prac­ti­cal propo­si­tion be­cause sci­en­tists re­quired the use of a spe­cial­ized fa­cil­i­ty to con­duct the test in a clin­i­cal tri­al set­ting. Ca­dent has solved this prob­lem by part­ner­ing with a com­pa­ny called Cog­ni­sion that has de­vel­oped a portable EEG sys­tem, Cur­tis said.

“The the­o­ry is that if we can turn up the NM­DA re­cep­tor us­ing al­losteric mod­u­la­tors — we can re­store the EEG sig­na­ture, which is con­sid­ered to be a pre­cur­sor in im­prov­ing cog­ni­tion. That gives us a rapid way in a Phase II to look at tar­get en­gage­ment in the pa­tient pop­u­la­tion that we’re go­ing af­ter be­fore we ever have to ask the cog­ni­tion ques­tion.”

Tim An­der­son

“We have sev­er­al shots on goal in in­di­ca­tions that don’t re­quire huge cap­i­tal in­vest­ments – we’re talk­ing about a 2-week phase II in ET, a 12-week phase II in SCA. Maybe a hun­dred pa­tients tops in these tri­als, so for rel­a­tive­ly small cap­i­tal we can get the val­ue in­flec­tive points,” Cur­tis said.

De­pend­ing on the re­sults of these mid-stage stud­ies, which the com­pa­ny ex­pects to read­out over the next 12-18 months, Ca­dent is open to all pos­si­bil­i­ties, such as fur­ther cap­i­tal rais­es, an IPO, a part­ner­ship and a takeover, he added.

Ca­dent al­so an­nounced it had hired in­dus­try vet­er­an Bob Dhager, who has worked with Co­v­ance, Sanofi $SNY and Glax­o­SmithK­line $GSK, as their chief med­ical of­fi­cer and that Cowen’s Tim An­der­son, among oth­ers, had joined the com­pa­ny’s board.

Hal Barron and Rick Klausner (GSK, Lyell)

Ex­clu­sive: GSK’s Hal Bar­ron al­lies with Rick Klaus­ner’s $600M cell ther­a­py start­up, look­ing to break new ground blitz­ing sol­id tu­mors

LONDON — Chances are, you’ve heard little or nothing about Rick Klausner’s startup Lyell. But that ends now.

Klausner, the former head of the National Cancer Institute, former executive director for global health at the Gates Foundation, co-founder at Juno and one of the leaders in the booming cell therapy field, has brought together one of the most prominent teams of scientists tackling cell therapy 2.0 — highlighted by a quest to bridge a daunting tech gap that separates some profound advances in blood cancers with solid tumors. And today he’s officially adding Hal Barron and GlaxoSmithKline as a major league collaborator which is pitching in a large portion of the $600 million he’s raised in the past year to make that vision a reality.

“We’ve being staying stealth,” Klausner tells me, then adding with a chuckle: “and going back to stealth after this.”

“Cell therapy has a lot of challenges,” notes Barron, the R&D chief at GSK, ticking off the resistance put up by solid tumors to cell therapies, the vein-to-vein time involved in taking immune cells out of patients, engineering them to attack cancer cells, and getting them back in, and more. “Over the years Rick and I talked about how it would be wonderful to take that on as a mission.”

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First place fin­ish: Eli Lil­ly just moved to fran­chise leader with their sec­ond mi­graine drug OK in 1 year

In a rare twist for Eli Lilly’s historically slow-moving R&D group, the pharma giant has seized bragging rights to a first-in-class new drug approval. And all signs point to an aggressive marketing followup as they look to outclass some major franchise rivals hobbled by internal dissension.

The FDA came through with an OK for lasmiditan on Friday evening, branding it as Reyvow and lining it up — once a substance classification comes through from the DEA — for a major market release. The oral drug binds to 5-HT1F receptors and is designed to stop an acute migraine after it starts. That makes it a complementary therapy to their CGRP drug Emgality, which has a statistically significant impact on preventing attacks.

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Allogene HQ Open House on September 17, 2019 in South San Francisco. (Jeff Rumans, Endpoints News)

The next 10 years: Where is biotech head­ed?

The last 10 years have seen a revolution in drug development. Timelines have shortened, particularly in oncology. Regulators have opened up. Investment has skyrocketed. China became a player. Biotechs have multiplied as gene and cell therapy has exploded — offering major new advances in the way diseases are treated, and sometimes cured.

So where are we headed from here? I journeyed out to San Francisco in September to discuss the answer to that question at Allogene’s open house. If the last 10 years have been an eye-opener, what does the next decade hold in store?

Patrick Mahaffy, Getty Images

Court green-lights Clo­vis case af­ter de­tail­ing ev­i­dence the board ‘ig­nored red flags’ on false safe­ty and ef­fi­ca­cy da­ta

Clovis investors have cleared a major hurdle in their long-running case against the board of directors, with a Delaware court making a rare finding that they had a strong enough case against the board to proceed with the action.

In a detailed ruling at the beginning of the month that’s been getting careful scrutiny at firms specializing in biotech and corporate governance, the Delaware Court of Chancery found that the attorneys for the investors had made a careful case that the board — a collection of experts that includes high-profile biotech entrepreneurs, a Harvard professor and well-known investigator as well as Clovis CEO Patrick Mahaffy — repeatedly ignored obvious warnings that Mahaffy’s executive crew was touting inflated, unconfirmed data for their big drug Roci. Serious safety issues were also reportedly overlooked while the company continued a fundraising campaign that brought in more than a half-billion dollars. And that leaves the board open to claims related to their role in the fiasco.

The bottom line:

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Bill Gates backs Gink­go Biowork­s' $350M raise to fu­el the buzzy syn­thet­ic bi­ol­o­gy 'rev­o­lu­tion'

If you want to understand Ginkgo Bioworks, the name should suffice: Bioworks, a spin off “ironworks,” that old industrial linchpin devoted to leveraging scale as a wellspring for vast new industries capable of remaking society. Ginkgo wants to be the ironworks for the revolution it’s heralded with as much fanfare as they can, playing off of one of the buzziest technologies in biotech.

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UCB bags a ri­val to Soliris in $2.1B buy­out deal — but will an in­creas­ing­ly vig­i­lant FTC sign off?

UCB is buying out Ra Pharma $RARX, announcing an acquisition deal that rings up at $48 a share, or $2.1 billion net of cash, and puts them toe-to-toe with Alexion on a clinical showdown.

Ra shares closed at $22.70 on Wednesday.

There’s a small pipeline in play at Ra, but UCB is going for the lead drug — a C5 inhibitor called zilucoplan in Phase III for myasthenia gravis (MG) looking to play rival to Alexion’s Soliris. Soliris has the market advantage, though, with a much earlier approval in MG in late 2017 that UCB feels confident in challenging.

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A new play­er is tak­ing the field in a push for a he­mo­phil­ia A gene ther­a­py, and it’s a big one

BioMarin, the execs at Spark (and buyer-to-be Roche) as well as the Sangamo/Pfizer team have a new rival striding onto the hemophilia block. And it’s a big one.

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Stuck with a PhI­II gene ther­a­py fail­ure at 96 weeks, Gen­Sight prefers the up­beat as­sess­ment

Two years after treatment, the best thing that GenSight Biologics $SIGHT can say about their gene therapy for vision-destroying cases of Leber Hereditary Optic Neuropathy is that it’s just a bit better than a placebo — just maybe because one treatment can cover both eyes.

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George Scangos / Credit: Cornell University

ARCH, Soft­Bank-backed Vir Biotech­nol­o­gy un­der­whelms with $143 mil­lion IPO

George Scangos went back to Wall Street, and came back 700 million pennies short.

Scangos’ vaunted startup Vir Biotechnology raised $143 million in an IPO they hoped would earn $150 million. Shares were priced at $20, the low-end of the $20-$22 target.

Launched with backing from ARCH Venture’s Robert Nelsen, Masayoshi Son’s SoftBank Vision Fund, and the Bill & Melinda Gates Foundation, the infectious disease startup was one of a new wave of well-resourced biotechs that emerged with deep enough coffers to pursue a full R&D line rather than slowly build their case by picking off a single lead program.