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.

Jim Mellon [via YouTube]

Health­i­er, longer lifes­pans will be a re­al­i­ty soon­er than you think, Ju­ve­nes­cence promis­es as it clos­es $100M round

Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017.  Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer and Amarin.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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