CEO Grace Colón (InCarda)

Look­ing to re­pur­pose an old drug to treat ir­reg­u­lar heart­beats, In­Car­da rais­es $30M in first Se­ries C close

A lit­tle less than two years af­ter com­plet­ing its $42 mil­lion Se­ries B round, In­Car­da has re­turned to the ven­ture well.

The San Fran­cis­co-based biotech an­nounced the first por­tion of its Se­ries C on Wednes­day, pulling in $30 mil­lion in new fund­ing. Most of the mon­ey will give enough run­way for In­Car­da’s In­Rhythm pro­gram, an in­haled ther­a­peu­tic aim­ing to treat sud­den episodes of ir­reg­u­lar heart­beats, through its Phase II tri­als and pre­pare it for Phase III.

Wednes­day’s fi­nanc­ing was led by an af­fil­i­ate of In­no­vi­va and al­so in­clud­ed ex­ist­ing in­vestors Deer­field Man­age­ment, Health­Cap and Morn­ing­side Ven­ture.

In­Car­da is study­ing how the ex­per­i­men­tal can­di­date, which re­pur­pos­es the old oral and IV drug fle­cainide in­to a neb­u­liz­er, can be used in a med­ical­ly su­per­vised set­ting as well as a self-ad­min­is­tered form, CEO Grace Colón told End­points News. The for­mer has com­plet­ed an open-la­bel Phase IIa study, with da­ta com­ing in No­vem­ber, while the lat­ter re­cent­ly be­gan a Phase IIb.

Colón laid out the time­line for all the tri­als as fol­lows — the med­ical­ly su­per­vised stud­ies will en­ter a Phase III in the first half of next year, with a read­out ex­pect­ed in ear­ly 2022; and the self-ad­min­is­tered Phase IIb will run in par­al­lel through the sec­ond half of 2021, with a Phase III to be­gin af­ter that’s been com­plet­ed.

Ul­ti­mate­ly, In­Car­da is seek­ing to close the gap be­tween heart rate con­trol and heart rhythm con­trol med­i­cines. When pa­tients typ­i­cal­ly go to the hos­pi­tal for atri­al fib­ril­la­tion, they’re giv­en drugs that slow the beat­ing of their hearts but may still leave the cham­bers beat­ing out of sync.

“Pa­tients are typ­i­cal­ly giv­en drugs like a be­ta block­er or cal­ci­um chan­nel block­er, which al­lows them to quick­ly feel some­what bet­ter but they’re still skip­ping beats,” Colón said. “Typ­i­cal­ly they’re kept in the ER to see if they con­vert spon­ta­neous­ly, but two-thirds of the pa­tients in the ER end up get­ting ad­mit­ted and kept overnight.”

There are three stages of chron­ic AF, Colón not­ed, and pa­tients may some­times be re­luc­tant to seek treat­ment un­til the dis­ease pro­gress­es. At first, the heart may on­ly be ar­rhyth­mic for a few min­utes to a few days at most, and those episodes typ­i­cal­ly re­solve them­selves. Pa­tients re­quire in­ter­ven­tion once they reach the per­sis­tent stage, as there’s no treat­ment once the con­di­tion be­comes per­ma­nent.

Right now, the rate con­trol med­i­cines giv­en in hos­pi­tals stop on­ly the no­tice­able symp­toms and can con­tribute to the pro­gres­sion of AF, Colón said. Where­as a rapid heart rate caus­es pal­pi­ta­tions, ar­rhyth­mia can lead to dizzi­ness and stroke if left un­treat­ed.

“It’s like re­boot­ing your com­put­er,” Colón said. “The sig­nals that gen­er­ate the atri­al fib­ril­la­tion are just not re­ceiv­ing the sig­nals to beat cor­rect­ly, it’s al­most like they’re get­ting scram­bled when they go in­to ar­rhyth­mia. When you treat them with an an­tiar­rhyth­mic, it re­sets the heart.”

Re­for­mu­lat­ing fle­cainide in­to an in­hal­able sub­stance proved to be a man­age­able task for In­Car­da’s founders, who Colón says are ex­perts in in­hala­tion and had pre­vi­ous­ly worked on cre­at­ing in­hal­able in­sulin treat­ments for di­a­betes. The drug, which has a nar­row ther­a­peu­tic win­dow, has fared well safe­ty-wise so far as it’s ab­sorbed quick­ly by the pul­monary vein and atri­um and then ex­punged be­fore it can get too tox­ic. Pa­tients tak­ing oral and IV fle­cainide most com­mon­ly ex­pe­ri­ence hy­poten­sion.

If all goes ac­cord­ing to plan, In­Car­da could launch the prod­uct in the med­ical­ly su­per­vised field as soon as 2023, Colón said. But she em­pha­sized that the com­pa­ny has to get through its tri­als first and fore­most.

“This is es­pe­cial­ly ex­cit­ing at a time when more and more pa­tients are us­ing mo­bile, wear­able and portable de­vices for their ar­rhyth­mia,” Colón said. “We feel that all of that ex­cite­ment and aware­ness that’s out there is great for pa­tients, how­ev­er they don’t have im­me­di­ate clin­i­cal util­i­ty, and that’s some­thing that we’ll be able to pro­vide.”

The top 100 bio­phar­ma VCs, Bob Brad­way places $2B bet in can­cer, gene edit­ing pi­o­neer's new big idea, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Before diving in, we had some news to share: Endpoints is launching a premium weekly report focusing on all things regulatory. Coverage will be led by our new senior editor, Zachary Brennan, who joins us from POLITICO. Arsalan Arif has more details in his Publisher’s Note.

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Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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UP­DAT­ED: Not 3 weeks af­ter tak­ing Hu­ma­cyte pub­lic, Ra­jiv Shuk­la launch­es an­oth­er blank check com­pa­ny

One of biotech’s earliest SPAC investors is back with another blank-check company, less than a month after his last effort announced its intent to merge.

Rajiv Shukla is intending to take a third lucky winner public with Alpha Healthcare Acquisition III, filing to go public Thursday with a $150 million raise penciled in. The move comes just a couple of weeks after Shukla’s second SPAC said it would jump to Nasdaq in tandem with Laura Niklason’s Humacyte in a $255 million new investment.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Bruce Cozadd, Jazz CEO (Jazz Pharmaceuticals)

Jazz CEO Bruce Cozadd cam­paigned for 6 months to buy GW Phar­ma. A 90% pre­mi­um sealed the deal — along with $17.6M in ‘re­ten­tion’ in­cen­tives

Jazz CEO Bruce Cozadd didn’t beat around the bush.

In his first video meeting with GW Pharma chief Justin Gover last July 8, he offered to pay $172 a share to get the company, which had beaten the odds in getting its remarkable cannabinoid drug Epidiolex across the regulatory finish line for epilepsy. GW’s stock closed at $129 that day.

Cozadd had already done his homework on the financing to make sure he could swing it the way he wanted. He just needed to do some due diligence before making the non-binding bid firm.

Paul Hudson, Getty Images

How does Paul Hud­son's $13.5M comp pack­age stack up against oth­er CEOs? He's in the 'first quar­tile'

Paul Hudson arrived at Sanofi like a hurricane, chopping off duds in the pipeline, shaking up the C-suite, striking big M&A deals and jumping into the Covid-19 vaccine race — all in an attempt to reboot a pharma giant notorious for its setbacks.

Now, we’re getting a look at what the CEO brought home in his first year on the job.

When all is said and done, Hudson will have made about $6.7 million in 2020, about $2.5 million of which has already been paid. The bigger figure includes a $2.3 million bonus that’s subject to approval at an April meeting, and another $1.8 million in variable compensation that has yet to be paid.

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An Ar­ray co-founder re-emerges as CEO of a small aca­d­e­m­ic spin­out, look­ing to re­make an old class of can­cer drugs

Tony Piscopio hadn’t worked as a bench scientist in years when, around 2011, he got put in touch with a team at the University of Colorado trying to revitalize an old approach to treating cancer.

Piscopio, who had co-founded Array Biopharma before heading to South Korea to launch a new company, was back in the states, unattached and intrigued. He founded a three-person company with two professors, Xuedong Liu and Gail Eckhardt, and while they worked on the biology side, he returned to his old chemist chair and began drawing up potential compounds on a computer, along with manufacturing processes to make them. Outsourcing companies synthesized or analyzed the results.

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Af­ter three years of courtship (and turn­downs), Mer­ck pounced on the first glance of clin­i­cal da­ta in $1.85B Pan­dion takeover

It’s almost become cliché for biotech executives to talk about the importance of keeping your options open and being prepared to go all the way. But when it comes to negotiating with a giant like Merck, a little patience can indeed go a long way.

Just ask Pandion Therapeutics.

Days ago we already learned that Merck is shelling out $1.85 billion to pick up the biotech and its slate of autoimmune hopefuls. What we didn’t know until the SEC disclosure dropped Thursday is that the deal comes after Pandion turned down two other proposals from Merck over the past three years and held out until the last minute for a sweetened deal.

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