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.”

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Peter Thiel (Riccardo Savi/Sipa via AP Images)

Tech bil­lion­aire Pe­ter Thiel backs a lead­ing psy­che­del­ic drug de­vel­op­er

Right on the heels of investing in antibody drug developer AbCellera, Facebook billionaire Peter Thiel has jumped into a syndicate putting up $125 million for a company with a portfolio of psychedelic drugs in the clinic for mental health.

The C round — which includes a $32 million conversion of notes to equity — will fuel the development programs at ATAI Life Sciences, a Berlin-based biotech that has assembled a portfolio of companies with psychedelic and non-psychedilc approaches to depression, anxiety and addiction.

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Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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Vipin Suri, Catamaran Bio CSO

Cata­ma­ran Bio sails in­to the CAR-NK wa­ters with a $42M launch round

Catamaran Bio’s founding members decided to jump into the CAR-NK game last December over drinks at a trendy bar in Boston.

They were sitting around a table, discussing an MD Anderson study which provided some of the first clinical proof that natural killer (NK) cells can be reengineered to attack tumors, much like CAR-T therapies. It was a “long and lively” discussion, COO Mark Boshar recalls. And by the time it was over, they had a starting point to launch a company.

Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

Simeon George, SR One CEO (SR One)

Scoop: SR One crew com­pletes a com­pli­cat­ed spin­out from Glax­o­SmithK­line. And now they have a $500M fund to in­vest on their own

It’s taken close to 2 years, but Simeon George and his team at SR One have completed their spinout from GlaxoSmithKline, ending a saga as one of the longest running venture arms of Big Pharma as they go out on their own to forge the next chapter with a new and independent $500 million fund.

GSK is sticking with the spinout, this time as a minority investor — though a big one. And I’m told that the R&D group at GSK will remain involved in evaluating their new plays, helping with the scientific due diligence involved in scouting the world for new opportunities during a period of explosive growth in biotech investing.

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