Grace Colón, InCarda CEO

With its eyes set on an IPO raise, In­Car­da un­rolls mid-stage da­ta back­ing in­haled ar­rhyth­mia drug

Work­ing to craft an old ar­ry­th­mia drug in­to a more user-friend­ly in­haled for­mu­la­tion, In­Car­da is ex­pect­ing to use new Phase II da­ta re­vealed Wednes­day as the foun­da­tion of a po­ten­tial IPO raise.

The pro­gram, re­pur­pos­ing the oral and IV drug fle­cainide in­to an in­halant, com­plet­ed the lat­est co­hort of its Phase II study with 50% of pa­tients suc­cess­ful­ly con­vert­ing their ir­reg­u­lar heart­beat episodes back to nor­mal rhythm with­in 90 min­utes, the San Fran­cis­co biotech said. That end­point will be the pri­ma­ry goal in a piv­otal Phase III study, ex­pect­ed to be­gin by the end of Sep­tem­ber.

And In­Car­da be­lieves the da­ta are strong enough to get a pos­si­ble IPO ready, as the biotech hired a CFO in con­junc­tion with the news. CEO Grace Colón told End­points News that In­Car­da is in the midst of rais­ing funds for a $70 mil­lion crossover round, and will ex­plore a jump to Nas­daq “should it make sense.”

So far in 2021, 65 biotechs have filed or priced their IPOs, ac­cord­ing to the End­points tal­ly.

Wednes­day’s da­ta come from a study eval­u­at­ing the fle­cainide neb­u­liz­er in a med­ical­ly su­per­vised set­ting, look­ing at in­di­vid­u­als with re­cent-on­set parox­ys­mal atri­al fib­ril­la­tion, or PAF. Pa­tients have been clam­or­ing for new treat­ments, Colón said, be­cause they typ­i­cal­ly re­ceive rate-con­trol­ling treat­ments in emer­gency rooms or oth­er set­tings when they ex­pe­ri­ence PAF episodes, rather than rhythm-con­trol­ling drugs.

“Things with high heart rate like 120 to 160 beats per minute, that’s just fast heart rate pal­pi­ta­tions,” Colón told End­points. “But they al­so ex­pe­ri­ence skipped beats and dizzi­ness, like they can’t breathe. When their heart is not beat­ing nor­mal­ly, they can get se­vere anx­i­ety. It’s a spe­cif­ic type of symp­toms.”

The on­ly cur­rent­ly ap­proved drug to treat these episodes, in­tra­venous ibu­tilide, on­ly has a 90-minute con­ver­sa­tion rate of 38% to 40%, In­Car­da says. Not on­ly did In­Car­da’s pro­gram hit the 50% mark in the Phase II study, but Colón said the mean time of con­ver­sion was just eight min­utes.

Ad­di­tion­al­ly, 72% of those whose heart­beats re­turned to nor­mal rhythm did so with­in the first half hour af­ter treat­ment.

Colón ex­pects much of the new crossover to be di­rect­ed to­ward the Phase III study, which is seek­ing to en­roll 400 pa­tients. Re­searchers are plan­ning to ran­dom­ize pa­tients to the drug arm at a 3-to-1 ra­tio with that 90-minute con­ver­sion rate as the pri­ma­ry, and will al­so check out a host of sec­ondary end­points such as re­lief of symp­toms, hos­pi­tal­iza­tions and time to dis­charge, among oth­ers.

In­Car­da is al­so con­duct­ing stud­ies for the drug in a self-ad­min­is­tered set­ting, with a cur­rent­ly on­go­ing Phase II, and is work­ing on a tri­al for re­peat use. Ini­tial ob­ser­va­tions in­di­cate that pa­tients who re­spond to their first use of the can­di­date be­come “very like­ly” to have a sec­ond re­sponse should an­oth­er episode pop up, Colón said.

There’s been lots of cul­tur­al aware­ness around this is­sue, she added, help­ing dri­ve In­Car­da’s re­search for­ward. Heart rate and rhythm track­ing tech­nol­o­gy has sprout­ed up every­where in wear­able prod­ucts like the Ap­ple Watch, mak­ing it even eas­i­er for pa­tients to keep track of their PAF episodes. In­Car­da has had ear­ly dis­cus­sions with com­pa­nies de­vel­op­ing some of these prod­ucts and will con­tin­ue look­ing for a part­ner should the piv­otal tri­al work out.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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Alan Hirzel, Abcam

Drug sup­pli­er Ab­cam brings a long­time col­lab­o­ra­tor in house as part of $340M buy­out pact

BioVision has supplied Abcam with research tools since 1999, and now the two are making it official as part of a merger unveiled Monday.

Abcam will buyout BioVision as part of a $340 million acquisition deal to bring aboard the supplier’s biochemical and cell-based assays for biological research, as well as recombinant proteins, antibodies and enzymes.

The deal will give Abcam control of BioVision’s portfolio and allow for both the expansion of research existing areas of focus such as oncology, neuroscience and epigenetics and preparation to expand into new products. As a part of the deal, Abcam will develop and supply products and services to NKY, the previous owner of BioVision and receive support for ongoing development and commercialization of in vitro diagnostic products.

Tib­so­vo clears an­oth­er hur­dle for Servi­er, but can it make Agios' old drug prof­itable?

When European regulators saw the data Agios used to win US approval for their AML drug Tibsovo, they sent the more than decade-old biotech back to the drawing board. A single, single-armed trial was not going to cut it.

On Monday, though, the drug’s new owners announced it had cleared a more rigorous study. In a randomized, Phase III trial of certain newly diagnosed patients, those who received a combination of Tibsovo and chemotherapy lived longer than those who received a combination of placebo and chemotherapy. Those patients also had higher response rates and complete remission rates.

UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; 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.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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