Iso­Plex­is aims to steer its 'bar­codes' to Nas­daq as Asia-fo­cused SPAC launch­es merg­er ef­forts

The biotech IPO train con­tin­ues steadi­ly chug­ging along, with a new pas­sen­ger punch­ing their tick­et late Tues­day.

Bran­ford, CT-based Iso­Plex­is is jump­ing aboard, sub­mit­ting its SEC pa­per­work with a $100 mil­lion ask pen­ciled in and aim­ing to bring its per­son­al­ized pro­tein “bar­codes” to Nas­daq. Tues­day’s S-1 comes a lit­tle over six months af­ter Iso­Plex­is nabbed a $135 mil­lion Se­ries D led by Per­cep­tive.

The fil­ing marks the lat­est in a long string of biotechs that joined the Nas­daq par­ty this year, and one Nas­daq of­fi­cial Jor­dan Saxe ex­pects to con­tin­ue. In a con­ver­sa­tion with End­points News ear­li­er this month, Saxe said the in­dex is in dis­cus­sions with about 250 biotechs aim­ing to list over the next year and a half.

Iso­Plex­is is charg­ing ahead with its plan to per­son­al­ize can­cer treat­ment us­ing its sin­gle-cell analy­sis tool to re­fine im­munother­a­pies. That tool has helped re­searchers cre­ate what the com­pa­ny calls “pro­teom­ic bar­code chips,” al­low­ing clos­er ex­am­i­na­tion of a pa­tient’s com­ple­ment of pro­teins with­in cells.

Though Iso­Plex­is is fo­cus­ing on can­cer right now, they have am­bi­tions to ex­pand in­to in­fec­tious dis­eases, in­flam­ma­to­ry con­di­tions and neu­ro­log­i­cal dis­eases, the S-1 said. The com­pa­ny be­lieves the sin­gle-cell ap­proach is key here, as it ar­gues pre­vi­ous pro­teomics ap­proach­es fo­cus on­ly on av­er­age cell ac­tiv­i­ty in the ag­gre­gate.

Sean Mack­ay

Re­searchers uti­lize Iso­Plex­is’ sys­tems for the analy­sis of func­tion­al pro­teins from sin­gle cells on “pro­teom­i­cal­ly bar­cod­ed” chips. Af­ter the chip is run on the Iso­Plex­is in­stru­ment, the com­pa­ny runs it through a soft­ware it de­vel­oped to an­a­lyze how a per­son’s im­mune sys­tem might re­spond to dif­fer­ent treat­ments, in a process CEO Sean Mack­ay termed “sin­gle-cell im­mune land­scap­ing” in an in­ter­view with End­points in Jan­u­ary.

Iso­Plex­is did not re­veal its plans on how it ex­pects to use IPO funds, say­ing on­ly in the S-1, “At this time we can­not spec­i­fy with cer­tain­ty the par­tic­u­lar us­es for the net pro­ceeds from this of­fer­ing.” The biotech fur­ther didn’t re­veal how much of the com­pa­ny each stake­hold­er owns, though it did say Mack­ay is the high­est-paid di­rec­tor af­ter he took home near­ly $1 mil­lion last year.

$50M Asia-fo­cused SPAC files for Nas­daq list­ing

Tues­day al­so saw the for­ma­tion of a new blank check com­pa­ny tar­get­ing the biotech sec­tor.

The SPAC comes from the CEO of phar­ma VC firm The Bal­loch Group, Ed­ward Wang. Wang plans to fo­cus ac­qui­si­tion ef­forts on a com­pa­ny based in Asia, and is pen­cil­ing in $50 mil­lion for the blank check raise.

In ad­di­tion to biotech, Wang not­ed he is al­so ex­plor­ing a merg­er with a com­pa­ny in the new en­er­gy and ed­u­ca­tion sec­tors. Cur­rent plans will cen­ter around a com­pa­ny val­ued be­tween $150 mil­lion and $300 mil­lion.

Ac­cord­ing to the S-1, the SPAC has con­nec­tions to a for­mer Chi­nese youth trav­el di­rec­tor, as CFO Yi Zhong served in this ca­pac­i­ty for 16 months be­tween 2016 and 2017. An­oth­er di­rec­tor, Ray­mond Gibbs, al­so spent time in the con­sumer goods in­dus­try.

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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Anthony Sun, Zentalis and Zentera CEO (Zentalis)

With clin­i­cal tri­als lined up for Zen­tal­is drugs, Chi­na's Zen­tera sets its sights on more deal­mak­ing and an IPO

As Zentalis geared up for an AACR presentation of early data on its WEE1 inhibitor earlier this year, its Chinese joint venture Zentera wasn’t idle, either.

Zentera, which has headquarters in Shanghai, had already nabbed clearance to start clinical trials in China for three of the parent company’s drugs. In May — just a month after Zentalis touted three “exceptional responses” out of 55 patients for their shared lead drug, ZN-c3 — it got a fourth CTA approval.

Thomas Soloway, T-knife CEO

What hap­pens when you give a mouse a hu­man self-anti­gen? In­vestors bet $110M to find out

T-knife Therapeutics launched last August on a mission to isolate T cell receptors not from human donors, but from mice. Now, with a new CEO and a candidate bound for the clinic, the Versant-backed company is reloading with a fresh $110 million.

“What we are trying to do for the field of TCR therapy and solid tumor therapy is very analogous to what the murine platforms have done in antibody development,” CEO Thomas Soloway told Endpoints News. 

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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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