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.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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