Po­sei­da pitch­es a $115M IPO on its claim that the sci­ence team has cre­at­ed a bet­ter BC­MA CAR-T

Is there enough en­thu­si­asm among biotech in­vestors to push through a $115 mil­lion-plus IPO on the lat­est biotech stak­ing out their claim with a new-and-im­proved BC­MA CAR-T ther­a­py?

Po­sei­da Ther­a­peu­tics is aim­ing to find that out in the very near fu­ture.

Er­ic Os­tertag

The San Diego-based biotech filed their S-1 on a busy Fri­day, just ahead of the big JP­Mor­gan con­fab that gets un­der­way Mon­day morn­ing in San Fran­cis­co. In it, they lay out an ear­ly snap­shot on Phase I da­ta for P-BC­MA-101 tar­get­ing mul­ti­ple myelo­ma — a fa­mil­iar tar­get in the CAR-T world these days.

Ac­cord­ing to the fil­ing, re­searchers have tracked 14 clin­i­cal re­spons­es among the first 19 pa­tients in their first hu­man study. And they in­clud­ed in that ORR every sign of ac­tiv­i­ty, from a com­plete re­sponse all the way through to a “min­i­mal re­sponse.” They al­so flagged CRs in 3 of 3 pa­tients get­ting the dose they plan to take in­to Phase II. And they down­played some se­ri­ous ad­verse events as like­ly linked to lym­phode­ple­tion, used to prep pa­tients for the drug.

The Phase II gets un­der­way in the first half of this year, and they’re plan­ning to push for an ac­cel­er­at­ed ap­proval on that study. No, the FDA has not signed off on that plan, but it wouldn’t be wild­ly un­rea­son­able to ex­pect that they might.

The rest of the pipeline is pre­clin­i­cal.

The way the orig­i­nal CAR-T works is pret­ty sim­ple. You take a pa­tient’s cell and adapt it, adding chimeric anti­gen re­cep­tors to di­rect T cells to can­cer. Po­sei­da is sell­ing its IPO on the as­ser­tion that they’ve de­vel­oped bet­ter tech to do the same job, us­ing a DNA mod­i­fi­ca­tion sys­tem that they say will se­lect more mem­o­ry T cells to do the work, which should make them more durable.

That’s the pitch, but they haven’t proved it yet.

Po­sei­da is rolling ahead in­to a tur­bu­lent stock mar­ket, where con­cerns about an eco­nom­ic slow­down and a trade war with Chi­na have tak­en a heavy toll on tech stocks. An­oth­er big con­cern: Mod­er­na $MR­NA was not able to hold on to its lofty mar­ket val­u­a­tion af­ter go­ing pub­lic, rais­ing con­cerns that in­vestors have grown tired of see­ing too many biotechs with too lit­tle da­ta to back up these of­fer­ings.

That en­vi­ron­ment will make this IPO and oth­ers filed re­cent­ly ones to watch.

Ma­lin Life Sci­ences out of Ire­land has the biggest stake in the biotech, at 33%. CEO Er­ic Os­tertag’s trust holds 15% while Ti­tan LLC has 13.6% of the stock and Lon­gi­tude Ven­ture Part­ners III holds 7.7%.

Os­tertag’s back­ground in­cludes found­ing Trans­posagen, based in Lex­ing­ton, KY. That com­pa­ny has been work­ing with gene edit­ing tech and cell reengi­neer­ing for year. Po­sei­da is a spin­out of that com­pa­ny, us­ing much the same tech, with an eye to de­vel­op­ing off-the-shelf cell ther­a­pies as well.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

Zachary Hornby. Boundless

'A fourth rev­o­lu­tion in can­cer ther­a­pies': ARCH-backed Bound­less Bio flash­es big check, makes big­ger promis­es in de­but

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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