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.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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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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Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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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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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

Overnight for­tunes are be­ing made in biotech these days — and it's both en­cour­ag­ing and more than a lit­tle bit scary

Just to complete the last leg of a running story I’ve been tracking for a few weeks, Olema $OLMA has come through its IPO from the Thursday night pricing at $19 a share with a market cap just north of $2 billion.

That leaves newly-named CEO Sean Bohen holding a batch of 1,110,896 shares with a strike price of $4.82. As of Tuesday morning, the stock is now trading at $53.40, giving him a portfolio value of $53.4 million. Not bad for someone who was hired in September.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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