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.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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Michael Rome (Foresite)

In search of 'house­hold health­care brands of the fu­ture,' Fore­site Cap­i­tal rais­es $969M to sa­ti­ate a tech-heavy ap­petite

Back in April 2018, just before Foresite Capital unveiled its $668 million Fund IV and a strategy to focus on tech-driven life science bets, one of its portfolio companies quietly made an announcement.

Fount Therapeutics, a drug discovery outfit backed by Foresite and Eshelman Ventures, had raised $22 million in Series A cash to hatch several fledgling spinouts. “The first ‘NewCo,’ Kinnate, will be focused on developing precision oncology treatments,” read a press release.

S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Masayoshi Son, SoftBank CEO (glen photo/Shutterstock)

Japan's Soft­Bank plots bil­lions in biotech in­vest­ments in move that could keep the val­u­a­tion flood ris­ing — re­port

The valuation crazy train in biotech continues to roll into the new year with more than a dozen companies taking a chance on Nasdaq and money flowing in from all sides. Now, a Japanese institutional investor is reportedly weighing an entry into the market in a big way — will it keep the bitcoin-esque flood rising?

Already a part-time investor in biotech, SoftBank could drop billions of dollars into the industry as part of helmsman Masayoshi Son’s plan to spend around $80 billion of the firm’s own assets, according to a report from Bloomberg citing people familiar with the plan.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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