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.

Daniel O'Day [via AP Images]

UP­DAT­ED: Look­ing to re­solve lin­ger­ing doubts, Gilead un­leash­es a $5B late-stage cash al­liance with Gala­pa­gos

Daniel O’Day is executing his first major development deal since taking over as CEO of Gilead $GILD. And he’s going in deep to ally himself with a longstanding partner.

O’Day announced today that he is spending $5 billion in cash to add new late-stage drugs to Gilead’s pipeline, picking up rights to Galapagos’ $GLPG Phase III IPF drug GLPG1690 alongside adoption of the biotech’s Phase IIb drug GLPG1972 for osteoarthritis. And Gilead is also putting billions more on the table for milestones, gaining options for everything else in Galapagos’ pipeline, with a shot at all rights outside of Europe.

UP­DAT­ED: Am­gen, No­var­tis scrap Alzheimer's stud­ies — is BACE fi­nal­ly dead or will Bio­gen and Ei­sai car­ry on?

The BACE theory of controlling Alzheimer’s died with failed pivotal projects at Merck, Eli Lilly and their partners at AstraZeneca. Now Amgen and Novartis have come along to bulldoze it under a mound of safety threats — leaving only Biogen and Eisai to carry on with a less than zero chance of success — with the notable addition that they may actually be doing harm to patients.

After the market closed Thursday, Amgen and Novartis announced that they were dumping two pivotal programs underway with the Banner Alzheimer’s Institute on their BACE drug CNP520 (umibecestat) after an independent review of the data indicated that patients’ cognitive abilities were actually worsening at a faster pace than the placebo arm.

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Christi Shaw at JP Morgan 2019. Jeff Rumans for Endpoints News

Fresh out of Eli Lil­ly, Christi Shaw sur­faces as Daniel O'­Day's new CEO at CAR-T pi­o­neer Kite

Well, that didn’t take long. 

We found out Thursday evening that Christi Shaw has given up her top post as the head of the Bio-Medicines group at Eli Lilly for the helm at CAR-T pioneer Kite. New Gilead CEO Daniel O’Day, a Roche veteran, had made finding a Kite CEO a top priority on his arrival at Gilead. And he went right for a headliner.

O’Day was clearly excited about the coup.

“We conducted an extensive search for a new leader at Kite and we believe that Christi’s unique set of skills will allow us to continue to build on our leadership position in cell therapy,” he said in a prepared statement. “Christi’s vast experience across complex therapeutic areas, and particularly in oncology, will serve Kite very well. She is clearly a leader who will bring teams and individuals together and I am confident she will build upon the entrepreneurial spirit at Kite as we seek to help more people with cancer around the world.”

Christi Shaw at JP Morgan 2019. Jeff Rumans for Endpoints News

Eli Lil­ly's Christi Shaw bows out of top post at the Bio-Med­i­cines unit

Less than 3 years after Eli Lilly CEO David Ricks recruited Novartis vet Christi Shaw to run their big Bio-Medicines business, she’s out.

In a statement put out Thursday morning, Lilly said that Shaw’s last day will come at the end of August. Patrik Jonsson, currently president and general manager of Lilly Japan, will succeed Shaw once he gets the paperwork sorted out.

Lilly’s shares dropped 4% on the news.

Jeff Poulton

Al­ny­lam’s Maraganore switch­es ‘per­haps the best CFO in mid-cap biotech’ with Shire vet Jeff Poul­ton

There’s a new CFO taking charge of the numbers at RNAi pioneer Alnylam.

Alnylam chief John Maraganore says that CFO Manmeet S. Soni is leaving in the proverbial pursuit of new opportunities. And he’s being replaced by ex-Shire CFO Jeff Poulton, not long after the Takeda takeover obliterated that position.

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Analy­sis: In most of the Big Phar­ma world, R&D spend­ing tow­ers over rev­enue from new drugs. Guess who beat the odds

It’s always been the case that there’s no medicine less useful than one that doesn’t make it to patients (unless you regard the task of R&D to be perpetually learning about swimming, while under water…). Yet, launching new medicines that physicians want, that payers will cover, and that patients will take, is a discipline that is unevenly distributed among the big players.

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President Donald Trump at State of the Union. AP Images

White House changes course to kill re­bate re­form

So what exactly is the White House’s plan to tackle rising drug prices? It doesn’t look like we will get definitive answers anytime soon. On the heels of President Donald Trump’s surprise revelation that an executive order is in the works to implement a “favored nations clause,” his administration is now putting out word that it has abandoned an earlier proposal to overhaul rebates.

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The FDA's Janet Wood­cock talks about some big changes she's push­ing for in drug de­vel­op­ment, and agency re­views

Janet Woodcock is perhaps the most influential regulator at the FDA. And when the head of CDER talks about the changes being made at the agency when it comes to clinical trial designs, or the need to reorganize for a specific disease arena, an assessment of the expansion of gene therapy or I/O, common development mistakes, and so on, you can be sure the industry pays attention to every word.

So it was with some eagerness that I opened up Geoffrey Porges’ summary of their recent conversation about the FDA. And I wasn’t disappointed. In a wide-ranging exchange with the SVB Leerink analyst, Woodcock discussed the growing importance of patient-reported outcomes in clinical trials, a campaign underway now to see if CROs would help spur more basket studies to compare drugs head-to-head, and much, much more.

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Ex-DARPA di­rec­tor pur­sues all-in-one can­cer pill as NED CEO; Karyopharm los­es com­mer­cial chief ahead of drug roll­out

“Why not try?”

That’s what Geoffrey Ling told me over the phone when asked about what led him to his journey to the position of CEO at NED Biosciences — a company with a lofty goal of creating an all-in-one oral drug to treat all types of cancer and making this drug available to not only developed nations, but also the developing world. 

Ling comes from an extensive background in medicine and the government. He is the co-leader of The Brain Health Project, a professor of neurology and an attending neurocritical care physician at John Hopkins University and Hospital, as well as the assistant director for Medical Innovation of the Science Division in president Obama’s White House Office of Science and Technology Policy (OSTP).