J&J turns its back on Capri­cor and its failed stem cell tech, tak­ing its mon­ey and rep with it

A lit­tle more than three years ago, J&J stepped up with a $12.5 mil­lion up­front to rent a front row seat on Capri­cor Ther­a­peu­tics’ $CAPR Phase II stem cell study, look­ing to see if their off-the-shelf ap­proach could mend a dam­aged heart. At the time, CEO Lin­da Mar­bán told me that it was well worth the year-long re­view ef­fort need­ed to bring the phar­ma gi­ant to the ta­ble, look­ing to roll ahead with $325 mil­lion in mile­stones.

Lin­da Mar­bán

“It says, OK, some­body very large and pow­er­ful is tak­ing a look at this tech­nol­o­gy and say­ing there’s some­thing there, and that’s the most ex­cit­ing thing for me,” she not­ed.

Thurs­day evening, two months af­ter the biotech not­ed that their 142-pa­tient study was head­ed to fail­ure, J&J said they weren’t in­ter­est­ed. They washed their hands of the part­ner­ship, hand­ed back full rights, and walked away from the deal.

Capri­cor shares dropped more than 10% Fri­day morn­ing.

Capri­cor is left with a stock that has been ham­mered down to pen­ny stock size, look­ing to ral­ly in­vestors around a plan to shift fo­cus to Duchenne mus­cu­lar dy­s­tro­phy with a plan to use their stem cell tech to tamp down on the in­flam­ma­tion that wreaks hav­oc on boys. LA-based Capri­cor — which ini­tial­ly set out to test the po­ten­tial of tech­nol­o­gy Lin­da Mar­bán’s hus­band, Ed­uar­do Mar­bán, de­vel­oped at Johns Hop­kins — not­ed in May that it would be cut­ting its work force.

Even three years ago, it was clear that the big play­ers had a wan­ing in­ter­est in stem cells. Once the sub­ject of in­tense spec­u­la­tion, stem cells and the com­pa­nies that de­vel­op them have been shunt­ed aside as re­peat­ed stud­ies fell far short of ex­pec­ta­tions — par­tic­u­lar­ly in heart re­pair. The Cal­i­for­nia In­sti­tute for Re­gen­er­a­tive Med­i­cine, which pro­vid­ed sig­nif­i­cant sup­port to Capri­cor, has been left de­fend­ing a long track record with lit­tle to show for it. There has been some re­newed hope by Bay­er, a few Japan­ese play­ers, and some oth­ers, though, that the tech­nol­o­gy has pro­gressed to the point where the field can start to pro­duce suc­cess­es.

The CEO now says they can get start­ed with a Duchenne study in the sec­ond half. And Mar­bán isn’t giv­ing up. In a pre­pared state­ment, she said:

Al­though Janssen’s de­ci­sion re­moves a po­ten­tial cor­po­rate part­ner for Capri­cor, this de­ci­sion al­so re­solves un­cer­tain­ty con­cern­ing the scope of the li­cense for CAP-1002 and pro­vides Capri­cor the free­dom to en­ter in­to new li­cens­ing and/or busi­ness de­vel­op­ment op­por­tu­ni­ties around this promis­ing ther­a­peu­tic can­di­date.

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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