Can Den­dreon’s new Provenge da­ta help ig­nite a turn­around for the fad­ed can­cer star?

Two years ago, when Valeant bought Den­dreon and its prostate can­cer cell ther­a­py Provenge out of bank­rupt­cy for $400 mil­lion, ob­servers marked it as an­oth­er step down a long and bumpy spi­ral for a treat­ment that had once been cel­e­brat­ed as a his­toric break­through. Valeant was the sole bid­der and a bad match.

Then CEO J. Michael Pear­son called the ac­qui­si­tion an ef­fec­tive way to launch Valeant in­to the can­cer field — but Pear­son wasn’t head­ed any­where. A year lat­er, the CEO was out the door and Valeant was in ut­ter dis­ar­ray as its busi­ness mod­el of buy­ing drugs and jack­ing the price be­came a ra­dioac­tive source of con­tro­ver­sy.

Provenge, though, has sur­vived the lat­est chap­ter of its trou­bled his­to­ry. A Chi­nese com­pa­ny, San­pow­er Group, struck a deal to buy the cell ther­a­py — built from cells ex­tract­ed from pa­tients — for $820 mil­lion, look­ing to pen­e­trate the huge Chi­nese can­cer drug mar­ket.  And the ex­ec­u­tive crew that runs Den­dreon re­leased new “re­al world” da­ta over the week­end to un­der­score its ef­fec­tive­ness among African-Amer­i­can men, push­ing to ex­pand the mar­ket and aware­ness for a drug that had been eclipsed by Xtan­di and Zyti­ga.

When the FDA ap­proved Provenge 7 years ago, it re­quired Den­dreon to set up a pa­tient reg­istry to track its im­pact. And now Den­dreon, look­ing to stage a come­back, has post­ed some of the new da­ta they’ve drawn from the reg­istry to un­der­score its po­ten­tial for a sub­set of African-Amer­i­can pa­tients primed to de­liv­er the best out­comes.

Com­par­ing African-Amer­i­cans and whites with sim­i­lar base­line char­ac­ter­is­tics, Den­dreon notes that they tracked an over­all sur­vival ben­e­fit of 9.3 months com­pared with Cau­casians (37.3 months vs 28.0 months, re­spec­tive­ly). And if you re­strict to pa­tients with PSA lev­els be­low me­di­an amounts, “African-Amer­i­can pa­tients demon­strat­ed an ad­di­tion­al OS ben­e­fit of near­ly two ad­di­tion­al years (20.9 months) com­pared with Cau­casian pa­tients (54.3 months vs. 33.4 months, re­spec­tive­ly).”

The da­ta were pre­sent­ed over the week­end at the 112th Amer­i­can Uro­log­i­cal As­so­ci­a­tion An­nu­al Meet­ing in Boston by lead au­thor A. Oliv­er Sar­tor.

Jim Caggiano

Jim Caggiano, pres­i­dent of Den­dreon, says the da­ta un­der­score the val­ue of us­ing Provenge at an ear­ly stage of the dis­ease, par­tic­u­lar­ly among African-Amer­i­can men who suf­fer from a sig­nif­i­cant­ly high­er risk of death from prostate can­cer.

“Den­dreon is back and bet­ter than ever,” Caggiano told me ahead of the da­ta re­view. “These find­ings are im­por­tant for all men.”

These new da­ta mark a big step to­ward ex­pand­ing the mar­ket for Provenge, says Caggiano, who was orig­i­nal­ly hired in­to Den­dreon by for­mer CEO Mitch Gold back in 2004 as the head of its sales ef­fort.

Gold, now back at work as a biotech en­tre­pre­neur, al­so out­lined some huge sales fore­casts that caused quick and painful trou­ble for Den­dreon. With new, more eas­i­ly ad­min­is­tered drugs ri­val­ing Provenge, the au­tol­o­gous cell ther­a­py nev­er had a chance to com­pare well.

Caggiano, though, says that the drug is be­ing used by a grow­ing group of pa­tients. Last year about 4,000 men were treat­ed with Provenge, he says, up from about 3,500. And San­pow­er’s will­ing­ness to pay more than twice what Valeant need­ed to pluck it out of bank­rupt­cy un­der­scores the grow­ing at­trac­tion.

San­pow­er should com­plete the buy­out soon, says Caggiano, and that will set the stage for new stud­ies to test Provenge with surgery and ra­di­a­tion, look­ing for ev­i­dence that an ag­gres­sive com­bi­na­tion can be cu­ra­tive.

Provenge is a long way from dy­ing out, says the Den­dreon pres­i­dent with all the en­thu­si­asm of a head cheer­leader. And he in­tends to try. But not every­one at the meet­ing was im­pressed.


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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,900+ biopharma pros reading Endpoints daily — and it's free.

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.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,900+ biopharma pros reading Endpoints daily — and it's free.

Mer­ck helps bankroll new part­ner Themis' game plan to fin­ish the chikun­gun­ya race and be­gin on­colyt­ic virus quest

As Themis gears up for a Phase III trial of its chikungunya vaccine, the Vienna-based biotech has closed out €40 million ($44 million) to foot the clinical and manufacturing bills.

Its heavyweight partners at Merck — which signed a pact around a mysterious “blockbuster indication” last month — jumped into the Series D, led by new investors Farallon Capital and Hadean Ventures. Adjuvant Capital also joined, as did current investors Global Health Investment Fund, aws Gruenderfonds, Omnes Capital, Ventech and Wellington Partners Life Sciences.