Jason O'Neill, Dendreon CEO

Years af­ter bank­rupt­cy, Den­dreon adds a con­tract man­u­fac­tur­ing wing

When CEO Ja­son O’Neill came aboard Den­dreon just a year ago, he saw that the com­pa­ny was in a unique po­si­tion: It oc­cu­pied a rare space as one of the few end-to-end providers of cell ther­a­py man­u­fac­tur­ing ser­vices. And if it were to add a di­vi­sion of con­tract man­u­fac­tur­ing arm to its op­er­a­tions, it would po­si­tion it­self as one of just four US com­pa­nies that are do­ing so.

So with that, the Seal Beach, Cal­i­for­nia-based bio­phar­ma com­pa­ny has es­tab­lished a con­tract man­u­fac­tur­ing and ser­vices di­vi­sion to bring late-stage clin­i­cal projects through to the mar­ket.

“We have this unique kind of abil­i­ty, an as­set with­in our com­pa­ny, and so we ex­plored it more deeply and re­al­ized ‘hey, we can do it,’ he said in a call with End­points News.

Not much will change phys­i­cal­ly about its two man­u­fac­tur­ing sites in Seal Beach and Seat­tle. Just the ad­di­tion of end-to-end man­u­fac­tur­ing of cell ther­a­pies and pa­tient lo­gis­tics for part­ner pro­grams.

Among Den­dreon’s clients, the pro­pos­al was over­whelm­ing­ly pos­i­tive, O’Neill said. But per­haps just as im­por­tant­ly, ven­ture cap­i­tal­ist part­ners are equal­ly as re­cep­tive to the idea, large­ly be­cause a large amount of mon­ey to build a man­u­fac­tur­ing site will not be need­ed be­fore the drug has even been ap­proved.

“It’s, for a lot of these guys, a great op­por­tu­ni­ty to de-risk what they’re do­ing and bring out a part­ner that ac­tu­al­ly has the cred­i­bil­i­ty to move the prod­uct through the FDA,” he said.

O’Neill was tabbed as the CEO in June 2020. His ré­sumé boasts a long list of phar­ma pow­er­hous­es, from Pfiz­er to Scher­ing-Plough and Bris­tol My­ers Squibb. In the 1990s, O’Neill spent near­ly 10 years at Sanofi, stopped briefly at Genen­tech, be­fore head­ing the im­munol­o­gy and oph­thal­mol­o­gy at Roche.

The com­pa­ny’s flag­ship prod­uct is Provenge, a ther­a­peu­tic vac­cine for prostate can­cer that us­es a pa­tient’s own im­mune cells. It has been pre­scribed to more than 40,000 men in the US since its ap­proval in 2010.

The com­pa­ny has come a long way back since fil­ing for bank­rupt­cy in 2014. When it launched Provenge, it faced trou­ble re­ceiv­ing re­im­burse­ments for the drug and had pumped mon­ey in­to a gi­gan­tic man­u­fac­tur­ing space be­cause it an­tic­i­pat­ed more de­mand than was the re­al­i­ty. A 2014 ar­ti­cle in Na­ture called the drug man­u­fac­tur­ing process “cum­ber­some” and ex­pen­sive at $93,000. Sales of the drug were just $283.7 mil­lion in 2013, far short of a pro­ject­ed $4.3 bil­lion in an­nu­al sales by 2020.

“It’s kind of a nice con­clu­sion to a rocky start for us,” O’Neill said.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,500+ biopharma pros reading Endpoints daily — and it's free.

Tadataka Yamada (Photographer: Kiyoshi Ota/Bloomberg via Getty Images)

Sci­ence pi­o­neer, phar­ma re­search chief, glob­al health ad­vo­cate and biotech en­tre­pre­neur Tadata­ka ‘Tachi’ Ya­ma­da has died

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

Thomas Lingelbach, Valneva CEO

A small vac­cine de­vel­op­er fa­vored by the UK gov­ern­ment in Covid-19 touts a PhI­II first in chikun­gun­ya

Before Valneva garnered the favor of the UK government as a potential supplier of Covid-19 vaccines, the French biotech prided itself on being the first company to bring a chikungunya vaccine into Phase III.

It now has positive pivotal results to back up the breakthrough therapy designation the FDA granted just weeks ago.

There are currently no approved jabs to prevent chikungunya virus infection despite decades of R&D efforts, a fact that underscores just how arduous traditional vaccine development can be, particularly for neglected tropical disease. In a absence of a major commercial market, the US government and NGOs such as CEPI have deployed various grants and incentives to spur on a small crew of academics and industry players, with Merck, via its acquisition of Themis, claiming a spot in that race.

Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,500+ biopharma pros reading Endpoints daily — and it's free.

Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

Zymer­gen's sud­den im­plo­sion shocked biotech. A lin­ger­ing loan could make things even worse

As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising efforts — could make the situation worse, according to public documents.

In December 2019, more than a year before Zymergen filed for what would eventually become a $500 million IPO, the “biofacturing” firm signed a $100 million credit facility with Perceptive to help supplement the nearly $700 million the company had raised across four VC rounds.

Am­gen adds new NC plant to the list as part of $1B man­u­fac­tur­ing ex­pan­sion plans state­side

What can $1 billion buy? If you’re Amgen, it’s good for two manufacturing facilities in the US.

The California-based drug giant will invest close to $550 million in a drug substance plant in Holly Springs, NC, adding itself to an ever-growing list of biotech companies that have decided to call North Carolina home, and marking its second drug manufacturing announcement in a little more than a month.

Bio­gen, Ei­sai are push­ing for an­oth­er ac­cel­er­at­ed Alzheimer's OK — this time for BAN2401

Now that the door at the FDA has been opened wide for Alzheimer’s drugs that can demonstrate a reduction in amyloid, Biogen and its partners at Eisai are pushing for a quick OK on the next drug to follow in the controversial path of aducanumab.

In a presentation to analysts, Eisai neurology chief Ivan Cheung outlined some bullish expectations for their newly-approved treatment and set the stage for what he believes will be a fast follow for BAN2401 (lecanemab) — after a dry spell in new drug development that’s lasted close to 20 years.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,500+ biopharma pros reading Endpoints daily — and it's free.

Jeffrey Bluestone, Sonoma CEO (Photo credit: Steve Babuljak)

Jeff Blue­stone just raised $265M to de­vel­op cu­ra­tive cell ther­a­pies. We asked him how

Jeff Bluestone had some big goals in mind when he decided to make a switch from a decades-long career in academia and non-profit research to a biotech startup CEO. And now — 18 months after the $40 million launch party — he has a whole lot more money on hand to pay for the considerable amount of work ahead at Sonoma Biotherapeutics.

This morning Bluestone is taking the wraps off a $265 million B round after boosting the core syndicate of A-list investors he started with. Even by today’s standards, that sum dwarfs the kind of $100 million-plus megarounds that have become standard fare in biotech over the last 2 years.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.