Kevin Boyle, Ziopharm Oncology CEO

UP­DAT­ED: Zio­pharm lays off half its staff af­ter man­u­fac­tur­ing is­sues force de­lays

New Zio­pharm CEO Kevin Boyle has on­ly been at the biotech for less than a month, but he’s al­ready en­gi­neer­ing ma­jor changes.

Late Mon­day af­ter­noon, Zio­pharm an­nounced a sweep­ing re­struc­tur­ing that in­volved elim­i­nat­ing more than half its work­force and 60 jobs in to­tal. The lay­offs were nec­es­sary to help the pen­ny stock play­er re­fo­cus its at­ten­tion on ad­vanc­ing its TCR pro­gram, which saw a set­back ear­li­er this year af­ter “un­fore­seen de­lays” at a con­tract man­u­fac­tur­er, Zio­pharm said.

“We ap­pre­ci­ate the many con­tri­bu­tions the im­pact­ed em­ploy­ees made to Zio­pharm and we com­mit to sup­port­ing these val­ued col­leagues dur­ing this tran­si­tion,” Boyle said in a state­ment.

In a fol­low-up email ear­ly Wednes­day morn­ing to End­points News, Boyle said the man­u­fac­tur­ing site in ques­tion did not al­lo­cate the prop­er re­sources to Zio­pharm’s projects.

“Dead­lines con­tin­ue to come and go with­out any work be­ing ad­vanced on our be­half,” Boyle wrote to End­points. “We’ve been told the ro­bust job mar­ket has caused fre­quent poach­ing of their em­ploy­ees and caused the clock to re­set on work­ing to man­u­fac­ture our prod­uct. We are now go­ing to be in con­trol of our own des­tiny and con­tin­ue to in­vest de­vel­op­ing in­ter­nal man­u­fac­tur­ing ca­pa­bil­i­ties.”

Zio­pharm’s TCR-T Li­brary pro­gram is now ex­pect­ed to dose its first pa­tient in a Phase I/II tri­al in the first half of 2022, pushed back from the sec­ond half of this year, the com­pa­ny added. The biotech blamed the de­lays on in­ad­e­quate re­sources at the man­u­fac­tur­er.

It’s been a tough 12 months for the Boston-based biotech, hav­ing suf­fered an ac­tivist at­tack last No­vem­ber and see­ing long­time CEO Lau­rence Coop­er leave a few months af­ter the dust set­tled in Feb­ru­ary. Af­ter a six-month search, Zio­pharm’s board set­tled on Boyle as his suc­ces­sor. Boyle came over af­ter a stint at Ku­ur Ther­a­peu­tics, which was bought out for $185 mil­lion in May.

The ac­tivist at­tack spanned sev­er­al weeks last fall fol­low­ing years of board turnover, with Zio­pharm fight­ing with Wa­ter­Mill As­set Man­age­ment Corp. in ugli­er and ugli­er press re­leas­es. The pair even spent the Thanks­giv­ing week­end last year at­tempt­ing to re­fute one an­oth­er and tout com­pet­ing in­ter­pre­ta­tions of an ISS re­port about the fu­ture of the com­pa­ny.

Ul­ti­mate­ly, Wa­ter­Mill was suc­cess­ful in the at­tack, con­vinc­ing enough share­hold­ers to elect two of its nom­i­nat­ed can­di­dates to the Zio­pharm board in De­cem­ber 2020. Wa­ter­Mill CEO Robert Post­ma was nom­i­nat­ed at the time and did not re­ceive enough votes, but has since joined the board as well.

Coop­er’s de­par­ture came the fol­low­ing Feb­ru­ary at the same time Zio­pharm an­nounced the “fan­tas­tic news” of an IND clear­ance for their TCR T cell ther­a­py pro­gram, the same li­brary that’s now see­ing man­u­fac­tur­ing de­lays. Re­searchers are aim­ing to uti­lize six “hotspot” TCRs from its li­brary, a “con­trolled IL-12” ap­proach and a third-gen­er­a­tion CD19 CAR-T.

Zio­pharm has a check­ered his­to­ry in drug de­vel­op­ment, as its stock price $ZIOP has not re­cov­ered since a pa­tient died in a study of its IL-12 gene ther­a­py in 2016, though it was lat­er deemed un­re­lat­ed to the treat­ment. Two years lat­er, Zio­pharm was forced to halt a Phase I CAR-T study af­ter the FDA placed a clin­i­cal hold and sought more in­for­ma­tion on chem­istry, man­u­fac­tur­ing and con­trols.

But ear­li­er this year, Zio­pharm saw some ear­ly, pos­i­tive over­all sur­vival da­ta for their con­trolled IL-12 treat­ment in glioblas­toma. Nonethe­less, shares are down more than 65% af­ter Zio­pharm hit a year­ly high in ear­ly Feb­ru­ary.

This ar­ti­cle was up­dat­ed on Sept. 29, 2021 to in­clude com­ment from Zio­pharm CEO Kevin Boyle.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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Joel Dudley, new partner at Innovation Endeavors (Bosch Health Campus)

For­mer Google CEO’s VC is mak­ing a big­ger push in­to the biotech world, hir­ing promi­nent Ther­a­nos skep­tic

Venture capital firm Innovation Endeavors has mainly had its focus on investments across the tech space, but it has been slowly turning its attention to the biotech world. Now, a new partner is coming into the fold showing that its interest in biotech is likely to grow further.

The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs since 2020.

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President Joe Biden signs the Democrats' landmark climate change and health care bill. From L-R: Sen. Joe Manchin (D-WV), Senate Majority Leader Chuck Schumer (D-NY), House Majority Whip James Clyburn (D-SC), Rep. Frank Pallone (D-NJ) and Rep. Kathy Castor (D-FL). (Susan Walsh/AP Images)

Pres­i­dent Biden signs ma­jor drug pric­ing re­forms in­to law: What's com­ing for bio­phar­ma?

President Joe Biden yesterday afternoon signed into law historic, decades-in-the-making new drug pricing reforms as part of a wider reconciliation bill that will likely take a chunk out of biopharma companies’ profits for some blockbusters just prior to generic or biosimilar competition.

The partisan bill (all Democrats in the House and Senate voted for it, and all Republicans voted against it) includes not only Medicare price negotiations — which won’t kick off until 2026, leaving ample time for a legal challenge — but mandatory inflation-related rebates, and a $2,000 annual cap on what seniors’ pay for their prescription drugs.

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