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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na chips in fur­ther on African vac­cine sup­ply — but ad­vo­cates are call­ing for even more

In a sign of its growing commitment to the continent, Moderna will supply up to 110 million doses of its Covid-19 vaccine to the African Union, the company announced Tuesday. And CEO Stéphane Bancel said it’s just the first step.

“We believe our vaccine can play an important role in addressing the needs of low-income countries given its combination of high Phase 3 efficacy against COVID-19, strong durability in the real-world evidence, and superior storage and handling conditions. We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe,” Bancel said in a statement.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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