Dennis Zaller, ROME Therapeutics CSO

ROME founder Rosana Kapeller re­cruits a CSO from the se­nior ranks of a ma­jor league R&D team

The phone call start­ed in­no­cent­ly enough.

Den­nis Za­ller, then the ex­ec­u­tive di­rec­tor for in­te­gra­tive sci­ences at Cel­gene/BMS, rang up Rosana Kapeller back in April to con­grat­u­late her on the $50 mil­lion Se­ries A for her new biotech, ROME Ther­a­peu­tics. The two had col­lab­o­rat­ed a few times when Kapeller worked for Nim­bus, and Za­ller, do­ing his due dili­gence, want­ed to see if the new start­up could be a fit for a new part­ner­ship.

But dis­cus­sions quick­ly mor­phed from a sim­ple how-do-you-do in­to some­thing else en­tire­ly — a job of­fer.

ROME an­nounced Wednes­day that Za­ller would be join­ing the biotech as chief sci­en­tif­ic of­fi­cer. So far, it’s the young com­pa­ny’s biggest hire to date.

Rosana Kapeller

“We had just start­ed our search, we had a group of in­di­vid­u­als we were do­ing our re­search for, we were just start­ing com­pil­ing the names,” Kapeller told End­points News. “And then the con­ver­sa­tion pro­ceed­ed in­to whether it would make sense ac­tu­al­ly for Den­nis to fi­nal­ly sam­ple the oth­er side in­stead of con­tin­u­ing to be on the big com­pa­ny side … it was re­al­ly like a to­tal con­ver­gence.”

“I knew some­thing in­ter­est­ing was bound to come out of this,” Za­ller added. “But I came away from it think­ing ‘Wow this is so in­ter­est­ing, I need to take a deep­er dive.’ And that’s where things land­ed.”

Za­ller is mak­ing the tran­si­tion to the biotech world af­ter rough­ly 30 years work­ing for Cel­gene and, pre­vi­ous­ly, Mer­ck in their drug dis­cov­ery out­fits. ROME boast­ed in its press re­lease that Za­ller had per­son­al­ly been a part of teams that ad­vanced near­ly three dozen mol­e­cules in­to the clin­ic.

The two re­called their first en­counter when Za­ller worked at Mer­ck sev­er­al years ago. Kapeller wouldn’t go in­to too much de­tail, but they were col­lab­o­rat­ing on an on­col­o­gy pro­gram that need­ed to show high se­lec­tiv­i­ty in its da­ta. Za­ller helped con­struct a plan that so im­pressed Kapeller, she kept in touch with him af­ter­wards.

Ul­ti­mate­ly, the key to that mu­tu­al ef­fort was the “truth-seek­ing” process, Za­ller said.

“One of the things that is sim­i­lar in the sci­en­tif­ic ap­proach I have with Rosana that came out of these in­ter­ac­tions is that we didn’t have a deal yet, but we both, as we went through this, re­al­ized it made no dif­fer­ence,” he said.

They fo­cused on: “What is the an­swer? Whether it’s good, whether it’s bad, let’s just do the right ex­per­i­ments and brain­storm it, be­cause the truth is all that mat­ters.”

Kapeller has brought with her sev­er­al for­mer col­leagues to fill out ROME’s lead­er­ship team, as she as­serts they all come with proven track records. Za­ller’s ad­di­tion to that ros­ter helps the biotech cre­ate a “high-per­form­ing cul­ture,” she said.

ROME fo­cus­es its re­search on a por­tion of the hu­man genome that for years has been de­scribed as “junk DNA,” or the 97% to 99% of ge­net­ic code that doesn’t code for pro­teins, known as the re­peatome. This seg­ment of the “junk” refers to about 60% of the genome that’s com­posed of re­peat­ed DNA el­e­ments and doesn’t code for pro­teins, Za­ller said.

Be­ing able to con­duct such stud­ies to try to treat can­cer and au­toim­mune dis­ease takes Za­ller back to ear­li­er in his ca­reer, he said, when he ran small­er lab­o­ra­to­ries where he was able to pro­vide an “in­tense fo­cus” on a small­er prob­lem rather than over­see­ing a large de­vel­op­men­tal op­er­a­tion.

And now, too, he gets to helm drug dis­cov­ery on that “oth­er side” in an emerg­ing field.

“This is still just the be­gin­ning,” Za­ller said. “Watch this space close­ly, be­cause it’s go­ing to be in­ter­est­ing.”

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Frank Zhang (AP Images)

Rocked by cus­toms in­ves­ti­ga­tion, Leg­end's CFO takes over as CEO Frank Zhang placed un­der house ar­rest

When Frank Zhang stepped down from GenScript — the contract research group he’s run for 18 years — to take up the CEO post at its CAR-T focused spinout Legend Biotech, he assured analysts that he was in for the long haul.

Just 49 days later, though, he’s been forced to hand back the title.

In a dramatic turn of events, Legend disclosed that Zhang is under house arrest in China as part of a customs investigation involving GenScript. While he remains the chairman, CFO Ying Huang has been tapped to double as interim CEO.

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UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Donald Trump, AP

Covid-19 roundup: Trump sug­gests Pfiz­er vac­cine could be first ap­proved; VBI Vac­cines inks de­vel­op­ment deal with Cana­da

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”