Slammed by a tri­al hold, Intar­cia ter­mi­nates stud­ies and ax­es staff in wake of an FDA re­jec­tion

Intar­cia’s trou­bled late-stage ef­forts to rev­o­lu­tion­ize the way di­a­betes is treat­ed has run in­to a fresh round of set­backs.

The Boston-based biotech — a pri­vate com­pa­ny once val­ued at $3.5 bil­lion — con­firmed to End­points News late Fri­day night that the com­pa­ny has cut 60 staffers and been hit by a clin­i­cal hold from the FDA.

Kurt Graves

Those set­backs come four months af­ter the FDA re­ject­ed Intar­cia’s im­plant­ed di­a­betes drug/de­vice, which is de­signed to de­liv­er sta­ble dos­es of ex­e­natide with twice-year­ly tune-ups. Intar­cia CEO Kurt Graves has long cham­pi­oned the de­vice as a cer­tain block­buster, earn­ing ku­dos and $600 mil­lion in Se­ries EE in­vest­ment cap­i­tal along the way.

The Boston Busi­ness Jour­nal first re­port­ed the lay­offs and the clin­i­cal hold. A com­pa­ny spokesper­son tells End­points:

As Intar­cia Ther­a­peu­tics, Inc. works to­wards re­sub­mis­sion and the ul­ti­mate goal of ap­proval for IT­CA 650, a holis­tic as­sess­ment of the or­ga­ni­za­tion was con­duct­ed and the de­ci­sion was made to re­struc­ture and re­shape the com­pa­ny to fo­cus on our crit­i­cal pri­or­i­ties. The re­struc­tur­ing and re­shap­ing in­volves rough­ly 60 po­si­tions that were re­duced across var­i­ous func­tions, how­ev­er, it al­so in­volves on­go­ing hir­ing in key ar­eas of the com­pa­ny that sup­port our 2018 pri­or­i­ties.  The net/net head­count changes are ex­pect­ed to be rel­a­tive­ly neu­tral over the course of the year.

Sep­a­rate­ly, the clin­i­cal hold was put in place for on­go­ing mar­ket­ing stud­ies and it is not re­lat­ed to the piv­otal tri­als da­ta in our NDA ap­pli­ca­tion.  The clin­i­cal hold was im­ple­ment­ed to al­low for an in­ves­ti­ga­tion of a 3rd par­ty lab re­sult, not pre­vi­ous­ly ob­served, dur­ing rou­tine long-term mon­i­tor­ing of IT­CA 650 prod­uct batch­es.  The in­ves­ti­ga­tion was re­cent­ly com­plet­ed and we plan to up­date the FDA to ad­dress the clin­i­cal hold around the time of our planned re­sub­mis­sion this year.

Bio­Cen­tu­ry re­port­ed Fri­day night that Intar­cia ter­mi­nat­ed two late-stage stud­ies ear­li­er in the week, not­ing that the ter­mi­na­tions were record­ed on clin­i­cal­tri­als.gov. Both those ter­mi­na­tions were record­ed as a “de­ci­sion by spon­sor.” The news ser­vice re­port­ed:

The ter­mi­nat­ed Phase II­Ib tri­al com­pared IT­CA 650 to em­pagliflozin or glimepiri­de as an add-on ther­a­py to met­formin in pa­tients with Type II di­a­betes. The sec­ond tri­al was a Phase III sub-study eval­u­at­ing IT­CA 650 in Type II di­a­bet­ic pa­tients with high base­line HbA1c.

The com­pa­ny spokesper­son had this to add:

For clar­i­ty on Bio­cen­tu­ry, the clin­i­cal hold im­pact­ed the two tri­als not­ed and did not re­late to the piv­otal tri­als in the NDA ap­pli­ca­tion.  The tri­als were be­ing done for com­mer­cial pur­pos­es and are not re­quired for the NDA re­view.

Holds and prod­uct re­jec­tions are not ac­knowl­edged or ex­plained by the FDA, which keeps most of its in­ter­ac­tions with com­pa­nies se­cret.

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.

#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.

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: 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.

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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#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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