Ready to de­clare a de­fin­i­tive come­back in two months, Im­munomedics stops PhI­II ear­ly, re­cruits new CEO

More than a year ago, hit by a sur­prise com­plete re­sponse let­ter from the FDA, Im­munomedics bid its then-CEO, Michael Pehl, adieu and be­gan a 15-month quest to re­solve the man­u­fac­tur­ing is­sues cit­ed in the CRL and seek a new leader — all the while mov­ing for­ward with a Phase III study on its lead drug for metasta­t­ic triple-neg­a­tive breast can­cer.

Harout Se­mer­jian

To­day the biotech said their stars are fi­nal­ly align­ing. Not on­ly is No­var­tis On­col­o­gy vet Harout Se­mer­jian com­ing on board as CEO to steer what they be­lieve will be a smooth sail to a new PDU­FA date in June, Im­munomedics has al­so been in­formed that their late-stage tri­al can be stopped ear­ly due to “com­pelling ev­i­dence of ef­fi­ca­cy.”

The turn­around is not ex­act­ly com­plete but it’s enough to win in­vestors over, near­ly dou­bling its shares $IM­MU to $18.77.

The rec­om­men­da­tion by the da­ta safe­ty mon­i­tor­ing com­mit­tee means that Im­munomedics doesn’t need to wait un­til a cer­tain num­ber of pa­tients to progress be­fore they be­gin an­a­lyz­ing the da­ta.

The Phase III AS­CENT study was de­signed to eval­u­ate how its an­ti­body-drug con­ju­gate dubbed sac­i­tuzum­ab govite­can im­pacts pro­gres­sion-free sur­vival, over­all sur­vival and re­sponse rates com­pared to chemother­a­py.

Be­hzad Ag­haz­adeh

The plan is to sub­mit the re­vised sta­tis­ti­cal analy­sis plan to the FDA in a mat­ter of hours, ex­ec­u­tive chair­man Be­hzad Ag­haz­adeh told End­points News Mon­day morn­ing.

“More im­por­tant­ly, it’s not so much that we don’t have to wait any longer for pa­tients to progress, the in­de­pen­dent da­ta safe­ty mon­i­tor com­mit­tee is in­di­cat­ing to us that the tri­al was suc­cess­ful,” he said.

He cau­tious­ly added that the ex­perts on the com­mit­tee ap­pear to in­di­cate that in ad­di­tion to the pri­ma­ry end­point in PFS, they are al­so see­ing pos­i­tive trends on oth­er end­points.

Julie Gralow

Julie Gralow, a Fred Hutch re­searcher who chaired the DSMC, called the re­sults “re­mark­able” — a com­ment that in­spired Cowen’s Phil Nadeau to note “there is lit­tle ques­tion that sac­i­tuzum­ab will soon be­come stan­dard of care in the treat­ment of re­lapsed and re­frac­to­ry mTNBC.”

To be clear, none of that should fac­tor in­to the FDA’s on­go­ing re­view of sac­i­tuzum­ab govite­can. Ag­haz­adeh still ex­pects an ac­cel­er­at­ed ap­proval by June 2. Af­ter all, ac­cord­ing to the com­pa­ny, the on­ly is­sues stop­ping reg­u­la­tors from do­ing so the first time around had to do with man­u­fac­tur­ing and oth­er pro­ce­dur­al mat­ters dis­cov­ered dur­ing in­spec­tions. Scott Canute, a board mem­ber who was tapped as ex­ec­u­tive di­rec­tor up­on Pehl’s de­par­ture, has helped en­sure re­me­di­a­tion is in place to ad­dress those con­cerns.

On the oth­er hand, de­spite the short­ened time­line, a full ap­proval wouldn’t come un­til 6, 9, or even 12 months from now.

Im­munomedics has pre­vi­ous­ly pre­sent­ed Phase II da­ta sug­gest­ing a 33% re­sponse rate and a me­di­an du­ra­tion of re­sponse of 7.7 months.

“It is 2 or 3 times high­er based on what we would ex­pect in chemother­a­py,” Ag­haz­adeh, who al­so man­ages Avoro Cap­i­tal (for­mer­ly ven­Bio Se­lect Ad­vi­sor), said. “For the re­sponse rate, gen­er­al­ly we would ex­pect high sin­gle-dig­it, low dou­ble-dig­it re­spons­es. And we would ex­pect about 3 to 4 months of du­ra­tion for chemother­a­py.”

For Nadeau, it all bodes well for fur­ther clin­i­cal de­vel­op­ment of sac­i­tuzum­ab govite­can, with 2025 sales pegged at $1.2 bil­lion:

With sac­i­tuzum­ab pro­duc­ing sim­i­lar Ph. II da­ta in r/r ER+/HER2- mBC and mTNBC, we think the AS­CENT re­sults par­tial­ly de-risk sac­i­tuzum­ab’s de­vel­op­ment in r/r ER+/HER2- mBC. IM­MU ex­pects to com­plete en­roll­ment in the Ph. III TROP­iCS-02 study in ER+/HER2- BC this year with in­ter­im da­ta (ORR) to be re­leased not long af­ter the com­ple­tion of en­roll­ment.

The re­spon­si­b­li­ty to re­al­ize all that — start­ing with a po­ten­tial near-term launch — now falls on the shoul­der of Se­mer­jian.

Se­mer­jian moved days ago from his last job as chief com­mer­cial of­fi­cer of Ipsen in Lon­don and, in a sign of the times, “is sit­ting at home in so-called self quar­an­tine to en­sure that he is able to safe­ly come to the com­pa­ny site on [his of­fi­cial start date of] April 16,” Ag­haz­adeh said.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).

David Arthur, Salarius Pharmaceuticals CEO

Salarius Phar­ma­ceu­ti­cals sees with­drawals, 3 of 13 pa­tient re­spon­ders in sar­co­ma tri­al

The Houston-based biotech Salarius Pharmaceuticals is lifting the cover on data from a Phase I/II trial for a drug currently on voluntary hold after a patient death, and the results appear to have underwhelmed investors.

Salarius’ candidate, dubbed seclidemstat, is an oral LSD1 inhibitor that is meant to treat Ewing sarcoma and FET-rearranged sarcomas in patients under 12 years old. The biotech had presented data with 13 patients with “first- and second-relapse Ewing sarcoma” who were treated in combination with topotecan and cyclophosphamide.