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.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Lund­beck sounds taps on an­oth­er CNS drug, re­treat­ing from a mine field still oc­cu­pied by a Mer­ck team

Lundbeck has snipped another clinical-stage branch of its CNS research, dumping a schizophrenia program after determining that their therapy would have no positive influence on the disease.

Designed originally as a 240-patient study, researchers set out in early 2019 to see if a homegrown drug dubbed Lu AF11167 could make it through a proof-of-concept study. The drug is a PDE10Ai inhibitor, targeting an enzyme which it said at the time offered a new pathway to retuning the body’s neurotransmitter dopamine. The big idea was that by hitting their target, the drug would modulate “dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors,” influencing negative symptoms of schizophrenia.

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Ab­b­Vie aban­dons a pi­o­neer­ing CRISPR R&D al­liance with Ed­i­tas as Brent Saun­der­s' deal is cast out

A little more than 3 years ago Allergan paid $90 million in a cash upfront to partner with gene editing player Editas on a CRISPR alliance focused on the eye. The lead program centered on LCA10, a rare, inherited retinal degenerative disease that appears in childhood and leads to blindness.

Allergan then went to AbbVie $ABBV in a buyout, and the pharma giant has no interest in moving forward on the gene editing front. The company punted it all back to Editas Thursday, with the biotech $EDIT noting in a statement after the market closed Thursday that it is regaining all rights for its ocular medicines, including EDIT-101.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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Le­vo Ther­a­peu­tics miss­es pri­ma­ry end­point in PhI­II tri­al of Prad­er-Willi drug — the lat­est set­back in a dis­as­ter-prone field

Marking yet another setback in the Prader-Willi Syndrome field, Levo Therapeutics failed to hit its primary endpoint in a Phase III study of intranasal carbetocin. But the biotech is now shifting its focus to the secondary endpoints in an effort to pluck victory out of the jaws of defeat.

The disorder, characterized by a false sense of starvation, is caused by the absence or deletion of a father’s chromosome 15. Illinois-based Levo’s potential therapy involves a selective oxytocin-receptor agonist.