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.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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As­traZeneca trum­pets the good da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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The Avance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Iron­wood kicks de­layed-re­lease Linzess for­mu­la­tion to the curb af­ter tri­al fail­ure

The delayed-release formulation of Ironwood and Allergan’s bowel drug Linzess will not see the light of day.

The experimental drug, MD-7246, failed to help patients with abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D) in a mid-stage study, prompting the partners to abandon the therapy.

First approved in 2012, Linzess (known chemically as linaclotide) enhances the activity of the intestinal enzyme guanylate cyclase-C to increase the secretion of intestinal fluid and then transit through the intestinal tract, as well as reduce visceral pain, to relieve pain and constipation associated with IBS.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Stymied by the pan­dem­ic, Im­munomedic­s' new CEO bows out, tak­ing a mil­lion bucks plus perks as he heads out the vir­tu­al ex­it

Just a little more than a month since taking over as the latest CEO to helm Immunomedics, $IMMU Harout Semerjian is exiting the company after being confronted by “logistical” obstacles thrown up by the pandemic that made it impossible for him to move from London to carry out the job. And he’s getting a little over a million dollars in cash plus perks to grease the skids on the way out.

Word of the changeup arrived right after the market closed Wednesday.

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