Im­munomedics lays out its case for an ac­cel­er­at­ed OK of IM­MU-132 in triple-neg­a­tive breast can­cer

Aditya Bar­dia, Mass­a­chu­setts Gen­er­al Hos­pi­tal Can­cer Cen­ter

A lit­tle over a month af­ter Seat­tle Ge­net­ics $SGEN snapped up the glob­al rights to Im­munomedics lead can­cer drug IM­MU-132 (sac­i­tuzum­ab govite­can) in a $2 bil­lion deal, in­clud­ing $300 mil­lion in cash, the Mor­ris Plains, NJ-based biotech de­tailed the da­ta they plan to hus­tle to the FDA from its pos­i­tive mid-stage study for triple-neg­a­tive breast can­cer.

While the study was a fair­ly small, sin­gle-arm probe of ef­fi­ca­cy and safe­ty, the two part­ners are plan­ning the short­est route pos­si­ble to see if they can get an ac­cel­er­at­ed ap­proval while the ther­a­py nav­i­gates a Phase III piv­otal study.

In­ves­ti­ga­tors in the study tracked a me­di­an over­all sur­vival rate of 16.6 months and a pro­gres­sion-free sur­vival time of six months for the drug, which has the FDA’s break­through ther­a­py des­ig­na­tion for TNBC. Al­so, 30% of the 69 heav­i­ly pre­treat­ed pa­tients in the sin­gle-arm study achieved an ob­jec­tive re­sponse — two com­plete and 19 par­tial.

“These re­sults are very en­cour­ag­ing giv­en the im­pres­sive clin­i­cal ac­tiv­i­ty seen in a re­frac­to­ry set­ting, dura­bil­i­ty of re­spons­es, and the safe­ty pro­file,” not­ed lead au­thor Aditya Bar­dia, MD, MPH, at­tend­ing physi­cian at Mass­a­chu­setts Gen­er­al Hos­pi­tal Can­cer Cen­ter. “The av­er­age PFS is about 3.5 months for stan­dard agents, in­clud­ing cis­platin, capecitabine, nab-pa­cli­tax­el, and eribu­lin, as re­port­ed in ear­li­er metasta­t­ic TNBC tri­als.”

Three out of four of the pa­tients in the study who had pre­vi­ous­ly been treat­ed with a check­point — and failed — al­so achieved a par­tial re­sponse, a snap­shot of pos­si­ble com­bo po­ten­tial the biotech plans to fol­low up on.

These da­ta were laid out in the Jour­nal of Clin­i­cal On­col­o­gy. And Im­munomedics stock bumped up on the re­port, which fol­lows ear­li­er re­ports of the drug’s ef­fi­ca­cy.

The drug is an an­ti­body-drug con­ju­gate, or armed an­ti­body, de­signed for pre­cise de­liv­ery of SN-38, the ac­tive metabo­lite of irinote­can. As such, it fits com­fort­ably in Seat­tle Ge­net­ics sphere.

The drug didn’t kill any­one, but it’s not with­out safe­ty is­sues. Thir­ty-nine per­cent of the pa­tients suf­fered from neu­trope­nia, with 7% ex­pe­ri­enc­ing febrile neu­trope­nia and 13% af­flict­ed by se­vere di­ar­rhea.

Re­marked Im­munomedics CEO Cyn­thia L. Sul­li­van:

“We are work­ing dili­gent­ly with the FDA to make this valu­able prod­uct can­di­date avail­able to this group of pa­tients as soon as pos­si­ble. Blind­ed, in­de­pen­dent ra­di­o­log­i­cal as­sess­ments are on­go­ing, and so far show a high con­cor­dance with lo­cal to­mog­ra­phy find­ings.”

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

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Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

Pascal Soriot, AstraZeneca CEO (AP Images)

As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19. However, follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.