As­traZeneca ax­es an­oth­er R&D track on dur­val­um­ab af­ter once again falling be­hind ri­vals

As­traZeneca CEO Pas­cal So­ri­ot

It’s not easy be­ing fourth.

The R&D team at As­traZeneca had thought that its sin­gle-arm study for its Phase II tri­al of the PD-L1 check­point dur­val­um­ab might have of­fered a short­cut to an ap­proval for sec­ond-line head and neck can­cer. But Mer­ck eas­i­ly beat them to the mar­ket with Keytru­da for head and neck with a nod in Au­gust and now Bris­tol-My­ers is breath­ing down its neck in the hope that they can cat­a­pult ahead — which would be wel­come af­ter the em­bar­rass­ing lung can­cer de­ba­cle.

So now As­traZeneca says it is scrap­ping plans to file for an ear­ly ap­proval in the in­di­ca­tion, un­like­ly to find reg­u­la­tors in­ter­est­ed in speed­ing an OK. Da­ta are ex­pect­ed this quar­ter, but don’t look for any quick pub­lic dis­cus­sion of what in­ves­ti­ga­tors found. The da­ta will be for in­ter­nal dis­cus­sion on­ly, and in “due course,” ac­cord­ing to As­traZeneca’s Q3 wrap-up.

That leaves As­traZeneca play­ing catch-up with three com­bi­na­tion stud­ies in head and neck can­cer, adding the CT­LA-4 treat­ment treme­li­mum­ab with dur­val­um­ab. But the R&D team has run in­to a de­lay here as well af­ter the FDA opt­ed to drop a par­tial hold on the com­bos a cou­ple of weeks ago.

The par­tial hold was in­sti­tut­ed af­ter in­ves­ti­ga­tors tracked bleed­ing events in the Phase III pro­gram. But the com­pa­ny cau­tions that all oth­er stud­ies in oth­er can­cers are pro­ceed­ing as planned, not­ing that such bleed­ing events are not un­usu­al in head and neck can­cer.

That said, As­traZeneca can ill af­ford any de­lays in the de­vel­op­ment of dur­val­um­ab/treme­li­mum­ab now. The com­pa­ny al­ready de­layed its de­vel­op­ment time­line for the check­point in­hibitor to al­low for com­bi­na­tion stud­ies, which As­traZeneca is count­ing on to make a splash with a late ar­rival in the field.

Now its chief hope in the field lies in get­ting its com­bo ap­proach to reg­u­la­tors for first-line non-small cell lung can­cer, ahead of a com­bi­na­tion of Op­di­vo and Yer­voy from Bris­tol-My­ers. The first piv­otal late-stage da­ta are ex­pect­ed in H1 2017.

It’s been a rough year for As­traZeneca, which has suf­fered a string of set­backs in 2016. And it’s not get­ting any eas­i­er. Mer­ck, Bris­tol-My­ers and Roche all beat the com­pa­ny to the mar­ket with im­pres­sive check­points, and the Pfiz­er/Mer­ck KGaA team is al­so play­ing catch-up as well.

As­traZeneca al­so out­lined the lat­est round of pro­grams to get cut out of the pipeline to­day. The scrap heap list in­clud­ed inebi­lizum­ab, its an­ti-CD19 an­ti­body, for dif­fuse large B cell lym­phoma, ME­DI3617 — a se­lec­tive an­giopoi­etin-2 in­hibitor — for sol­id tu­mors and cedi­ranib for PSR ovar­i­an can­cer. Back in Sep­tem­ber As­traZeneca pulled its ap­pli­ca­tion at the EMA for cedi­ranib, say­ing that reg­u­la­tors had some dif­fer­ing opin­ions on the drug’s safe­ty/ben­e­fit ra­tio.

As­traZeneca CEO Pas­cal So­ri­ot prefers to sweep away set­backs in foot­notes, re­serv­ing the head­line treat­ment for new pipeline ad­vances. To­day, though, the im­pact of gener­ic com­pe­ti­tion con­tin­ued to sav­age the phar­ma gi­ant’s rev­enue num­bers, set­ting a bleak back­ground for So­ri­ot’s trade­mark R&D bull­ish­ness. The com­pa­ny has scored sig­nif­i­cant progress with two new can­cer drugs, Tagris­so and Lyn­parza, but the com­pa­ny is not mak­ing near­ly the progress it promised in­vestors when So­ri­ot fend­ed off a takeover at­tempt by Pfiz­er. As­traZeneca al­so post­ed $674 mil­lion in rev­enue from ex­ter­nal­iza­tion deals done on as­sets that have ei­ther failed to mea­sure up in the clin­ic or no longer fit the com­pa­ny’s com­mer­cial/R&D fo­cus, which leans heav­i­ly on dur­val­um­ab.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Scoop: Gilead ter­mi­nates ear­ly-stage FLT3 tri­al in sol­id tu­mors

Gilead chopped a Phase Ib dose escalation study in recent days, with an update to the federal trials database saying the premature termination followed an “internal safety assessment.”

The IV-administered FLT3 agonist, dubbed GS-3583, was being tested as a monotherapy in 13 patients with advanced solid tumors. The goal of the trial was to find out what dose to test in a Phase II, or maximum tolerated dose.

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Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

As­traZeneca’s Su­san Gal­braith high­lights twin wins for the can­cer drug pipeline at SABCS, as oral SERD ex­cels

It’s a good time to be the head of R&D for oncology at AstraZeneca. And no one gets that quite like Susan Galbraith.

Today, Galbraith is at the San Antonio Breast Cancer Symposium, highlighting the data on two key drugs in the cancer pipeline: mid-stage results for its oral SERD camizestrant among patients after one line of therapy, and the AKT drug capivasertib, wrapping the Phase III. Both fall neatly into the range of successes, beating out fulvestrant in hormone receptor-positive, HER2-negative breast cancer.

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