Ab­b­Vie grap­ples with an­oth­er set­back as 2 PhI­II tri­als for its PARP veli­parib flop

Up un­til now, PARP in­hibitors have been blaz­ing a broad, long trail of suc­cess in the clin­ic, with Lyn­parza, Rubra­ca and now Ze­ju­la hit­ting a busy and grow­ing mar­ket for can­cer pa­tients.

Ab­b­Vie CEO Richard Gon­za­lez

But Ab­b­Vie $AB­BV won’t be join­ing that crowd any­time soon.

Re­searchers at the com­pa­ny chose to an­nounce late Wednes­day that their PARP, veli­parib, failed in two Phase III stud­ies in pa­tients with squa­mous non-small cell lung can­cer (NSCLC) and triple neg­a­tive breast can­cer.

De­tails will have to wait un­til an up­com­ing can­cer drug con­fer­ence. But Ab­b­Vie prepped a few short words for the late-stage bur­ial de­tail.

“Re­search shows there is a role for PARP in­hibitors in can­cers as­so­ci­at­ed with DNA re­pair deficits, such as those with BR­CA mu­ta­tions. In these clin­i­cal tri­als, we want­ed to ex­plore whether a PARP in­hibitor could aug­ment chemother­a­py in pa­tients with squa­mous non-small cell lung can­cer and triple neg­a­tive breast can­cer by dis­rupt­ing the re­pair of can­cer cells,” said Gary Gor­don, the VP of on­col­o­gy clin­i­cal de­vel­op­ment at Ab­b­Vie. “Un­for­tu­nate­ly, these da­ta do not sup­port the use of veli­parib in com­bi­na­tion with chemother­a­py in these pa­tients.”

There’s plen­ty of work ahead as the rest of the new wave of PARPs looks to broad­en la­bels and ex­pand mar­ket pen­e­tra­tion. Still to be heard from? Pfiz­er, which grabbed ta­la­zoparib in their $14 bil­lion ac­qui­si­tion of Medi­va­tion. The phar­ma gi­ant will need to do much bet­ter than Ab­b­Vie if it wants to jus­ti­fy the price it paid.

Ab­b­Vie has been hus­tling up a big late-stage ef­fort to bring new drugs to the mar­ket, be­fore it los­es patent pro­tec­tion on the all-im­por­tant $16 bil­lion Hu­mi­ra flag­ship fran­chise. But it’s been strug­gling on the can­cer front, fail­ing so far to im­press an­a­lysts with Ro­va-T, which it ac­quired in a $10 bil­lion buy­out.

Ge­of­frey Porges at Leerink likes some of Ab­b­Vie’s late-stage pro­grams, but he’s writ­ing off veli­parib as es­sen­tial­ly worth­less. He not­ed:

While two dis­ap­point­ing tri­als would not nor­mal­ly com­plete­ly doom a pro­gram, the lack of ef­fect in­deed con­firms our view that veli­parib has lim­it­ed ac­tiv­i­ty and is not com­pet­i­tive with oth­er prod­ucts in this class. For this rea­son we are tak­ing the prob­a­bil­i­ty of suc­cess (POS) of the pro­gram to ze­ro, and re­duc­ing our rev­enue and earn­ings ex­pec­ta­tions ac­cord­ing­ly.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,800+ biopharma pros reading Endpoints daily — and it's free.

As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,800+ biopharma pros reading Endpoints daily — and it's free.

An­oth­er failed tri­al for Or­p­hazyme's 'pipeline-in-a-pro­duc­t' leaves shad­ow on drug's fu­ture

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,800+ biopharma pros reading Endpoints daily — and it's free.

Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

UP­DAT­ED: EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,800+ biopharma pros reading Endpoints daily — and it's free.

Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,800+ biopharma pros reading Endpoints daily — and it's free.

In­cyte ponies up $12M to set­tle char­i­ty foun­da­tion kick­back claims; US ex­er­cis­es op­tion for more dos­es of mon­key­pox vac­cine

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.