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.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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