Frus­trat­ed Eli Lil­ly may have to set­tle for a lone­ly last-place fin­ish in the block­buster CDK 4/6 race

A frus­trat­ed Eli Lil­ly will have to wait pa­tient­ly for its close­ly-watched Phase III study of the CDK 4/6 breast can­cer drug abe­maci­clib to wrap up next year be­fore it gets the fi­nal read out on its ef­fect on sur­vival rates. The phar­ma gi­ant re­port­ed that the piv­otal tri­al will have to con­tin­ue “as the in­ter­im ef­fi­ca­cy cri­te­ria were not met.”

Fi­nal re­sults are now ex­pect­ed some­time in the first half of 2017, which could de­lay a launch in­to 2018.

The ex­ec­u­tive crew at Lil­ly had raised hopes that abe­maci­clib, a des­ig­nat­ed “break­through” drug at the FDA, could be prepped for a mar­ket launch on the in­ter­im da­ta. And that had fol­lowed some dis­cus­sion on whether the mid-stage re­sults would be suf­fi­cient. Dis­ap­point­ed in­vestors drove Lil­ly’s shares down 1.5% in pre-mar­ket trad­ing Wednes­day morn­ing.

The de­lay puts Lil­ly well be­hind No­var­tis in the com­pe­ti­tion to hus­tle a com­peti­tor to Pfiz­er’s Ibrance to the mar­ket­place for breast can­cer pa­tients. Just days ago No­var­tis gained a break­through drug des­ig­na­tion for LEE011 (ri­bo­ci­clib) in com­bi­na­tion with letro­zole for the treat­ment of hor­mone re­cep­tor pos­i­tive, hu­man epi­der­mal growth fac­tor re­cep­tor 2-neg­a­tive (HR+/HER2-) ad­vanced or metasta­t­ic breast can­cer. The BTD came through af­ter the phar­ma gi­ant end­ed the MONALEESA-2 study among pre­vi­ous­ly un­treat­ed breast can­cer pa­tients ear­ly, con­clud­ing that it had clear ev­i­dence of ef­fi­ca­cy that could be used for a near-term ap­pli­ca­tion.

Ac­cord­ing to the tri­al de­sign on clin­i­cal­tri­, Lil­ly’s drug was re­strict­ed to pa­tients who have not pre­vi­ous­ly been treat­ed with a CDK 4/6 drug. If that makes its way to the la­bel, Lil­ly’s treat­ment would not be al­lowed for any pa­tient who had been treat­ed with ei­ther Pfiz­er’s Ibrance or No­var­tis’s LEE011. And with both of those drugs on the mar­ket ahead of Lil­ly, that could sig­nif­i­cant­ly shrink its mar­ket reach.

“It’s im­por­tant to un­der­stand that ri­bo will com­pete with pal­bo up­front in 1L mBC in ER+/HER2- and abe­ma will be 4th or 5th line with around 20% RR, ap­prox com­pa­ra­ble to oth­er drugs in that same sit­u­a­tion,” notes Sal­ly Church, who cov­ers the on­col­o­gy field in her Biotech Strat­e­gy Blog, in an email mes­sage.  “Will the FDA want more ef­fi­ca­cy or equiv­a­lent?  I think Lil­ly are in a risky po­si­tion.  Look up the past noise on ix­abepi­lone and eribu­lin in that set­ting – they did not get an easy ride from FDA at all.”

Lil­ly ex­pe­ri­enced one of the most painful droughts in pipeline pro­duc­tiv­i­ty over the past decade, but re­cent­ly has made a come­back with a slate of late-stage pro­grams like this with block­buster po­ten­tial. Any fresh ev­i­dence that the com­pa­ny con­tin­ues to have trou­ble ac­cel­er­at­ing pipeline ef­forts, though, won’t help its rep in the drug de­vel­op­ment field.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Reshma Kewalramani, Vertex CEO (Vertex via YouTube)

Bat­tling a line­up of skep­tics, Ver­tex claims an­oth­er ear­ly clin­i­cal win — this time in kid­ney dis­ease

Vertex claimed its second early-stage win of the fall Wednesday, announcing positive results in a small study on a genetically defined form of kidney disease.

The 16-patient, Phase II trial focused on patients with focal segmental glomerulosclerosis, a rare disease where kidneys are unable to filter blood properly. Over 13 weeks on an experimental pill, the level of protein in the patients’ urine fell by an average of 47.6%.

With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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As lead drug runs in­to a wall, De­ci­phera slims down its pipeline, puts 140 jobs on the chop­ping block

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

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