Best in class? Eli Lil­ly claims a lead role awaits its CDK 4/6 drug abe­maci­clib af­ter PhI­II suc­cess

Levi Gar­raway, Lil­ly

The phar­ma gi­ant says their drug abe­maci­clib gar­nered promis­ing da­ta in an in­ter­im analy­sis of MONARCH-3, a breast can­cer tri­al that matched their drug with ei­ther of two aro­matase in­hibitors — letro­zole or anas­tro­zole — against on­ly the aro­matase in­hibitor. The full da­ta will be rolled out lat­er, with Lil­ly lim­it­ing it­self to the boast that their drug has the po­ten­tial to be the best-in-class ther­a­py in the like­ly three-way strug­gle to come.

In­ves­ti­ga­tors re­cruit­ed women with hor­mone-re­cep­tor-pos­i­tive, hu­man epi­der­mal growth fac­tor re­cep­tor 2-neg­a­tive (HER2-) ad­vanced breast can­cer.

Lil­ly had dropped well be­hind the two fron­trun­ners with their broad and am­bi­tious Phase III pro­gram. MONARCH 1 and MONARCH 2 da­ta are be­ing teed up to reg­u­la­tors at the FDA and EMA in this quar­ter, with the MONARCH 3 pack­age be­ing prepped for a Q3 de­liv­ery.

Lil­ly is rac­ing to catch up with No­var­tis, which gained an ap­proval for Kisqali (ri­bo­ci­clib) in March. And Pfiz­er scored the land­mark ap­proval in the field with Ibrance in 2015, help­ing that com­pa­ny achieve a not­ed ad­vance in can­cer drug R&D.

The pri­ma­ry end­point of the Lil­ly study was PFS, with key sec­ondary end­points of ORR, over­all sur­vival and safe­ty. And Sea­mus Fer­nan­dez at Lil­ly was pleas­ant­ly sur­prised by the in­ter­im suc­cess — par­tic­u­lar­ly as an ear­li­er tri­al had to run its full course be­fore Lil­ly could claim a win.

This is an un­ex­pect­ed win for LLY, in our view, as we and most in­vestors ex­pect­ed the tri­al to go to com­ple­tion at its planned fi­nal analy­sis at the end of this year.

An­a­lysts will be look­ing for the ac­tu­al da­ta to see how it mea­sures up with ri­vals, par­tic­u­lar­ly af­ter Lil­ly man­aged to stun the bio­phar­ma world with news that the FDA had re­ject­ed baric­i­tinib, wide­ly ex­pect­ed to breeze through to an OK. Lil­ly has yet to ex­plain what went wrong, which is not help­ing its R&D cred­i­bil­i­ty af­ter three straight fail­ures for its lead Alzheimer’s drug solanezum­ab.

“To­day marks an­oth­er im­por­tant mile­stone in our clin­i­cal de­vel­op­ment pro­gram for abe­maci­clib, a drug we be­lieve has the po­ten­tial to be best in class,” said Levi Gar­raway, se­nior vice pres­i­dent, glob­al de­vel­op­ment and med­ical af­fairs, Lil­ly On­col­o­gy. “We are very ex­cit­ed about the re­sults seen in pa­tients with breast can­cer, from sin­gle-agent ac­tiv­i­ty to clin­i­cal­ly mean­ing­ful ben­e­fit when used in com­bi­na­tion with ful­ves­trant or aro­matase in­hibitors. Along with ad­di­tion­al abe­maci­clib clin­i­cal tri­als in oth­er tu­mor types, these da­ta un­der­score Lil­ly’s com­mit­ment to de­liv­er­ing life-chang­ing med­i­cines to treat and cure peo­ple liv­ing with can­cer around the world.”

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

Zachary Hornby. Boundless

'A fourth rev­o­lu­tion in can­cer ther­a­pies': ARCH-backed Bound­less Bio flash­es big check, makes big­ger promis­es in de­but

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Mer­ck helps bankroll new part­ner Themis' game plan to fin­ish the chikun­gun­ya race and be­gin on­colyt­ic virus quest

As Themis gears up for a Phase III trial of its chikungunya vaccine, the Vienna-based biotech has closed out €40 million ($44 million) to foot the clinical and manufacturing bills.

Its heavyweight partners at Merck — which signed a pact around a mysterious “blockbuster indication” last month — jumped into the Series D, led by new investors Farallon Capital and Hadean Ventures. Adjuvant Capital also joined, as did current investors Global Health Investment Fund, aws Gruenderfonds, Omnes Capital, Ventech and Wellington Partners Life Sciences.