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.”

Fangliang Zhang, AP Images

Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.

RA Cap­i­tal, Hill­house join $310M rush to back Ever­est's climb to com­mer­cial heights in Chi­na

Money has never been an issue for Everest Medicines. With an essentially open tab from their founders at C-Bridge Capital, the biotech has gone two and a half years racking up drug after drug, bringing in top exec after top exec, and issuing clinical update after update.

But now other investors want in — and they’re betting big.

Everest is closing its Series C at $310 million. The first $50 million comes from the Jiashan National Economic and Technological Development Zone; the remaining C-2 tranche was led by Janchor Partners, with RA Capital Management and Hillhouse Capital as co-leaders. Decheng Capital, GT Fund, Janus Henderson Investors, Rock Springs Capital, Octagon Investments all joined.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.