#ES­MO18: No­var­tis claims a key win in breast can­cer with PI3K drug alpelis­ib

MU­NICH — PI3K in­hibitors have had their prob­lems over the years, fail­ing some stud­ies, prov­ing to be dis­ap­point­ing in terms of dura­bil­i­ty in oth­ers. But No­var­tis $NVS be­lieves it may have come up with part of the an­swer with its lat­est da­ta on BYL719 (alpelis­ib) in com­bi­na­tion with ful­ves­trant.

Their al­pha-spe­cif­ic drug for PIK3CA mu­tat­ed HR+/HER2- ad­vanced breast can­cer, BYL719 plus ful­ves­trant near­ly dou­bled the pro­gres­sion-free sur­vival times for pa­tients, hit­ting 11 months com­pared to 5.7 months for a con­trol arm treat­ed on­ly with ful­ves­trant.

Fab­rice An­dré, the re­search di­rec­tor and head of IN­SERM Unit U981, called the re­sults the da­ta the “most en­cour­ag­ing” re­sults seen to date in this pa­tient group.

Rough­ly 40% of HR+ ad­vanced breast can­cer pa­tients have a PIK3CA mu­ta­tion, mak­ing this a sig­nif­i­cant piece of the over­all mar­ket.

The da­ta were re­leased over the week­end at ES­MO18.

An­dré says this drug is a stand­out, per­haps be­cause it is al­pha spe­cif­ic. Due to low­er tox­i­c­i­ty, the ma­jor­i­ty of the pa­tients can re­main on ther­a­py longer, he adds, which would ex­plain their hope for achiev­ing more durable re­spons­es than what’s been seen in oth­er PI3K pro­grams.

No­var­tis is now look­ing to fol­low up with talks at key reg­u­la­to­ry groups about an OK.

No­var­tis has had its is­sues with PI3K be­fore. The Swiss com­pa­ny hand­ed world­wide com­mer­cial rights to the late-stage bu­parlis­ib to one of Chi­na’s new up­start biotechs — rais­ing some thorny is­sues about how ques­tion­able drug as­sets may be passed to new play­ers for a com­mer­cial roll­out.

And Roche de­cid­ed to scrap its con­tender taselis­ib last June af­ter in­ves­ti­ga­tors re­port­ed a slight, 2-month pro­gres­sion-free sur­vival ad­van­tage for the drug — along with a sketchy safe­ty pro­file com­mon to the class — com­bined with ful­ves­trant hor­mone ther­a­py in a Phase III study of metasta­t­ic breast can­cer. 

No­var­tis, though, be­lieves it has grounds for an ap­proval, based large­ly on the speci­fici­ty of the drug.

“We are ex­cit­ed about the mean­ing­ful re­sults seen in SO­LAR-1 and about the pos­si­bil­i­ty to reimag­ine what po­ten­tial treat­ment op­tions could look like for pa­tients liv­ing with PIK3CA mu­tat­ed HR+/HER2- ad­vanced breast can­cer – some of who were pre­vi­ous­ly treat­ed with a CDK4/6 in­hibitor,” said Samit Hi­rawat, the head of No­var­tis On­col­o­gy Glob­al Drug De­vel­op­ment. “We are ac­tive­ly en­gag­ing in dis­cus­sions on these re­sults with health au­thor­i­ties world­wide.”

Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

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.

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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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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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.

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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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.