#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.”

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

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Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

A couple of the Big 15 biopharma companies in R&D hit the gas on research spending last year. Merck and Sanofi still have lots to prove in the pipeline, and they’re willing to gamble large sums to make a better future for themselves.

Doing nothing would be infinitely worse.

But collectively, the top players rang up a modest 2.4% increase in spending in 2022, which didn’t cover inflationary pressures. And that set the tone for an extraordinarily cautious year for the industry — even as it laid out about $127 billion to advance new drugs or up the ante on approved therapies.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

Gun­ning for 2023 ap­proval, GSK de­tails PhI­II da­ta for Jem­per­li in front­line en­dome­tri­al can­cer

GSK has a new slate of data to offer on its PD-1 inhibitor, Jemperli — data that the pharma giant hopes will cement one of the four drug approvals it’s expecting this year.

While Jemperli (dostarlimab) is already approved for a subset of patients with second-line endometrial cancer, GSK set out in the Phase III RUBY trial to test it as an earlier line of treatment while also enrolling a broader group of patients. In an interim analysis, Jemperli was shown to extend progression-free survival for both the subset and the overall trial population when added to chemotherapy.

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Doug Williams, departing Codiak BioSciences CEO

Co­di­ak files for Chap­ter 11 bank­rupt­cy as most ex­ec­u­tives head for the ex­it

Codiak BioSciences has filed for Chapter 11 bankruptcy, spelling an end to the employment of most executives, including founder Doug Williams, as the biotech says it “expects to consummate a sale.”

The eight-year journey at Codiak is nearing an end with Williams; CFO Linda Bain; medical chief David Mauro; scientific head Sriram Sathyanarayanan; legal and compliance chief Yalonda Howze; and SVP of HR Nicole Barna all packing up their bags in the first few days of April. Chief technology officer Konstantin Konstantinov will stay.

Chaim Lebovits, BrainStorm Cell Therapeutics CEO

Brain­Storm gets FDA ad­comm for ALS drug af­ter failed tri­al and RTF

BrainStorm Cell Therapeutics has had a rocky road trying to get its ALS treatment through to the FDA, including a particularly difficult setback after the FDA slapped the company with a refusal to file (RTF) letter in November after it submitted its original BLA in September last year.

But there’s a glimmer of hope for BrainStorm’s ALS treatment, NurOwn – the FDA will hold an advisory committee meeting to discuss the company’s BLA for the treatment, the company announced today.

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Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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Max Colao, OncoVerity CEO

Tiny mul­ti­omics biotech se­cures for­mer J&J drug, new ex­ecs and new fi­nanc­ing

A new spinout from Belgium’s argenx seeks to give new life to a candidate once in-licensed to J&J.

OncoVerity announced Monday afternoon that it had in-licensed cusatuzumab from argenx. The biotech also appointed two new C-suite executives and secured a $30 million Series A round.

CEO Max Colao joins OncoVerity after working as Aurinia’s commercial chief, and stints at Alexion and Amgen. New CMO Clay Smith has been associate chief of the University of Colorado’s hematology division.

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