Pi­lot project pro­vides a snap­shot of ef­fec­tive­ness of Pfiz­er’s PARP con­tender ta­la­zoparib

Jen­nifer Lit­ton, MD An­der­son Can­cer Cen­ter

You can ex­pect some no­table re­search up­dates on the slate of late-stage PARP in­hibitors at this week­end’s an­nu­al Eu­ro­pean So­ci­ety of Med­ical On­col­o­gy meet­ing. And an ear­ly teas­er on what’s to come at ES­MO should help whet every­one’s ap­petite for more.

Jen­nifer Lit­ton, the prin­ci­pal in­ves­ti­ga­tor in the Phase III ta­la­zoparib study and an in­ves­ti­ga­tor at MD An­der­son Can­cer Cen­ter, set up a small pi­lot study that used the PARP in­hibitor on a group of 13 breast can­cer pa­tients with BR­CA mu­ta­tions.

These pa­tients were giv­en the drug ahead of pre-sur­gi­cal chemo, and Lit­ton says her group tracked an av­er­age 78% tu­mor shrink­age among the women in the study. The full range ex­tend­ed from 30% to 98%.

“Ac­knowl­edg­ing that this is a small study, I can’t think of any sys­temic ther­a­py that gives re­sults this con­sis­tent­ly strong in on­ly two months,” Lit­ton said. A few weeks ago, Lit­ton start­ed an ex­ten­sion of the pi­lot, en­rolling the first 6 of 20 pa­tients who can shed fur­ther light on the drug’s use in treat­ing breast can­cer. And her group is us­ing back­ing from MD An­der­son’s Moon Shots pro­gram for the work, look­ing to quick­ly ad­vance new ther­a­pies for can­cer.

“If this study pro­duces sim­i­lar­ly strong re­sults, the next step would be to di­rect­ly com­pare ta­la­zoparib to chemother­a­py in the pre-sur­gi­cal, cu­ra­tive set­ting,” Lit­ton added, “We might be able to de­lay or re­place chemother­a­py if we can get sim­i­lar ef­fi­ca­cy with less tox­i­c­i­ty from treat­ment.”

That’s an in­trigu­ing piece of the puz­zle for Pfiz­er $PFE, which agreed to pay $14 bil­lion for Medi­va­tion to get its hands on Xtan­di as well as the late-stage PARP drug. These drugs work by block­ing a DNA re­pair path­way and there has been a con­sid­er­able amount of re­search demon­strat­ing their ef­fec­tive­ness as well as a rel­a­tive­ly good safe­ty pro­file.

The big show this week­end, though, will be re­served for Tesaro $TSRO and Clo­vis On­col­o­gy $CLVS, which both have close­ly-watched PARPs lin­ing up for po­ten­tial ap­provals. For Clo­vis, ru­ca­parib presents its first re­al op­por­tu­ni­ty to gain a cru­cial­ly im­por­tant FDA ap­proval. And Tesaro has been fu­el­ing high hopes with its own late-stage da­ta set. Share prices on both com­pa­nies have been soar­ing over the last few months.

We’ll keep you post­ed on the re­sults.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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As­traZeneca gains EU nod for di­a­betes triple; Am­gen and Duke launch re­al-world PC­SK9 ob­ser­va­tion­al study

→ Weeks after winning EU approval to start marketing dapagliflozin as Forxiga, AstraZeneca has racked up another OK for a triplet combo involving the SGLT2 diabetes drug. Named Qtrilmet, the pill combines Forxiga with the DPP-4 inhibitor Onglyza (saxagliptin) and the bedrock drug metformin in a modified-release format. That 3-in-1 approach proved superior in reducing average blood glucose levels to a number of other dual combinations across 5 Phase III trials, including Forxiga plus metformin, Onglyza with metformin, or glimepiride with metformin.

Five drugs, in­clud­ing two No­var­tis ther­a­pies, win EMA en­dorse­ment

As is custom, an EMA panel on Friday issued its weekly recommendations on marketing applications submitted by drug developers. This week, the agency backed the use of five new therapies — including two Novartis drugs — but issued no negative reviews.

Novartis’ S1P drug for relapsing forms of multiple sclerosis (MS) drug, Mayzent (known chemically as siponimod), which was approved by the FDA in March — has been given the nod by the EMA. The Swiss drugmaker already sells its other MS drug, Gilenya, in both regions.

Atom­wise's X-37 spin­out gets $14.5 mil­lion to launch AI dis­cov­ery ef­forts

The folks behind Atomwise’s spinout X-37 like to think in cosmological metaphors, and you can think of their AI drug development model as probes sent into space from a central station. That station just got $14.5 million in Series A funding from DCVC Bio, Alpha Intelligence Capital and Hemi Ventures to back those missions.

X-37 uses Atomwise’s AI platform to identify drug targets and – unlike the parent company, which largely sticks to computers  – bring those into a wet lab and preclinical testing.  In addition to AI professionals, it’s led in by part by drug developers from Velocity Pharmaceutical Development.

Ab­bott Lab­o­ra­to­ries CEO Miles White pass­es ba­ton down to suc­ces­sor; Lon­za CEO Marc Funk hits the ex­it

→ Abbott Laboratories has named a successor to CEO Miles White after he announced that he was stepping down in March after 21 years of service. Robert Ford, the company’s COO and president, will take the helm. Ford is known for his work in the $25 billion merger between St. Jude Medical into Abbott in January 2017. White will remain with the company as executive chairman of the board. 

→ After snapping up Novartis’ Swiss facility, Novartis Center of Excellence, in July, Lonza has announced that their CEO, Marc Funk, is hitting the exit for “personal reasons.” Funk has been the CEO of the company for less than a year — brought onto the company back in March. In the meantime, chairman Albert Baehny will serve as interim CEO. 

BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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