#ES­MO18: Crowned with a break­through ti­tle, Clo­vis takes an ear­ly lead as it races for a fast OK for Rubra­ca in prostate can­cer

MU­NICH — With Lyn­parza from As­traZeneca and Mer­ck ex­pand­ing on a big lead for ovar­i­an and breast can­cer, Clo­vis On­col­o­gy $CLVS is map­ping a sep­a­rate route in prostate can­cer for their PARP ri­val Rubra­ca that may pay off hand­some­ly.

The Boul­der, CO-based biotech turned up in Mu­nich to­day to un­veil an ear­ly look at Phase II da­ta from their TRI­TON2 study, with a 44% con­firmed ob­jec­tive re­sponse rate in 25 sec­ond-line, RE­CIST-evalu­able pa­tients with a BR­CA1/2 al­ter­ation. Re­searchers al­so claimed a 51% PSA re­sponse rate in 45 prostate can­cer pa­tients as well as some bio­mark­er re­ac­tions that they count as a promis­ing sign for the fu­ture da­ta to come out of the pro­gram.

We al­ready knew that the da­ta would be up­beat at ES­MO. Clo­vis won a break­through drug des­ig­na­tion from the FDA for the cas­tra­tion-re­sis­tant crowd of pa­tients based on the ear­ly mid-stage re­sults. 

That move en­cour­aged An­drew Berens at Leerink to of­fer a cheer at the time:

We see BTD as en­cour­ag­ing for the com­pa­ny ahead of the pre­sen­ta­tion of Phase 2 da­ta at ES­MO on 10/21, and con­tin­ue to be­lieve that prostate can­cer ex­pan­sion could add a unique di­men­sion to the Clo­vis sto­ry.

If the da­ta hold up, Clo­vis could be on track to win­ning the first, ac­cel­er­at­ed ap­proval in prostate can­cer, with a pitch com­ing by the end of 2019. Berens es­ti­mates that an ap­proval there would be worth $580 mil­lion in peak sales for that in­di­ca­tion alone.

That’s an up­beat as­sess­ment for a com­pa­ny that has had to deal with an SEC in­ves­ti­ga­tion in­to the way they han­dled their ro­ci da­ta. You’ll note that Clo­vis re­strict­ed it­self to con­firmed ORRs for Rubra­ca’s prostate can­cer da­ta af­ter be­ing ac­cused of play­ing fast and loose with the ro­ci re­sults, mis­lead­ing their in­vestors at the time.

Lat­er over the week­end we’ll find out the hard da­ta that As­traZeneca nailed down for Lyn­parza in front­line main­te­nance ovar­i­an can­cer, which they have al­ready hailed as promis­ing. These PARP in­hibitors in­ter­fere with DNA re­pair mech­a­nisms, killing tar­get­ed, fast grow­ing can­cer cells. 

It’s a crowd­ed field, es­pe­cial­ly now that Pfiz­er just won an OK for its PARP, the fourth on the US mar­ket, with Tesaro al­so in the mix. These PARPs, though, have proven to be quite sim­i­lar, so a first-to-mar­ket suc­cess may pro­vide on­ly a tem­po­rary win, with tol­er­a­bil­i­ty of­fer­ing one way for a leader to dis­tin­guish it­self.

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

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

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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