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.

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.

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.