Dutch VC For­bion is hop­ping on the ever-length­en­ing SPAC train.

To be led by Jasper Bos, who joined For­bion Growth as a gen­er­al part­ner back in May just af­ter the fund closed at $428 mil­lion, For­bion Eu­ro­pean Ac­qui­si­tion will tar­get late-stage op­por­tu­ni­ties in the life sci­ences in­dus­try in Eu­rope to merge with and bring on­to Nas­daq.

Cyril Less­er, se­nior con­troller at For­bion, will be the CFO while Bos serves as CEO.

Af­ter a record year for biotech SPACs, the craze for blank check com­pa­nies ap­pears to be in a bit of a lull re­cent­ly, al­though it’s clear­ly not stop­ping ex­pe­ri­enced in­vestors who think they will be able to spot a de­cent pri­vate com­pa­ny to flip pub­lic.

As is stan­dard with these types of deals, For­bion Eu­ro­pean Ac­qui­si­tion is pen­cil­ing in a $100 mil­lion raise by sell­ing shares at $10 apiece — a pitch cen­tered around the man­age­ment team’s ex­pe­ri­ence, net­work and ex­per­tise. It may raise an­oth­er $20 mil­lion “at the clos­ing of an ac­qui­si­tion,” the com­pa­ny added. — Am­ber Tong

Kro­nos Bio re­leas­es ear­ly in­ter­im da­ta on CDK9 in­hibitor

On­col­o­gy biotech Kro­nos Bio an­nounced da­ta from its on­go­ing Phase I/II clin­i­cal tri­al of its oral CDK9 in­hibitor KB-0742, which is be­ing de­vel­oped to treat MYC-am­pli­fied sol­id tu­mors.

Among the 12 pa­tients treat­ed in the tri­al, KB-0742 had a ter­mi­nal half-life of 24 hours, with ap­prox­i­mate­ly 2 to 2.5-fold ac­cu­mu­la­tion be­tween days 1 and 10. Ac­cord­ing to Kro­nos, this long plas­ma half-life sup­ports the biotech’s ap­proach to defin­ing a ther­a­peu­tic win­dow for CDK9 in­hi­bi­tion.

Fur­ther dose es­ca­la­tion — the first part of the two-stage tri­al — is re­quired to reach de­sired lev­els of CDK9 in­hi­bi­tion.

The na­ture and sever­i­ty of the ad­verse events ob­served have been con­sis­tent with what is typ­i­cal­ly seen among heav­i­ly pre­treat­ed pa­tients with ad­vanced can­cer in Phase I tri­als, and Kro­nos Bio is con­tin­u­ing to en­roll in the tri­al.

“These ear­ly da­ta are en­cour­ag­ing, and we look for­ward to con­tin­u­ing the tri­al and es­tab­lish­ing a rec­om­mend­ed Phase II dose,” said Kro­nos Bio CEO and pres­i­dent Nor­bert Bischof­berg­er.

While the first stage is de­ter­min­ing safe­ty of the drug and find­ing a dosage lev­el for pa­tients, the sec­ond stage of the tri­al will en­roll pa­tients with MYC-am­pli­fied or over-ex­press­ing tu­mors, as well as oth­er tran­scrip­tion­al­ly ad­dict­ed tu­mor types, to as­sess the an­ti-tu­mor ac­tiv­i­ty of KB-0742 at the rec­om­mend­ed Phase II dose. — Paul Schloess­er

Gilead goes with Ama­zon Web Ser­vices as its cloud provider

Gilead had de­cid­ed on Ama­zon for its cloud ser­vices.

Gilead an­nounced this morn­ing that it is go­ing with Ama­zon Web Ser­vices as its cloud provider — cit­ing AWS’s on­line port­fo­lio for in­fra­struc­ture and oth­er ser­vices.

Ac­cord­ing to Gilead, AWS’ ca­pa­bil­i­ties in ma­chine learn­ing and an­a­lyt­ics fu­el de­ci­sion mak­ing across the phar­ma — from bio­mark­er dis­cov­ery to man­u­fac­tur­ing and clin­i­cal tri­al re­cruit­ment.

“With AWS as our pre­ferred cloud provider, our re­searchers can use AWS’s port­fo­lio of ser­vices to gain the in­sights, agili­ty, and se­cu­ri­ty need­ed to de­liv­er new med­i­cines at speed,” said Gilead SVP and CIO Marc Berson in a pre­pared state­ment.

In ad­di­tion, Gilead has moved more than 50% of its da­ta cen­ter foot­print to AWS over the past year through an ac­cel­er­at­ed cloud mi­gra­tion pro­gram with AWS Pro­fes­sion­al Ser­vices. The com­pa­ny al­so plans to mi­grate hun­dreds of ap­pli­ca­tions to AWS, which in­clude ap­pli­ca­tions that sup­port in­dus­try good prac­tice guide­lines and reg­u­la­tions in ar­eas like drug man­u­fac­tur­ing, stor­age and dis­tri­b­u­tion.

As a re­sult, Gilead will be ac­cel­er­at­ing its plans to up­grade its IT op­er­a­tions with AWS, while avoid­ing up­front costs to re­fresh hard­ware and the sus­tained costs of run­ning an “al­ways on,” on-premis­es IT land­scape pro­vi­sioned for peak use. — Paul Schloess­er

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.