In the wake of Calithera Bio­sciences ax­ing a third of its work­force in Jan­u­ary over a failed Phase II tri­al with lead drug tela­gle­na­s­tat in pa­tients with re­nal cell car­ci­no­ma, they just got slammed with the sec­ond half of a dou­ble wham­my.

The South San Fran­cis­co biotech an­nounced this morn­ing that it is ter­mi­nat­ing an­oth­er Phase II tri­al in­volv­ing the drug — this tri­al had the drug plus stan­dard-of-care chemo be­ing used in pa­tients with NSCLC with ei­ther KEAP1 or NFR2 mu­ta­tions.

The KEAP­SAKE clin­i­cal tri­al was canned be­cause there was no ob­serv­able clin­i­cal ben­e­fit, ac­cord­ing to an in­ter­im analy­sis.

While Calithera CEO Su­san Mo­lin­eaux was dis­ap­point­ed in the out­come of the tri­al, she main­tained that the KEAP­SAKE tri­al was a well-run study.

“We al­so want to ex­press our sin­cere grat­i­tude to the pa­tients who par­tic­i­pat­ed in the tri­al and their fam­i­lies, as well as the physi­cians who served as in­ves­ti­ga­tors for the tri­al and their site staff,” said Mo­lin­eaux in a pre­pared state­ment. “We re­main com­mit­ted to pa­tients with dif­fi­cult-to-treat can­cers and will con­tin­ue to ad­vance our in­ves­ti­ga­tion­al tar­get­ed ther­a­pies for bio­mark­er-spe­cif­ic pa­tient pop­u­la­tions.”

The ran­dom­ized, place­bo-con­trolled, dou­ble-blind study had 40 pa­tients ran­dom­ized — and avail­able ef­fi­ca­cy da­ta led to the con­clu­sion that there was a very low prob­a­bil­i­ty for the study to achieve a pos­i­tive re­sult. While the biotech has no plans to con­tin­ue the de­vel­op­ment of tela­gle­na­s­tat at this time, the firm es­ti­mates the cost sav­ings re­sult­ing from end­ing the tri­al will be $10-15 mil­lion.

Swiss biotech rais­es $49M Se­ries A — co-led by 5AM, Roche and Sofinno­va Part­ners

Swiss biotech Gly­co­Era AG an­nounced this morn­ing that the com­pa­ny closed a $49 mil­lion Se­ries A round.

The round, co-led by 5AM Ven­tures, Roche Ven­ture Fund and Sofinno­va Part­ners, raised funds to ex­pand the com­pa­ny and its plat­form tech­nol­o­gy in de­vel­op­ing as­sets for sev­er­al dis­ease in­di­ca­tions, ac­cord­ing to a com­pa­ny state­ment.

But as part of the round, Gly­co­Era is bring­ing on a few new mem­bers to its board of di­rec­tors: Mi­ra Chau­rushiya of 5AM, Monique Schiers­ing from Roche’s Ven­ture Fund and Graziano Seghezzi with Sofinno­va Part­ners. They will join Gly­co­Era’s co-founders, Veron­i­ca Gam­bil­lara Fon­ck and Amir Farid­moay­er, as well as In­nospark Ven­tures ad­vi­sor Ganesh Kaun­dinya on the board.

“Back­ing teams is a core part of the Sofinno­va strat­e­gy, so we are de­light­ed to be work­ing, once again, with a group of vet­er­ans who were in­stru­men­tal in the suc­cess of an­oth­er Sofinno­va port­fo­lio com­pa­ny, Gly­co­V­axyn,” Seghezzi said in a pre­pared state­ment. “We have enor­mous con­fi­dence in Gly­co­Era’s po­ten­tial to car­ry its ground­break­ing tech­nol­o­gy for­ward in­to mul­ti­ple ther­a­peu­tic ar­eas.”

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.