Mer­ck has new da­ta out from two Phase III tri­als on its pneu­mo­coc­cal con­ju­gate vac­cine can­di­date cov­er­ing 15 dif­fer­ent serotypes.

The pro­gram, dubbed V114, was test­ed in the first study in healthy adults aged 50 or old­er, with pa­tients re­ceiv­ing ei­ther the ex­per­i­men­tal vac­cine or the ap­proved Pre­vnar 13, fol­lowed by Mer­ck’s Pneu­movax 23 vac­cine one year lat­er. Af­ter that pe­ri­od, im­mune re­spons­es were com­pa­ra­ble in both vac­ci­na­tion groups for the 15 serotypes in V114.

In the sec­ond tri­al, which stud­ied the V114 vac­cine in adults be­tween 18 and 49 years old with un­der­ly­ing med­ical con­di­tions as­so­ci­at­ed with high­er risks of pneu­mo­coc­cal dis­ease, Mer­ck’s can­di­date saw com­pa­ra­ble im­mune re­spons­es to Pre­vnar 13 in the 13 over­lap­ping serotypes. V114 al­so showed high­er im­mune re­spons­es in the two serotypes not in­clud­ed in the Pre­vnar vac­cine — 22F and 33F — 30 days af­ter vac­ci­na­tion.

Those two ad­di­tion­al serotypes are among the most com­mon caus­es of in­va­sive pneu­mo­coc­cal dis­ease in adults old­er than 65 out of more than 90 to­tal serotypes. Mer­ck said its plans to file with the FDA for ap­proval be­fore the end of the year re­mains on track. — Max Gel­man

Armed with stel­lar PhI­II, Bris­tol My­ers, Ex­elix­is are flagged in­to the FDA’s fast lane

The FDA is of­fer­ing swift ac­tion on the ap­pli­ca­tion to com­bine Op­di­vo and Cabome­tyx for ad­vanced re­nal cell car­ci­no­ma. The part­ners picked up a pri­or­i­ty re­view for their pitch, with a PDU­FA date of Feb. 20.

Giv­en their track records, though, reg­u­la­tors may not re­quire all that time to make a de­ci­sion.

The de­vel­op­ers sub­mit­ted da­ta from the Phase 3 Check­Mate -9ER tri­al to back their ap­pli­ca­tion. The col­lab­o­ra­tors pulled the cur­tain back on some stel­lar da­ta for their com­bi­na­tion of Op­di­vo (the PD-1) and Cabome­tyx (the TKI) at ES­MO, mark­ing a sig­nif­i­cant ad­vance for the block­buster Bris­tol My­ers fran­chise while of­fer­ing a big leg up for the team at Ex­elix­is. — John Car­roll

Re­verse merg­er adds ra­di­a­tion de­fense to im­munomod­u­la­tion play­er’s menu

Im­munomod­u­la­tion-fo­cused biotech Cy­to­com is merg­ing with Cleve­land Bi­o­Labs to grab a spot on Nas­daq — and ex­pand its al­ready-broad port­fo­lio even fur­ther.

While the new com­pa­ny will be named Cy­to­com, Cleve­land Bi­o­Labs’ lead can­di­date, en­tolimod, will re­main in the pipeline for fur­ther de­vel­op­ment in can­cer and ra­di­a­tion de­fense. Mean­while, Cy­to­com will con­tin­ue to de­vel­op its four late-stage pro­grams for Crohn’s dis­ease, fi­bromyal­gia, mul­ti­ple scle­ro­sis and pan­cre­at­ic can­cer.

Michael Han­d­ley

That makes Cy­to­com, which was found­ed on a plat­form dubbed Ad­vanced Im­munomod­u­lat­ing Mul­ti-re­cep­tor Sys­tem, of­fi­cial­ly a play­er in acute ra­di­a­tion in­jury, on­col­o­gy, in­fec­tious dis­ease, in­flam­ma­tion and au­toim­mune-me­di­at­ed con­di­tions.

“We plan to uti­lize the com­bined plat­form to fur­ther dri­ve val­ue with ad­di­tion­al clin­i­cal and com­mer­cial prod­ucts and con­tin­ue to seek strate­gic part­ner­ships and ac­qui­si­tions,” CEO Michael Han­d­ley said in a state­ment.

Just a few months ago he en­gi­neered an all-stock deal to buy out a sub­sidiary of the con­tract re­search or­ga­ni­za­tion ImQuest, bag­ging new tools for in­ter­nal drug dis­cov­ery and de­vel­op­ment. — Am­ber Tong

Sci­ence 37 and Sig­nant part­ner on vir­tu­al clin­i­cal tri­als 

Sci­ence 37 and Sig­nant Health are team­ing up to pave the way for vir­tu­al cen­tral ner­vous sys­tem-fo­cused clin­i­cal tri­als.

David Co­man

The part­ner­ship will com­bine Sci­ence 37’s tech­nol­o­gy and net­work of pa­tients, telemed­i­cine staff, cen­tral raters and mo­bile nurs­es with Sig­nant’s elec­tron­ic clin­i­cal out­comes as­sess­ment soft­ware and ran­dom­ized and tri­al sup­ply man­age­ment (RTSM) tech­nol­o­gy. As a re­sult, pa­tients will have more op­tions for par­tic­i­pat­ing in clin­i­cal tri­als, in­clud­ing vir­tu­al and hy­brid mod­els.

The goal, ac­cord­ing to Sci­ence 37 CEO David Co­man, is to “bring clin­i­cal tri­als to pa­tients.”

“Out of ne­ces­si­ty, our in­dus­try has ac­cel­er­at­ed the path­way to dig­i­tal­ly en­abled clin­i­cal tri­als,” Sig­nant CEO Roger Smith said in a state­ment. “That’s why we are proud to part­ner with Sci­ence 37 and help all clin­i­cal tri­al stake­hold­ers con­tin­ue the progress we have col­lec­tive­ly made in clin­i­cal tri­al con­duct.” — Nicole De­Feud­is 

AstraZeneca and GSK are once again wrangling over talent.

The British pharma giant has filed suit against former VP and head of investor relations Chris Sheldon as he prepares to start a new job at its rival next month. AstraZeneca argued in a London court filing that Sheldon would be violating a non-compete agreement, which he was paid more than $774,000 in shares to sign back in 2021, Bloomberg reported.

GSK has landed a new first from UNICEF — the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”