News brief­ing: Mer­ck preps FDA pitch af­ter adding more da­ta on V114; Bris­tol My­ers, Ex­elix­is get quick re­view for can­cer com­bo

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 

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Chris Sheldon, AstraZeneca's former VP and head of investor relations

As­traZeneca files law­suit against for­mer ex­ec as he jumps to GSK

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.

Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

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.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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Joel Dudley, new partner at Innovation Endeavors (Bosch Health Campus)

For­mer Google CEO’s VC is mak­ing a big­ger push in­to the biotech world, hir­ing promi­nent Ther­a­nos skep­tic

Venture capital firm Innovation Endeavors has mainly had its focus on investments across the tech space, but it has been slowly turning its attention to the biotech world. Now, a new partner is coming into the fold showing that its interest in biotech is likely to grow further.

The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs since 2020.

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