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prepmod vaccine :: Article Creator What Went Wrong With The 'Tiny Nonprofit' Behind The State's Beleaguered Vaccine Site When Gov. Charlie Baker released vaccine eligibility to a million more Massachusetts residents last week, state websites crumpled under a virtual stampede of people rushing to secure appointments. Users were left in online limbo for hours, and many gaped at how something so critical could be entrusted to, in their eyes, flimsy web services and fragile program designs. "Foolish system. Ill-Designed. Who are the people that designed it?" seethed Steve Rosenfeld, 70, from Worcester in a written comment to WBUR after he failed to get an appointment. The nonprofit Maryland Partnership for Prevention runs one of the crucial websites that crashed last week, a service it provides in more than two dozen states across the country. The company's software allows people to register their COVID-19 vaccines and make a...

A cancer vaccine that might work? Moderna posts 'promising' early snapshot for Merck-partnered program and raids Bristol Myers for a new cancer R&D chief - Endpoints News

Re­mem­ber that per­son­al­ized can­cer vac­cine Mod­er­na was de­vel­op­ing?

As the world awaits da­ta from its late-stage Covid-19 can­di­date, the mR­NA play­er is in­ter­rupt­ing its most in­ten­sive­ly watched pro­gram with an up­beat ear­ly snap­shot of da­ta from its mes­sen­ger RNA can­cer vac­cine mR­NA-4157. And the Mod­er­na team is us­ing the oc­ca­sion to in­tro­duce a new chief for their on­col­o­gy unit, raid­ed from Bris­tol My­ers Squibb’s can­cer group.

When com­bined with Mer­ck’s Keytru­da in the Phase I KEYNOTE-603 tri­al, re­searchers re­port, the vac­cine ap­pears some­what ef­fec­tive in shrink­ing tu­mors. Among 10 pa­tients with HPV-neg­a­tive head and neck squa­mous cell car­ci­no­ma, the over­all re­sponse rate is 50%: 2 com­plete re­spons­es and 3 par­tial re­spons­es. And it is trans­lat­ing to con­sid­er­able ben­e­fit over the PD-1 in­hibitor alone:

Me­di­an pro­gres­sion free sur­vival (mPFS) is 9.8 months, which com­pares fa­vor­ably to the pub­lished ORR and mPFS of 14.6% and 2.0 months re­spec­tive­ly, for Keytru­da monother­a­py. In­clud­ing four pa­tients with sta­ble dis­ease, the Dis­ease Con­trol Rate (DCR) is 90% (9/10). Me­di­an du­ra­tion of re­sponse has not been reached.

“The da­ta are pre­lim­i­nary and the sam­ple size is small, but it is promis­ing,” Uni­ver­si­ty of Ari­zona pro­fes­sor Julie Bau­man, who’s pre­sent­ing the in­ter­im da­ta at The So­ci­ety for Im­munother­a­py of Can­cer’s An­nu­al Meet­ing, said in a state­ment. “A phase I tri­al is about safe­ty first and fore­most, and we now know this treat­ment is safe and tol­er­a­ble. But, we al­so have a strong sig­nal to point us to fur­ther study this in head and neck can­cer.”

Jef­feries an­a­lyst Michael Yee ob­served that the re­sults com­pare fa­vor­ably even with the Keytru­da/chemo com­bo, the stan­dard of care in first-line treat­ment, which yields an ORR of 36% and mPFS of 4.9 months.

“While 4/5 re­spon­ders achieved PR af­ter 2 dos­es of Keytru­da pri­or to mR­NA-4157, all 4 re­spons­es deep­ened af­ter mR­NA-4157 ad­min­is­tra­tion w/ 2 PRs con­vert­ing to CRs,” he wrote “Add’l, one pt pro­gressed on Keytru­da, but start­ed to re­spond af­ter mR­NA-4157.”

In the mi­crosatel­lite sta­ble col­orec­tal car­ci­no­ma group, though, no re­spons­es were ob­served out of 17 pa­tients.

With a clean tol­er­a­bil­i­ty so far, Mod­er­na now plans to ex­pand the HN­SCC co­hort to 40 pa­tients. For each one, the com­pa­ny tai­lor makes a vac­cine with mes­sen­ger RNA that en­codes up to 20 neoepi­topes that its al­go­rithms pre­dict would stir up the strongest im­mune re­sponse.

It will be do­ing so un­der the lead­er­ship of Praveen Aa­nur, who’s jump­ing from Bris­tol My­ers Squibb to be­come Mod­er­na’s ther­a­peu­tic area head for on­col­o­gy de­vel­op­ment. Aa­nur spent the last 7 years work­ing on Bris­tol My­ers’ im­muno-on­col­o­gy pipeline. He re­ceived an MBBS from Ban­ga­lore Uni­ver­si­ty, an MPH from the Uni­ver­si­ty of Al­aba­ma and an MBA from Co­lum­bia Uni­ver­si­ty School of Busi­ness.

Can­cer vac­cines are gain­ing trac­tion among hefty bio­phar­ma play­ers again as new biotechs spring up fol­low­ing a se­ries of clin­i­cal dis­as­ters among the gen-1 play­ers. Re­gen­eron is al­lied with BioN­Tech — now a house­hold name thanks to its Pfiz­er-part­nered Covid-19 ef­fort — on a Phase II test­ing a 4-anti­gen can­di­date, while Roche re­cent­ly shelled out $200 mil­lion for a neoanti­gen pro­gram.



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