SAN DIEGO — Since Her­cept­in's ap­proval in 1998, breast can­cer has been re­shaped from a near-term death sen­tence in­to — in many cas­es — a chron­ic dis­ease. Now, re­searchers hope darax­on­ra­sib from Rev­o­lu­tion Med­i­cines will launch the same type of trans­for­ma­tion in pan­cre­at­ic can­cer.

A re­cent Phase 3 find­ing on darax­on­ra­sib “is one of the most im­por­tant things that’s hap­pened in can­cer ther­a­peu­tics in the last 30 to 40 years,” Stifel health­care di­rec­tor Tim Opler said. “This is very much a Her­ceptin-type mo­ment.”

Be­fore Her­ceptin’s ap­proval, chemother­a­py was of­ten the on­ly treat­ment for breast can­cer, po­ten­tial­ly keep­ing the can­cer at bay for a few months. But the tu­mors would re­cur in most cas­es, leav­ing pa­tients with­out fur­ther op­tions.

Carvyk­ti shows promise in pa­tients be­fore full-blown mul­ti­ple myelo­ma: Re­searchers from Dana-Far­ber Can­cer In­sti­tute shared that 20 pa­tients with high-risk smol­der­ing mul­ti­ple myelo­ma all saw signs of their dis­ease go away af­ter re­ceiv­ing Carvyk­ti, a CAR-T ther­a­py mar­ket­ed by John­son & John­son and Leg­end Biotech. Smol­der­ing myelo­ma is a pre­cur­sor dis­ease to mul­ti­ple myelo­ma, where rough­ly half of high-risk pa­tients will progress to ac­tive can­cer in two years.

At a me­di­an of 15.3 months, any re­main­ing myelo­ma cells were un­de­tectable in the blood of all 20 pa­tients as part of the Phase 2 tri­al. Sev­en pa­tients faced neu­ro­tox­i­c­i­ties that are known to be re­lat­ed to Carvyk­ti treat­ment, with three fac­ing on­go­ing neu­ro­tox­i­c­i­ties that did not in­ter­fere much with dai­ly liv­ing. The da­ta were al­so pub­lished in Na­ture Med­i­cine. Cur­rent­ly, the on­ly ap­proved treat­ment for these pa­tients is J&J's Darza­lex, though pa­tients have long been put un­der ob­ser­va­tion with­out in­ter­ven­tion as well. Carvyk­ti is cur­rent­ly ap­proved to treat sec­ond-line and lat­er mul­ti­ple myelo­ma pa­tients, and is be­ing stud­ied as a front­line treat­ment. — Lei Lei Wu

Flag­ship Pi­o­neer­ing, the life sci­ence in­vest­ment firm that helped make med­i­cines out of mR­NA by launch­ing Mod­er­na, has sim­i­lar­ly grand am­bi­tions for DNA.

On Tues­day, the firm un­veiled its lat­est start­up, Serif Bio­med­i­cines, backed with $50 mil­lion to tack­le one of the tough­est chal­lenges in gene ther­a­py: de­liv­er­ing DNA in­to the body with­out the aid of an en­gi­neered virus.

Swap­ping virus­es for oth­er de­liv­ery ves­sels like lipid nanopar­ti­cles could lead to safer and cheap­er treat­ments. Sev­er­al oth­er biotech star­tups have tried and failed to get the ap­peal­ing idea to work. But Serif be­lieves it could be close to solv­ing the prob­lem, and it’s try­ing to dis­tance it­self from the tar­nished “non-vi­ral gene ther­a­py” nomen­cla­ture that its de­funct pre­de­ces­sors of­ten used.