A BTK in­hibitor Bio­gen punt­ed out of its pipeline years ago has flopped its first clin­i­cal test.

Day­ton Mis­feldt

Sune­sis Phar­ma said it would not be tak­ing ve­cabru­ti­nib in­to the Phase II por­tion of its Phase Ib/II tri­al af­ter re­view­ing ini­tial da­ta that sug­gest lim­it­ed ef­fi­ca­cy even at the high­est dose. The tri­al had en­rolled adult pa­tients with re­lapsed/re­frac­to­ry chron­ic lym­pho­cyt­ic leukemia (CLL) and oth­er B-cell ma­lig­nan­cies. The safe­ty pro­file was “ex­cel­lent”; it just didn’t seem to have much of an ef­fect.

Day­ton Mis­feldt, the Bay City Cap­i­tal VC who’s been in­ter­im CEO for more than two years, summed it up this way:

One par­tial re­mis­sion was ob­served af­ter 11 treat­ment cy­cles in a CLL pa­tient treat­ed in Co­hort 5 (300 mg BID) and a num­ber of pa­tients treat­ed across the dose range ex­plored (25 mg to 500 mg BID) saw sta­ble dis­ease; how­ev­er, no oth­er re­mis­sions have been ob­served.

The Phase Ib pro­gram will con­tin­ue while Sune­sis ex­ecs de­cide on the drug’s fate. Shares of the South San Fran­cis­co com­pa­ny on the Nas­daq — a pen­ny­s­tock — plum­met­ed 43.68% to $0.35 pre-mar­ket.

For now, Sune­sis will shift its fo­cus and re­sources to a PDK-1 in­hibitor dubbed SNS-510 — a process that should be fa­mil­iar to the com­pa­ny by now.

When it went pub­lic in 2005, the lead prod­uct can­di­date was SNS-595 (vosarox­in), a cell-cy­cle in­hibitor lat­er po­si­tioned for leukemia. Reg­u­la­tors spurned their Phase III da­ta and Sune­sis end­ed up out-li­cens­ing it to De­n­o­vo Bio­phar­ma, which spe­cial­izes in find­ing ap­plic­a­ble sub­groups for drugs that have com­plet­ed tri­als with “un­sat­is­fac­to­ry ef­fi­ca­cy.” Not much came out of the sec­ond project to de­vel­op an Au­ro­ra ki­nase in­hibitor, ei­ther.

The cur­rent pipeline of two con­sists en­tire­ly of as­sets orig­i­nat­ing from a col­lab­o­ra­tion with Bio­gen, who was al­so an eq­ui­ty hold­er. Aside from ve­cabru­ti­nib, a non-co­va­lent in­hibitor of BTK that promised to help Im­bru­vi­ca-re­sis­tant pa­tients, SNS-510 tar­gets PI3K-de­pen­dent and PIP3-in­de­pen­dent path­ways.

With Take­da on board as a part­ner, an IND is in the works for the end of 2020. The cash re­serves should be enough to get them there — but like­ly not that much be­yond.

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.