Ver­tex will start hu­man test­ing of a new-and-im­proved ver­sion of its stem cell ther­a­py for type 1 di­a­betes.

Reg­u­la­tors cleared Ver­tex’s IND for its stem cell-de­rived pan­cre­at­ic islet cell ther­a­py VX-264 in type 1 di­a­betes, the com­pa­ny an­nounced Thurs­day.

While the new can­di­date us­es the same islet cells as VX-880, Ver­tex’s orig­i­nal stem cell pro­gram for di­a­betes, it al­so makes use of an im­muno­pro­tec­tive de­vice that po­ten­tial­ly elim­i­nates the need for im­muno­sup­pres­sion. Pa­tients who take im­muno­sup­pres­sants may face a range of side ef­fects, in­clud­ing an in­creased risk of in­fec­tion. The de­vice used in this pro­gram was in­vent­ed by Sem­ma Ther­a­peu­tics, which was ac­quired by Ver­tex in 2019, and fur­ther de­vel­oped at Ver­tex, ac­cord­ing to a spokesper­son.

The news comes sev­er­al months af­ter Ver­tex struck a $320 mil­lion deal to ac­quire Vi­a­Cyte and its oth­er stem cell pro­gram for di­a­betes. The deal was in­tend­ed to ac­cel­er­ate Ver­tex’s over­all di­a­betes pipeline, but did not play in­to the de­vel­op­ment of ei­ther VX-880 or VX-264, ac­cord­ing to the com­pa­ny.

Both com­pa­nies had been at­tempt­ing to re­ju­ve­nate pa­tients’ abil­i­ties to pro­duce their own in­sulin us­ing stem cell trans­plants. Vi­a­Cyte was go­ing for an “off-the-shelf” gene-edit­ed ap­proach en­cap­su­lat­ed in im­mune-evad­ing de­vices that re­searchers thought could pre­vent re­jec­tion.

“VX-880 has suc­cess­ful­ly demon­strat­ed clin­i­cal proof of con­cept in T1D, and the ac­qui­si­tion of Vi­a­Cyte will ac­cel­er­ate our goal of trans­form­ing, if not cur­ing T1D by ex­pand­ing our ca­pa­bil­i­ties and bring­ing ad­di­tion­al tools,” CEO Resh­ma Ke­wal­ra­mani said in a state­ment at the time.

Ver­tex plans to launch a Phase I/II tri­al in the first half of this year and is al­ready con­duct­ing a Phase I/II in Cana­da, it said on Thurs­day.

Ed­i­tor’s Note: This sto­ry has been up­dat­ed through­out to re­flect that Vi­a­Cyte’s tech­nol­o­gy was not used in the de­vel­op­ment of VX-880 or VX-264. A pre­vi­ous ver­sion of this sto­ry in­cor­rect­ly stat­ed that VX-264 was de­vel­oped us­ing tech­nol­o­gy from the Vi­a­Cyte ac­qui­si­tion. The sto­ry has been cor­rect­ed to re­flect that the de­vice used in this pro­gram was in­vent­ed by Sem­ma Ther­a­peu­tics, which was ac­quired by Ver­tex in 2019, and fur­ther de­vel­oped at Ver­tex.

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.