Long­time stem cell play­er Vi­a­Cyte has teamed up with a ma­te­ri­als sci­ence com­pa­ny in an ef­fort to solve im­muno­sup­pres­sion chal­lenges and ad­vance its type 1 di­a­betes treat­ments.

Ex­pand­ing on an ex­ist­ing col­lab­o­ra­tion, Vi­a­Cyte and W.L. Gore have agreed to com­bine the biotech’s PEC-En­cap can­di­date with a Gore-pro­duced mem­brane in what they hope will elim­i­nate the need for im­muno­sup­pres­sive drugs. Such treat­ments have cre­at­ed for­eign body re­spons­es in the past, and stamp­ing these re­ac­tions out is the main goal, Vi­a­Cyte CEO Paul Laikind said.

Such re­spons­es “ba­si­cal­ly can lead to a de­po­si­tion of what’s called for­eign-body gi­ant cells on the sur­face of the de­vice” and in­ter­fere with its process­es, Laikind told End­points News. Vi­a­Cyte and Gore’s fo­cus is cut­ting these re­ac­tions out en­tire­ly.

The prod­uct is de­signed to be im­plant­ed un­der­neath the skin and de­liv­er pan­cre­at­ic prog­en­i­tor cells that can se­crete in­sulin and con­trol blood glu­cose lev­els, in essence be­com­ing func­tion­al tis­sue. Not on­ly do the com­pa­nies aim to pro­vide this treat­ment but al­so pro­tect the cells from the hosts’ im­mune sys­tems, as the mem­brane al­lows for the cre­ation of a vas­cu­lar net­work on the sur­face of the de­vice.

Kevin D’Amour

“Those pan­cre­at­ic cells stay in the de­vice, and we’re es­sen­tial­ly re­plac­ing the nor­mal hu­man cells that are lost or dys­func­tion­al in di­a­betes pa­tients,” said Vi­a­Cyte CSO Kevin D’Amour. “They’re be­hold­en to in­ject­ing ex­oge­nous in­sulin to con­trol their blood sug­ar.”

Even though Laikind said the goal is to, es­sen­tial­ly, cure type 1 di­a­betes by way of these cell and hor­mone re­place­ments, the com­pa­nies would be con­tent by sim­ply re­duc­ing the need for in­jectable in­sulin use as that would still con­sti­tute a sig­nif­i­cant ther­a­peu­tic ad­vance.

Erin Hutchin­son

Erin Hutchin­son, a busi­ness leader at Gore, said the tricky part in cre­at­ing the right kind of mem­brane is get­ting the lev­el of per­me­abil­i­ty ex­act­ly cor­rect.

“You don’t want the cells in­side to es­cape and you don’t want the im­mune sys­tem to get in,” Hutchin­son said. “On the oth­er hand, you do want to al­low for trans­port, for things like oxy­gen, in­sulin, glu­cose, etc. And so that’s kind of the chal­lenge, de­sign­ing a mem­brane as part of an over­all de­vice that can do that.”

Stem cell R&D had been a hype train in ear­ly in­vest­ments but has since turned in­to a long-run­ning af­fair, and Vi­a­Cyte is no dif­fer­ent from oth­er such biotechs in this re­gard. The com­pa­ny had at­tempt­ed pair­ing its stem cell tech­nol­o­gy with a dif­fer­ent mem­brane be­fore, but ran in­to trou­ble when pa­tients de­vel­oped those for­eign body re­spons­es. That led them to col­lab­o­rate with Gore, which first signed on to an agree­ment in 2017 and then chipped in with $10 mil­lion as part of a larg­er Vi­a­Cyte fund­ing round in No­vem­ber 2018.

Phase I/II clin­i­cal tri­als of PEC-En­cap with the new mem­brane are un­der­way af­ter some de­lays re­lat­ed to Covid-19. Ear­ly in­di­ca­tions are promis­ing, Laikind said, but the com­pa­nies still need to go down the path of com­mer­cial­iza­tion.

“The im­mune re­sponse is pret­ty con­sis­tent among pa­tients, cer­tain­ly some will re­act more ag­gres­sive­ly than oth­ers,” Laikind said. “But the de­sign of the de­vice is meant to pro­tect the cells from the im­mune re­sponse of any pa­tient … We re­al­ly be­lieve we’re down to the fi­nal step to­ward a com­mer­cial prod­uct in prov­ing the ef­fec­tive de­liv­ery of graft­ing.”

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.