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.”

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Roche is gambling on a new way of discovering drug targets and, ultimately, promising to infuse more than $375 million into a small biotech if all goes well.

A spinout of the Netherlands Cancer Institute and Oxford University, Scenic Biotech set out to pioneer a field that’s gaining some traction among top VCs in the US: to harness the natural protecting powers of genetic modifiers — specific genes that suppress a disease phenotype.

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.