Vi­iV Health­care and ma­jor­i­ty own­er Glax­o­SmithK­line have cleared an­oth­er im­por­tant hur­dle on a long-run­ning quest to chal­lenge Gilead’s dom­i­nance in pre­ven­ta­tive HIV treat­ments.

The fi­nal analy­sis of a new study shows the GSK sub­sidiary’s long-last­ing in­jec­tion, cabote­gravir, proved 66% more ef­fec­tive in HIV pre­ven­tion than Gilead’s break­through Tru­va­da pill. And they now in­tend to carve away some of the block­buster rev­enue that Gilead has en­joyed for years.

The study, re­leased Tues­day, com­pared the ef­fects of pa­tients tak­ing cabote­gravir ver­sus those tak­ing dai­ly oral pills. With­in the in­jec­tion arm of the test, re­searchers doc­u­ment­ed on­ly 13 cas­es of HIV, or an in­ci­dence rate of 0.41%. In the pill arm, 39 cas­es were found, amount­ing to a rate of 1.22%. The study al­so not­ed high lev­els of ad­her­ence to dai­ly oral ther­a­py.

Due to the Covid-19 pan­dem­ic, the blind­ed phase of the study was halt­ed in May. Af­ter a fi­nal analy­sis and re­view, Vi­iV was able to con­firm the in­jec­tions proved more ef­fec­tive than dai­ly pills at the high­light­ed 66 per­cent rate.

Kim­ber­ly Smith

“This ad­vance­ment has the po­ten­tial to be a game-chang­er for HIV pre­ven­tion, of­fer­ing … the con­ve­nience of re­duced dos­ing from dai­ly to just six times per year,” Kim­ber­ly Smith, R&D chief at Vi­iV, told Reuters.

The re­sults of the study come as gener­ic ver­sions of Tru­va­da, a once-dai­ly pill that re­duces the risk of con­tract­ing HIV through sex by about 99 per­cent, are about to hit the mar­ket. Tru­va­da and De­scovy, an­oth­er Gilead HIV treat­ment, have al­lowed the com­pa­ny to es­sen­tial­ly own the en­tire drug sec­tor ever since Tru­va­da was green-lit by the FDA in 2012 as the first pre­ven­ta­tive mea­sure for HIV.

How­ev­er, Gilead is fac­ing a law­suit from ac­tivists claim­ing the com­pa­ny ex­tend­ed its mo­nop­oly by il­le­gal­ly al­ter­ing de­vel­op­ment times, and a law­suit from the US gov­ern­ment al­leg­ing im­prop­er patent prac­tices. Gilead has al­so faced heavy crit­i­cism of price goug­ing, as Tru­va­da treat­ment can cost around $20,000 per year.

Tru­va­da net­ted Gilead $2.8 bil­lion in sales last year in both HIV pre­ven­tion and treat­ment.

Though Tru­va­da and De­scovy are al­ready high­ly ef­fec­tive treat­ments, GSK hopes it can sell the idea of in­creased com­pli­ance with its new drug. Be­cause cabote­gravir on­ly re­quires one in­jec­tion every two months, pa­tients are less like­ly to for­get to take it, as op­posed to the risk of miss­ing a dai­ly Tru­va­da pill.

Cabote­gravir has had its own share of road bumps as well. Back in De­cem­ber, the FDA is­sued a com­plete re­sponse let­ter to Vi­iV and re­ject­ed its ap­pli­ca­tion for month­ly cabote­gravir in­jec­tions, cit­ing man­u­fac­tur­ing and con­trol con­cerns. As a re­sult, the NDA for the bi­month­ly reg­i­men was pushed back from the first quar­ter of 2020.

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

Boston, MA-based startup GentiBio landed a $20 million seed fund from three investors to dive into engineered regulatory T cell (EngTreg) development.

Marquee investors OrbiMed, Novartis Venture Fund and RA Capital Management have backed GentiBio’s mission to develop EngTregs for the treatment of autoimmune, alloimmune, autoinflammatory, and allergic diseases. Unlike other companies studying treatments using a patient’s own Tregs, GentiBio plans to make use of CD4+ immune cells, found in the blood.

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.