The NIH to­day an­nounced the kick­off of a na­tion­al clin­i­cal tri­als net­work to test vac­cines and oth­er treat­ments that could pre­vent in­fec­tion with SARS-CoV-2, the virus that caus­es in­fec­tion with Covid-19.

The net­work has been es­tab­lished by the Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases (NI­AID) through the merg­er of four pre­vi­ous­ly ex­ist­ing clin­i­cal tri­als net­works that fo­cused on HIV/AIDS.

Alex Azar HHS

“Start­ing this sum­mer, this new net­work will lever­age ex­ist­ing in­fra­struc­ture and en­gage com­mu­ni­ties to se­cure the thou­sands of vol­un­teers need­ed for late-stage clin­i­cal tri­als of promis­ing vac­cines,” said Health and Hu­man Ser­vices Sec­re­tary Alex Azar.

The net­work, dubbed the Covid-19 Pre­ven­tion Tri­als Net­work (COVPN), is a func­tion­al unit of Op­er­a­tion Warp Speed, the fed­er­al part­ner­ship fo­cused on speed­ing the de­vel­op­ment and de­liv­ery of COVID-19 di­ag­nos­tics, ther­a­peu­tics and vac­cines.

Vac­cine test­ing is to be led by Lar­ry Corey of Fred Hutchin­son Can­cer Re­search Cen­ter (Seat­tle), and Kath­leen Neuzil of the Uni­ver­si­ty of Mary­land (Col­lege Park). The vac­cine arm of COVPN will use a har­mo­nized pro­to­col that per­mits cross-tri­al analy­sis, with more than 100 US and in­ter­na­tion­al tri­al sites be­ing planned.

Mod­er­na’s mR­NA-1273 vac­cine, which was de­vel­oped joint­ly with NI­AID, is ex­pect­ed to be test­ed in the first phase 3 clin­i­cal tri­al con­duct­ed through COVPN, with a start date ex­pect­ed this sum­mer.

Mon­o­clon­al an­ti­body test­ing will be an­oth­er COVPN fo­cus; this arm will be led by My­ron Co­hen of the Uni­ver­si­ty of North Car­oli­na (Chapel Hill) and Emory Uni­ver­si­ty’s David Stevens.

The COVPN web­site fea­tures a se­cure, be­spoke da­ta col­lec­tion plat­form that al­lows in­di­vid­u­als to en­roll in a rolling clin­i­cal tri­al par­tic­i­pant reg­istry from which po­ten­tial study par­tic­i­pants can be con­tact­ed and screened for study par­tic­i­pa­tion.

The hub of op­er­a­tions will be at Fred Hutchin­son Can­cer Re­search Cen­ter, where staff will over­see a com­mu­ni­ty en­gage­ment frame­work de­signed to achieve quick re­cruit­ment of large num­bers of re­search vol­un­teers.

“Each of the Phase 3 clin­i­cal tri­als that the COVPN will con­duct will re­quire thou­sands of vol­un­teers,” said NIH Di­rec­tor Fran­cis Collins. “Com­mu­ni­ty en­gage­ment, par­tic­u­lar­ly with the com­mu­ni­ties most vul­ner­a­ble to COVID-19’s se­vere out­comes, will be crit­i­cal to the suc­cess of this re­search en­deav­or.”

“Hav­ing a safe and ef­fec­tive med­ical coun­ter­mea­sure to pre­vent COVID-19 would en­able us to not on­ly save lives but al­so help end the glob­al pan­dem­ic,” said NI­AID Di­rec­tor An­tho­ny Fau­ci. “Cen­tral­iz­ing our clin­i­cal re­search ef­forts in­to a sin­gle tri­als net­work will ex­pand the re­sources and ex­per­tise need­ed to ef­fi­cient­ly iden­ti­fy safe and ef­fec­tive vac­cines and oth­er pre­ven­tion strate­gies against COVID-19.”

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

RAPS: First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.

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.

Myovant is getting ready to roll out its commercial operations to back relugolix, now under FDA review for prostate cancer.

The startup has added a fresh $200 million in support from Sumitomo Dainippon Pharma, which controls a majority of the stock $MYOV. Sumitomo is handing the cash over as a loan, bringing its total to $600 million. Myovant — which is gearing up for a showdown with AbbVie — has also filed an NDA to sell relugolix for uterine fibroids and recently posted positive late-stage data for endometriosis.