Icosavax nabs $51M as syn­thet­ic virus heads to­ward clin­ic

A new biotech is us­ing an ar­ti­fi­cial virus-like par­ti­cle to try to vac­ci­nate against the res­pi­ra­to­ry syn­cy­tial virus (RSV), a flu-like dis­ease for which no vac­ci­na­tion or cure ex­ists.

Icosavax launch­es with a $51 mil­lion Se­ries A fi­nanc­ing from Qim­ing Ven­ture Part­ners USA, Adams Street Part­ners, Sanofi Ven­tures and Nan­oDi­men­sion that will pro­pel it in­to a Phase I tri­al for IVX-121, their new vac­cine for old­er adults.

“The mag­ic of the VLP is that it looks and smells like a virus but it’s safe,” CEO Adam Simp­son told End­points News. “You get all the ben­e­fits of your body giv­ing off the dan­ger sig­nal with­out the down­side.”

RSV will af­fect vir­tu­al­ly all chil­dren be­low the age of 2, ac­cord­ing to the NIH, in­duc­ing a mild cold for most but forc­ing a small per­cent­age to be hos­pi­tal­ized. It can have se­vere con­se­quences in old­er adults, an­nu­al­ly con­tribut­ing to the deaths of 14,000 Amer­i­cans.

Simp­son wants you to pic­ture a soc­cer ball. He wants you to pic­ture it be­cause it’s rough­ly what a virus looks like if you add lit­tle anti­gen prongs to every black tile, and thus its rough­ly what their virus-like par­ti­cle (VLP) looks like.

This par­ti­cle works like a stan­dard virus-based vac­cine, trig­ger­ing the body’s im­mune re­sponse by bind­ing to lym­pho­cyte cells and mak­ing them think the body is in­fect­ed. Simp­son ar­gues this is safer than a con­ven­tion­al vac­cine be­cause it doesn’t in­volve any ac­tu­al for­eign virus.

This VLP, though, is crit­i­cal for RSV for oth­er rea­sons, he said. A vac­cine for the very com­mon virus has elud­ed re­searchers for years in large part be­cause the virus changes form dra­mat­i­cal­ly when it comes in­to con­tact with a cell. The trick, then, was to de­vise a vac­cine that would prime the body’s im­mune sys­tem against the virus’s pre-con­tact form.

The NIH cre­at­ed an anti­gen for that form last year, Simp­son said — pro­vid­ing a prong for Icosavax to at­tach to their VLP.

“What we’ve been able to do is come up with a tech­nique to make this soc­cer-ball-look­ing struc­ture with com­plex anti­gens and ac­tu­al­ly man­u­fac­ture it,” Simp­son said, “And that’s what’s nev­er been done be­fore.”

VLPs are al­ready wide­ly used for vac­cines, in­clud­ing for in­oc­u­la­tion against he­pati­tis B and hu­man pa­pil­lo­mavirus. But Simp­son and the builders of the VLP at the In­sti­tute for Pro­tein De­sign at the Uni­ver­si­ty of Wash­ing­ton told End­points this presents a ma­jor step for­ward by al­low­ing re­searchers to build them from scratch, us­ing com­pu­ta­tion­al mod­els — tech­niques, they said, that could be used in build­ing vac­cines for oth­er virus­es that have thus far elud­ed re­searchers.

The new mod­el works by mim­ic­k­ing the repet­i­tive struc­ture the body au­to­mat­i­cal­ly as­so­ciates with virus­es, Neil King told End­points.

“The beau­ti­ful thing about the par­ti­cle we’ve de­signed is they’re very ro­bust and ver­sa­tile,” King, an as­sis­tant pro­fes­sor at the In­sti­tute for Pro­tein De­sign said. “You could use the par­ti­cles to make HIV vac­cines or malar­ia vac­cines or flu vac­cines as well as RSV just by swap­ping out dif­fer­ent anti­gens.”

Icosavax will soon be­gin a Phase Ib tri­al on old­er adults, eval­u­at­ing safe­ty and proof-of-con­cept. Simp­son said they will soon look at oth­er in­di­ca­tions but de­clined to name them.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

Endpoints News writer Nicole DeFeudis has posted a snapshot of all the companies, universities and hospital-based groups now racing through the clinic, ranking them according to their place in the pipeline as well as the latest remarks available on timelines. And we’ll keep this lineup updated right through the end of the year, as the checkered flags start to fall, possibly as early as October.

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Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Credit: Galaxy Life Sciences

Galaxy Life Sci­ences lands $50 mil­lion deal to build in cen­tral Mass­a­chu­setts bio­man­u­fac­tur­ing park

Webster, MA-based real estate developer Galaxy Life Sciences struck a roughly $50 million deal to build in a biomanufacturing park in Worcester, an up-and-coming biotech hotspot about an hour west of Boston.

Galaxy paid $1.9 million for a 6-acre plot, on which it intends to construct a $50 million building grossing 95,000 to 180,000 square feet. The space will be designed to accommodate research and development, or manufacturing, and could employ 125 to 150 workers, according to the Worcester Telegram & Gazette. Construction is expected to begin this spring and wrap up in about a year.

No­vo gets PhI­II he­mo­phil­ia tri­als for a Roche ri­val back on track af­ter com­plet­ing work-around on blood clot threat

After abruptly shutting down three hemophilia studies back in March due to serious safety issues, Novo Nordisk is getting things going again.

The Danish pharma gave the go-ahead to resume Phase III trials for its concizumab candidate, which are investigating subcutaneous prophylaxis treatment in hemophilia A and B patients regardless of inhibitor status. Novo Nordisk had halted the studies after three patients experienced non-fatal blood clots.

Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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No­var­tis’ CAR-T part­ner in Chi­na wraps $383M take-pri­vate deal en­gi­neered by CEO

After 13 years on Nasdaq, Cellular Biomedicine Group is returning to private hands.

CEO Tony (Bizuo) Liu is a key advocate of the deal, leading a consortium of mostly Chinese investors including other top company execs, Yunfeng Capital and TF Capital — even as the company is getting more entrenched in the US with its CAR-T and other cell therapy work.

Shareholders are receiving $19.75 per share $CBMG, which translates to a premium of 31.4% over the 30 trading-day average price as of August 11. The stock, though, has dropped significantly since the consortium first put in its proposal in November. Compared to then, the acquisition price marks only a 11.8% increase.

Argentine President Alberto Fernandez at an Aug. 12, 2020 press conference (Juan Mabromata/Pool via AP)

Covid-19 roundup: As­traZeneca teams with Ar­genti­na, Mex­i­co to sup­ply Latin Amer­i­ca; Brazil, Philip­pines in talks with Rus­sia

The global network building AstraZeneca and Oxford’s Covid-19 vaccine grew again this week.

Argentine President Alberto Fernandez said Wednesday after a meeting with company executives that Argentina and Mexico would produce and supply AstraZeneca’s adenovirus vector vaccine for all of Latin America outside Brazil, according to Reuters. The deal, financed in part by Mexican billionaire Carlos Slim, will involve AstraZeneca transferring its technology to the Spanish-Argentinian biotech mAbxience, who will then produce 150 million doses of the vaccine for delivery in the first half of 2021.

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Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.