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.

No­var­tis bags a new gene ther­a­py for vi­sion loss, and this is one pre­clin­i­cal ven­ture that did­n't come cheap

Cyrus Mozayeni got excited when he began to explore the academic work of Ehud Isacoff and John G. Flannery at UC Berkeley.

Together, they were engaged in finding a gene therapy approach to pan-genotypic vision restoration in patients with photoreceptor-based blindness, potentially restoring the vision of a broad group of patients. And they did it by using a vector to deliver the genetic sequence for light sensing proteins.

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Daphne Koller, Getty

Bris­tol My­er­s' Richard Har­g­reaves pays $70M to launch a neu­rode­gen­er­a­tion al­liance with a star play­er in the ma­chine learn­ing world

Bristol Myers Squibb is turning to one of the star upstarts in the machine learning world to go back to the drawing board and come up with the disease models needed to find drugs that can work against two of the toughest targets in the neuro world.

Daphne Koller’s well-funded insitro is getting $70 million in cash and near-term milestones to use their machine learning platform to create induced pluripotent stem cell-derived disease models for ALS and frontotemporal dementia.

Eli Lilly CEO David Ricks at the Rose Garden, May 26, 2020 (Evan Vucci/AP Images)

Eli Lil­ly lines up a block­buster deal for Covid-19 an­ti­body, right af­ter it failed a NI­AID tri­al

Two days after Eli Lilly conceded that its antibody bamlanivimab was a flop in hospitalized Covid-19 patients, the US government is preparing to make it a blockbuster.

The pharma giant reported early Wednesday that it struck a deal to supply the feds with 300,000 vials of the drug at a cost of $375 million — once it gets an EUA stamp from the FDA. And once that 2-month supply deal is done, the government has an option on another 650,000 doses on the same terms — which could potentially add another $812 million.

CMO Merdad Parsey (Gilead)

Gilead hits the brakes on a tri­fec­ta of mid- and late-stage stud­ies for their trou­bled fil­go­tinib pro­gram. It's up to the FDA now

Gilead $GILD execs haven’t decided exactly what to do with filgotinib in the wake of the slapdown at the FDA on their rheumatoid arthritis application, but they’re taking a time out for a slate of studies until they can gain some clarity from the agency. And without encouraging guidance, this drug could clearly be axed from the pipeline.

In their Q3 report out Wednesday afternoon, the company says researchers have “paused” a Phase III study for psoriatic arthritis along with a pair of Phase II trials for ankylosing spondylitis and uveitis. Late-stage studies for ulcerative colitis and Crohn’s are continuing, but you can see for yourself how big a hole this leaves in the inflammatory disease pipeline, with obvious implications if the company abandons filgo altogether.

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Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Charles Baum, Mirati CEO

UP­DAT­ED: Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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Christian Rommel (via Roche)

Bay­er fol­lows R&D deal spree by raid­ing Roche's can­cer group for its new re­search chief

The day after Bayer signed off on a $4 billion deal designed to put the company among the leaders in gene therapy development, the pharma giant has recruited a new chief for its R&D division. And they opted for an expert in the cancer field.

Christian Rommel, Roche’s head of discovery and early-stage oncology development, has been tapped to take over the job. Joerg Moeller, who got the top research post after early- and late-stage development roles were combined 2 years ago, is hitting the exit “to pursue other career opportunities.”

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Albert Bourla, AP

UP­DAT­ED: Where's the Pfiz­er ef­fi­ca­cy read­out? CEO Bourla says 'soon,' but you're go­ing to have to wait for it

Pfizer CEO Albert Bourla had promised repeatedly that the pharma giant would know if its leading Covid-19 vaccine is effective by the end of this month — now just a few days away.

Instead, the company reported early Tuesday that it has yet to conduct any interim efficacy analyses. And it won’t now until sometime next month.

The news was included in a slide for their Q3 report.

In the morning Q3 call with analysts, Bourla says that they expect efficacy data “soon,” but noted that they wouldn’t be able to say anything until all the administrative work was done on the interim, which would take about a week. And he added that Pfizer isn’t going to say anything else about that hot topic until they have the data in hand.

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For­mer Al­ler­gan pro­gram posts pos­i­tive topline PhI­II re­sults in pres­by­opia in an R&D win post-Ab­b­Vie merg­er

The battered pipeline AbbVie $ABBV acquired in its $63 billion buyout of Allergan picked up a rare win Wednesday morning.

Allergan announced that a pair of Phase III studies for an experimental ophthalmic solution in presbyopia, an age-related condition resulting in a problem focusing on nearby objects, met their primary endpoint in vision tests associated with the condition. The data puts the program on track for a NDA sometime in the first half of next year.