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.

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

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Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Game on: Re­gen­eron's BC­MA bis­pe­cif­ic makes clin­i­cal da­ta de­but, kick­ing off mul­ti­ple myelo­ma matchup with Bris­tol-My­ers

As J&J attempts to jostle past Bristol-Myers Squibb and bluebird for a landmark approval of its anti-BCMA CAR-T — and while GlaxoSmithKline maps a quick path to the FDA riding on its own BCMA-targeting antibody-drug conjugates — the bispecifics are arriving on the scene to stake a claim for a market that could cross $10 billion per year.

The main rivalry in multiple myeloma is shaping up to be one between Regeneron and Bristol-Myers, which picked up a bispecific antibody to BCMA through its recently closed $74 billion takeover of Celgene. Both presented promising first-in-human data at the ASH 2019 meeting.

FDA lifts hold on Abeon­a's but­ter­fly dis­ease ther­a­py, paving way for piv­otal study

It’s been a difficult few years for gene and cell therapy startup Abeona Therapeutics. Its newly crowned chief Carsten Thiel was forced out last year following accusations of unspecified “personal misconduct,” and this September, the FDA imposed a clinical hold on its therapy for a form of “butterfly” disease. But things are beginning to perk up. On Monday, the company said the regulator had lifted its hold and the experimental therapy is now set to be evaluated in a late-stage study.

Roche faces an­oth­er de­lay in strug­gle to nav­i­gate Spark deal past reg­u­la­tors — but this one is very short

Roche today issued the latest in a long string of delays of its $4.3 billion buyout of Philadelphia-based Spark Therapeutics. The delay comes as little surprise — it is their 10th in as many months — as their most recent delay was scheduled to expire before a key regulatory deadline.

But it is notable for its length: 6 days.

Previous extensions had moved the goalposts by about 3 weeks to a month, with the latest on November 22 expiring tomorrow. The new delay sets a deadline for next Monday, December 16, the same day by which the UK Competition and Markets Authority has to give its initial ruling on the deal. And they already reportedly have lined up an OK from the FTC staff – although that’s only one level of a multi-step process.

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KalVis­ta's di­a­bet­ic mac­u­lar ede­ma da­ta falls short — will Mer­ck walk away?

Merck’s 2017 bet on KalVista Pharmaceuticals may have soured, after the UK/US-based biotech’s lead drug failed a mid-stage study in patients with diabetic macular edema (DME).

Two doses of the intravitreal injection, KVD001, were tested against a placebo in a 129-patient trial. Patients who continued to experience significant inflammation and diminished visual acuity, despite anti-VEGF therapy, were recruited to the trial. Typically patients with DME — the most frequent cause of vision loss related to diabetes — are treated with anti-VEGF therapies such as Regeneron’s flagship Eylea or Roche’s Avastin and Lucentis.

UP­DAT­ED: Ob­sE­va makes case for best-in-class hor­mone sup­pres­sive ther­a­py in pos­i­tive uter­ine fi­broid study

About a month after the Swiss biotech disclosed a failed late-stage study in its IVF program, ObsEva on Monday unveiled positive pivotal data on its experimental treatment for heavy menstrual bleeding triggered by uterine fibroids.

ObsEva in-licensed the drug, linzagolix, from Japan’s Kissei Pharmaceutical in 2015. Two doses of the drug (100 mg and 200 mg) were tested against a placebo in the 535-patient Phase III study, dubbed PRIMROSE 2, in patients who were both on and off hormonal add-back therapy (ABT).

Samit Hirawat. Bristol-Myers Squibb

Bris­tol-My­ers is mak­ing a bee-line to the FDA with pos­i­tive liso-cel da­ta — but is it too late in the CAR-T game?

Bristol-Myers Squibb came to ASH this past weekend with a variety of messages on the new cancer drugs they had acquired in the big Celgene buyout, including liso-cel, the lead CAR-T program picked up in the $9 billion Juno acquisition. And one of the most important was that they had the pivotal efficacy and safety data needed to snag an approval from the FDA next year, with the BLA on track for a filing this month.