Rough­ly a year and a half since its last raise, Icosavax scored a fresh goal Wednes­day morn­ing in nab­bing new funds for its soc­cer ball-like VLP vac­cine tech. And the Seat­tle-based com­pa­ny is bring­ing in a high-pro­file set of new in­vestors.

Icosavax un­veiled a $100 mil­lion Se­ries B, backed by Pe­ter Kolchin­sky’s RA Cap­i­tal Man­age­ment and Per­cep­tive Ad­vi­sors, among oth­ers. Kolchin­sky scores a board seat with the raise, as the biotech plans to use its new­found cash to ad­vance a hand­ful of vac­cine pro­grams for SARS-CoV-2 and virus­es that trig­ger pneu­mo­nia.

Neil King

The big idea around Icosavax cen­ters around its virus-like par­ti­cle vac­cine plat­form, de­vel­oped out of the lab of Neil King at the Uni­ver­si­ty of Wash­ing­ton. King and his team built on years-old re­search of how some vi­ral pro­teins could spon­ta­neous­ly as­sem­ble them­selves, work­ing out a de­sign sys­tem for sim­i­lar par­ti­cles with soft­ware.

His re­search pro­duces an end re­sult of what’s es­sen­tial­ly a par­ti­cle shaped like a soc­cer ball — the “white” parts mak­ing up the struc­ture and the “black” spots rep­re­sent­ing the dis­played anti­gens. It’s the same tech­nol­o­gy King is us­ing to de­vel­op a “su­per-sea­son­al” flu vac­cine de­scribed in a new pa­per pub­lished just a few weeks ago, though Icosavax wasn’t in­volved in that re­search.

Orig­i­nal­ly, Icosavax had been work­ing on a vac­cine for res­pi­ra­to­ry syn­cy­tial virus. The com­pa­ny is still work­ing on that can­di­date, which in­cor­po­rates an anti­gen that has com­plet­ed a Phase I study run by the NIH. Wednes­day’s funds will be used for not on­ly this pro­gram, known as IVX-121, but a new­er can­di­date that aims to tack­le two virus­es at once, CEO Adam Simp­son told End­points News.

One of the break­throughs dis­cov­ered at the NIH dealt with the na­ture of the RSV anti­gen it­self. The virus, un­be­knownst to re­searchers for years, is a shapeshifter — it presents dif­fer­ent­ly af­ter it in­vades cells. His­tor­i­cal­ly, sci­en­tists had gone af­ter the post-fu­sion form of the virus, but that didn’t stop the virus from caus­ing in­fec­tions.

But the NIH man­aged to sta­bi­lize an anti­gen rep­re­sent­ing the pre­fu­sion form of the virus, Simp­son said, which is ul­ti­mate­ly what Icosavax li­censed.

In the 17 or so months fol­low­ing the last round, Icosavax has ad­vanced its RSV pro­gram as in­tend­ed, and is now al­so look­ing to make a dual vac­cine to fight both RSV and hu­man metap­neu­movirus. Both are preva­lent caus­es of pneu­mo­nia from the vi­ral side of things, as op­posed to bet­ter-known pneu­mo­coc­cal bac­te­ria.

“In this case we’ll have two dif­fer­ent ‘soc­cer balls’ in one vial,” Simp­son told End­points. The de­sign could have fea­tured a sin­gle soc­cer ball dis­play­ing both RSV and hM­PV as well.

The plan, Simp­son added, is to start with the RSV vac­cine and then “lay­er” the hM­PV anti­gens in­to the shot as de­vel­op­ment con­tin­ues. IVX-121 is ex­pect­ed to en­ter an­oth­er clin­i­cal tri­al lat­er this year, and based on the da­ta should en­able the bi­va­lent vac­cine stud­ies.

Icosavax’s Covid-19 pro­gram al­so got some love from the in­vestor group, with some of Wednes­day’s funds head­ed to­ward a Phase I tri­al launch for the can­di­date this year. This vac­cine, dubbed IVX-411, has al­ready re­ceived $10 mil­lion in back­ing from the Bill and Melin­da Gates Foun­da­tion. Am­gen is al­so chip­ping in on the man­u­fac­tur­ing side, agree­ing to pro­duce a crit­i­cal com­po­nent of the com­pound and al­low­ing for a more rapid tran­si­tion in­to Phase I.

Simp­son stayed mum on time­lines for da­ta read­outs, not­ing that with the pan­dem­ic still rag­ing en­roll­ment rates can be dif­fi­cult to pre­dict. And de­spite the crossover na­ture of the round, he de­murred about po­ten­tial IPO plans, say­ing “we’re well aware of the mar­ket.”

RA Cap­i­tal Man­age­ment led the round, and Per­cep­tive was joined by oth­er new in­vestors Janus Hen­der­son In­vestors, Viking Glob­al In­vestors, Cor­morant As­set Man­age­ment, Omega Funds, and Sur­vey­or Cap­i­tal. Icosavax’s ex­ist­ing in­vestors al­so par­tic­i­pat­ed, in­clud­ing Qim­ing Ven­ture Part­ners USA, Adams Street Part­ners, Sanofi Ven­tures, and ND Cap­i­tal. A pre­vi­ous­ly an­nounced fund­ing from Open Phil­an­thropy was in­clud­ed in this round.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.