CEO Adam Simpson (Icosavax)

Icosavax keeps up the ex­cite­ment for its VLP 'soc­cer balls,' earn­ing the RA Cap­i­tal stamp of ap­proval in $100M Se­ries B

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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

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.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

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.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.