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.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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Christian Hogg, Hutchmed CEO

Hutchmed files for $600M+ IPO in Hong Kong as lead on­col­o­gy drug su­r­u­fa­tinib awaits FDA's good graces

In oncology, a flush of Chinese-developed drugs has the biopharma industry rethinking the poles of power in R&D as the blossoming nation continues to make a name for itself and pick up bundles of cash in the process. Now, as its lead drug faces a pivotal FDA review, the company formerly known as Chi-Med is planting its flag on home soil with a massive public offering.

Hutchmed — recently renamed from Chi-Med, or Hutchison China MediTech — will look to raise $603 million as part of a Hong Kong IPO that serves as a homecoming of sorts for the Chinese-based oncology player, which has listed on Nasdaq since 2016.

President Biden (AP Images)

Biden in­vests $3B in­to an­tivi­ral de­vel­op­ment for Covid-19

The Biden administration on Thursday unveiled a new plan to invest more than $3 billion into speeding new antivirals to treat Covid-19.

The plan will allow NIH to evaluate, prioritize and advance antiviral candidates to Phase II clinical trials, using contractors and the NIH’s National Center for Advancing Translational Sciences laboratories to de-risk early stage development.

“New antivirals that prevent serious COVID-19 illness and death, especially oral drugs that could be taken at home early in the course of disease, would be powerful tools for battling the pandemic and saving lives,” said NIAID director Anthony Fauci.

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FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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