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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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Albert Bourla, Pfizer CEO (Evan Vucci, AP Images)

Covid-19 roundup: Pfiz­er ex­pands in­to France; Omi­cron-spe­cif­ic ver­sion of Mod­er­na's boost­er com­ing soon 

As the hype surrounding Pfizer’s antiviral Covid-19 pill swirls, the pharma announced that it will build a production facility in France to make the drug as a part of a five-year investment.

Pfizer will team up with Novasep to install equipment and initiate tech transfer and on-site development at Novasep’s Mourenx facility. The move is a part of a $594 million investment in France.

“We are of course proud to contribute to the manufacturing of this medicine which has shown in clinical trials to have a positive impact on hospitalization among at-risk Covid-19 patients,” Novasep’s CEO Michel Spagnol said in a statement. “This contract also validates our investment strategy for several years and our focus on small molecules.”