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.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

New Charles River Laboratories High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. (Charles River)

Charles Riv­er Lab­o­ra­to­ries to start cell and gene ther­a­py man­u­fac­tur­ing at UK site in Sep­tem­ber

While Massachusetts-based Charles River Laboratories has been on an acquisition spree, they are not against planting their flag. The latest move by the company sees them crossing the pond to establish a manufacturing site in the UK.

The company on Tuesday opened its cell and gene therapy manufacturing center at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. The expansion follows Charles River’s acquisition of Cognate BioServices and Cobra Biologics in 2021 for $875 million. Cognate is a plasmid DNA, viral vector and cell therapy CDMO.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”

#Can­nes­Lions2022: Con­sumer health ex­ecs call on agen­cies to in­volve pa­tients in cre­ative process

CANNES — When Tamara Rogers joined GSK back in 2018, “science was king and R&D were the gods.” Now the global chief marketing officer of consumer healthcare wants to make room for another supreme being: the consumer.

As health and wellness becomes more relevant to consumers amid the pandemic, four health-focused executives called on marketers to involve patients in their creative process in a panel discussion at the Cannes Lions advertising creativity festival.

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