Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months sep­a­rat­ed from a dis­ap­point­ing read­out of its Covid-19 vac­cine, Icosavax is back with what it calls pos­i­tive topline da­ta for a dif­fer­ent VLP vac­cine can­di­date — al­though in­vestors aren’t im­pressed.

IVX-121, a vac­cine can­di­date for res­pi­ra­to­ry syn­cy­tial virus (RSV), ap­peared to gen­er­ate “ro­bust” im­mune re­spons­es among both young and old­er adults, as mea­sured by neu­tral­iz­ing an­ti­bod­ies, and ap­peared gen­er­al­ly well-tol­er­at­ed, Icosavax re­port­ed.

Neil King

The in­ter­im Phase I/Ib re­sults of­fer key proof of con­cept for the Seat­tle-based biotech’s foun­da­tion­al virus-like par­ti­cle plat­form tech­nol­o­gy, said CEO Adam Simp­son. VLP is spon­ta­neous­ly as­sem­bling pro­teins that Icosavax co-founder and syn­thet­ic bi­ol­o­gy re­searcher Neil King pre­vi­ous­ly de­scribed as akin to soc­cer balls in shape.

“They al­so reaf­firm our strat­e­gy to com­bine mul­ti­ple pathogen tar­gets in one vac­cine,” he said in a state­ment. “As planned, Icosavax will now progress de­vel­op­ment of IVX-121 com­bined with a hu­man metap­neu­movirus (hM­PV) VLP, as our IVX-A12 bi­va­lent vac­cine can­di­date.”

RSV and hM­PV are two lead­ing caus­es of pneu­mo­nia, he added, and nei­ther has an ap­proved vac­cine.

A host of com­pa­nies, though, are gun­ning to bring the first RSV vac­cine to the mar­ket, with Pfiz­er, GSK and Bavar­i­an Nordic all tout­ing late-stage da­ta.

Icosavax li­censed a pre­fu­sion sta­bi­lized form of the RSV F anti­gen from the NIH. But its plan, spelled out in an S-1 when it went pub­lic last year, has al­ways been to forego a mono­va­lent shot in fa­vor of a 2-in-1 vac­cine.

In a note, Cowen’s Phil Nadeau not­ed the neu­tral­iz­ing an­ti­body titers gen­er­at­ed by IVX-121 — up to 7,687 IU/mL for the younger group and up to 7,561 IU/mL for the old­er group — “are in the range of those pro­duced by Pfiz­er’s RSV vac­cine can­di­date PF-06482077 (RSVpreF) and GSK’s RSVpreF3 OA, sug­gest­ing that Icosavax has a vi­able RSV com­po­nent for its RSV+hM­PV vac­cine.”

Roger Song at Jef­feries al­so gave the da­ta a thumbs-up:

While in­vestors may think nAb GM­FR is gen­er­al­ly com­pa­ra­ble to comps’ (slight­ly low­er in old­er pop­u­la­tion) thus un­clear the mar­ket po­si­tion­ing giv­en late to mar­ket, we see Co’s vac­cine could be dif­fer­en­ti­at­ed in mul­ti­ple fronts, sup­port­ed by to­day’s pre­lim­i­nary da­ta: 1) no drop off in nAb titer from young to old­er adults, 2) very be­nign re­ac­to­genic­i­ty/tol­er­a­bil­i­ty, 3) wide win­dow for com­bo vac­cine giv­en equiv­a­lent im­muno­genic­i­ty at the low­est dose and fa­vor­able AE at the high­est dose.

Nonethe­less, shares are down about 14% in pre-mar­ket trad­ing, putting the stock price at $7.27.

In ad­di­tion to its vac­cine, Icosavax al­so test­ed an alu­minum hy­drox­ide ad­ju­vant in the tri­al to make sure it didn’t work, as it’s failed in oth­er com­pa­nies’ stud­ies be­fore. And in­ves­ti­ga­tors found that the ad­ju­vant did not make a dif­fer­ence.

The com­pa­ny plans to file an IND and start a Phase I tri­al for IVX-A12 in the sec­ond half of the year.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Steve Paul, Karuna Therapeutics CEO (Third Rock)

Karuna's schiz­o­phre­nia drug pass­es a close­ly-watched PhI­II test, will head to FDA in mid-2023

An investigational pill that combines a former Eli Lilly CNS compound with an overactive bladder drug was better than placebo at reducing a scale of symptoms experienced by patients with schizophrenia in a Phase III trial.

Karuna Therapeutics’ drug passed the primary goal in EMERGENT-2, the Boston biotech said early Monday morning, alongside quarterly earnings. The study is the first of Karuna’s four Phase III clinical trials to read out in schizophrenia and will provide the backbone to the biotech’s first drug approval application, slated for mid-2023.

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No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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