Stéphane Bancel at the Endpoints #JPM20 breakfast panel in San Francisco, January 2020 (Photo: Jeff Rumans, Endpoints News)

Mod­er­na says Covid-19 vac­cine boost­er in­creased im­mune re­sponse against vari­ants of con­cern

About a month af­ter an­nounc­ing their vari­ant-spe­cif­ic Covid-19 vac­cine boost­ers showed promis­ing re­sults in mice, Mod­er­na says it now has some hu­man da­ta to back it up.

Vol­un­teers giv­en a boost­er shot about six to eight months af­ter re­ceiv­ing their sec­ond dose saw in­creased an­ti­body lev­els against SARS-CoV-2 and two vari­ants of con­cern: B.1.351, which was first iden­ti­fied in South Africa, and P.1, first iden­ti­fied in Brazil, the com­pa­ny said on Wednes­day.

The analy­sis came from par­tic­i­pants who were giv­en ei­ther a third dose of mR­NA-1273 (the orig­i­nal vac­cine cur­rent­ly au­tho­rized in the US), or mR­NA-1273.351, a strain-matched boost­er tar­get­ing the B.1.351 vari­ant. Mod­er­na is cur­rent­ly test­ing mR­NA-1273.211 — a 50/50 com­bi­na­tion of mR­NA 1273 and mR­NA-1273.351 — in a dif­fer­ent arm of the Phase II study.

Fol­low­ing a boost of ei­ther mR­NA-1273 or mR­NA-1273.351, par­tic­i­pants’ neu­tral­iz­ing an­ti­bod­ies in­creased to lev­els sim­i­lar to or high­er than those seen against the an­ces­tral strain af­ter first vac­ci­na­tion, Mod­er­na said. Fif­teen days post-boost­er, the vari­ant-spe­cif­ic shot ap­peared to be more ef­fec­tive than the orig­i­nal vac­cine at in­creas­ing an­ti­body lev­els against the B.1.351 strain, pro­duc­ing geo­met­ric mean titer lev­els more than one-and-a-half times high­er than mR­NA-1273.

Al­so from the re­sults:

The rel­a­tive de­crease in neu­tral­iz­ing titers be­tween the wild-type (D614G) and B.1.351 as­says al­so im­proved with mR­NA-1273.351 boost­er, from a 7.7-fold dif­fer­ence pri­or to boost to a 2.6-fold dif­fer­ence 15 days af­ter  boost, sug­gest­ing a po­ten­tial­ly more bal­anced im­mune re­sponse against the test­ed vari­ants.

Safe­ty and tol­er­a­bil­i­ty da­ta were “gen­er­al­ly com­pa­ra­ble” to those seen af­ter the sec­ond dose of the orig­i­nal vac­cine in pre­vi­ous Phase II and III tri­als, Mod­er­na said. The re­sults have been sub­mit­ted as a preprint to bioRx­iv, and will be sub­mit­ted for peer-re­viewed pub­li­ca­tion af­ter Mod­er­na wraps up the mR­NA-1273.211 por­tion of the study.

“We are en­cour­aged by these new da­ta, which re­in­force our con­fi­dence that our boost­er  strat­e­gy should be pro­tec­tive against these new­ly de­tect­ed vari­ants. The strong and rapid boost in titers  to lev­els above pri­ma­ry vac­ci­na­tion al­so clear­ly demon­strates the abil­i­ty of mR­NA-1273 to in­duce im­mune mem­o­ry,” CEO Stéphane Ban­cel said in a state­ment.

Ban­cel told End­points News last month that he ex­pects the virus to mu­tate very quick­ly in the next cou­ple years, due to the fact that many peo­ple haven’t yet been vac­ci­nat­ed or in­fect­ed. He be­lieves there will be a need for sev­er­al boosts over the next cou­ple years, “es­pe­cial­ly peo­ple at high risk.” Then in 2023 or 2024, as the speed at which the vac­cine mu­tates slows down, a boost per year might be enough, he said.

“Our mR­NA plat­form  al­lows for rapid de­sign of vac­cine can­di­dates that in­cor­po­rate key virus mu­ta­tions, po­ten­tial­ly al­low­ing  for faster de­vel­op­ment of fu­ture al­ter­na­tive vari­ant-matched vac­cines should they be need­ed,” Ban­cel said Wednes­day.

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.

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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Vipin Garg, Altimmune CEO

Al­tim­mune’s shares halved af­ter in­ter­im look at PhII weight loss drug da­ta

Altimmune’s attempt to catch up to Novo Nordisk and Eli Lilly’s GLP-1 drugs hit an investor snag Tuesday after the biotech shared interim Phase II weight loss data.

The Maryland biotech’s pemvidutide is a GLP-1/glucagon dual receptor agonist meant to activate GLP-1 receptors to squash appetite and glucagon to ramp up energy use. The 2.4 mg dose showed a placebo-adjusted weight loss of 9.7% at week 24 of 48, which Jefferies analysts said would be comparable to Novo Nordisk’s semaglutide (Wegovy) and Eli Lilly’s tirzepatide (Mounjaro).

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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President Joe Biden (AP Photo/Susan Walsh)

Biden signs law re­quir­ing more de­clas­si­fi­ca­tions on Covid-19's ori­gins

President Joe Biden yesterday signed into law a bill requiring the Office of the Director of National Intelligence to declassify information on the origins of Covid-19 within 90 days.

The new law directs the federal government to “declassify any and all information relating to potential links between the Wuhan Institute of Virology and the origin of the Coronavirus Disease 2019”, including information regarding researchers at the lab who fell ill in the fall of 2019 like names, symptoms, and job roles.