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.

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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 five 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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Robert Califf, FDA commissioner (Tom Williams/CQ Roll Call via AP Images)

Hop­ing to ex­pand mon­key­pox vac­cine sup­ply, US paves the way for new route of ad­min­is­tra­tion

After making it clear that the US’ current monkeypox vaccine supply is insufficient, the FDA on Tuesday authorized a new route of administration that should increase the number of available doses by five-fold.

Regulators cleared Bavarian Nordic’s Jynneos vaccine for intradermal injection in adults older than 18. Unlike subcutaneous injection — the current method by which vaccine is delivered under the skin — an intradermal jab goes directly into the skin. It’s believed that this method requires less vaccine, since the dermis is rich in dendritic cells which specialize in taking up foreign antigens and presenting them to the immune system, according to Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston.

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Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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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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US to stop sup­ply­ing Lil­ly's mAb for Covid-19 this month as com­mer­cial mar­ket awaits

Federal officials said yesterday that shipments of Eli Lilly’s bebtelovimab — one of the final two remaining mAb treatments for Covid-19 — would halt later this month, setting up a commercial market where the government no longer pays for the doses and hospitals and other clinics will have to purchase supplies.

According to ASPR, the arm of HHS that ships Covid-19 drugs, states have ordered 627,536 bebtelovimab courses, and 383,515 courses have been administered as of July 31. The US has paid Lilly a total of about $1.27 billion for all of the courses so far, amounting to about $2,100 per course to start and then receiving a discounted $1,833 ASP for the later part of the deal. According to the Wall Street Journal, Lilly’s list price for bebtelovimab is $2,100 per dose.

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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HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.