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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.