Covid-19 roundup: Mer­ck pre­pares new study on their $425M Covid drug; CO­V­AX be­gins roll­out but huge dis­par­i­ties still loom

Mer­ck spent $425 mil­lion to buy out On­coIm­mune in No­vem­ber, pre­sum­ably un­der the be­lief that they could scale up their drug for se­vere Covid-19 and get it through the FDA on the strength of a Phase III tri­al the small­er biotech com­plet­ed in Sep­tem­ber.

The FDA threw a wrench in those plans. The agency told Mer­ck last week that the 203-per­son study wasn’t suf­fi­cient to show the drug was ef­fec­tive. Now, Bloomberg re­ports, Mer­ck is prepar­ing an ad­di­tion­al Phase III study, one that will push re­sults — and any chance of ap­proval — back to the end of the year.

It’s an­oth­er Covid-19 set­back for Mer­ck, a Big Phar­ma long known for elite re­search, par­tic­u­lar­ly in in­fec­tious dis­ease; two years ago, they de­vel­oped the first vac­cine for Ebo­la. The com­pa­ny joined the pan­dem­ic fight late, and the var­i­ous tech­nolo­gies they’ve de­vel­oped have since stum­bled. They axed their two vac­cine pro­grams af­ter dispir­it­ing ear­ly re­sults, and they’ve said lit­tle about an Emory-de­vel­oped oral an­tivi­ral they li­censed and put in Phase III.

The FDA’s de­ci­sion is par­tic­u­lar­ly sur­pris­ing giv­en how the Mer­ck-On­coIm­mune buy­out came about. Bloomberg re­port­ed that Op­er­a­tion Warp Speed chief Mon­cef Slaoui bro­kered the deal af­ter the small biotech said their drug re­duced the risk of res­pi­ra­to­ry fail­ure or death in a Phase III tri­al. HHS then gave Mer­ck a con­tract for $356 mil­lion to sup­ply 100,000 dos­es by June.

“It’s not that the agency wasn’t im­pressed by the da­ta, be­cause they were,” Nicholas Kart­so­nis, Mer­ck’s clin­i­cal in­fec­tious dis­ease chief told Bloomberg. “They just want more of it, and more com­fort that if we’re in­deed go­ing to bring this for­ward, that the da­ta gets repli­cat­ed.”

CO­V­AX be­gins roll­out but huge dis­par­i­ties still loom

CO­V­AX, the WHO and Gates-backed vac­cine-shar­ing pro­gram, has had a rocky start, edged out in the hunt for vac­cines by the wealth­i­est coun­tries in the world. As shots rolled out in the US, the UK, and Eu­rope, CO­V­AX large­ly stood on the side­lines: At the end of Feb­ru­ary, more than 100 of the world’s poor­est coun­tries had yet to re­ceive a sin­gle dose.

The pro­gram, though, is be­gin­ning to set bench­marks. They post­ed their first round of glob­al vac­cine al­lo­ca­tions on Tues­day, sched­ul­ing 237 mil­lion dos­es of the As­traZeneca-Ox­ford vac­cine to ship to 142 na­tions by the end of May. The first ones be­gan on Mon­day, af­ter 600,000 dos­es land­ed in Ghana and 500,000 dos­es in Côte d’Ivoire.

The al­lo­ca­tions still amount to drops in the buck­et com­pared to the roll­out in the US alone, where more than 500 mil­lion dos­es have been se­cured in the same time pe­ri­od. Pres­i­dent Biden said Tues­day that the US would have enough vac­cines for its en­tire el­i­gi­ble adult pop­u­la­tion by May —  a bench­mark most of the world may not hit for years.

In ad­di­tion to shots from As­traZeneca, a com­pa­ny that pri­or­i­tized glob­al scale and ac­cess, CO­V­AX will soon be­gin to see shots from oth­er ma­jor de­vel­op­ers. Just over 1 mil­lion Pfiz­er-BioN­Tech vac­cines are in­clud­ed in the first al­lo­ca­tion and No­vavax, which has yet to be au­tho­rized any­where but re­cent­ly showed its vac­cine was high­ly ef­fec­tive in the UK and mod­er­ate­ly ef­fec­tive in South Africa, has pledged 1.1 bil­lion dos­es.

NIH pulls plug on con­va­les­cent plas­ma in pa­tients

The NIH is singing last rites on con­va­les­cent plas­ma.

More than a year af­ter doc­tors around the coun­try be­gan band­ing to­geth­er to get con­va­les­cent plas­ma off the ground as an emer­gency, stop­gap treat­ment for a new, emer­gency virus — and six months af­ter for­mer Pres­i­dent Trump pushed the FDA au­tho­rize it — the NIH has halt­ed its tri­al in con­va­les­cent plas­ma for mod­er­ate pa­tients af­ter a da­ta safe­ty and mon­i­tor­ing board found it had lit­tle ef­fect.

The study, called C3PO and launched in Au­gust, was one of the best hopes for prov­ing con­va­les­cent plas­ma could be an ef­fec­tive treat­ment for Covid-19. Al­though oth­er stud­ies, in­clud­ing the Mayo Clin­ic’s con­tro­ver­sial ex­pand­ed ac­cess pro­gram, fo­cused on se­vere pa­tients, re­searchers be­lieved it should work bet­ter the ear­li­er it was ad­min­is­tered. Small­er stud­ies from oth­er coun­tries bol­stered that be­lief.

The study had en­rolled 511 out of a planned 900 pa­tients. It showed the ther­a­py was safe but un­like­ly to help the group stud­ied.

The FDA al­ready be­gan to roll back its con­tro­ver­sial EUA for con­va­les­cent plas­ma last month, in the face of new ev­i­dence point­ing to its in­ef­fec­tive­ness in hos­pi­tal­ized pa­tients. They said it would on­ly be used in hos­pi­tal­ized pa­tients with ear­ly-stage dis­ease or an im­paired abil­i­ty to make their own an­ti­bod­ies.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.