Tedros Adhanom Ghebreyesus (Denis Balibouse/Pool Photo via AP Images)

WHO rec­om­mends against the use of con­va­les­cent plas­ma for Covid-19

The World Health Or­ga­ni­za­tion said late to­day that it’s not rec­om­mend­ing the use of con­va­les­cent plas­ma as a treat­ment for Covid-19 for mild or se­vere cas­es, but some US ex­perts dis­agree with the rec­om­men­da­tions and say there are pa­tients who can ben­e­fit from the plas­ma of those who’ve re­cov­ered from Covid-19.

The rec­om­men­da­tion is in­formed by a re­view of 16 RCTs and a “meta-analy­sis on an­ti­bod­ies and cel­lu­lar ther­a­pies for covid-19,” the WHO said, adding in a state­ment:

De­spite its ini­tial promise, cur­rent ev­i­dence shows that it [con­va­les­cent plas­ma] does not im­prove sur­vival nor re­duce the need for me­chan­i­cal ven­ti­la­tion, and it is cost­ly and time-con­sum­ing to ad­min­is­ter. As such, the WHO makes a strong rec­om­men­da­tion against the use of con­va­les­cent plas­ma in pa­tients with non-se­vere ill­ness, and a rec­om­men­da­tion against its use in pa­tients with se­vere and crit­i­cal ill­ness, ex­cept in the con­text of a ran­domised con­trolled tri­al (RCT).

The WHO wrote in the BMJ that, “Most im­por­tant­ly, giv­en there was no ben­e­fit demon­strat­ed in any of the crit­i­cal or im­por­tant out­comes for non-se­vere covid-19, the GDG [Guide­line De­vel­op­ment Group] did not see any jus­ti­fi­ca­tion for the re­sources (in­clud­ing time and cost) that would be as­so­ci­at­ed with ad­min­is­tra­tion of con­va­les­cent plas­ma.”

The an­nounce­ment builds on re­cent­ly pub­lished da­ta show­ing that while con­va­les­cent plas­ma has proven to be gen­er­al­ly safe, it al­so failed to show signs of ef­fi­ca­cy in some large RCTs of out­pa­tients, in­clud­ing on mor­tal­i­ty in a UK tri­al of those hos­pi­tal­ized with Covid, pub­lished in The Lancet in May, and an­oth­er for out­pa­tients in Au­gust in the New Eng­land Jour­nal of Med­i­cine.

In the re­sults pub­lished in the NE­JM, the NIH-fund­ed tri­al en­rolled more than 500 pa­tients, ran­dom­ized to re­ceive ei­ther plas­ma or place­bo with­in one week af­ter the on­set of symp­toms. Covid-19 pro­gres­sion oc­curred in 77 pa­tients (30%) in the con­va­les­cent plas­ma group and in 81 pa­tients (31.9%) in the place­bo group. Five pa­tients in the plas­ma group and one pa­tient in the place­bo group died, and the tri­al was stopped ear­ly in Feb­ru­ary due to lack of ef­fi­ca­cy.

But ex­perts still think there may be times when con­va­les­cent plas­ma could help peo­ple with Covid-19, ei­ther when it’s de­tect­ed ear­ly enough and high enough titers can be used (as CBER di­rec­tor Pe­ter Marks has said) or for those whose im­mune sys­tems may be de­fi­cient in some way.

“Based on avail­able da­ta I do not agree with this con­clu­sion” from the WHO, Shmuel Shoham, as­so­ciate pro­fes­sor of med­i­cine at Johns Hop­kins Uni­ver­si­ty, told End­points News. “When used at the right time and with high enough titers, COVID-19 Con­va­les­cent Plas­ma (CCP) is ef­fec­tive and gen­er­al­ly safe. The wide­spread avail­abil­i­ty of CCP makes it an op­tion in places where mon­o­clon­al an­ti­bod­ies are not read­i­ly avail­able. There is ad­di­tion­al da­ta that will soon be avail­able from the Johns Hop­kins out­pa­tient stud­ies.”

The FDA still main­tains an EUA for con­va­les­cent plas­ma, which was nar­rowed last Feb­ru­ary to on­ly high titer units and for hos­pi­tal­ized pa­tients who are in the ear­ly stages of the dis­ease. It re­mains to be seen if the WHO’s new rec­om­men­da­tion will change the EUA.

An FDA spokesper­son told End­points that it’s aware of but not com­ment­ing on the WHO’s an­nounce­ment, and the FDA EUA for con­va­les­cent plas­ma re­mains in ef­fect at this time. The EUA was reis­sued on March 9, 2021 and amend­ed in June. The FDA does not col­lect da­ta on how many peo­ple have been treat­ed with con­va­les­cent plas­ma un­der the EUA, and about 70,000 peo­ple ac­cessed con­va­les­cent plas­ma un­der an ex­pand­ed ac­cess pro­gram at the Mayo Clin­ic that the FDA helped to es­tab­lish.

Jeff Hen­der­son, as­so­ciate pro­fes­sor of med­i­cine at Wash­ing­ton Uni­ver­si­ty School of Med­i­cine in St. Louis, told End­points, “Much has been learned about COVID-19 patho­gen­e­sis in the past year and a half. Rel­e­vant to ther­a­peu­tics, we have learned that SARS-CoV-2 patho­gen­e­sis pro­ceeds through an ear­ly phase of vi­ral repli­ca­tion to a lat­er phase of in­flam­ma­tion-as­so­ci­at­ed tis­sue dam­age. Stud­ies that take this in­to ac­count have de­tect­ed ef­fi­ca­cy sig­nals when high titer COVID-19 con­va­les­cent plas­ma is ad­min­is­tered ear­ly in dis­ease to pa­tients with mild to mod­er­ate COVID-19.”

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

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Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

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.

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TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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