Take­da, CSL Behring fold big plas­ma al­liance af­ter PhI­II flop — join­ing a slew of an­ti­bod­ies that failed to help hos­pi­tal­ized pa­tients

The big plas­ma al­liance spear­head­ed by Take­da and CSL Behring has a big Phase III ver­dict: Adding their hy­per­im­mune in­tra­venous im­munoglob­u­lin prod­uct to Gilead’s remde­sivir does not stall dis­ease pro­gres­sion.

Dubbed H-Ig, the treat­ment was sup­posed to be a high­er grade ver­sion of con­va­les­cent plas­ma, which for­mer Pres­i­dent Don­ald Trump once hailed as a “his­toric break­through.” But it seems to be fol­low­ing plas­ma down the same path to­ward ob­so­les­cence.

Julie Kim

Com­ing a year af­ter the com­pa­nies an­nounced the part­ner­ship — which they called a bold move to find an­swers amid un­cer­tain­ty — the fail­ure would mark an end to their work, which had in­clud­ed man­u­fac­tur­ing the prod­uct at-risk.

“We are es­pe­cial­ly proud that we pooled re­sources, brought our plas­ma ex­per­tise and in­fra­struc­ture to­geth­er at our own cost to ben­e­fit pub­lic health and added to our un­der­stand­ing of a com­plex field,” said Julie Kim, pres­i­dent of Take­da’s plas­ma-de­rived ther­a­pies busi­ness unit. She co-led the ini­tia­tive with Bill Mez­zan­otte, head of R&D at CSL Behring.

Fund­ed by the NIH, the ITAC tri­al had en­rolled 600 adult pa­tients hos­pi­tal­ized for Covid-19 across 11 coun­tries and of­fered them in­ves­ti­ga­tion­al H-Ig plas­ma treat­ments. In ad­di­tion to Take­da and CSL Behring, Emer­gent BioSo­lu­tions and Gri­fols al­so sup­plied some of the clin­i­cal ma­te­r­i­al, which was processed and pu­ri­fied in a way that re­sult­ed in more con­cen­trat­ed neu­tral­iz­ing an­ti­body ac­tiv­i­ty while min­i­miz­ing safe­ty is­sues.

“IgG con­cen­tra­tion and IgG spe­cif­ic to SARS-CoV-2 were in­creased over 10-fold from con­va­les­cent plas­ma to the fi­nal prod­uct,” a group from Gri­fols de­scribed in a re­cent pa­per. “Nor­mal­ized en­zyme-linked im­munosor­bent as­say ac­tiv­i­ty (per mg/ml IgG) was main­tained through­out the process. Pro­tein con­tent in these fi­nal prod­uct batch­es was 100% IgG, con­sist­ing of 98% monomer and dimer forms. Po­ten­tial­ly haz­ardous pro­teins (IgM, IgA, and an­ti-A, an­ti-B, and an­ti-D) were re­duced to min­i­mal lev­els.”

In­ves­ti­ga­tors com­pared the clin­i­cal sta­tus of pa­tients in each group on day 7 of fol­lowup, mea­sur­ing a spec­trum of out­comes from lim­it­ing symp­toms to death. The com­pa­nies didn’t say much be­yond the fact that H-Ig didn’t meet the pri­ma­ry end­point, say­ing they will pub­lish the re­sults lat­er.

The hos­pi­tal­ized pa­tient pop­u­la­tion has been an elu­sive group for an­ti­bod­ies, de­feat­ing a slew of can­di­dates from Eli Lil­ly, Glax­o­SmithK­line/Vir and Brii Bio.

Plas­ma from healthy donors who have re­cov­ered from Covid-19, mean­while, has al­so had trou­ble liv­ing up to ear­ly ex­pec­ta­tions.

The UK’s RE­COV­ERY tri­al stopped re­cruit­ing pa­tients for its con­va­les­cent plas­ma arm af­ter an in­de­pen­dent da­ta mon­i­tor­ing com­mit­tee found no sig­nif­i­cant im­prove­ment in mor­tal­i­ty.

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

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

Endpoints Premium

Premium subscription required

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

President Biden (AP Images)

Biden in­vests $3B in­to an­tivi­ral de­vel­op­ment for Covid-19

The Biden administration on Thursday unveiled a new plan to invest more than $3 billion into speeding new antivirals to treat Covid-19.

The plan will allow NIH to evaluate, prioritize and advance antiviral candidates to Phase II clinical trials, using contractors and the NIH’s National Center for Advancing Translational Sciences laboratories to de-risk early stage development.

“New antivirals that prevent serious COVID-19 illness and death, especially oral drugs that could be taken at home early in the course of disease, would be powerful tools for battling the pandemic and saving lives,” said NIAID director Anthony Fauci.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

Jeff Albers, Blueprint CEO

Blue­print Med­i­cines nabs 4th ap­proval in bid to­ward prof­itabil­i­ty

Blueprint Medicines’ push to profitability continues.

On Wednesday, the Cambridge biotech announced the FDA approved its longtime lead drug, Ayvakit, for advanced systemic mastocytosis, a group of debilitating rare diseases where one type of immune cell — mast cells — builds up uncontrollably in a particular organ. The decision came on the heels of Phase III trials showing that more than half of late-stage patients who received the drug responded to it and did so for just over three years.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

Franz-Werner Haas, CureVac CEO (Christoph Schmidt/picture-alliance/dpa/AP Images)

UP­DAT­ED: Cure­Vac blames vari­ants as a close­ly-watched Covid vac­cine goes down in flames, fail­ing piv­otal study with woe­ful da­ta

CureVac was widely expected to come in with a late but likely late-stage winner in the race to develop new vaccines for the Covid-19 pandemic. Instead, late Wednesday, the German biotech said their mRNA candidate CVnCoV flat failed a pivotal trial — quashing any hopes for a quick entry in the blockbuster field and gutting their share price.

CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. Initial analyses suggest age and strain dependent efficacy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.