In a first, Re­gen­eron's an­ti­body cock­tail re­duces deaths for a sub­group of hos­pi­tal­ized Covid-19 pa­tients

Sci­en­tists have come up with the first ev­i­dence that Re­gen­eron’s an­ti­body cock­tail, which has so far on­ly been au­tho­rized for the out­pa­tient set­ting, may re­duce deaths of hos­pi­tal­ized Covid-19 pa­tients — al­beit on­ly a sub­set.

The com­bi­na­tion of casiriv­imab and imde­vimab is the sub­ject of the lat­est da­ta cut from RE­COV­ERY, the large-scale UK-based tri­al test­ing a va­ri­ety of po­ten­tial treat­ments. In to­tal, 9,785 pa­tients hos­pi­tal­ized with Covid-19 were en­rolled in this arm of the study and were ran­dom­ly as­signed to re­ceive ei­ther usu­al care plus the in­tra­venous com­bo or usu­al care alone.

Al­though Re­gen­eron has bur­nished the pro­file of its drugs with new da­ta against new vari­ants, like Eli Lil­ly, its suc­cess has been lim­it­ed to mild to mod­er­ate cas­es or as a pro­phy­lax­is. De­spite an ear­ly set­back among the most se­vere pa­tients, the biotech is still run­ning a tri­al in­volv­ing pa­tients who are hos­pi­tal­ized but re­quire no or lit­tle oxy­gen (with ini­tial da­ta in­di­cat­ing an an­tivi­ral ef­fect) — as the search for ther­a­pies that can help the sick­est pa­tients goes on.

The new re­sults are thus “very ex­cit­ing,” said joint chief in­ves­ti­ga­tor Pe­ter Hor­by.

In par­tic­u­lar, the com­bo ap­pears to keep cer­tain pa­tients who were seroneg­a­tive at base­line — mean­ing they had not mount­ed an an­ti­body re­sponse against the virus — from dy­ing. About one-third of the over­all group were seroneg­a­tive.

Fo­cus­ing on this co­hort for the pri­ma­ry analy­sis, in­ves­ti­ga­tors found that the an­ti­body treat­ment re­duced the 28-day mor­tal­i­ty by 20% over usu­al care: 24% of the seroneg­a­tive pa­tients in the an­ti­body group died ver­sus 30% of the usu­al care arm (95% con­fi­dence in­ter­val 0·70–0·91; p=0·001). In oth­er words, they wrote, “for every 100 such pa­tients treat­ed with the an­ti­body com­bi­na­tion, there would be six few­er deaths.”

The same ef­fect was not seen in seropos­i­tive pa­tients. When pool­ing da­ta from this larg­er group as well as those with un­known sta­tus with the seroneg­a­tive pa­tients, no sig­nif­i­cant ef­fect was re­port­ed in re­duc­ing deaths. Over­all, 20% of all pa­tients in the an­ti­body group died com­pared to 21% of those who re­ceived usu­al care (p=0.17).

It was im­por­tant to make the dif­fer­en­ti­a­tion, said Fiona Watt — ex­ec­u­tive chair of the Med­ical Re­search Coun­cil, which fund­ed the tri­al — “giv­en the cost of drugs.”

Nonethe­less, the find­ing that the an­ti­body cock­tail worked in any group at all was “ex­cel­lent news,” ac­cord­ing to joint chief in­ves­ti­ga­tor Mar­tin Lan­dray.

“Peo­ple have been very, very skep­ti­cal, that any treat­ment against this par­tic­u­lar virus would work by the time peo­ple get in hos­pi­tal,” he said in a me­dia brief­ing, as re­port­ed by Reuters. “If you haven’t raised an­ti­bod­ies of your own, you re­al­ly would ben­e­fit from get­ting some.”

On top of a low­er death rate, seroneg­a­tive pa­tients al­so got out of the hos­pi­tal soon­er, with a four-day dif­fer­ence in me­di­an du­ra­tion of hos­pi­tal stay (13 days ver­sus 17 days for usu­al care group) — and 64% of them were dis­charged alive by day 28, com­pared to 58%. The num­bers al­so sug­gest that if they were not on in­va­sive me­chan­i­cal ven­ti­la­tion at base­line, they were at low­er risk of pro­gress­ing to that point or dy­ing.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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Alan Hirzel, Abcam

Drug sup­pli­er Ab­cam brings a long­time col­lab­o­ra­tor in house as part of $340M buy­out pact

BioVision has supplied Abcam with research tools since 1999, and now the two are making it official as part of a merger unveiled Monday.

Abcam will buyout BioVision as part of a $340 million acquisition deal to bring aboard the supplier’s biochemical and cell-based assays for biological research, as well as recombinant proteins, antibodies and enzymes.

The deal will give Abcam control of BioVision’s portfolio and allow for both the expansion of research existing areas of focus such as oncology, neuroscience and epigenetics and preparation to expand into new products. As a part of the deal, Abcam will develop and supply products and services to NKY, the previous owner of BioVision and receive support for ongoing development and commercialization of in vitro diagnostic products.

Tib­so­vo clears an­oth­er hur­dle for Servi­er, but can it make Agios' old drug prof­itable?

When European regulators saw the data Agios used to win US approval for their AML drug Tibsovo, they sent the more than decade-old biotech back to the drawing board. A single, single-armed trial was not going to cut it.

On Monday, though, the drug’s new owners announced it had cleared a more rigorous study. In a randomized, Phase III trial of certain newly diagnosed patients, those who received a combination of Tibsovo and chemotherapy lived longer than those who received a combination of placebo and chemotherapy. Those patients also had higher response rates and complete remission rates.

UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Covid-19 roundup: Re­gen­eron's mAB gets ex­pand­ed EUA; mR­NA drug­mak­ers spike price of vac­cines in EU sup­ply deal

The FDA has expanded the authorization for Regeneron’s Covid-19 treatment Regen-Cov in an announcement Friday.

The authorization now covers post-exposure prophylaxis for those exposed to an infected person or who are at high risk of exposure “in an institutional setting” like a nursing home or a prison, and are not fully vaccinated or expected to provide a sufficient immune response.

Regeneron experts predict that 3% of the US population may not be able to fully respond to Covid-19 vaccinations.

Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; 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.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.