Yuval Cohen, Corbus CEO (Corbus via YouTube)

An­oth­er Cor­bus pro­gram hits the skids af­ter late-stage flop, plum­met­ing the small biotech's shares

Cor­bus Phar­ma­ceu­ti­cals’ plans to po­si­tion lenaba­sum as a pipeline-in-a-prod­uct aren’t go­ing so well.

Af­ter shelv­ing a pro­gram in scle­ro­der­ma, the Nor­wood, MA-based biotech has re­vealed that its lead can­di­date failed both the pri­ma­ry and sec­ondary end­points in an­oth­er Phase III tri­al.

Lenaba­sum failed to show a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence in to­tal im­prove­ment com­pared with place­bo in treat­ing der­mato­myosi­tis, a rare dis­ease that caus­es mus­cle in­flam­ma­tion and skin rash, the com­pa­ny said Thurs­day. The news sent Cor­bus’ $CRBP stock spi­ral­ing around 30% ear­ly Thurs­day morn­ing.

Par­tic­i­pants in the study re­ceived one of two dos­es of lenaba­sum (20 mg or 5 mg) twice a day, or a place­bo, all in ad­di­tion to back­ground treat­ments. At week 28, those in the 20 mg group saw a mean to­tal im­prove­ment score (TIS) of 28.3, ver­sus 26.7 in the place­bo group. How­ev­er, the p-val­ue came in at 0.1965, which is far over the gold­en 0.05 num­ber of­ten used in drug tri­als to mea­sure sta­tis­ti­cal sig­nif­i­cance.

“We are dis­ap­point­ed that the tri­al did not meet the pri­ma­ry end­point of TIS at Week 28,” CMO and head of re­search Bar­bara White said in a state­ment.

Lenaba­sum is a small mol­e­cule that binds to and ac­ti­vates CB2, which is ex­pressed on ac­ti­vat­ed im­mune cells. The Phase III study, dubbed DE­TER­MINE, en­rolled pa­tients with two types of der­mato­myosi­tis: those who have both mus­cle weak­ness and skin in­volve­ment, and those with skin in­volve­ment but no sig­nif­i­cant mus­cle weak­ness.

In an at­tempt to look on the bright side, Cor­bus said high­er TIS scores were seen in par­tic­i­pants who had mus­cle weak­ness and were treat­ed with two 20 mg dos­es com­pared to place­bo, with a nom­i­nal p-val­ue of 0.0302. And pa­tients with skin symp­toms but no mus­cle weak­ness showed greater im­prove­ments on the Cu­ta­neous Der­mato­myosi­tis Ac­tiv­i­ty and Sever­i­ty In­dex (CDASI), which mea­sures in­flam­ma­to­ry skin in­volve­ment, with a nom­i­nal p-val­ue of 0.0166.

How­ev­er, the drug flopped on an­oth­er sec­ondary end­point: ef­fect on lung func­tion. No sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence was seen at week 28 com­pared to the con­trol group, ac­cord­ing to Cor­bus.

CEO Yu­val Co­hen told End­points News that the com­pa­ny will have a dis­cus­sion with reg­u­la­tors, and if the next step is to con­duct an­oth­er study, they’ll dis­cuss which pa­tients and which end­points to fo­cus on.

“While, again, we did not hit on the pri­ma­ry, it’s the sec­ond time that we’re see­ing signs of what we think is clear: clin­i­cal ac­tiv­i­ty,” he said. “What we’re al­so wait­ing for are the bio­mark­er da­ta from skin biop­sies. In our Phase II, the bio­mark­er da­ta was very en­cour­ag­ing.”

Lenaba­sum is the com­pa­ny’s on­ly clin­i­cal can­di­date, ac­cord­ing to their web­site. It has oth­er CB2 ag­o­nists in the works for sol­id tu­mors, as well as CB1 in­verse ag­o­nists for me­tab­o­lism dis­eases and two mon­o­clon­al an­ti­bod­ies for sol­id tu­mors and fi­bro­sis.

Cor­bus spent years build­ing up in­vestors’ hope in lenaba­sum. But back in Sep­tem­ber, the drug failed a Phase III study for a rare au­toim­mune con­di­tion called scle­ro­der­ma. The fol­low­ing month, it an­nounced it would shave its work­force by 54%. The com­pa­ny, which once had hopes for lenaba­sum as a pipeline in a prod­uct, said it would re­fo­cus on pro­grams in der­mato­myosi­tis and sys­temic lu­pus ery­the­mato­sus, and its pre­clin­i­cal can­di­dates.

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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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.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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