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.

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.

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.

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.