Af­ter los­ing its high-pro­file rheuma­toid arthri­tis part­ner­ship just two years ear­li­er, Sanofi’s Bel­gium-based biotech Abl­ynx could once again put an Ab­b­Vie pact on the chop­ping block af­ter post­ing a Phase II flop this morn­ing.

Abl­ynx re­port­ed out bad news that vo­bar­il­izum­ab dis­ap­point­ed yet again, fail­ing to meet its pri­ma­ry end­points in a Phase II lu­pus study. It’s the same drug that fiz­zled in RA, which Ab­b­Vie punt­ed back in 2016.

The drug was the sub­ject of a glob­al li­cens­ing agree­ment inked with Ab­b­Vie back in 2013, which came with an up­front pay­ment of $175 mil­lion and mile­stones up to $665 mil­lion. The deal gave Ab­b­Vie the op­tion to li­cense vo­bar­il­izum­ab in RA and in lu­pus. It’s un­clear what Ab­b­Vie will choose, but the fu­ture isn’t look­ing good for vo­bar­il­izum­ab.

Robert Zeldin

“Ab­b­Vie will re­view the com­plete da­ta set when avail­able from the Phase II Steady SLE study to de­ter­mine whether to ex­er­cise its op­tion to li­cense vo­bar­il­izum­ab,” Abl­ynx said in a state­ment. “Should Ab­b­Vie ex­er­cise the op­tion, it would trig­ger a pay­ment to Abl­ynx. If the op­tion is not ex­er­cised, Abl­ynx’s agree­ment with Ab­b­Vie would ter­mi­nate.”

Abl­ynx, which has a nanobody plat­form tech and sev­er­al drugs in its pipeline, was snatched up by Sanofi for $4.8 bil­lion in Jan­u­ary. That was af­ter shoot­ing down two pre­vi­ous bids from No­vo Nordisk. The deal got Sanofi Abl­ynx’s lead drug capla­cizum­ab, which has shown con­sid­er­able promise in treat­ing the ul­tra-rare blood clot­ting dis­or­der ac­quired throm­bot­ic throm­bo­cy­topenic pur­pu­ra (aTTP).

Still, the vo­bar­il­izum­ab fail­ure will like­ly sting. The failed Phase II study en­rolled 312 pa­tients with lu­pus across five treat­ment arms. Ad­verse events that led to study drug dis­con­tin­u­a­tion were re­port­ed in 12.4% of all vo­bar­il­izum­ab treat­ed pa­tients com­pared to 6.5% in the place­bo group. Two deaths were re­port­ed in the vo­bar­il­izum­ab group.

“We are dis­ap­point­ed that vo­bar­il­izum­ab didn’t show a dose re­sponse in the analy­sis of the study’s pri­ma­ry end­point, how­ev­er, vo­bar­il­izum­ab was well tol­er­at­ed in all test­ed dose groups, con­firm­ing its fa­vor­able safe­ty pro­file,” said Abl­ynx CMO Robert Zeldin in a state­ment. “We will con­tin­ue to an­a­lyze the full da­ta set and thank the study par­tic­i­pants and their fam­i­lies as well as the in­ves­ti­ga­tors and staff who con­tributed to this study.”

After being struck by a rare disease as a healthy third year medical student, David Fajgenbaum began an arduous journey chasing his own cure. Amidst the hustle of this year’s JP Morgan conference, the digital trials platform Medable partnered with Endpoints Studio to share Dr. Fajgenbaum’s story with the drug development industry.

What follows is an edited transcript of the conversation between Medable CEO Dr. Michelle Longmire and Dr. Fajgenbaum, and it is full of lessons for biotech executives charged with bringing the next generation of medicines to patients.

Grifols once paid Aradigm $26 million for a stake in its inhaled antibiotics. But with Aradigm now in bankruptcy, the Spanish drugmaker is dishing out a final $3.2 million to buy it all.

The fire sale — which comes one year after Aradigm filed for Chapter 11 following a regulatory trifecta for disaster — will see Grifols obtain assets and IP to Apulmiq (formerly Pulmaquin and Linhaliq in Europe), Lipoquin and free ciprofloxacin. In addition to waiving its claims in the bankruptcy case, Grifols also agreed to milestone payments up to $3 million more upon any regulatory approvals.

Almost a year and a half after DBV Technologies pulled its peanut allergy immunotherapy patch from FDA review, the biotech will get their day in court. The FDA has scheduled an advisory committee hearing for May 15.

In the two-horse race to develop the first immunotherapy for peanut allergy, DBV had the early lead, filing an NDA for their patch in 2018. But on December 20 of that year, the company withdrew their application after, they said, meeting with regulators and determining they had not submitted “sufficient detail regarding data on manufacturing procedures and quality controls.” Aimmune filed their BLA 3 days later and won approval as the first immunotherapy for peanuts this month.

→ Days after Kura Oncology announced the departure of co-founder Antonio Gualberto, we finally know where he wound up. Eisai subsidiary H3 Biomedicine has recruited him as CMO to finding the right patients to its four clinical-stage small molecule assets hitting genomic drivers of cancer.

“Challenges of these and many other precision medicine approaches are on one hand technical — a need for robust and precise diagnostics — and on the other hand derived by the challenge to alter standard clinical practice in settings where patient screening, e.g. by tumor DNA sequencing, is not standard practice,” he wrote to Endpoints News on his way back to Boston from Eisai’s Tokyo offices. “Only compelling clinical activity can drive clinicians and pathologists to modify standard clinical practice.”