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.”

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Over a decade after launch, Blueprint Medicines nabbed the first approval for their first drug earlier this year. Now, as they move forward with a Roche-partnered global launch, they’re touting data that could push them into more patients.

The Jeff Albers-led Cambridge biotech released their full pivotal data for Ayvakit in patients with advanced systemic mastocytosis. In one 53-person study, they showed that 76% of patients responded to the drug, 36% had complete responses and that on average their responses lasted for just over 3 years. A smaller, 32-patient study had a 75% response rate and most were still responding after 10.4 months, the last follow-up.

Flagship is building a big-name C-suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.