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.”

For iTeos, it turned out, $75 million could only last so long.

Two years after announcing their eye-catching Series B raise, the Belgian biotech is back with an even larger Series B-2: $125 million.

The now $200 million financing illustrates the vast capital available for those with promising new immuno-oncology compounds, particularly those that might be used in combination with existing therapies. In December, iTeos announced a collaboration with Merck to test its lead compound with Keytruda this year. The proceeds will push forward that trial and help fund the ongoing Phase I/II trials for that compound, EOS-850, and a second one, EOS-448.

In a leap to the gene therapy space, Daiichi Sankyo has dropped $200 million to access Ultragenyx’s manufacturing technology, providing the rare disease biotech with plenty of cash and a stock boost amid a general cash crunch.

For $125 million in cash and a $75 million equity investment, Daiichi Sankyo has bought a non-exclusive license to the IP around two platforms with which it plans to develop AAV-based gene therapy products. The Japanese pharma is purchasing the stock $RARE at $60 per share, more than a third above its current price of $44.43.

Gilead’s bid to overturn a jury verdict that ordered it to pay Bristol Myers Squibb about $752 million for CAR-T patents owned by its subsidiary Juno Therapeutics has ended in vain.

The ruling leaves Gilead vulnerable to an even bigger $1.5 billion payment that Bristol is now demanding — adding fuel to the fiery criticism some analysts are already heaping on its $11.9 billion Kite buyout.

In a 30-page document unsealed on Monday, Judge James Otero of the district court in Los Angeles struck down several different arguments for a new decision. Here are Morgan Stanley analysts’ takeaways:
The court, in particular, denied Kite’s contentions (1) that Juno’s patent is invalid, (2) the damages award was unreasonable, and (3) that a new trial should take place. The court also denied Kite’s argument that its infringement was not willful.
Gilead is likely to appeal to the federal circuit, they noted, but the odds are not in their favor as the same standard for evidence will be applied in that court. Appeals typically take 16 months.

Scientists began with making recombinant versions of naturally-occurring human proteins, then graduated to monoclonal antibodies. Now, rather than replicating moieties within the body, researchers are modifying these molecules to have precise biology in a functional manner.

This technology, referred to as bispecific antibodies, is already being employed to fight cancer. In early 2018, Pandion Therapeutics was born to reverse-engineer the science into the realm of autoimmune and inflammatory disorders.

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).