Just weeks af­ter Astel­las agreed to pay Aquinox Phar­ma­ceu­ti­cals $25 mil­lion up­front for Asian rights to their lead drug rosip­tor, the lit­tle biotech says their Phase III tri­al was a com­plete dis­as­ter, leav­ing noth­ing to sal­vage.

David Main

CEO David Main didn’t sug­ar­coat it. No mat­ter how hard they stud­ied the da­ta, the in­ter­sti­tial cys­ti­tis drug clear­ly couldn’t beat a place­bo. He said:

We have con­duct­ed a num­ber of sen­si­tiv­i­ty, sub­pop­u­la­tion, and sec­ondary end­point analy­ses and none demon­strate a ben­e­fit of rosip­tor over place­bo.

In­vestors bet­ting on a key suc­cess here clear­ly weren’t hap­py. Aquinox’s shares $AQXP were swift­ly dec­i­mat­ed, div­ing 85%.

The Van­cou­ver-based biotech had hoped for bet­ter, re­cruit­ing 433 pa­tients suf­fer­ing from in­ter­sti­tial cys­ti­tis/blad­der pain syn­drome for the study, which had the same de­sign as Phase II.

Af­ter bury­ing the drug pro­gram, and watch­ing its mar­ket cap shriv­el, Main says it’s time to study what kind of strate­gic al­ter­na­tives re­mains open. There is a mid-stage study un­der­way for the same drug — a small mol­e­cule ac­ti­va­tor of SHIP1 — in chron­ic pro­sta­ti­tis/chron­ic pelvic pain syn­drome. But vir­tu­al­ly all of its eggs were in the one drug bas­ket.

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).

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.