Chris­t­ian Hogg Chi-Med

→ One of Chi-Med’s late-stage fa­vorites is grad­u­at­ing ear­ly from its Phase III study, hav­ing met its pri­ma­ry end­points at in­ter­im analy­sis. The Hong Kong-head­quar­tered biotech left out the num­bers in its brief state­ment, which not­ed that su­r­u­fa­tinib hit a PFS goal among pa­tients with ex­tra-pan­cre­at­ic neu­roen­docrine tu­mors. CEO Chris­t­ian Hogg has tapped the drug, along­side savoli­tinib, for ap­provals over the next two years to fol­low up on the land­mark OK for fruquin­tinib in Chi­na.

→ Am­gen $AMGN and Al­ler­gan $AGN have nabbed an OK to mar­ket their Her­ceptin copy­cat — chris­tened Kan­jin­ti — in the US for all ap­proved in­di­ca­tions of the Roche block­busters in­clud­ing HER2-over­ex­press­ing breast can­cer and gas­tric or gas­troe­sophageal junc­tion ade­no­car­ci­no­ma. “Kan­jin­ti is the sec­ond of four biosim­i­lars from Am­gen and Al­ler­gan’s col­lab­o­ra­tion to be ap­proved by the FDA,” David Nichol­son, Al­ler­gan’s chief re­search and de­vel­op­ment of­fi­cer, not­ed.

David Nichol­son Al­ler­gan

→ Last year, Sun Phar­ma­ceu­ti­cals en­tered the crowd­ed mar­ket for plaque pso­ri­a­sis with its IL-23 in­hibitor Ilumya. On Fri­day, the In­di­an drug­mak­er said the mon­o­clon­al an­ti­body — in-li­censed from Mer­ck $MRK back in 2014 for $80 mil­lion — cleared a mid-stage study in pa­tients with pso­ri­at­ic arthri­tis. The in­ter­im analy­sis re­vealed that over 71% of pa­tients treat­ed with the drug ex­pe­ri­enced a 20% im­prove­ment in joint and skin symp­toms, meet­ing the pri­ma­ry end­point of the study.

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.