A BTK in­hibitor Bio­gen punt­ed out of its pipeline years ago has flopped its first clin­i­cal test.

Day­ton Mis­feldt

Sune­sis Phar­ma said it would not be tak­ing ve­cabru­ti­nib in­to the Phase II por­tion of its Phase Ib/II tri­al af­ter re­view­ing ini­tial da­ta that sug­gest lim­it­ed ef­fi­ca­cy even at the high­est dose. The tri­al had en­rolled adult pa­tients with re­lapsed/re­frac­to­ry chron­ic lym­pho­cyt­ic leukemia (CLL) and oth­er B-cell ma­lig­nan­cies. The safe­ty pro­file was “ex­cel­lent”; it just didn’t seem to have much of an ef­fect.

Day­ton Mis­feldt, the Bay City Cap­i­tal VC who’s been in­ter­im CEO for more than two years, summed it up this way:

One par­tial re­mis­sion was ob­served af­ter 11 treat­ment cy­cles in a CLL pa­tient treat­ed in Co­hort 5 (300 mg BID) and a num­ber of pa­tients treat­ed across the dose range ex­plored (25 mg to 500 mg BID) saw sta­ble dis­ease; how­ev­er, no oth­er re­mis­sions have been ob­served.

The Phase Ib pro­gram will con­tin­ue while Sune­sis ex­ecs de­cide on the drug’s fate. Shares of the South San Fran­cis­co com­pa­ny on the Nas­daq — a pen­ny­s­tock — plum­met­ed 43.68% to $0.35 pre-mar­ket.

For now, Sune­sis will shift its fo­cus and re­sources to a PDK-1 in­hibitor dubbed SNS-510 — a process that should be fa­mil­iar to the com­pa­ny by now.

When it went pub­lic in 2005, the lead prod­uct can­di­date was SNS-595 (vosarox­in), a cell-cy­cle in­hibitor lat­er po­si­tioned for leukemia. Reg­u­la­tors spurned their Phase III da­ta and Sune­sis end­ed up out-li­cens­ing it to De­n­o­vo Bio­phar­ma, which spe­cial­izes in find­ing ap­plic­a­ble sub­groups for drugs that have com­plet­ed tri­als with “un­sat­is­fac­to­ry ef­fi­ca­cy.” Not much came out of the sec­ond project to de­vel­op an Au­ro­ra ki­nase in­hibitor, ei­ther.

The cur­rent pipeline of two con­sists en­tire­ly of as­sets orig­i­nat­ing from a col­lab­o­ra­tion with Bio­gen, who was al­so an eq­ui­ty hold­er. Aside from ve­cabru­ti­nib, a non-co­va­lent in­hibitor of BTK that promised to help Im­bru­vi­ca-re­sis­tant pa­tients, SNS-510 tar­gets PI3K-de­pen­dent and PIP3-in­de­pen­dent path­ways.

With Take­da on board as a part­ner, an IND is in the works for the end of 2020. The cash re­serves should be enough to get them there — but like­ly not that much be­yond.

The race to find a vaccine for the novel coronavirus continues to heat up, as the European Commission’s pilot R&D arm taps French biotech Osivax to head up its unique approach to the research.

Aiming to develop a universal jab for the flu and Covid-19, Osivax secured around $20 million in “blended financing” from the European Innovation Council. About $3 million comes from a Covid-19 “accelerator grant” and will go toward completing Osivax’s signature flu vaccine, dubbed OVX836 and currently in Phase IIa. The rest will be included as part of Osivax’s Series B funding, which aims to launch the Phase IIb portion of the study.

ViiV Healthcare and majority owner GlaxoSmithKline have cleared another important hurdle on a long-running quest to challenge Gilead’s dominance in preventative HIV treatments.

The final analysis of a new study shows the GSK subsidiary’s long-lasting injection, cabotegravir, proved 66% more effective in HIV prevention than Gilead’s breakthrough Truvada pill. And they now intend to carve away some of the blockbuster revenue that Gilead has enjoyed for years.

Two years after it first emerged from stealth mode, Flagship’s Foghorn Therapeutics has nabbed its first Big Pharma partner as Merck signs on to the biotech’s vision of drugging the very shape of DNA.

The deal, worth up to $425 million but with the upfront cash undisclosed, comes as Foghorn nears a pivot to a clinical stage biotech. The Cambridge-based company has added nearly 60 staffers from the 25 it had when it first emerged out of Flagship and, CEO Adrian Gottschalk said, they have finally refined the screening technology at the heart of the company, with plans to file their first IND towards the end of the year.

The pandemic stock market has proven fruitful for virtually any type of biotech. Now a 7-year-old cell therapy startup will see how much it can yield for a company that specializes in fighting viruses.

AlloVir, a company that until 2019 largely lived off grant money, has filed for a $100 million IPO to back its line of off-the-shelf, virus-fighting T cells. Although in normal circumstances, $100 million could be a solid return for a biotech that got its first major round of funding only last year, we’ll have to wait to see how much the company ultimately earns. As Covid-19 has sent investor money scurrying to almost anyone in drug development, every single biotech to go public this year has prized above their midpoint or upsized their offering, according to Renaissance Capital, sometimes dramatically so.