As Ac­tu­ate Ther­a­peu­tics ramps up re­cruit­ment for what it calls a “ground­break­ing” Phase I/II in­volv­ing re­frac­to­ry blood can­cers and sol­id tu­mors, the biotech has se­cured $21.7 mil­lion to fund the en­deav­or in the US and be­yond.

Daniel Schmitt

Found­ed in 2015 with tech li­censed from the Uni­ver­si­ty of Illi­nois-Chica­go and North­west­ern — ac­cord­ing to a de­tailed time­line on its web­site — Ac­tu­ate is fix­at­ed on glyco­gen syn­thase ki­nase-3β, an en­zyme as­so­ci­at­ed with a range of dis­eases from bipo­lar dis­or­der to di­a­betes. Over­ex­pres­sion of GSK-3β is “heav­i­ly im­pli­cat­ed in chemo- and ra­diore­sis­tance in tu­mor cells,” mak­ing it a promis­ing tar­get for tough-to-treat can­cers such as glioblas­toma, ovar­i­an, breast and pan­cre­at­ic can­cers.

Kairos Ven­tures, which spe­cial­izes in help­ing aca­d­e­mics bring their tech­nolo­gies to the mar­ket­place, led the round with par­tic­i­pa­tion from DEF­TA Part­ners and Tech Coast An­gels. Bios Part­ners al­so chipped in, hav­ing been part of Ac­tu­ate’s pre­vi­ous $3.8 mil­lion Se­ries A.

The cash in­fu­sion al­lows Ac­tu­ate to ex­pand its clin­i­cal tri­al to Eu­rope, CEO Daniel Schmitt said, for which it plans to en­roll 250 pa­tients span­ning 30 tu­mor types in its tri­al, with a com­ple­tion date set for late 2022. The drug, 9-ING-41, will be test­ed both as a monother­a­py and in com­bi­na­tion with chemo.

Frank Giles, who left a po­si­tion as North­west­ern’s di­rec­tor of de­vel­op­men­tal ther­a­peu­tics to be­come CMO at Fort Worth, TX-based Ac­tu­ate two years ago, added that ini­tial study da­ta will in­form a pe­di­atric pro­gram in neu­rob­las­toma, “where 9-ING-41’s pre-clin­i­cal ac­tiv­i­ty is note­wor­thy.”

Im­age Source: Shut­ter­stock

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19, but follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.

Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.

Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.