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

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.