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 top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.

Flagship is building a big-name C-suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

Zai Lab is set to net more than $761 million from its secondary listing in Hong Kong after pricing the IPO at $72.51 (HKD$562) — just a hair below its Nasdaq closing price on Monday, Bloomberg and Nikkei Asian Review reported.

A pioneer in bringing Western drugs to China, co-founder and CEO Samantha Du has more than tripled Zai Lab’s market cap in the three years it’s been public in the US. The HKEX listing is designed to fund R&D and commercialization for the current portfolio while fueling new in-licensing pacts, the biotech wrote in a filing.