One of “Phar­ma Bro” Mar­tin Shkre­li’s for­mer biotechs came back from the dead dur­ing the Covid-19 pan­dem­ic thanks to its drug can­di­date tar­get­ing cy­tokine storms. Now, that com­pa­ny has scored it­self a place in a NI­AID-spon­sored tri­al.

Hu­mani­gen $HGEN, trad­ing for 46 cents per share as re­cent­ly as mid-March, an­nounced Mon­day af­ter­noon that its lenzilum­ab will be test­ed in com­bi­na­tion with remde­sivir in NI­AID’s Big Ef­fect Tri­al, ef­fec­tive­ly cat­e­go­riz­ing it as a high-pri­or­i­ty Covid-19 ther­a­peu­tic can­di­date. The drug com­bo will be test­ed against remde­sivir, a broad-spec­trum an­tivi­ral that has shown in ear­ly stud­ies to treat some symp­toms of Covid-19, and a place­bo.

Need­less to say, Hu­mani­gen CEO Cameron Dur­rant is quite ex­cit­ed by the news.

“This is ar­guably the world’s fore­most re­search for pub­lic health, gov­ern­ment-sup­port­ed or­ga­ni­za­tion,” Dur­rant told End­points News. “And they se­lect­ed lenzilum­ab to be a par­tic­i­pant in this pro­gram. We think that that’s ex­tra­or­di­nar­i­ly val­i­dat­ing.”

Dur­rant couldn’t com­ment on the time­line for the tri­al, cit­ing the NIH’s spon­sor­ship. NI­AID couldn’t be im­me­di­ate­ly reached for re­quests to com­ment.

Be­fore the pan­dem­ic, Hu­mani­gen was last in the news about three years ago when it was de­vel­op­ing a drug to treat Cha­gas dis­ease, but got beat­en to the punch by a non­prof­it group. What had been a promis­ing pro­gram be­came a dud and sent in­vestors flee­ing.

But since mid-March, when com­pa­nies around the world were look­ing at ex­ist­ing drugs to treat Covid-19, lenzilum­ab has been in the spot­light with its stock price up to near­ly $5 per share — an al­most 1,000 per­cent in­crease — in four months. Hu­mani­gen is cur­rent­ly en­gag­ing in its own Phase III tri­al, and Dur­rant in­sists this won’t be an­oth­er mishap like three years ago.

Though a fail­ure on Covid-19 here would like­ly pop this bal­loon in­stant­ly, the Cha­gas can­di­date “was a com­plete­ly dif­fer­ent pro­gram and com­plete­ly in the rearview mir­ror. So, of course, we’re op­ti­mistic.”

Da­ta for lenzilum­ab in Covid-19 treat­ment are fair­ly lim­it­ed thus far; a non-con­trolled preprint of 12 pa­tients with coro­n­avirus-re­lat­ed se­vere pneu­mo­nia was re­leased last month. In that study, 11 of those pa­tients saw clin­i­cal im­prove­ments with an av­er­age time to dis­charge of five days, and they did not ex­hib­it any se­ri­ous ad­verse ef­fects.

The Cal­i­for­nia-based biotech’s main fo­cus is cy­tokine storm re­search and it has been study­ing the ef­fi­ca­cy of lenzilum­ab, a GM-CSF mon­o­clon­al an­ti­body, in treat­ing over­ac­tive im­mune re­spons­es seen in graft-ver­sus-host dis­ease and CAR-T can­cer ther­a­pies. This mech­a­nism has been a brighter spot in vac­cine re­search than the com­pet­ing Re­gen­eron-backed IL-6 treat­ment, which suf­fered a set­back in Phase II tri­als in late April.

Be­cause Covid-19 ex­hibits a sim­i­lar pathol­o­gy to GvHD and CAR-T re­spons­es, Dur­rant said lenzilum­ab treat­ments could be ap­plied to those in­fect­ed by the coro­n­avirus.

Back in 2015, Shkre­li and an in­vest­ment group bought a ma­jor­i­ty stake in the com­pa­ny, then known as Kalo­Bios. When Shkre­li was ar­rest­ed for se­cu­ri­ties fraud, Kalo­Bios fired him, de­clared bank­rupt­cy and re-emerged as Hu­mani­gen in 2016.

On June 2, Hu­mani­gen scored $71.8 mil­lion in pri­vate eq­ui­ty to help fund its Phase III lenzilum­ab tri­als and scale the drug should it be ap­proved.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

J&J revealed a summary of new Covid-19 vaccine data today, including new results showing booster shots may help with protection.

A Phase III study (ENSEMBLE 2) looked at booster shots at two different points in time: a second shot 56 days after the first shot, or a second shot six months after the first. The eight-week shot showed increased protection against symptomatic Covid-19, with the following levels of protection: