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.

Gritstone Oncology has had a big week, and it’s only Wednesday.

On Tuesday, the biotech revealed plans to start clinical testing of an experimental Covid-19 vaccine — in tandem with NIAID — that can also target other coronaviruses, with the goal of preventing future pandemics should SARS-CoV-2 prove difficult to cure with current vaccines. Then, on Wednesday morning, Gritstone licensed lipid nanoparticle technology from Genevant Sciences to develop what it’s calling “self-amplifying RNA vaccines” against Covid-19.

A month after filing the IND application for its human extracellular matrix designed to regenerate knee cartilage, Histogen has hit a roadblock.

The FDA on Tuesday verbally notified the San Diego-based biotech that it was placing a clinical hold on the planned Phase I/II clinical trial of HST-003 due to pending CMC information and additional questions needed to complete their review.

Histogen had planned to test the safety and efficacy of implanting hECM within microfracture interstices and related cartilage defects to regenerate that cartilage in conjunction with a microfracture procedure. The company said in a press release that it expects to receive written notice of the clinical hold from the FDA by Feb 12.

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

The past two months have been tough for Bristol Myers Squibb and its checkpoint inhibitor Opdivo after setbacks in lung and brain cancers. But in the battle against Merck’s Keytruda, any success matters — and now Bristol could be looking at a quick approval for Opdivo in an unmatched indication.

The FDA will launch a speedy review of a combination of Bristol Myers Squibb’s Opdivo and chemotherapy to treat first-line patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma, the drugmaker said Wednesday. The agency set an action date of May 25 for the application.