Cameron Durrant, Humanigen CEO (Columbia University Technology Ventures via YouTube)

Hu­mani­gen mo­men­tum barges on as Covid-19 can­di­date is se­lect­ed for NI­AID tri­al

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.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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Andrew Allen, Gritstone CEO (Gritstone via website)

Grit­stone con­tin­ues Covid-19 push with deal to de­vel­op 'self-am­pli­fy­ing RNA' vac­cines, as shares con­tin­ue bal­loon­ing

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.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Ugur Sahin, BioNTech CEO (AP Images)

Covid-19 roundup: BioN­Tech of­fers da­ta show­ing Pfiz­er-part­nered vac­cine pro­tects against vari­ant; No­vavax at­trib­ut­es re­spon­si­bil­i­ty for PhI­II de­lay to OWS

Ugur Sahin and his team at BioNTech have proffered more evidence that their Pfizer-partnered Covid-19 vaccine can protect people from a much-feared variant of SARS-CoV-2.

Colloquially known as the UK variant, the B.1.1.7 lineage triggered alarms because it appeared more transmissible. Among a series of mutations on its spike protein — the key antigen that all frontrunners in the vaccine race targeted — N501Y was of particular concern because it’s located on the receptor-binding site.

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FDA hits the brakes on His­to­gen's knee car­ti­lage ther­a­py, ask­ing for more in­fo on man­u­fac­tur­ing process

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.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

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.

Bris­tol My­ers Squibb gets re­view date for Op­di­vo com­bo in gas­tric can­cer, look­ing to over­turn Keytru­da's 3-year lead

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.

Covid-19 claims an­oth­er PDU­FA vic­tim as Glax­o­SmithK­line push­es back planned PD-1 roll­out

Bristol Myers Squibb isn’t the only pharma giant that’s been standing in the FDA’s waiting line for site inspections.

GlaxoSmithKline is telling us today that their H2 2020 PDUFA deadline for the PD-1 drug dostarlimab — picked up in its Tesaro buyout — was pushed back due to a delay in the manufacturing site inspection needed for a regulatory decision. And that is forcing the company to revise its timeline.

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