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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Greg Mayes, Antios Therapeutics CEO

An­tios' HBV col­lab axed af­ter clin­i­cal hold, but biotech be­lieves safe­ty in­ci­dent is not treat­ment-re­lat­ed

The FDA has placed a clinical hold on a Phase IIa study of Antios Therapeutics’ investigational hepatitis B med, CEO Greg Mayes confirmed to Endpoints News in an emailed statement.

A safety report was delivered to the biotech on May 17 after a patient dosed in a triple combination cohort of the study had experienced bradycardia and hypotension. The triple combo included Antios’ ATI-2173, Assembly Biosciences’ vebicorvir and Viread, an approved antiviral for HIV and hepatitis B.

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Tim Schoen, BioMed Realty CEO

Life sci­ences de­vel­op­er Bio­Med Re­al­ty buys San Fran­cis­co ho­tel for $75M — re­port

In a somewhat unconventional deal, life sciences real estate developer BioMed Realty has bought a 169-room Hilton Garden Inn in South San Francisco for $75 million, the San Francisco Business Times reported.

BioMed Realty, an affiliate of Blackstone, has multiple life sciences and technology office projects in the Bay Area, including three sites within a five-minute drive of the hotel.

While the sale of the hotel property was announced earlier this month, the sellers, Summit and GIC, did not identify the buyer at the time.

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Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.