FDA side­swipes Ne­oleukin with clin­i­cal hold on lead im­munother­a­py can­di­date, sends shares plum­met­ing

Nat­ur­al killer and CD8 T cells for on­col­o­gy have been a hotbed of in­vest­ment in re­cent years, with some Big Phar­ma play­ers dab­bling in the ef­fort. A small­er com­peti­tor, Seat­tle’s Ne­oleukin Ther­a­peu­tics, hoped to give its IL-2 in­no­va­tor a shot at boost­ing those cells with­out the tox­i­c­i­ty con­cerns, but the FDA had oth­er ideas.

The FDA has placed a clin­i­cal hold on Ne­oleukin’s IND ap­pli­ca­tion for NL-201, a de no­vo cy­tokine re­cep­tor ag­o­nist for IL-2 and IL-15, which it hoped to test in ex­pand­ing CD8 T cells and nat­ur­al killer cells for use in on­co­log­ic ther­a­peu­tic ar­eas, the com­pa­ny said Fri­day.

The FDA re­quired Ne­oleukin to come up with a new as­say for the ther­a­py that would more ac­cu­rate­ly mea­sure the amount of pro­tein be­ing ad­min­is­tered to pa­tients in a pos­si­ble Phase I tri­al and en­sure the cor­rect dos­ing and ad­min­is­tra­tion of the drug, Ne­oleukin said. The FDA al­so posed “ad­di­tion­al ques­tions” to the biotech un­con­nect­ed to the hold that were not dis­closed in a re­lease.

Jonathan Drach­man

“We will work dili­gent­ly to ad­dress the FDA’s ques­tions as quick­ly as pos­si­ble,” CEO Jonathan Drach­man said in a state­ment. “We be­lieve that we will be able to de­vel­op the re­quest­ed as­say and re­spond with­in the next sev­er­al months. While we do not have a de­fin­i­tive time­line as to when we will be able to ob­tain clear­ance to pro­ceed, we look for­ward to work­ing with the FDA to sat­is­fy their re­quests.”

On the heels of the news, Ne­oleukin $NLTX was trad­ing down 18% be­fore the bell Fri­day at around $12.97.

Ne­oleukin, which launched with re­search out of the Uni­ver­si­ty of Wash­ing­ton in Jan­u­ary 2019, looked to shake up the IL-2 space by stim­u­lat­ing the ex­pan­sion of tu­mor fight­ing cells while side­step­ping pro­tein re­cep­tor CD25, which has been tied to tox­i­c­i­ty con­cerns.

In Au­gust 2019, the com­pa­ny went pub­lic af­ter a re­verse merg­er with Aquinox Phar­ma­ceu­ti­cals, which took a 61.42% stake in the new com­pa­ny in ex­change for $65 mil­lion in cap­i­tal for Ne­oleukin.

As part of that merg­er, Drach­man as­sumed the CEO role as David Main stepped away, mark­ing a new be­gin­ning for the team. Drach­man brought on VP ap­pointees Daniel Sil­va, Umut Ulge and Carl Walkey to con­tin­ue their work in re­search, trans­la­tion­al med­i­cine and cor­po­rate de­vel­op­ment, re­spec­tive­ly.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

FDA+ roundup: Ad­comm date set for Cy­to­ki­net­ics heart drug; New gener­ic drug guid­ance to re­duce fa­cil­i­ty de­lays

The FDA has set Dec. 13 as the day that its Cardiovascular and Renal Drugs Advisory Committee will review Cytokinetics’ potential heart drug, setting up a key vote ahead of a Feb. 28, 2023 PDUFA date.

The drug, known as omecamtiv mecarbil, read out its first Phase III in November 2020, hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as the key to breaking into the market, failing to significantly differ in reducing cardiovascular death from placebo.

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

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Two CRLs lat­er, Illi­nois-based CD­MO hit with FDA warn­ing let­ter over 's­pore-form­ing' bac­te­ria and fun­gi

Dupo, IL-based contract manufacturer Sterling Pharmaceuticals has had a long, tough year.

Last September, partner Verrica Pharmaceuticals’ NDA for a potential skin disease treatment was hit with a second CRL, with the company pinning the problems on Sterling. Eight months later, Verrica was hit with a third CRL due to further issues at Sterling, following a February reinspection by FDA of the Sterling site.

Kaile Zagger, Infinant Health CEO

UC Davis mi­cro­bio­me spin­out re­brands in­fant sup­ple­ment busi­ness with na­ture fo­cus

When Kaile Zagger took the helm of UC Davis spinout Evolve Biosystems several months ago, the company billed itself as a probiotic maker.

However, she believes the company’s Evivo supplement designed to help infants develop a healthy gut microbiome is “so much more” — and that, she said, calls for a rebrand.

Evolve has, well, evolved into Infinant Health, the company announced on Monday. The new name is a mash-up of the words “infant” and “infinite,” representing the company’s goal of expanding beyond infant care. While its sole product, Evivo, is intended for newborns, Infinant is “quickly developing” an option for kids through the age of two.

David Cory, Eiger BioPharmaceuticals CEO (via MultiVu)

FDA re­jects Eiger's emer­gency use re­quest for re­pur­posed Covid-19 treat­ment

Eiger BioPharmaceuticals is no longer planning to submit an emergency use application to the FDA.

The Palo Alto, CA-based biotech had hoped to repurpose its hepatitis D treatment, peginterferon lambda, for mild-to-moderate Covid-19 — submitting a request to the FDA for a pre-EUA meeting back in September with data from a Phase III platform trial in hand.

However, that meeting was rejected by federal regulators because of “concerns about the conduct of the TOGETHER study,” per an Eiger statement.

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