Bill Henshaw, Axcella Health CEO

Ax­cel­la re­duces work­force by 85%, pri­or­i­tizes long Covid drug re­search

Af­ter miss­ing its pri­ma­ry goal in Phase IIa tri­als for its long Covid drug, Ax­cel­la Health an­nounced Wednes­day that it’s cut­ting 85% of its work­force, has hired a bank to ex­plore strate­gic al­ter­na­tives, and is reshuf­fling its pipeline.

Bob Crane

As part of the re­struc­tur­ing, CFO Bob Crane and chief peo­ple of­fi­cer Vir­ginia Dean are leav­ing the biotech, and the com­pa­ny is now ex­plor­ing “a range of strate­gic al­ter­na­tives to max­i­mize share­hold­er val­ue,” in­clud­ing work­ing with an in­vest­ment bank — of­ten a sign that it will sell it­self or seek last-re­sort fi­nanc­ing.

Its main drug can­di­date is called AXA1125, which the com­pa­ny has been study­ing in the liv­er dis­ease NASH as well as for a long Covid ther­a­py. It will now put all of its bets on long Covid, with the hope that sig­nals it saw in NASH tri­als could pro­vide some lev­el of ben­e­fit to long Covid pa­tients.

Vir­ginia Dean

The com­pa­ny said it on­ly has the cap­i­tal to keep the lights on in­to the first quar­ter of 2023, based on earn­ings from Au­gust.

AXA1125 missed the pri­ma­ry end­points in its Phase IIa tri­al: phos­pho­cre­a­tine re­cov­ery rate af­ter mod­er­ate ex­er­cise. But the com­pa­ny said it saw promis­ing clin­i­cal signs from the drug with pa­tients’ men­tal and phys­i­cal fa­tigue and would push it for­ward in­to Phase III.

There is cur­rent­ly no treat­ment for long Covid, a dis­ease where chron­ic fa­tigue is a com­mon in­di­ca­tor. Ax­cel­la cit­ed re­ports from a re­cent Con­gres­sion­al sub­com­mit­tee on long Covid that de­tailed the im­pacts of the dis­ease on peo­ple and the econ­o­my: one mil­lion Amer­i­cans have been pushed out of work, and the dis­ease con­tributed to ap­prox­i­mate­ly $1 tril­lion in lost earn­ings and $529 bil­lion in in­creased med­ical spend­ing.

Its NASH tri­al, a Phase IIb study, found that the drug was as­so­ci­at­ed with re­duced liv­er stiff­ness. Liv­er stiff­ness is as­so­ci­at­ed with a Covid-19 in­fec­tion and can con­tin­ue even af­ter the ini­tial in­fec­tion pe­ri­od in long Covid, re­sult­ing in long-term dam­age, ac­cord­ing to a study based on pa­tients at Mass­a­chu­setts Gen­er­al Hos­pi­tal be­tween 2019 and 2022.

Mar­garet Koziel

“We be­lieve AXA1125 could be an im­por­tant first line agent for the large and un­served pa­tient pop­u­la­tions with Long COVID Fa­tigue and NASH, and with our cur­rent cap­i­tal con­straints, we are re­align­ing our ef­forts to best pre­serve the val­ue of our pro­grams and plat­form,” Ax­cel­la CMO Mar­garet Koziel said in a state­ment.

Ax­cel­la is one of on­ly a dozen or so small biotechs look­ing at the con­di­tion, in­clud­ing Tonix Phar­ma­ceu­ti­cals. Com­pa­nies like Atea and PureTech Health stopped look­ing in­to the mys­te­ri­ous con­di­tion af­ter failed tri­als.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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