Mark Smith, Finch Therapeutics CEO

Bear mar­ket shows no signs of abat­ing, claim­ing Finch Ther­a­peu­tics as the lat­est lay­off vic­tim

Much ink has been spilled over the con­tin­u­ing wave of lay­offs hit­ting the biotech in­dus­try, and that doesn’t look to be stop­ping any­time soon.

Finch Ther­a­peu­tics re­port­ed Tues­day morn­ing that it would be lay­ing off 37 staffers, or ap­prox­i­mate­ly 20% of its work­force, per an SEC fil­ing. The de­ci­sion to cut costs comes about a month af­ter Finch said the FDA had placed a treat­ment for C. dif­fi­cile in­fec­tions on par­tial clin­i­cal hold, and rough­ly three weeks af­ter paus­ing its he­pati­tis B pro­gram.

“This was a dif­fi­cult de­ci­sion; how­ev­er, we be­lieve this de­ci­sion will put us in a stronger fi­nan­cial po­si­tion to ex­e­cute up­on our strate­gic pri­or­i­ties and con­tin­ue to de­liv­er on our mis­sion to har­ness the mi­cro­bio­me to serve pa­tients and their fam­i­lies,” CEO Mark Smith said in a pre­pared state­ment.

Finch shares $FNCH, al­ready down 64% since the start of the year, showed no change as the mar­ket opened Tues­day.

Tues­day’s lay­offs may have been in the works fol­low­ing a rough March, which saw the FDA hold and the he­pati­tis B pause. Reg­u­la­tors had re­quest­ed Finch pro­vide more in­for­ma­tion on its screen­ing pro­to­cols for C. dif­fi­cile in­fec­tions, the biotech said, re­port­ed­ly point­ing to is­sues at a man­u­fac­tur­er Finch had ac­quired while a Phase II study was un­der­way.

The man­u­fac­tur­er, Open­Bio­me, was placed on hold in late 2019, but Finch was al­lowed to con­tin­ue us­ing donor sam­ples from be­fore then in its study. The hold was re­leased in Jan­u­ary 2021, and Finch bought the com­pa­ny’s man­u­fac­tur­ing tech two months lat­er. Finch be­gan dos­ing Phase III pa­tients last No­vem­ber, but the FDA re­turned with ques­tions this past Jan­u­ary.

At the time it re­port­ed the hold, Finch al­so not­ed that some pa­tients were dosed in this study while the hold was in ef­fect. The com­pa­ny says it’s re­view­ing the mat­ter.

The biotech fol­lowed up at the end of March say­ing it had re­spond­ed to the hold no­tice and ob­tained ad­di­tion­al feed­back from the agency. Per Finch, ex­ecs not­ed reg­u­la­tors want­ed changes to the Phase III test­ing al­go­rithm used to di­ag­nose sus­pect­ed re­in­fec­tions, as well as more in­fo on the tri­al’s sta­tis­ti­cal analy­sis plan. The com­pa­ny is ex­pect­ing “at least” a one quar­ter de­lay.

Finch’s March 31 up­date al­so re­vealed the biotech would be paus­ing he­pati­tis B ac­tiv­i­ties “fol­low­ing a strate­gic re­view” of its pipeline. The move will al­low Finch to fo­cus on its C. dif­fi­cile and autism spec­trum dis­or­der pro­grams.

The biotech, much like its in­dus­try com­pa­tri­ots, falls on hard times as 2022 is yet to let up on the sec­tor. Finch’s lay­offs come as part of a broad­er reshift­ing with­in the biotech space fol­low­ing record ac­tiv­i­ty dur­ing the pre­vi­ous two years.

Much of the down­turn has been cap­tured in the XBI, an in­dex mea­sur­ing the in­dus­try’s per­for­mance as a whole. It’s down about 30% on the year and down al­most 50% from its peak in Feb­ru­ary 2021. And some­times, the move­ments ap­pear to be hap­pen­ing ran­dom­ly: on Mon­day, for ex­am­ple, the XBI fell 5% de­spite the lack of ma­jor news.

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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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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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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.

Tony Johnson, Goldfinch Bio CEO (Goldfinch via YouTube)

Kid­ney dis­ease drug­mak­er Goldfinch Bio shuts down

Goldfinch Bio, attempting to make treatments for kidney diseases and diabetic nephropathy, is shutting down.

President and CEO Tony Johnson confirmed to Endpoints News Friday afternoon that the biotech shut down after “fundraising challenges in the current macro-environment.” Fierce Biotech first reported the news.

Johnson, who joined in 2017 after a stint as SVP of early clinical development at AstraZeneca, said in a text that the company “entered the ABC process recently,” referring to an assignment for the benefit of the creditors, which provides a different wind-down avenue than a bankruptcy.

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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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Dutch biotech starts liq­ui­da­tion af­ter end­ing PhI­II in GVHD

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi.

Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019.

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Robert Hariri, Celularity CEO (Vivien Killilea/Getty Images for Brain Mapping Foundation)

Celu­lar­i­ty warns of loom­ing lay­offs, spot­lights ear­ly pro­grams as mon­ey runs dry

Celularity has warned “a substantial portion” of its employees that layoffs could be looming in the face of a reprioritization effort. In the same breath, it touted some of its very early next-gen candidates in degenerative diseases and oncology.

“While Celularity is hopeful that there will be no need to substantially reduce its headcount, the notifications were provided in accordance with applicable law and to maintain full transparency with its employees,” the news release reads, in part.

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.