Mark Smith, Finch Therapeutics CEO

FDA slaps hold on Finch's mi­cro­bio­me C. dif­fi­cile treat­ment, as biotech blames Covid-19 and old man­u­fac­tur­er

Drug­mak­ers work­ing on treat­ments for C. dif­fi­cile in­fec­tions are hav­ing a bad week.

Just one day af­ter Pfiz­er re­port­ed its C. dif­fi­cile vac­cine can­di­date did not hit the pri­ma­ry end­point in a Phase III study, Finch Ther­a­peu­tics is find­ing it­self in a sim­i­lar po­si­tion. The biotech said Tues­day its mi­cro­bio­me treat­ment for the in­fec­tion was placed on clin­i­cal hold by the FDA last week, with reg­u­la­tors seek­ing more in­fo on Finch’s screen­ing pro­to­cols.

News of the hold sent Finch shares $FNCH down about 14% af­ter Mon­day’s clos­ing bell.

Like Pfiz­er, Finch blamed the Covid-19 pan­dem­ic for its trou­bles, point­ing to an FDA safe­ty alert from March 2020 over the po­ten­tial SARS-CoV-2 trans­mis­sion risk through mi­cro­bio­me treat­ments. In con­junc­tion with the alert, reg­u­la­tors put Finch’s IND and then-man­u­fac­tur­er on par­tial hold so as to add Covid-19 test­ing to any donor ma­te­r­i­al re­ceived af­ter Dec. 1, 2019.

As Finch tells it, re­searchers were able to con­tin­ue dos­ing in an on­go­ing Phase II tri­al, us­ing donor sam­ples be­fore that date. In Jan­u­ary 2021, the man­u­fac­tur­er, Open­Bio­me, was re­leased from clin­i­cal hold and Finch then bought the man­u­fac­tur­ing tech two months lat­er. In No­vem­ber, Finch be­gan dos­ing par­tic­i­pants in a Phase III tri­al us­ing the same screen­ing meth­ods it says were used by Open­Bio­me and sub­se­quent­ly ac­quired.

But the FDA reached out in Jan­u­ary, os­ten­si­bly with some ques­tions, and sent the clin­i­cal hold no­tice on Feb. 24. As a re­sult, Finch is paus­ing en­roll­ment in that Phase III study, its sec­ond piv­otal study look­ing to eval­u­ate the mi­cro­bio­me treat­ment.

Finch did note that some pa­tients were dosed in this piv­otal study while the hold was in ef­fect. The com­pa­ny said in a press re­lease it is con­duct­ing a re­view of the mat­ter. End­points News has reached out for com­ment and will up­date ac­cord­ing­ly.

Pre­vi­ous­ly, the ther­a­py dubbed CP101 passed its first Phase III test with nom­i­nal sta­tis­ti­cal sig­nif­i­cance, hit­ting the pri­ma­ry end­point of a sus­tained clin­i­cal cure through week 8. Be­tween treat­ment and place­bo, Finch re­port­ed a 33.8% rel­a­tive risk re­duc­tion, good for a p-val­ue of p=0.0488.

The treat­ment re­mained durable too, the com­pa­ny said, not­ing 73.5% of par­tic­i­pants sus­tained the cure ef­fects through 24 weeks, com­pared to 59.4% on place­bo. Finch’s ther­a­py proved more sta­tis­ti­cal­ly sig­nif­i­cant here, notch­ing a p-val­ue of p=0.0347.

Where Finch goes from here is not yet clear, as the com­pa­ny said it’s still eval­u­at­ing how long a de­lay could be in its topline read­out. Finch is al­so test­ing CP101 in chron­ic he­pati­tis B, with stud­ies cur­rent­ly in the pre­clin­i­cal phase, and it’s al­so not clear how these stud­ies might be im­pact­ed.

Though Finch is in for some chop­py wa­ters ahead, it’s ar­guably in a more fa­vor­able po­si­tion than Pfiz­er or Sum­mit Ther­a­peu­tics, which is de­vel­op­ing an an­tibi­ot­ic for C. dif­fi­cile in­fec­tions. Nei­ther Pfiz­er nor Sum­mit record­ed sta­tis­ti­cal­ly sig­nif­i­cant Phase III re­sults and Finch al­ready has one un­der its belt.

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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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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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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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 ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Post-hoc analy­sis: EMA's CHMP re­jects Ipsen's po­ten­tial drug for rare ge­net­ic dis­ease

The European Medicines Agency’s Committee for Medicinal Products for Human Use on Friday rejected Ipsen Pharma’s potential treatment for a rare genetic disease known as fibrodysplasia ossificans progressiva (FOP), which causes extra bone to form outside the skeleton.

The EMA said on its website that it could not draw any firm conclusions on the benefits of the French biopharma’s Sohonos (palovarotene), which selectively targets the retinoic-acid receptor gamma (RARγ), “as the applicant’s conclusion was based on a post-hoc analysis which was neither scientifically nor clinically justified and pre-specified study objectives were not met.”

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Steve Harr, Sana Biotechnology CEO

Four years in, Sana gets first FDA go-ahead to bring can­cer treat­ment in­to the clin­ic

Sana Biotechnology is finally headed to the clinic.

Thursday afternoon, the biotech announced the FDA had cleared its application to start a clinical trial for its allogeneic, or “off-the-shelf,” CAR-T cell therapy targeting the antigen CD19 for patients with B-cell lymphomas and leukemias. Sana said its therapy, dubbed SC291, was designed to evade the immune system, which could help cell therapy produce a more durable response in patients, a concern that has followed such off-the-shelf therapies that use donor cells as opposed to a patient’s own cells.

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