Mark Enyedy, ImmunoGen president and CEO

FDA be­stows ac­cel­er­at­ed ap­proval on Im­muno­Gen's ovar­i­an can­cer drug, with con­fir­ma­to­ry an­swer com­ing soon

Three and a half years ago, Im­muno­Gen ran up against an FDA brick wall. Its ovar­i­an can­cer drug, mirve­tux­imab so­rav­tan­sine, failed a Phase III study, forc­ing the biotech to scale back and lay off more than two-thirds of its staff. Ex­ecs tight­ened their belts to pre­serve the cash they had left.

And Mon­day, af­ter shep­herd­ing the pro­gram through an­oth­er piv­otal tri­al, the move ap­peared to pay off.

The FDA ap­proved Im­muno­Gen’s drug Mon­day af­ter­noon, cap­ping the turn­around af­ter the biotech slashed its staff from about 300 to 80. The an­ti­body-drug con­ju­gate, which will be brand­ed as Ela­here, is the US’ first new treat­ment for ad­vanced ovar­i­an can­cer in at least sev­en years. Ela­here comes with a black box warn­ing for oc­u­lar tox­i­c­i­ty.

Pric­ing in­for­ma­tion was not im­me­di­ate­ly avail­able, but an Im­muno­Gen spokesper­son told End­points News man­age­ment will un­veil the price dur­ing an in­vestor call Tues­day morn­ing. This sto­ry will be up­dat­ed ac­cord­ing­ly. Im­muno­Gen shares $IMGN rose 12% pre-mar­ket.

Im­muno­Gen won an ac­cel­er­at­ed ap­proval here, with the Phase III tri­al show­ing enough re­duc­tion in tu­mor shrink­age to mer­it a green light. The con­fir­ma­to­ry study, which Im­muno­Gen says is al­ready ful­ly en­rolled, is ex­pect­ed to read out topline da­ta ear­ly next year. As part of Mon­day’s ap­proval, Im­muno­Gen al­so sub­mit­ted ini­tial con­fir­ma­to­ry da­ta to the FDA.

Ad­di­tion­al­ly, that tri­al is not dou­ble-blind­ed, but rather an open-la­bel com­par­i­son of Ela­here and in­ves­ti­ga­tor’s choice of chemother­a­py. The pri­ma­ry end­point of the study is pro­gres­sion-free sur­vival.

As with all ac­cel­er­at­ed ap­provals, the FDA de­ci­sion is con­tin­gent on the con­fir­ma­to­ry da­ta. Reg­u­la­tors have tried to crack down re­cent­ly on dan­gling ac­cel­er­at­ed ap­provals, where the drugs are left on the mar­ket de­spite con­fir­ma­to­ry fails. Some an­a­lysts see a small chance Ela­here could fall in­to this cat­e­go­ry.

SVB’s Jonathan Chang es­ti­mates a 75% chance of Ela­here suc­cess — peg­ging 64% odds the con­fir­ma­to­ry study meets the end­point out­right, and a 30% chance the tri­al fails but the drug isn’t pulled.

The ap­proval it­self was based on a sin­gle-arm study show­ing an over­all re­sponse rate of 31.7% in 106 ovar­i­an can­cer pa­tients who’d re­ceived be­tween one to three pre­vi­ous sys­temic treat­ments. Re­searchers saw five pa­tients achieve a com­plete re­sponse and a me­di­an du­ra­tion of re­sponse of 6.9 months.

Though Mon­day’s de­ci­sion proved the cap­stone of a long turn­around jour­ney, the path ap­peared ten­u­ous at times. Af­ter an ini­tial cut of da­ta in No­vem­ber 2021 sig­naled Im­muno­Gen may have suc­cess­ful­ly re­sus­ci­tat­ed the drug, a deep­er look dis­ap­point­ed the fol­low­ing March and sent its stock tum­bling 17%.

Ela­here is an an­ti­body-drug con­ju­gate de­signed to tar­get fo­late re­cep­tor al­pha. Be­tween 35% and 40% of ovar­i­an can­cer pa­tients ex­press high lev­els.

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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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.

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.

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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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.

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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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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