Thomas Cannell, Sesen

FDA re­jects Sesen Bio's blad­der can­cer pitch, send­ing shares spi­ral­ing back to pen­ny stock ter­ri­to­ry

Sesen Bio re­ceived some bad news Fri­day af­ter­noon that it said was “un­ex­pect­ed,” briefly slash­ing shares by more than 80% and be­low $1 for the first time in near­ly a year.

The biotech re­port­ed it re­ceived a CRL from the FDA re­gard­ing its blad­der can­cer can­di­date Vicineum, an an­ti­body-drug con­ju­gate ac­quired in the com­pa­ny’s buy­out of Toron­to-based Viven­tia back in 2016. Trad­ing was halt­ed for about an hour on Fri­day, with Sesen en­ter­ing the halt at about $6 per share and emerg­ing bat­tered with a $0.86 stock price.

Ahead of the clos­ing bell, Sesen shares re­cov­ered mod­est gains to close at $2.11, down 57% from Fri­day’s open. Ex­pec­ta­tions had swirled among in­vestors lead­ing up to the PDU­FA date, sched­uled for next Wednes­day, as Sesen’s stock price rose about 43% from Thurs­day’s open to Fri­day’s halt.

“We are deeply dis­ap­point­ed by this un­ex­pect­ed re­sult, and it is an un­for­tu­nate day for pa­tients suf­fer­ing from BCG-un­re­spon­sive NMIBC,” CEO Thomas Can­nell said in a state­ment. “We re­main ded­i­cat­ed to our mis­sion to save and im­prove the lives of pa­tients by bring­ing new treat­ment op­tions to pa­tients, and we in­tend to work close­ly with the FDA to un­der­stand next steps.”

Sesen de­scribed the rea­son for the CRL as a com­bi­na­tion of man­u­fac­tur­ing is­sues and re­quests for more da­ta and sta­tis­ti­cal analy­ses. The Cam­bridge, MA-based com­pa­ny plans to meet with the FDA “as soon as pos­si­ble” and said reg­u­la­tors pro­vid­ed rec­om­men­da­tions for how to boost the da­ta pack­age.

Vicineum us­es a re­com­bi­nant fu­sion pro­tein at­tached to a ge­net­i­cal­ly en­gi­neered pep­tide, with re­searchers aim­ing to tar­get spe­cif­ic anti­gens on the sur­face of tu­mor cells to treat can­cers. The FDA had giv­en Sesen pri­or­i­ty re­view for the pro­gram back in Feb­ru­ary, with Can­nell say­ing at the time Sesen un­der­stood the agency’s guid­ance “very clear­ly” and “found the re­view process to be col­lab­o­ra­tive and en­gag­ing.”

Sesen had sub­mit­ted da­ta from an open-la­bel Phase III study that en­rolled 133 pa­tients with high-risk, BCG-un­re­spon­sive non-mus­cle in­va­sive blad­der can­cer.

The pa­tients had pre­vi­ous­ly been on BCG im­munother­a­py, and the most re­cent da­ta came from 93 in­di­vid­u­als whose can­cer had not spread from the blad­der in­to the mus­cle or oth­er tis­sue. Sesen re­port­ed that 39% of those pa­tients achieved a com­plete re­sponse af­ter three months, with fol­low-ups at six, nine and 12 months see­ing CRs of 28%, 21% and 15%, re­spec­tive­ly.

Vicineum had giv­en Sesen new life af­ter a for­mer lead pro­gram failed twice and was sub­se­quent­ly li­censed out to Roche. But Fri­day’s news sent Sesen back in­to deep pen­ny-stock ter­ri­to­ry, and it re­mains to be seen how or whether the biotech plans to re-work its datasets and CMC is­sues to the FDA’s lik­ing.

In an­tic­i­pa­tion of a po­ten­tial ap­proval, Sesen had been launch­ing sig­nif­i­cant com­mer­cial ef­forts over the last sev­er­al months, ef­forts that ramped up in re­cent weeks and now may need to be paused. The biotech re­port­ed it had com­plet­ed hir­ing about 60 new sales reps at the end of Ju­ly — rep­re­sent­ing 97% of its sales force — and hired a new as­sis­tant gen­er­al coun­sel and chief com­pli­ance of­fi­cer as the cal­en­dar turned to Au­gust. As re­cent­ly as Ju­ly 14, Sesen paint­ed a pos­i­tive pic­ture fol­low­ing a meet­ing with the FDA.

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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