Sesen's PhI­II blad­der can­cer da­ta send stock south as in­vestors fret over safe­ty

Fol­low­ing a brand­ing makeover just last week, Sesen Bio (which used to go by Eleven Bio­ther­a­peu­tics) has pub­lished three-month da­ta for its blad­der can­cer drug Vicini­um. The re­sults have some in­vestors cau­tious, as the com­pa­ny’s stock — trad­ing un­der the fresh­ly mint­ed tick­er sym­bol $SESN — is down 23% since the an­nounce­ment.

Stephen Hurly

Sesen was lit­tle more than a shell with a bank ac­count a cou­ple years ago af­ter its lead drug failed twice and it com­plet­ed a deal to li­cense out its re­main­ing pro­gram to Roche. But then the en­ti­ty ac­quired Toron­to-based Viven­tia, snag­ging its now lead drug can­di­date Vicini­um, a next-gen an­ti­body-drug con­ju­gate to treat high-grade non-mus­cle in­va­sive blad­der can­cer.

The new Vicini­um da­ta came from an on­go­ing Phase III tri­al called Vista, which en­rolled 133 pa­tients with high-grade NMIBC. These pa­tients had pre­vi­ous­ly been on BCG im­munother­a­py, a stan­dard treat­ment that doesn’t al­ways de­liv­er, said Ri­an Dick­stein, an in­ves­ti­ga­tor in the tri­al.

“For those pa­tients who re­lapse or who don’t re­spond at all, the stan­dard al­ter­na­tive is rad­i­cal cys­tec­to­my,” Dick­stein said in a state­ment. “In a cys­tec­to­my, the blad­der is re­moved along with sur­round­ing lymph nodes and oth­er or­gans that con­tain can­cer.”

Ri­an Dick­stein

Vicini­um is a hope­ful al­ter­na­tive to los­ing the blad­der. Vicini­um was de­vel­oped us­ing the com­pa­ny’s pro­pri­etary tar­get­ed pro­tein ther­a­peu­tics plat­form. The ther­a­py is com­prised of a re­com­bi­nant fu­sion pro­tein that tar­gets ep­ithe­lial cell ad­he­sion mol­e­cule (Ep­CAM) anti­gens on the sur­face of tu­mor cells to de­liv­er a po­tent pro­tein pay­load, Pseudomonas Ex­o­tox­in A.

The com­pa­ny said Ep­CAM is over­ex­pressed in NMIBC but not in healthy blad­der cells, so hom­ing in on it will hope­ful­ly de­crease tox­ic ef­fects in healthy tis­sues.

Sesen’s ef­fi­ca­cy da­ta, which came from 111 pa­tients with can­cer that had not spread from the blad­der in­to mus­cle or oth­er tis­sue, showed that Vicini­um had a com­plete re­sponse rate of 43%.

Four se­ri­ous ad­verse events re­lat­ed to the treat­ment were re­port­ed in the da­ta, in­clud­ing acute kid­ney in­jury or re­nal fail­ure and cholesta­t­ic he­pati­tis, the com­pa­ny said. But 72% of the ad­verse events were classed as grade 1 or 2.

Still, the se­ri­ous ad­verse events ap­pear to have some in­vestors wor­ried, with the com­pa­ny’s stock drop­ping from $3.00 per share to $2.30 by Mon­day’s close.

Stephen Hurly, the com­pa­ny’s pres­i­dent and CEO, said the da­ta are en­cour­ag­ing.

“The Vista tri­al three-month da­ta are en­cour­ag­ing for our com­pa­ny and the pa­tients with high-grade NMIBC who have been un­der­served for many years,” Hurly said. “We have made tremen­dous progress over the last sev­er­al years to get us to where we are to­day, and I am proud of what our team has ac­com­plished. Our new name is a re­flec­tion of the jour­ney we’ve tak­en to get to this point and rep­re­sents our mis­sion of im­prov­ing lives. With 12-month da­ta ex­pect­ed by mid-2019, we are con­tin­u­ing to ad­vance Vicini­um to as­sess its full po­ten­tial in treat­ing this dev­as­tat­ing can­cer.”

Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

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But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Jason Kelly. Mike Blake/Reuters via Adobe

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The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.