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.”

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Try­ing to shake up the Parkin­son's par­a­digm, Ab­b­Vie sub­mits NDA for con­tin­u­ous, 24-hour in­fu­sion ther­a­py

AbbVie is approaching the FDA with a new therapy to potentially treat Parkinson’s disease, using prodrugs of two medications commonly used for the condition.

The Big Pharma submitted its NDA for ABBV-951, a solution of levodopa and carbidopa prodrugs being evaluated in advanced Parkinson’s patients who don’t respond well to oral therapy, AbbVie announced Friday morning. Researchers are hoping a positive Phase III study that reads out in late October will help move things along quickly at the agency.

Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Emer Cooke, EMA director (AP Photo/Geert Vanden Wijngaert)

Ahead of FDA, EMA rec­om­mends au­tho­riz­ing new gene ther­a­py treat­ment for ul­tra-rare dis­ease

Aromatic amino acid decarboxylase (AADC) deficiency is an ultra-rare genetic disease that leaves patients unable to produce certain hormones in the brain, such as dopamine and serotonin, usually leading to developmental delays, weak muscle tone and inability to control the movement of the limbs. It can also lead to multiple organ failure.

To date, there have been no treatments approved for AADC deficiency, which has been identified in less than 150 patients.

Ather­sys tries to post-hoc-an­a­lyze its way out of an­oth­er tri­al fail for stroke stem cell ther­a­py

Athersys’ stem cell therapy has failed yet again.

In a 206-person trial conducted in Japan, Athersys’ stem cell therapy for stroke failed its primary endpoint of “excellent outcome,” a combined measure of three stroke recovery scores.

While a greater percentage of patients in the treatment group reached the primary endpoint compared to placebo, that difference was not statistically significant.

Siddhartha Mukherjee (Brian Ach/Getty Images for The New Yorker)

All Blue's $733M bid to ac­quire Zymeworks turns hos­tile as board bat­tles back — af­ter a biotech celebri­ty jumps in

Yesterday, the team at All Blue Capital — bent on the takeover of a badly battered Zymeworks — brought in celebrated oncologist, Pulitzer prize-winning writer and biotech exec Siddhartha Mukherjee to add some glitz to their proposed board. But they’re still not winning over any converts.

This morning, Zymeworks’ board officially turned this acquisition offer into a hostile showdown, rejecting the unsolicited offer and marshaling its forces to prevent a buyout at $10.50 per share.

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