Sesen Bio, af­ter years on the edge of ir­rel­e­van­cy, scores speedy re­view for long ges­tat­ing blad­der can­cer pro­gram

Af­ter years spent in the pen­ny stock range, Sesen Bio has nabbed a long-await­ed FDA re­view for its an­ti­body-drug con­ju­gate blad­der can­cer pro­gram.

Thomas Can­nell

The FDA will give an ac­cel­er­at­ed au­dit to Sesen and its blad­der can­cer can­di­date Vicineum, an an­ti­body-drug con­ju­gate ac­quired in the com­pa­ny’s buy­out of Toron­to-based Viven­tia back in 2016. Sesen is pen­ciled in for an Aug 18 PDU­FA, and there is no ad­comm on the dock­et right now, the com­pa­ny said.

“We have been meet­ing with the FDA reg­u­lar­ly for the past two years on the ap­pli­ca­tion for Vicineum,” CEO Thomas Can­nell said in a state­ment. “We un­der­stand the FDA’s po­si­tion and guid­ance very clear­ly and have found the re­view process to be col­lab­o­ra­tive and en­gag­ing.”

News of the pri­or­i­ty re­view os­ten­si­bly pleased in­vestors, send­ing Sesen $SESN shares up more than 10% in ear­ly Tues­day trad­ing.

The idea be­hind the ex­per­i­men­tal drug is to use a re­com­bi­nant fu­sion pro­tein, at­tached to a ge­net­i­cal­ly en­gi­neered pep­tide, to tar­get spe­cif­ic anti­gens on the sur­face of tu­mor cells. It seeks out what are called ep­ithe­lial cell ad­he­sion mol­e­cule anti­gens, or Ep­CAM, that are over­ex­pressed in NMIBC and us­es the pep­tide teth­er to al­low for min­i­mal spillover tox­i­c­i­ty.

Sesen ap­plied for Vicineum to treat high-risk, BCG-un­re­spon­sive non-mus­cle in­va­sive blad­der can­cer and sub­mit­ted da­ta from a 133-pa­tient Phase III tri­al, which is still con­duct­ing the fol­low-up stage. Pa­tients in the sin­gle-arm Phase III tri­al had pre­vi­ous­ly been on BCG im­munother­a­py, a stan­dard treat­ment that doesn’t al­ways work.

The most re­cent batch of ef­fi­ca­cy da­ta, which came from 93 pa­tients with can­cer that had not spread from the blad­der in­to mus­cle or oth­er tis­sue, showed the pro­gram had a com­plete re­sponse rate of 39% af­ter three months. Lat­er da­ta al­so showed com­plete re­spons­es at the 6-, 9- and 12- month pe­ri­ods. Re­spec­tive­ly, those time frames re­sult­ed in rates of 28%, 21% and 15%.

The pro­gram’s safe­ty da­ta, which ap­peared to spook in­vestors three years ago when top-line re­sults were first re­leased, showed that 78% of side ef­fects were des­ig­nat­ed as Grade 1 or Grade 2. But there were four treat­ment-re­lat­ed side ef­fects not­ed at the time, in­clud­ing acute kid­ney in­jury, re­nal fail­ure and cholesta­t­ic he­pati­tis.

Those events, which sent the com­pa­ny’s stock down about 23% af­ter the ini­tial an­nounce­ment, don’t seem to have reg­u­la­tors wor­ried, how­ev­er.

With Tues­day’s news, Sesen is prepar­ing to sub­mit da­ta to Eu­ro­pean reg­u­la­tors in the next one to two months. The com­pa­ny is al­so wait­ing to hear back from Chi­nese health au­thor­i­ties over a pos­si­ble ap­proval of their IND ap­pli­ca­tion.

Blad­der can­cer isn’t the on­ly area Sesen is seek­ing to treat with Vicineum. The com­pa­ny is al­so look­ing at squa­mous cell car­ci­no­ma of the head and neck, hav­ing com­plet­ed a Phase II tri­al in the US. Sesen is al­so look­ing at Vicineum com­bi­na­tion part­ners, study­ing the pro­gram with As­traZeneca’s Imfinzi in the same in­di­ca­tion as the NMIBC monother­a­py.

The can­di­date has giv­en Sesen new life af­ter its for­mer lead pro­gram failed twice and it com­plet­ed a deal to li­cense out its re­main­ing pro­gram to Roche.

The top 100 bio­phar­ma VCs, Bob Brad­way places $2B bet in can­cer, gene edit­ing pi­o­neer's new big idea, 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.

Before diving in, we had some news to share: Endpoints is launching a premium weekly report focusing on all things regulatory. Coverage will be led by our new senior editor, Zachary Brennan, who joins us from POLITICO. Arsalan Arif has more details in his Publisher’s Note.

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Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slapdown, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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Bruce Cozadd, Jazz CEO (Jazz Pharmaceuticals)

Jazz CEO Bruce Cozadd cam­paigned for 6 months to buy GW Phar­ma. A 90% pre­mi­um sealed the deal — along with $17.6M in ‘re­ten­tion’ in­cen­tives

Jazz CEO Bruce Cozadd didn’t beat around the bush.

In his first video meeting with GW Pharma chief Justin Gover last July 8, he offered to pay $172 a share to get the company, which had beaten the odds in getting its remarkable cannabinoid drug Epidiolex across the regulatory finish line for epilepsy. GW’s stock closed at $129 that day.

Cozadd had already done his homework on the financing to make sure he could swing it the way he wanted. He just needed to do some due diligence before making the non-binding bid firm.

UP­DAT­ED: Not 3 weeks af­ter tak­ing Hu­ma­cyte pub­lic, Ra­jiv Shuk­la launch­es an­oth­er blank check com­pa­ny

One of biotech’s earliest SPAC investors is back with another blank-check company, less than a month after his last effort announced its intent to merge.

Rajiv Shukla is intending to take a third lucky winner public with Alpha Healthcare Acquisition III, filing to go public Thursday with a $150 million raise penciled in. The move comes just a couple of weeks after Shukla’s second SPAC said it would jump to Nasdaq in tandem with Laura Niklason’s Humacyte in a $255 million new investment.

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Paul Hudson, Getty Images

How does Paul Hud­son's $13.5M comp pack­age stack up against oth­er CEOs? He's in the 'first quar­tile'

Paul Hudson arrived at Sanofi like a hurricane, chopping off duds in the pipeline, shaking up the C-suite, striking big M&A deals and jumping into the Covid-19 vaccine race — all in an attempt to reboot a pharma giant notorious for its setbacks.

Now, we’re getting a look at what the CEO brought home in his first year on the job.

When all is said and done, Hudson will have made about $6.7 million in 2020, about $2.5 million of which has already been paid. The bigger figure includes a $2.3 million bonus that’s subject to approval at an April meeting, and another $1.8 million in variable compensation that has yet to be paid.

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CMO Levi Garraway (Genentech)

Fo­cus­ing on the bright side, FDA OKs Roche's Actem­ra for rare lung dis­ease de­spite PhI­II flop

Actemra’s failure to hit the primary endpoint in a Phase III study didn’t stop the FDA from granting Roche priority review. And it’s certainly not standing in the way of a sixth approval for Roche’s IL-6 drug.

Regulators have cleared Actemra, or tocilizumab, for systemic sclerosis-associated interstitial lung disease in adult patients. Roche’s big Genentech subsidiary notes that it is the first biologic approved for this rare disease.