Dan Kemp, Wugen CEO

A stealthy start­up is lever­ag­ing nat­ur­al killer cells with 'mem­o­ry-like' abil­i­ties to go af­ter blood can­cer and be­yond

The promise of next-gen, “off-the-shelf” cell ther­a­pies have thor­ough­ly en­tranced bio­phar­ma with the promise of low­er­ing man­u­fac­tur­ing costs and po­ten­tial­ly chal­leng­ing dom­i­nant check­point in­hibitors. But to get there, com­pa­nies need a po­tent ther­a­py and one that can be con­tin­u­ous­ly sourced from donors.

A new biotech un­cloak­ing from a lengthy de­vel­op­ment pe­ri­od thinks it may have solved that puz­zle.

Wu­gen, a pri­mar­i­ly St. Louis, MO-based team with an of­fice in San Diego, closed a whop­ping $172 mil­lion B round Thurs­day with plans to ad­vance its slate of off-the-shelf “mem­o­ry-like” nat­ur­al killer cell ther­a­pies, which the biotech thinks of­fers greater cy­to­tox­i­c­i­ty and dura­bil­i­ty than stan­dard NK cells.

Abing­worth and Ty­bourne Cap­i­tal Man­age­ment led the round with an ex­pan­sive slate of new and ex­ist­ing in­vestors on board.

Wu­gen is built off re­search from Todd Fehniger’s lab at Wash­ing­ton Uni­ver­si­ty in St. Louis on the ef­fect of mem­o­ry NK cells in blood can­cer, melanoma and be­yond. In 2016, Fehniger’s team post­ed da­ta from a Phase I study of lead can­di­date WU-NK-101, show­ing a 60% over­all re­sponse rate and 45% re­sponse rate among 15 acute myeloid leukemia pa­tients.

Op­er­at­ing in stealth, Wu­gen used a $36 mil­lion A round in ear­ly 2020 to build up its pipeline. Now, with even more pre­clin­i­cal da­ta to back up its proof of con­cept, Wu­gen is ready for the spot­light.

More re­cent­ly, Fehniger, who has re­mained at Wu­gen as a sci­en­tif­ic ad­vi­sor, post­ed an ar­ti­cle in Clin­i­cal Can­cer Re­search last month show­ing that mem­o­ry-like NK cells — in­nate im­mune cells that can pass along “mem­o­ry” of spe­cif­ic anti­gens — showed greater cy­to­tox­i­c­i­ty and a more durable re­sponse against melanoma tu­mors than oth­er NK cells.

Re­searchers used a com­plex of cy­tokines, in­clud­ing hu­man-de­rived IL-12, IL-15 and IL-18, to prime and ac­ti­vate those cells ex vi­vo be­fore in­fu­sion, ef­fec­tive­ly “su­per­charg­ing” the ther­a­pies to tar­get and elim­i­nate tu­mor cells. In ad­vanced melanoma, an in­di­ca­tion where im­mune check­point in­hibitors dom­i­nate but near­ly half of pa­tients don’t re­spond to T cell-di­rect­ed ther­a­pies, a po­tent NK cell ther­a­py could of­fer a mean­ing­ful op­tion for pa­tients.

With WU-NK-101, which is di­rect­ed at the CD16 anti­gen, the team is study­ing the drug so­lo for AML as well as in com­bi­na­tion with Er­bitux. They’re al­so test­ing it af­ter check­point in­hibitors in head and neck can­cer and melanoma. Mean­while, a fol­low-on NK can­di­date, dubbed WU-NK-201, is cur­rent­ly in ear­ly pre­clin­i­cal test­ing for sol­id tu­mors, one of many next-gen cracks at the elu­sive field. Wu­gen ad­di­tion­al­ly has an off-the-shelf CAR-T pro­gram — the lead can­di­date is WU-CART-007 for T-cell acute lym­phoblas­tic leukemia — that is al­so in pre­clin­i­cal de­vel­op­ment.

The 40-per­son team is helmed by CEO Dan Kemp, who left his role as head of cell ther­a­pies busi­ness de­vel­op­ment and op­er­a­tions at Take­da in April to take a crack at build­ing Wu­gen af­ter be­ing “re­al­ly blown away” by the Fehniger team’s ear­ly da­ta.

Now, Wu­gen is gear­ing for an open-la­bel Phase II test for WU-NK-101 in AML, which is slat­ed to be­gin in Au­gust and en­roll 104 pa­tients, ac­cord­ing to clin­i­cal­tri­als.gov. The study’s pri­ma­ry end­point is ORR. Sec­ondary end­points in­clude OS and EFS. The tri­al is ex­pect­ed to wrap in Feb­ru­ary 2024.

Kemp, who arranged Take­da’s “buy-to-build” pick­up of Gam­maDelta Ther­a­peu­tics in 2017 — a deal worth up to $100 mil­lion — and the Japan­ese drug­mak­er’s CAR-NK pact with MD An­der­son in 2019, said that ex­pe­ri­ence of­fered him a tri­al by fire on the fron­tier of cell ther­a­py.

“We re­al­ly kicked the tires and learned as the cell ther­a­py field evolved over the last five or so years,” he said.

The big dif­fer­ence in Wu­gen’s plat­form is the lack of en­gi­neer­ing that goes in­to each ther­a­py. Un­like CAR-NK, for in­stance, the donor-de­rived mem­o­ry NK cells used in Wu­gen’s tech­nol­o­gy are sim­ply primed for pro­lif­er­a­tion and then al­lowed to do their thing in vi­vo. A small­er man­u­fac­tur­ing pro­file means a sin­gle do­na­tion can be used to cre­ate hun­dreds of in­di­vid­ual ther­a­pies, Kemp said.

With the newest round of funds, Wu­gen ex­pects to keep ad­vanc­ing its pipeline as well as rapid­ly scal­ing up its team for the ap­proach­ing clin­i­cal gaunt­let. Kemp ex­pects Wu­gen’s work­force, now at 40, to dou­ble in the com­ing six to eight months to pre­pare for the fu­ture.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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Anthony Sun, Zentalis and Zentera CEO (Zentalis)

With clin­i­cal tri­als lined up for Zen­tal­is drugs, Chi­na's Zen­tera sets its sights on more deal­mak­ing and an IPO

As Zentalis geared up for an AACR presentation of early data on its WEE1 inhibitor earlier this year, its Chinese joint venture Zentera wasn’t idle, either.

Zentera, which has headquarters in Shanghai, had already nabbed clearance to start clinical trials in China for three of the parent company’s drugs. In May — just a month after Zentalis touted three “exceptional responses” out of 55 patients for their shared lead drug, ZN-c3 — it got a fourth CTA approval.

Thomas Soloway, T-knife CEO

What hap­pens when you give a mouse a hu­man self-anti­gen? In­vestors bet $110M to find out

T-knife Therapeutics launched last August on a mission to isolate T cell receptors not from human donors, but from mice. Now, with a new CEO and a candidate bound for the clinic, the Versant-backed company is reloading with a fresh $110 million.

“What we are trying to do for the field of TCR therapy and solid tumor therapy is very analogous to what the murine platforms have done in antibody development,” CEO Thomas Soloway told Endpoints News. 

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UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; 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.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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