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.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Pharma brands are trying to figure out new ways to better reach patients and doctors, but also measure results. (Credit: Shutterstock)

Do phar­ma TV and so­cial ads work? Phar­ma mar­ket­ing agen­cies adopt­ing new tech so­lu­tions to find out

It’s a timeworn advertising question — is my ad campaign working? In pharma, that can be an especially difficult question to answer in part because of privacy regulations, but also because the brands spend a lot of money on TV commercials where viewers can’t directly click on an ad.

Healthcare marketing services companies like Lasso and CMI Media Group are trying to change that with new measurement methods and partnerships that aim to get closer to patients’ and physicians’ actions.

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Corey McCann, Pear Therapeutics CEO

Pear Ther­a­peu­tics touts Q2 growth while scal­ing back full-year goals and chop­ping 9% of staff

Pear Therapeutics set some ambitious goals back in March, predicting a five-fold boost in revenue and a surge in new prescriptions for its digital therapeutics. Now the company is scaling back those estimates and chopping 9% of its workforce — an all-too-common occurrence in biotech lately.

CEO Corey McCann unveiled Pear’s Q2 numbers on Thursday, touting a 20% quarter-over-quarter revenue growth totaling $3.3 million. That’s more than double what the company made in Q2 2021, and McCann thinks the team could see a nearly four-fold jump in revenue this year, falling in the range of $14 million to $16 million.

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Benjamin Oakes, Scribe Therapeutics CEO

CEO of Doud­na spin­out: With­in five years, genome ed­i­tors will have a 're­al­ly big im­pact' on pa­tients' lives

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.