The jump from crossover rounds to biotech IPO is quick­er than ever.

Just weeks af­ter un­veil­ing Se­ries B rounds, MPM-backed Were­wolf and Mer­ck-part­nered Arti­va are spelling out plans to go pub­lic on Nas­daq. Both have pen­ciled in the stan­dard goal of rais­ing $100 mil­lion.

That fig­ure is fast be­com­ing an un­re­li­able place­hold­er, as many com­pa­nies have gone on to raise a lot more. Lu­ca Santarel­li’s Swiss rare dis­ease play­er Vec­tivBio, though, stuck close to the range, bag­ging $127.5 mil­lion from its Nas­daq de­but.

Howl­ing Were­wolf pounces

Dan Hick­lin

Boston-based Were­wolf — which is go­ing the ex­tra mile and shoot­ing for $HOWL as the tick­er — out­lined some of its plans to hit the clin­ic back in Jan­u­ary, when CEO Dan Hick­lin took the wraps off a $72 mil­lion Se­ries B.

Us­ing an en­gi­neer­ing plat­form dubbed PREDA­TOR, the com­pa­ny has three mol­e­cules be­long­ing to a class they dub In­dukines, which com­pris­es four com­po­nents: a cy­tokine, an in­ac­ti­va­tion do­main, a half-life ex­ten­sion do­main and a link­er that can be cleaved by pro­teas­es found in tu­mors. That way, they rea­son, the drug stays qui­et through­out the body and on­ly trig­gers an in­flam­ma­to­ry ef­fect against can­cer.

The sys­tem makes use of tech­nolo­gies from Har­poon — a fel­low MPM com­pa­ny — in­clud­ing “polypep­tides and a bind­ing moi­ety for con­di­tion­al ac­ti­va­tion of cer­tain polypep­tides.” In ad­di­tion to promis­ing roy­al­ties and ex­chang­ing cer­tain oth­er patent rights, Were­wolf paid a grand $500,000 up­front to Har­poon, which is build­ing an op­er­a­tion around T cell en­gage­ment.

With an ini­tial fo­cus on IL-2 and IL-12, Were­wolf is look­ing to be­gin hu­man test­ing for WTX-124 and WTX-330 in 2022. The third can­di­date aims to con­di­tion­al­ly ac­ti­vate IFN-a.

The com­pa­ny is so young that it’s on­ly burned through $51.9 mil­lion to get here — less than the $56 mil­lion Se­ries A they had launched with.

MPM claims the li­on’s share of stock at 20.75%, fol­lowed by UBC On­col­o­gy Im­pact Fund and RA Cap­i­tal, each a lit­tle more than 11%. Oth­er in­vestors in­clude Tai­ho Ven­tures, Deer­field, Arkin and UPMC.

Hick­lin, who al­so owns about 3% of shares af­ter tak­ing the top job in Au­gust 2019, was re­ward­ed with a 2020 com­pen­sa­tion pack­age worth close to $3 mil­lion. CMO Ran­di Isaacs made $887,539, the bulk in op­tion awards grant­ed as she joined in No­vem­ber; CSO Cyn­thia Sei­del-Dugan got a sim­i­lar pay at $837,294.

Arti­va sheds light on trans-Pa­cif­ic NK cell man­u­fac­tur­ing process

Tom Far­rell

Un­til ear­li­er this year, Arti­va didn’t have much of a pro­file in bio­phar­ma land. For­mer Bel­licum CEO Tom Far­rell had as­sem­bled an NK cell ther­a­py com­pa­ny, lean­ing heav­i­ly on a “huge­ly im­pres­sive” man­u­fac­tur­ing fa­cil­i­ty be­long­ing to Green Cross Lab­Cell in Ko­rea, gath­ered $78 mil­lion in Se­ries A mon­ey and did the news rounds last June, then stayed large­ly qui­et.

That changed when Mer­ck signed a col­lab­o­ra­tion worth near­ly $2 bil­lion in mile­stones to pick up the off-the-shelf NK cell tech. Arti­va quick­ly fol­lowed up with a $120 mil­lion Se­ries B, de­signed to kick­start Phase I/II for its lead pro­gram in non-Hodgkin’s lym­phoma.

The part­ner­ship deal, Arti­va re­vealed in its S-1, gave GC Lab­Cell a 28% stake in the biotech, al­most dou­ble the hold­ings of 5AM Ven­tures, ven­Bio, RA Cap­i­tal and more than quadru­ple what Ven­rock has.

To make the prod­ucts, the US team sources cord blood units with fa­vor­able char­ac­ter­is­tics — such as a nat­ur­al high affin­i­ty vari­ant of the re­cep­tor CD16 — from a pub­lic cord bank. Arti­va then ships the ma­te­r­i­al to Ko­rea, where GC Lab­Cell runs a new­ly built com­mer­cial site:

Af­ter man­u­fac­tur­ing, the drug prod­uct is cry­op­re­served, shipped back to the Unit­ed States and dis­trib­uted to clin­i­cal tri­al sites where it will be thawed and ad­min­is­tered in an out-pa­tient set­ting. The process gen­er­ates suf­fi­cient NK cells to treat hun­dreds to thou­sands of pa­tients from a sin­gle cord blood unit, de­pend­ing on the prod­uct and dos­ing reg­i­men, and pro­duces a con­sis­tent­ly ac­tive NK cell prod­uct, with lit­tle donor-to-donor vari­abil­i­ty.

Fred Aslan

Arti­va is gun­ning for a lead­ing po­si­tion in what, af­ter many years, has re­cent­ly be­come a boom­ing field. Big Phar­mas like Take­da and J&J are join­ing a slate of small­er play­ers in ex­plor­ing the po­ten­tial of NK cell ther­a­pies in all their fla­vors. While it’s al­so work­ing on CAR-NK ap­proach­es, Arti­va’s first can­di­date is a “non-ge­net­i­cal­ly mod­i­fied, but op­ti­mized, cord blood-de­rived NK cell ther­a­py.”

Far­rell pock­et­ed more than $1.2 mil­lion for steer­ing the com­pa­ny be­fore turn­ing over to Fred Aslan in Jan­u­ary.

From $810M buy­out to spin­off IPO in less than 2 years

Lu­ca Santarel­li tells a straight­for­ward sto­ry about Vec­tivBio. Af­ter sell­ing Ther­a­chon to Pfiz­er in an $810 mil­lion deal, the Roche vet im­me­di­ate­ly spun out with the new com­pa­ny, tak­ing their Phase II drug apraglu­tide for short bow­el syn­drome.

The IPO was a nat­ur­al next step on the heels of a mega-raise of $110 mil­lion an­nounced last Oc­to­ber, with the fo­cus still square­ly on ex­e­cut­ing the Phase III and lay­ing the foun­da­tion for com­mer­cial­iza­tion work.

A long-act­ing syn­thet­ic pep­tide ana­log of GLP-2, apraglu­tide re­mains the sole as­set in the com­pa­ny and will be de­ployed in a range of rare gas­troin­testi­nal dis­or­ders out­side of SBS.

Topline re­sults for the lead in­di­ca­tion, in SBS in­testi­nal fail­ure, are ex­pect­ed in 2023.

While Vec­tivBio is look­ing to in-li­cense or ac­quire ad­di­tion­al drugs for the pipeline, the IPO pro­ceeds are most­ly go­ing to­ward the core pro­gram — in­clud­ing a Phase II tar­get­ing a sub­group of SBS-IF pa­tients with colon-in-con­ti­nu­ity anato­my and proof of con­cept in apraglu­tide’s util­i­ty for gas­troin­testi­nal man­i­fes­ta­tions of graft-ver­sus-host dis­ease.

Santarel­li has quite a bit of skin in the game, hav­ing saved 8.8% of the shares for him­self. Ver­sant and Or­biMed are the largest stock­hold­ers at around 15% each, while oth­ers — FCPI Bpifrance In­no­va­tion, No­vo and Cowen — each have less than 10%.

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.