Luca Santarelli, VectivBio CEO

MPM-backed Were­wolf, Mer­ck-part­nered Arti­va make quick IPO flip while Lu­ca Santarel­li's biotech rais­es $127.5M

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%.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

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.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

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.

David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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GSK and IQVIA launch plat­form of US vac­ci­na­tion da­ta, show­ing drop in adult rates

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

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Ab­b­Vie sur­veys emo­tion­al im­pact of chron­ic leukemia con­di­tion, finds 'roller coast­er' of emo­tions

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.

Bernhardt Zeiher, outgoing Astellas CMO (Astellas)

Q&A: Astel­las' re­tir­ing head of de­vel­op­ment re­flects on gene ther­a­py deaths

For anyone who’s been following discussions about the safety alarms surrounding the adeno-associated viruses (AAV) commonly used to deliver gene therapy, Astellas should be a familiar name.

The Japanese pharma — which bought out Audentes Therapeutics near the end of 2019 and later built a gene therapy unit around the acquisition — rocked the field when it reported three patient deaths in a trial testing AT132, the lead program from Audentes designed to treat a rare muscle disease called X-linked myotubular myopathy (XLMTM).

When the company restarted the trial, it adjusted the dose and instituted a battery of other measures to try to prevent the same thing from happening again. But tragically, the first patient to receive the new regimen died just weeks after administration. The therapy remains under clinical hold, and just weeks ago, Astellas flagged another safety-related hold for a separate gene therapy candidate. In the process of investigating the deaths, the company has also taken flak about the way it disclosed information.

Big questions remain — questions that can have big implications about the future of AAV gene therapies.

Bernhardt Zeiher did not imagine any of it when he first joined Astellas as the therapeutic area leader in inflammation, immunology and infectious diseases. But his ascent to chief medical officer and head of development coincided almost exactly with Astellas’ big move into gene therapy, putting him often in the driver’s seat to grapple with the setbacks.

As Zeiher prepares to retire next month after a 12-year tenure — leaving the unfinished tasks to his successor, a seasoned cancer drug developer — he chatted with Endpoints News, in part, to discuss the effort to understand what happened, lessons learned and the criticism along the way.

The transcript has been lightly edited for length and clarity.

Endpoints: I want to also ask you a bit about the gene therapy efforts you’ve been working on. Astellas has really been at the forefront of discovering the safety concerns associated with AAV gene therapy. What’s that been like for you?

Zeiher: Well, I have to admit, it’s been a bit of a roller coaster. We acquired Audentes. Huge amount of enthusiasm. What we saw with AT132 — that was the lead program in XLMTM — was just remarkable efficacy. I mean, kids who went from being on ventilators, not able to eat for themselves, sit up, do things like that, to off ventilators, walking, you know, really — one investigator called it this Lazarus-like effect. It was just really dramatic efficacy. And then to have the safety events that occurred. So they actually occurred within that first year of the acquisition. So we had the three patient deaths. Me and my organization became very, very much involved. In fact, Ed Conner, who had been the chief medical officer, he left after some of the deaths, but I stepped in as the kind of acting chief medical officer, we had another chief medical officer who was involved, and then we had a fourth death, and I became acting again for a period of time.

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