ADC Ther­a­peu­tics beefs up mon­ster $200M round with fresh $76M haul

Days af­ter Roche se­cured ac­cel­er­at­ed ap­proval for its an­ti­body-drug con­ju­gate, Lau­sanne, Switzer­land-based ADC Ther­a­peu­tics has clinched an­oth­er $76 mil­lion to its al­ready hefty $200 mil­lion round of fi­nanc­ing un­veiled in 2017.

The fresh in­jec­tion brings ADC’s ven­ture haul to $531 mil­lion.

Chris Mar­tin ADC

The funds will set the on­col­o­gy com­pa­ny up with “a strong bal­ance sheet to fund prepa­ra­tions for a po­ten­tial Bi­o­log­ic Li­cense Ap­pli­ca­tion (BLA) for AD­CT-402 (lon­cas­tux­imab tesirine) in re­lapsed or re­frac­to­ry dif­fuse large B-cell lym­phoma (DL­B­CL) in the sec­ond half of 2020, as well as prepa­ra­tions for a piv­otal Phase II tri­al of AD­CT-301 (cami­dan­lum­ab tesirine) in Hodgkin lym­phoma based on our re­cent end of Phase I meet­ing with the U.S. Food and Drug Ad­min­is­tra­tion,” said ADC chief Chris Mar­tin, in a state­ment on Wednes­day.

An­ti­body-drug con­ju­gates are a class of ther­a­peu­tics in which a can­cer-killing tox­in is at­tached to a spe­cif­ic an­ti­body us­ing a biodegrad­able link­er. They are de­signed to min­i­mize the ef­fects of the chemother­a­py on healthy cells while max­i­miz­ing tu­mor cell death, which is why the tech­nol­o­gy is some­times likened to a tro­jan horse as it is en­gi­neered to go un­no­ticed, de­liv­er­ing chemother­a­pies to cells ex­press­ing the anti­gen tar­get.

Un­like the first gen­er­a­tion of an­ti­body-drug con­ju­gates that were steered to the mar­ket by Seat­tle Ge­net­ics and oth­ers, ADC Ther­a­peu­tics is us­ing pyrroloben­zo­di­azepine-based war­heads that it sus­pects will be more po­tent and mit­i­gate drug re­sis­tance, even in hard-to-treat tu­mors.

Mar­tin served as one of the orig­i­nal board mem­bers at ADC back in 2011 when the biotech was launched. In 2013, he en­gi­neered the sale of UK’s Spirogen — where he was CEO — to As­traZeneca in a $440 mil­lion deal, which the British drug­mak­er paired with a $20 mil­lion in­vest­ment in ADC. ADC and Spirogen al­so share the pyrroloben­zo­di­azepine-based war­head tech­nol­o­gy.

ADC’s two lead pro­grams (402 and 301) first re­port­ed pos­i­tive ear­ly-stage da­ta in 2016, and the com­pa­ny has since up­dat­ed its da­ta. The com­pa­ny’s re­searchers, led by CMO Jay Fein­gold —  for­mer VP of can­cer re­search at Wyeth — pre­sent­ed up­dat­ed Phase I da­ta at Amer­i­can So­ci­ety of Hema­tol­ogy (ASH) meet­ing on the 402 pro­gram, which takes aim at a tar­get fa­vored by the CAR-T crowd: CD19. In 139 evalu­able pa­tients with re­lapsed or re­frac­to­ry DL­B­CL, the sci­en­tists reg­is­tered an over­all re­sponse rate (ORR) was 43.3% — com­pris­ing 23.6% com­plete re­spons­es and 19.7% par­tial re­spons­es.

ADC al­so pub­lished fresh phase I da­ta on its ex­per­i­men­tal 301 drug at ASH. In 113 pa­tients with Hodgkin’s lym­phoma, who have failed mul­ti­ple lines of ther­a­py, re­searchers doc­u­ment­ed an ORR of 86.5%, in­clud­ing a lofty 43% com­plete re­sponse rate.

The piv­otal (Phase II) 402 DL­B­CL tri­al is ex­pect­ed to read­out in the third quar­ter of 2019 — and a piv­otal (Phase II) 301 study in Hodgkin lym­phoma pa­tients is ex­pect­ed to kick off in the com­ing months. Last year, the com­pa­ny aban­doned an ear­ly-stage study in pa­tients with HER2-pos­i­tive can­cers eval­u­at­ing its drug, AD­CT-502, af­ter it failed to im­press.

The com­pa­ny — which has a work­force of 120 and op­er­a­tions in Lon­don, New Jer­sey and San Fran­cis­co — an IPO is al­so on the cards, Mar­tin told End­points News.

Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

SpringWorks and Satsuma — both biotech spinouts that have closed B rounds in April — are loading up with IPO cash to boost their respective late-stage plans.
SpringWorks

Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings. In the process, the Stamford, CT-based team is also drawing the curtains on the partnerships it has in mind for the pair of assets it had initially licensed from Pfizer.

Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.

Jim Mellon [via YouTube]

Health­i­er, longer lifes­pans will be a re­al­i­ty soon­er than you think, Ju­ve­nes­cence promis­es as it clos­es $100M round

Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million Series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017. Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer $PFE and Amarin $AMRN.

AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.