Eye­ing an IPO, ADC Ther­a­peu­tics fu­els piv­otal can­cer tri­als with a $200M mega-round backed by As­traZeneca

Just days af­ter Gilead and its new sub­sidiary Kite won a ground­break­ing FDA ap­proval for their CAR-T ther­a­py Yescar­ta for B-cell lym­phomas, Lau­sanne, Switzer­land-based ADC Ther­a­peu­tics is rolling out a jaw-drop­ping $200 mil­lion mega-round to gam­ble — in part — on a next-gen an­ti­body-drug con­ju­gate that the back­ers feel can com­pete just fine with the per­son­al­ized cell ther­a­py.

The lat­est round brings ADC’s to­tal ven­ture take to $455 mil­lion, po­si­tion­ing them for a pair of Phase II stud­ies that po­ten­tial­ly could put them in line for an ac­cel­er­at­ed ap­proval — par­tic­u­lar­ly if they come close to match­ing the orig­i­nal proof-of-con­cept da­ta that was post­ed last June.

Chris Mar­tin was one of the orig­i­nal board mem­bers at ADC back in 2011 when the biotech was launched. Al­most ex­act­ly three years ago he helped arrange the sale of the UK’s Spirogen — where he was CEO — to As­traZeneca in a $440 mil­lion deal, which the phar­ma gi­ant paired with a $20 mil­lion in­vest­ment in ADC. As­traZeneca matched that in­vest­ment with an un­spec­i­fied li­cens­ing deal with ADC which is in the clin­ic. Au­ven Ther­a­peu­tics — found­ed by Stephen Evans-Freke and Pe­ter Corr in Lau­sanne — fund­ed both com­pa­nies and Mar­tin be­came the CEO at ADC two years ago.

Chris Mar­tin

Au­ven Ther­a­peu­tics al­so joined the ex­pand­ed syn­di­cate on this round, along­side Red­mile, the Wild fam­i­ly of­fice and As­traZeneca, among oth­er un­named in­vestors.

But ADC and Spirogen didn’t just share a com­mon fi­nan­cial pedi­gree, they al­so share a tech­nol­o­gy: pyrroloben­zo­di­azepine-based war­heads which the re­searchers be­lieve are or­ders of mag­ni­tude bet­ter than the first gen­er­a­tion of an­ti­body-drug con­ju­gates that were steered to the mar­ket by Seat­tle Ge­net­ics and oth­ers. These drugs use an an­ti­body to steer their way to can­cer cells and then drop a tox­ic pay­load where they are in­tend­ed to do the most good.

Last sum­mer, ADC backed up its new-wave boast by rolling out an ear­ly snap­shot of Phase I hu­man da­ta from its two lead ther­a­pies — AD­CT-301 and AD­CT-402.

Their 402 pro­gram tar­gets CD19, a fa­vorite in the CAR-T crowd. And re­searchers un­der CMO Jay Fein­gold, a for­mer VP of can­cer re­search at Wyeth, reg­is­tered a 57% over­all re­sponse rate, with an im­pres­sive 43% com­plete re­sponse tal­ly in drug-re­sis­tant cas­es of dif­fuse large B-cell lym­phomas. Their drug 301 came in with a 38% over­all re­sponse rate in a small group of re­frac­to­ry Hodgkin’s lym­phoma pa­tients.

Mar­tin, in his own un­der­stat­ed way, tells me: “We were en­cour­aged by that.”

ADC has been grow­ing as the cash con­tin­ues to roll in. Now 66 staffers, Mar­tin ex­pects to have a pay­roll of 70 by year’s end. On­ly 14 of those jobs are ac­tu­al­ly in Lau­sanne, the rest are scat­tered around the biotech world. The pre­clin­i­cal work is done in Lon­don, clin­i­cal de­vel­op­ment in New Jer­sey and man­u­fac­tur­ing is in San Fran­cis­co, where they’ve been work­ing with Stem­cen­trx, now a sub­sidiary of Ab­b­Vie.

Both of these mid-stage stud­ies are ex­pect­ed to get start­ed in the first half of next year, with 402 out front with a Q1 launch. Mar­tin ex­pects pa­tient re­cruit­ment to take about 6 months, with da­ta by the end of 2018 or ear­ly 2019, when they can re­view about fil­ing with the reg­u­la­to­ry agen­cies. Mar­tin isn’t promis­ing ex­act­ly when that will be, but fil­ing on Phase II in can­cer is now stan­dard op­er­at­ing pro­ce­dure in the on­col­o­gy world.

“At the mo­ment,” he says, “our over­all guid­ing prin­ci­ple is to get ef­fec­tive drugs in­to pa­tients that need it as quick­ly as pos­si­ble.”

While Yescar­ta has been post­ing im­pres­sive out­comes ahead of 402, Mar­tin doesn’t feel like they’ve been beat­en to the punch on DL­B­CL. Quite the con­trary. With a drug that can be de­liv­ered straight to pa­tients, pre­sum­ably at a low­er cost and sim­i­lar ef­fi­ca­cy, with a much safer side ef­fect pro­file, he feels the lit­tle biotech can com­pete with Gilead and its glob­al mar­ket­ing or­ga­ni­za­tion.

By next year, ADC will al­so have six ther­a­pies in the clin­ic — with two more lin­ing up INDs — open­ing up some more part­ner­ing prospects.

In the mean­time, Mar­tin is al­so qui­et­ly con­fi­dent that the com­pa­ny will be in a good po­si­tion to IPO, when the time is right. At this point, with a pri­vate syn­di­cate ready to come up with the biggest Eu­ro­pean biotech round in some three years, he says an IPO would have just proven to be a ma­jor dis­trac­tion. Un­til the right time, he says, ADC re­mains “IPO ready,” with au­dit­ed fi­nan­cials and a prospec­tus it’s keep­ing up to date as they pro­ceed.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Af­ter sell­ing to Genen­tech, the old Je­cure team is back at an RNA-fo­cused start­up — and more en­thu­si­as­tic than ever

When Genentech swooped in to buy NASH-focused Jecure Therapeutics back in 2018, a handful of the startup’s executives weren’t quite ready to disperse.

It had been just three years since Jecure launched with a preclinical portfolio of NLRP3 inhibitors — and the takeover came sooner than anyone, including CEO Jeff Stafford, had expected. So he got talking with James Veal and Gretchen Bain, two serial entrepreneurs in charge of Jecure’s R&D.