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.

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus -- chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

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Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

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Left top to right: Mark Timney, Alex Denner, Vas Narasimhan. (The Medicines Company, Getty, AP/Endpoints News)

In a play-by-play of the $9.7B Med­Co buy­out, No­var­tis ad­mits it over­paid while of­fer­ing a huge wind­fall to ex­ecs

A month into his tenure at The Medicines Company, new CEO Mark Timney reached out to then-Novartis pharma chief Paul Hudson: Any interest in a partnership?

No, Hudson told him. Not now, at least.

Ten months later, Hudson had left to run Sanofi and Novartis CEO Vas Narasimhan was paying $9.7 billion for the one-drug biotech – the largest in the string of acquisitions Narasimhan has signed since his 2017 appointment.

The deal was the product of an activist investor and his controversial partner working through nearly a year of cat-and-mouse negotiations to secure a deal with Big Pharma’s most expansionist executive. It represented a huge bet in a cardiovascular field that already saw two major busts in recent years and brought massive returns for two of the industry’s most eye-raising names.

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Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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Game on: Re­gen­eron's BC­MA bis­pe­cif­ic makes clin­i­cal da­ta de­but, kick­ing off mul­ti­ple myelo­ma matchup with Bris­tol-My­ers

As J&J attempts to jostle past Bristol-Myers Squibb and bluebird for a landmark approval of its anti-BCMA CAR-T — and while GlaxoSmithKline maps a quick path to the FDA riding on its own BCMA-targeting antibody-drug conjugates — the bispecifics are arriving on the scene to stake a claim for a market that could cross $10 billion per year.

The main rivalry in multiple myeloma is shaping up to be one between Regeneron and Bristol-Myers, which picked up a bispecific antibody to BCMA through its recently closed $74 billion takeover of Celgene. Both presented promising first-in-human data at the ASH 2019 meeting.

FDA lifts hold on Abeon­a's but­ter­fly dis­ease ther­a­py, paving way for piv­otal study

It’s been a difficult few years for gene and cell therapy startup Abeona Therapeutics. Its newly crowned chief Carsten Thiel was forced out last year following accusations of unspecified “personal misconduct,” and this September, the FDA imposed a clinical hold on its therapy for a form of “butterfly” disease. But things are beginning to perk up. On Monday, the company said the regulator had lifted its hold and the experimental therapy is now set to be evaluated in a late-stage study.

Roche faces an­oth­er de­lay in strug­gle to nav­i­gate Spark deal past reg­u­la­tors — but this one is very short

Roche today issued the latest in a long string of delays of its $4.3 billion buyout of Philadelphia-based Spark Therapeutics. The delay comes as little surprise — it is their 10th in as many months — as their most recent delay was scheduled to expire before a key regulatory deadline.

But it is notable for its length: 6 days.

Previous extensions had moved the goalposts by about 3 weeks to a month, with the latest on November 22 expiring tomorrow. The new delay sets a deadline for next Monday, December 16, the same day by which the UK Competition and Markets Authority has to give its initial ruling on the deal. And they already reportedly have lined up an OK from the FTC staff – although that’s only one level of a multi-step process.

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