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.

Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

Jeff Albers, Blueprint CEO

Di­ag­nos­tic champ Roche buys its way in­to the RET ti­tle fight with Eli Lil­ly, pay­ing $775M in cash to Blue­print

When Roche spelled out its original $1 billion deal — $45 million of that upfront — with Blueprint to discover targeted therapies against immunokinases, the biotech partner’s RET program was still preclinical. Four years later, pralsetinib is on the cusp of potential approval and the Swiss pharma giant is putting in much more to get in on the commercial game.

Roche gains rights to co-develop and co-commercialize the drug, with sole marketing responsibility for places outside the US and China (where CStone has staked its claim).

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Mene Pangalos, AstraZeneca R&D chief (AstraZeneca via YouTube)

A day af­ter Mod­er­na vac­cine re­sults, ru­mors swirl of pend­ing As­traZeneca da­ta

A day after Moderna and the NIH published much-anticipated data from their Phase I Covid-19 vaccine trial, attention is turning to AstraZeneca which, according to a UK report, is expected to publish its own early data tomorrow.

ITV’s Robert Peston reported that AstraZeneca will publish the Phase I data in The Lancet. 

AstraZeneca and Moderna represent the two most ambitious Covid-19 vaccine efforts, having set the quickest timelines for approval (though they were recently joined in that regard by the Pfizer-BioNTech partnership) and some of the loftiest goals in total doses. Yet there is even less known about AstraZeneca’s vaccine’s effect on humans than there was about Moderna’s before yesterday. Although, in a controversial move, Moderna released some statistics from its Phase I in May, AstraZeneca has yet to say anything about what it saw in its Phase I trial — a move consistent with the scientific convention to withhold data until it can be published in a peer-reviewed journal.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

‘Plan­ning to vac­ci­nate every­one in the US,’ Mod­er­na out­lines ef­forts to sup­ply their Covid-19 vac­cine as man­u­fac­tur­ing ramps up ahead of PhI­II

Twelve days from the planned start of their Phase III pivotal trial, the executive crew at Moderna has set up the manufacturing base needed to begin production of the first 500,000 doses of their Covid-19 vaccine with plans to feed it into a global supply chain. But the initial batches will likely be ready in the US first, where company CEO Stéphane Bancel plans to be able to vaccinate everyone.

“We have started making commercial product at-risk, and will continue to do so every day and every week of the month,” Bancel told analysts during their morning call on the Phase I data just published in the New England Journal of Medicine.

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Carolyn Loew, Glympse Bio CEO

Gilead-part­nered Glympse snares $46.7M for their NASH-snoop­ing biosen­sors

Since its emergence at JP Morgan six years ago, the NASH field has been held back not only by the question of how to treat the disease, but also by the question of how you diagnose it. It’s simply not that difficult to tell if a liver is fatty or scarred or in full-on cirrhosis.

The method used in most trials is needle biopsy, where you take a hollow needle, stick it through someone’s skin and into their liver and suck out some cells. You stain those cells and examine them under the microscope. It’s safe but very painful, and that pain limits how often you can test a patient in a trial, and, down the line, how many of the millions of Americans suspected to have NASH would actually be tested for the disease and potentially prescribed an approved drug.

Covid-19 roundup: Vac­cine by end of 2020? Ken Fra­zier warns hype do­ing 'grave dis­ser­vice'

When it comes to setting expectations about a Covid-19 vaccine, Ken Frazier does not mince words.

Over a month after first casting doubts on the aggressive 12- to 18-month timeframe championed by the US government and his biopharma peers, the Merck CEO again cautioned against any hype around a quick vaccine approval.

In a wide-ranging interview with Harvard Business School professor Tsedal Neeley that touched other big topics such as race, Frazier emphasized that vaccines take a long time to develop. He would know: Out of the seven new vaccines introduced around the world in the past 25 years, four came from Merck.

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Alex Zhavoronkov (Insilico)

'Longevi­ty as a ser­vice': In­sil­i­co spins off AI biotech that trains deep learn­ing on an­ti-ag­ing treat­ments

Since its inception in 2014, Insilico has racked up deal after deal on the promise that artificial intelligence can hasten drug development, touting their work on discovering small molecules. The biotech’s founder, Alex Zhavoronkov, has published several scientific papers quantifying just how impactful this technology can be.

On Tuesday, Zhavoronkov extended his AI expertise into the field of anti-aging.