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.
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.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 41,800+ biopharma pros who read Endpoints News by email every day.Free Subscription