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.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Sanofi and GSK reach deal with Cana­da for 72 mil­lion vac­cine dos­es

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the biotech.

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Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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J&J re­leas­es PhI­II safe­ty blue­print for Covid-19 vac­cine tri­al. How does it stack up to Mod­er­na, Pfiz­er and As­traZeneca?

Along with the initiation of its Phase III Covid-19 vaccine study announced Wednesday morning, Johnson & Johnson has also released its trial protocol, giving an inside look at how the company is conducting its late-stage research.

The move comes after the other three companies conducting Phase III’s in the US — Moderna, Pfizer and AstraZeneca — each disclosed their own trial blueprints within the last week. Though the release of such protocols is typically done after trials have been completed, drug developers had come under intensifying pressure to do so given the approaching November presidential election.

Isaac Veinbergs, Libra CEO

With $29M in Se­ries A, Boehringer-backed Li­bra looks to tack­le neu­rode­gen­er­a­tion through cel­lu­lar clean­ing

Can the natural process by which cells clean out toxic proteins be harnessed to create potential treatments for neurodegenerative disorders?

That’s the question Libra Therapeutics will be trying to answer, as the new biotech officially launched Wednesday morning with $29 million in Series A financing. The company has three preclinical programs at the ready, with its lead candidate targeting ALS and frontotemporal dementia. But CEO Isaac Veinbergs said he hopes to develop therapies for a wide range of diseases, including Parkinson’s, Alzheimer’s and Huntington’s.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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