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.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.