ADC Ther­a­peu­tics beefs up mon­ster $200M round with fresh $76M haul

Days af­ter Roche se­cured ac­cel­er­at­ed ap­proval for its an­ti­body-drug con­ju­gate, Lau­sanne, Switzer­land-based ADC Ther­a­peu­tics has clinched an­oth­er $76 mil­lion to its al­ready hefty $200 mil­lion round of fi­nanc­ing un­veiled in 2017.

The fresh in­jec­tion brings ADC’s ven­ture haul to $531 mil­lion.

Chris Mar­tin ADC

The funds will set the on­col­o­gy com­pa­ny up with “a strong bal­ance sheet to fund prepa­ra­tions for a po­ten­tial Bi­o­log­ic Li­cense Ap­pli­ca­tion (BLA) for AD­CT-402 (lon­cas­tux­imab tesirine) in re­lapsed or re­frac­to­ry dif­fuse large B-cell lym­phoma (DL­B­CL) in the sec­ond half of 2020, as well as prepa­ra­tions for a piv­otal Phase II tri­al of AD­CT-301 (cami­dan­lum­ab tesirine) in Hodgkin lym­phoma based on our re­cent end of Phase I meet­ing with the U.S. Food and Drug Ad­min­is­tra­tion,” said ADC chief Chris Mar­tin, in a state­ment on Wednes­day.

An­ti­body-drug con­ju­gates are a class of ther­a­peu­tics in which a can­cer-killing tox­in is at­tached to a spe­cif­ic an­ti­body us­ing a biodegrad­able link­er. They are de­signed to min­i­mize the ef­fects of the chemother­a­py on healthy cells while max­i­miz­ing tu­mor cell death, which is why the tech­nol­o­gy is some­times likened to a tro­jan horse as it is en­gi­neered to go un­no­ticed, de­liv­er­ing chemother­a­pies to cells ex­press­ing the anti­gen tar­get.

Un­like the first gen­er­a­tion of an­ti­body-drug con­ju­gates that were steered to the mar­ket by Seat­tle Ge­net­ics and oth­ers, ADC Ther­a­peu­tics is us­ing pyrroloben­zo­di­azepine-based war­heads that it sus­pects will be more po­tent and mit­i­gate drug re­sis­tance, even in hard-to-treat tu­mors.

Mar­tin served as one of the orig­i­nal board mem­bers at ADC back in 2011 when the biotech was launched. In 2013, he en­gi­neered the sale of UK’s Spirogen — where he was CEO — to As­traZeneca in a $440 mil­lion deal, which the British drug­mak­er paired with a $20 mil­lion in­vest­ment in ADC. ADC and Spirogen al­so share the pyrroloben­zo­di­azepine-based war­head tech­nol­o­gy.

ADC’s two lead pro­grams (402 and 301) first re­port­ed pos­i­tive ear­ly-stage da­ta in 2016, and the com­pa­ny has since up­dat­ed its da­ta. The com­pa­ny’s re­searchers, led by CMO Jay Fein­gold —  for­mer VP of can­cer re­search at Wyeth — pre­sent­ed up­dat­ed Phase I da­ta at Amer­i­can So­ci­ety of Hema­tol­ogy (ASH) meet­ing on the 402 pro­gram, which takes aim at a tar­get fa­vored by the CAR-T crowd: CD19. In 139 evalu­able pa­tients with re­lapsed or re­frac­to­ry DL­B­CL, the sci­en­tists reg­is­tered an over­all re­sponse rate (ORR) was 43.3% — com­pris­ing 23.6% com­plete re­spons­es and 19.7% par­tial re­spons­es.

ADC al­so pub­lished fresh phase I da­ta on its ex­per­i­men­tal 301 drug at ASH. In 113 pa­tients with Hodgkin’s lym­phoma, who have failed mul­ti­ple lines of ther­a­py, re­searchers doc­u­ment­ed an ORR of 86.5%, in­clud­ing a lofty 43% com­plete re­sponse rate.

The piv­otal (Phase II) 402 DL­B­CL tri­al is ex­pect­ed to read­out in the third quar­ter of 2019 — and a piv­otal (Phase II) 301 study in Hodgkin lym­phoma pa­tients is ex­pect­ed to kick off in the com­ing months. Last year, the com­pa­ny aban­doned an ear­ly-stage study in pa­tients with HER2-pos­i­tive can­cers eval­u­at­ing its drug, AD­CT-502, af­ter it failed to im­press.

The com­pa­ny — which has a work­force of 120 and op­er­a­tions in Lon­don, New Jer­sey and San Fran­cis­co — an IPO is al­so on the cards, Mar­tin told End­points News.

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.

Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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As­traZeneca pub­lish­es Covid-19 vac­cine PhI­II pro­to­cols in lock­step with Mod­er­na and Pfiz­er. How are they dif­fer­ent?

Following in the steps of Moderna and Pfizer, the other two American drugmakers currently in Phase III trials for their Covid-19 vaccines, AstraZeneca posted its own study protocols over the weekend. The move is the latest in a series of rare peeks behind the curtain, as such blueprints are typically shared once such trials are completed.

“Given the unprecedented global impact of the Coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial. As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials. AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company said in a statement.

Sebastian Nijman (file photo)

Roche looks to ge­net­ic mod­i­fiers for new drug tar­gets, team­ing up with Dutch biotech in $375M deal

Roche is gambling on a new way of discovering drug targets and, ultimately, promising to infuse more than $375 million into a small biotech if all goes well.

A spinout of the Netherlands Cancer Institute and Oxford University, Scenic Biotech set out to pioneer a field that’s gaining some traction among top VCs in the US: to harness the natural protecting powers of genetic modifiers — specific genes that suppress a disease phenotype.

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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