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.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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The Avance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

As­traZeneca trum­pets the good da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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Stymied by the pan­dem­ic, Im­munomedic­s' new CEO bows out, tak­ing a mil­lion bucks plus perks as he heads out the vir­tu­al ex­it

Just a little more than a month since taking over as the latest CEO to helm Immunomedics, $IMMU Harout Semerjian is exiting the company after being confronted by “logistical” obstacles thrown up by the pandemic that made it impossible for him to move from London to carry out the job. And he’s getting a little over a million dollars in cash plus perks to grease the skids on the way out.

Word of the changeup arrived right after the market closed Wednesday.

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