Af­ter mega-round in­vest­ment, ADC Ther­a­peu­tics cans PhI tri­al in HER2

Af­ter rais­ing a $200 mil­lion mega-round just months ago, Swiss drug­mak­er ADC Ther­a­peu­tics is ax­ing one of its pro­grams due to tox­i­c­i­ty is­sues.

Jay Fein­gold

The cut drug pro­gram, called AD­CT-502, is one of the com­pa­ny’s sev­er­al an­ti­body-drug con­ju­gate (ADC) can­di­dates in de­vel­op­ment for sol­id and blood can­cers. The 502 drug was be­ing test­ed in a Phase I tri­al with pa­tients who have HER2-pos­i­tive can­cers. But as the com­pa­ny’s CMO Jay Fein­gold ex­plains it, the HER-2 tar­get­ed ADC wasn’t work­ing well enough in low dos­es, which is a prob­lem con­sid­er­ing the side ef­fects.

“Pyrroloben­zo­di­azepine dimers are ex­treme­ly po­tent and have a well char­ac­ter­ized safe­ty pro­file that in­cludes flu­id re­ten­tion and pul­monary ede­ma. For most PBD AD­Cs this can be man­aged by se­lect­ing dos­ing reg­i­mens that are ef­fi­ca­cious with man­age­able tox­i­c­i­ties. How­ev­er, dur­ing dose es­ca­la­tion in this tri­al we did not achieve the nec­es­sary ef­fi­ca­cy at tol­er­at­ed dos­es re­quired for pa­tient ben­e­fit.”

ADC Ther­a­peu­tics’ CEO Chris Mar­tin al­so not­ed that HER2 per­haps wasn’t the best tar­get for the com­pa­ny.

Chris Mar­tin

“Pa­tients with HER2 ex­press­ing tu­mors have mul­ti­ple ther­a­peu­tic op­tions in­clud­ing nov­el ther­a­pies in clin­i­cal de­vel­op­ment that are pro­duc­ing en­cour­ag­ing da­ta. ADC Ther­a­peu­tic’s strat­e­gy is to progress a deep pipeline of AD­Cs in­to Phase I in or­der to as­sess their clin­i­cal and mar­ket po­ten­tial based on ac­tu­al hu­man da­ta, and on­ly to progress in­to lat­er stage de­vel­op­ment those AD­Cs that demon­strate the po­ten­tial to be best in class in ar­eas of high un­met med­ical need.”

The com­pa­ny cur­rent­ly has three oth­er ADC pro­grams in the clin­ic and three more head­ing to the clin­ic with­in the next 9 months, and it’s stress­ing that 502’s fate won’t im­pact its oth­er can­di­dates. The com­pa­ny’s two lead pro­grams (402 and 301) saw pos­i­tive Phase I da­ta re­port­ed out in 2016.

That may or may not ease the wor­ries of in­vestors, who’ve backed the 6-year-old com­pa­ny with $455 mil­lion in to­tal cap­i­tal, in­clud­ing a $200 mil­lion mega-round re­port­ed in Oc­to­ber.

Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

Tillman Gerngross, Adagio Therapeutics CEO

An­ti­body leg­end Till­man Gern­gross is el­bow­ing his way in­to the Covid-19 R&D cru­sade: 'I don’t see this end­ing any­time soon'

One of the most influential — and outspoken — scientists at work in the field of antibody discovery is jumping into the frenzied race to create new therapeutics to treat and prevent Covid-19. And he’s operating with the conviction that the current outbreak now once again spreading like wildfire will create plenty of demand for what he has in mind.

Dartmouth professor and Adimab CEO Tillman Gerngross tells me he’s raised $50 million from a group of close VCs to spin out a new company — Adagio Therapeutics — with a full C-suite team assembled to hire up a staff and keep rolling toward the clinic.

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Full Bril­in­ta study re­sults show the blood thin­ner re­duces rate of sec­ondary stroke

AstraZeneca once projected its Brilinta drug to peak at $3.5 billion in sales, and though the blood thinner never reached that lofty goal, it received the latest positive signs in a string of recent good news.

The pharma released full details from its THALES study Thursday morning, which measured the effects of Brilinta and aspirin against aspirin alone in treating patients who had an acute ischemic stroke or transient ischemic attack. When taken twice daily with once-a-day aspirin for 30 days, the Brilinta combo reduced the risk of stroke and death by 17 percent, meeting the primary endpoint of the study.

Norbert Bischofberger, Kronos CEO

Gilead­'s ex-R&D chief Bischof­berg­er heads back to the biotech gi­ant to pick up a pair of late-stage drugs that had been put aside

Norbert Bischofberger knows entospletinib well.

Back during his long, blockbuster run as head of R&D at Gilead, researchers had once held some high hopes for this drug. But to make it work, he and the team felt it would need a new companion diagnostic to identify patients. There was talk of a combo approach to give it more punch. But the market was small, making them wonder if it would be worth going through a lengthy development cycle to get it through a pivotal.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

The $1B Mer­ck-Bay­er drug that di­vid­ed car­di­ol­o­gists in March gets pri­or­i­ty re­view

Three months after Merck published in the New England Journal of Medicine data that left doctors and investors divided over just how well its experimental heart drug worked, the FDA has handed that drug priority review. A decision is now due by January 20, 2021.

Merck first announced the drug, known as vericiguat, as a Phase III success last November. In 2016, Merck had paid $1 billion upfront for US rights to the Bayer-developed drug. Early projections foresaw a few hundred million a year in sales, but the unspecified late-stage success raised the possibility for far more. After all, Novartis’s flagship heart drug, Entresto, was earning $1.7 billion per year and was expected to reach up to $4 billion in annual sales.

GSK’s Shin­grix leader Guil­laume Pfe­fer has jumped on board Flag­ship to helm a biotech hy­brid as Afeyan’s lat­est CEO-part­ner

After spending 4 years in a senior post with GlaxoSmithKline’s star team positioning Shingrix for a blockbuster approval, Guillaume Pfefer is headed back to the biotech world — in style.

Pfefer has signed on to join Noubar Afeyan’s busy group of partners at Flagship, and he’s taking the helm of an upstart — which today is being merged with another Flagship startup — with some grand plans of its own. The announcement this morning notes that Pfefer will run Kintai Therapeutics, one of the grads of the Flagship labs.

Donald Trump and Anthony Fauci (AP Images)

Covid-19 roundup: Rus­sia hack­ers tar­get US, UK vac­cine and drug re­searchers; Fau­ci fires back at White House cam­paign to un­der­mine him

Russia has tried to steal a Covid-19 vaccine and therapeutics researcher from pharmaceutical and academic institutions in the US, UK and Canada, Britain’s National Cyber Security Centre said Thursday.

The NCSC said that hacking attempts came from a group known as APT129, also known as “Cozy Bear,” that “almost certainly operate as part of Russian intelligence services.” The Canadian Communication Security Establishment, US Department for Homeland Security, the Cybersecurity Infrastructure Security Agency, and the National Security Agency shared the assessment, the NCSC said.

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