$60M in, Ab­b­Vie is trig­ger­ing a $625M-plus plan to de­vel­op a new im­muno-on­col­o­gy drug that is go­ing af­ter GARP

Ab­b­Vie $AB­BV has de­cid­ed to jump in­to clin­i­cal de­vel­op­ment work with a new im­muno-on­col­o­gy drug for its on­col­o­gy pipeline. 

Two years af­ter the com­pa­ny com­mit­ted $60 mil­lion in an up­front and near-term pre­clin­i­cal mile­stones to its part­ner ar­genx (Eu­ronext Brus­sels: ARGX), re­searchers are com­ing back for the com­mer­cial rights to a ther­a­py dubbed ARGX-115. And Ab­b­Vie — which has fin­ished pay­ing the full $20 mil­lion in ear­ly goal pay­ments — is down for up to $625 mil­lion in mile­stones if it can make the drug work as hoped.

So­phie Lu­cas

You may not rec­og­nize the tar­get: gly­co­pro­tein A rep­e­ti­tions pre­dom­i­nant, or GARP. GARP sits on the sur­face of reg­u­la­to­ry T cells — Tregs — which has be­come a pipeline of its own as drug de­vel­op­ers go all out in track­ing the next-gen I/O drugs that they hope to add be­hind the first wave of check­point in­hibitors. Tregs blunt an im­mune at­tack on can­cer cells, so mas­ter­ing them has be­come a big deal in bio­phar­ma.

Ar­genx got in­to the game in 2015, at­tract­ed to the lab work be­ing done by So­phie Lu­cas at the de Duve In­sti­tute at the Catholic Uni­ver­si­ty in Bel­gium. Her team was look­ing at the role of GARP in pro­duc­ing TGF-ß, which ap­plies the brakes to the im­mune sys­tem.

Anil Sing­hal

“The abil­i­ty to mod­u­late the body’s own im­mune sys­tem to fight can­cer is one of the most promis­ing sci­en­tif­ic ad­vance­ments over the past decade,” Anil Sing­hal, for­mer ear­ly on­col­o­gy re­search at Ab­b­Vie, said at the time. “We be­lieve that the ARGX-115 pro­gram is a unique op­por­tu­ni­ty to ex­plore the po­ten­tial to block cer­tain im­mune-sup­pres­sive path­ways that al­low can­cers to grow.”

Sing­hal’s group is al­so sup­port­ing new re­search work at ar­genx that takes it all one step fur­ther, putting them in a po­si­tion to lock up any new GARP-re­lat­ed mol­e­cules they find.

Tim van Hauw­er­meiren, the CEO at ar­genx, al­so is hang­ing on to co-pro­mo­tion rights in Eu­rope.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

The Melon family, as seen in Concussion Awareness Now's latest campaign

Ab­bott in­tro­duces the Mel­on fam­i­ly to raise con­cus­sion aware­ness

Abbott is renewing its concussion awareness campaign, weeks after the company received FDA clearance for its lab-based traumatic brain injury (TBI) blood test.

The unbranded campaign features three generations of the Melon family — animated talking melons who slip on toys or take a spill while playing pickleball.

“Don’t mess with your melon. If you hit it, get it checked,” a narrator says.