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.

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 That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled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.

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.

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.