AbbVie, argenx sign $685M preclinical immuno-oncology deal

AbbVie ($ABBV) continues apace with its oncology pipeline buildup as today it signs a major deal with Belgium’s argenx to gain access to its preclinical immuno-oncology candidate.

The U.S. drugmaker has signed the deal with the Ghent, Belgium-based argenx that will see the biotech complete preclinical testing of ARGX-115 and if all goes well, then hand over human testing to AbbVie.

The U.S. giant will pay an upfront fee of $40 million for these rights, and also top this up with near-term preclinical milestones worth $20 million. The small biotech is in-line to receive additional development, regulatory and commercial payments up to $625 million, as well as double-digit royalties on sales if the drug gains approval.  

But wait, there’s more to the deal. As well as the ARGX-115 program, AbbVie will fund further GARP-related research by argenx for an initial period of two years. The Humira producer can also license the candidates coming from this research--for which argenx could get further milestone and royalty payments.

The drug was discovered with the de Duve Institute/Université Catholique de Louvain /WELBIO just over a year ago via argenx’s “Innovative Access Program” that sees it work closely with academic groups to help it find new targets.

ARGX-115, currently at the preclinical stage, works by stimulating a patient’s immune system after a tumor has suppressed the immune system by co-opting different immunosuppressive cells such as regulatory T-cells (Tregs)--which can inhibit other immune effector cells through the production of active TGF-β.

Argenx said that the membrane protein GARP plays a key role in the regulation of production of active TGF-β by Tregs and in preclinical studies of ARGX-115, the drug has shown it can inhibit the immunosuppressive activity of human Tregs by binding to GARP-inactive TGF-β complex and preventing release of active TGF-β.

The biotech’s chief business officer Debbie Allen told FierceBiotech that given its mechanism of action, the drug could potentially treat all cancers--and could also be used with other meds, such as checkpoint inhibitors in future testing.

She said that the biotech had “enormous interest” in ARGX-115 when it touted the drug for partners last year, and is now looking to fill up its pipeline with similar candidates to this drug, to “give us an edge both commercially and financially.”

She said the company weren’t going public on the timeline for when the drug will enter the clinic for human testing--but said it was “well advanced” in its preclinical tests.

Back in January, the biotech sold shares worth €16 million ($17.5 million) to the major U.S. asset manager Federated Investors as it looked to take a step further into the U.S. market.

CEO Tim Van Hauwermeiren told FierceBiotech argenx has a “strong cash position” of around €54 million before the AbbVie deal, and began trading on the Euronext exchange in 2014 after a €40 million IPO--but there have been questions over whether the company will hear the call of Nasdaq.

Hauwermeiren said: “The ability to access U.S. capital markets is important and yes, going on the Nasdaq is a strategic option we are looking at. The deal with AbbVie of course also helps us with the U.S. market and it’s a competitive advantage to be able to play there.”

In terms of its future, Hauwermeiren said that whatever road you go down, “eventually you will find yourself in a partnership with a pharma company, either to buy you out or commercialize your products.”

Argenx also has several other drugs in early-stage testing, but these remain separate from the AbbVie deal. This includes RGX-110 and ARGX-111, a pair of cancer programs in Phase Ib with its autoimmune drug ARGX-113 following closely behind. Hauwermeiren said once these have reached clinical proof of concept, they may become available for pharma partnerships.

While being argenx’s biggest financial deal to date, the pact will also help AbbVie shore up its early-stage oncology pipeline--with the drugmaker only fielding a few cancer meds, including its Roche ($RHHBY) co-marketed blood cancer drug venetoclax.

AbbVie has been buying up a number of cancer assets in recent years--including its major $21 billion buy for Pharmacyclics--and in February rumors began circling that the company could team up with Germany’s Boehringer (also light on cancer meds) for an oncology partnership potentially worth billions of dollars.

Just yesterday it signed a 5-year deal with the University of Chicago that will see both work together to advance research in several areas of oncology, which could include: breast, lung, prostate, colorectal and hematological cancers. The drugmaker said it also gained an option for an exclusive license to certain University of Chicago discoveries made under the agreement.

- check out the release