Novartis, whose presence in prostate cancer is largely driven by the radiopharmaceutical Pluvicto, is expanding its chances in the disease with a deal that brings a Phase 3-ready small molecule into a new therapeutic modality called targeted protein degradation.
The drug ARV-766 was developed by Arvinas of New Haven, Connecticut. The deal announced Thursday calls for an upfront payment of $150 million by Novartis. The Swiss pharmaceutical giant could spend up to $1 billion more if the molecule hits development, regulatory and commercial milestones.
Targeted protein degradation uses a small molecule to attack a disease-causing protein and mark it for disposal by the cell’s built-in system for eliminating old or damaged proteins. Arvinas specializes in protein degradation drugs and the company’s pipeline includes various cancers and neurological diseases. Arvinas said preclinical research of ARV-766 has shown activity in androgen receptor tumors with mutations or amplifications, both of which can lead to resistance to available targeted cancer therapies.
Arvinas’ research had actually produced two programs that target the androgen receptor to treat prostate cancer. Last fall, Arvinas presented Phase 1/2 data suggesting that ARV-766 was the better of the two, providing superior efficacy and tolerability in patients with metastatic castration-resistant prostate cancer. The biotech company said it would advance ARV-766 into pivotal testing. Now the responsibility shifts to Novartis.
“We believe Novartis’ expertise and scale will expand the development of ARV-766 and its potential as a first-in-class treatment for patients with prostate cancer,” John Houston, president and CEO of Arvinas, said in a prepared statement. “This strategic transaction also validates our innovative PROTAC protein degradation platform and its potential to deliver new treatments.”
Through the agreement, Novartis will be responsible for the global clinical development and commercialization of ARV-766. The deal also gives the pharmaceutical giant all rights to a preclinical program to treat AR-V7, an androgen receptor variant that was not or not effectively targeted by Arvinas’ other androgen receptor-targeting drug candidates. Arvinas describes this molecule as a next-generation drug that targets both the AR-V7 variant and the full-length androgen receptor.
Arvinas has successfully placed other programs in the hands of major pharmaceutical companies. In 2021, Pfizer committed $1 billion to develop an Arvinas drug that targets the estrogen receptor to treat breast cancer. This molecule, now called Vepdegestrant, is currently in Phase 3 testing.
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