Novartis, whose presence in prostate cancer is mainly through the radiopharmaceutical Pluvicto, is expanding its prospects in the disease, striking a deal that brings a Phase 3-ready small molecule in the emerging therapeutic modality called targeted protein degradation.
The drug, ARV-766, was developed by New Haven, Connecticut-based Arvinas. The deal announced Thursday calls for Novartis to pay $150 million up front. The Swiss pharmaceutical giant could shell out up to $1 billion more if the molecule achieves development, regulatory, and commercial milestones.
Targeted protein degradation involves using a small molecule to target a disease-causing protein, marking it for disposal by the cell’s built-in system for eliminating old or damaged proteins. Arvinas specializes in protein degrader drugs, and the company’s pipeline spans various cancers and neurological disorders. Arvinas said ARV-766’s preclinical research showed activity in androgen receptor tumors with mutations or amplifications, both of which can lead to resistance to available targeted cancer therapies.
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Arvinas’s research had actually yielded two programs that target the androgen receptor to treat prostate cancer. Last fall, Arvinas unveiled Phase 1/2 data indicating ARV-766 was the better of the two, offering superior efficacy and tolerability in patients with metastatic castration-resistant prostate cancer. The biotech said it would advance ARV-766 into pivotal testing. Now that responsibility shifts to Novartis.
“We believe the expertise and scale of Novartis will broaden the development of ARV-766 and its potential to be a first- and best-in-class treatment for patients with prostate cancer,” Arvinas President and CEO John Houston said in a prepared statement. “This strategic transaction also further validates our innovative PROTAC protein degrader platform and its potential to deliver new treatments.”
The agreement makes Novartis responsible for worldwide clinical development and commercialization of ARV-766. The deal also gives the pharma giant all rights to a preclinical program addressing AR-V7, an androgen receptor variant that was not degraded or was not potently degraded by Arvinas’s other androgen receptor-targeting drug candidate. Arvinas describes this molecule as a next-generation drug that targets the AR-V7 variant as well as the full length androgen receptor.
Arvinas has successfully placed other programs in the hands of big pharma companies. In 2021, Pfizer committed $1 billion to partner on an Arvinas drug that targets the estrogen receptor to treat breast cancer. That molecule, now named vepdegestrant, is currently in Phase 3 testing.
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Photo: Sebastien Bozon/AFP, via Getty Images
