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Novartis (NVS) Inks Deal for ARVN's Prostate Cancer Candidate

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Novartis (NVS - Free Report) entered into an exclusive strategic license agreement with a clinical-stage biotechnology company, Arvinas, Inc. (ARVN - Free Report) , for the worldwide development and commercialization of the latter’s pipeline candidate ARV-766.  Shares of ARVN were up on the news.

The deal also includes an asset purchase agreement for the sale of Arvinas’ preclinical AR-V7 program to Novartis.

Per the terms of the deal, Novartis will be responsible for the global development and commercialization of ARV-766. NVS will also receive the research, development, manufacturing and commercialization rights for the preclinical AR-V7 program.

In exchange, Arvinas will obtain an upfront payment of $150.0 million. Additionally, ARVN will be eligible to receive additional development, regulatory and commercial milestones of up to $1.01 billion, as well as tiered royalties for ARV-766.

ARV-766 is Arvinas’ second-generation PROTAC androgen receptor (AR) degrader. The candidate is designed to target AR with a different profile than bavdegalutamide as a potential treatment for men with metastatic castration-resistant prostate cancer (mCRPC).

Interim data from an updated analysis of the ongoing phase I/II trial of ARV-766 (data cutoff August 23, 2023) demonstrated broad signals of efficacy and favorable tolerability in mCRPC patients with tumors harboring any AR LBD mutations, including AR L702H. The candidate was well tolerated.

Consequently, ARVN stated that it plans to prioritize the initiation of a phase III study with ARV-766 in mCRPC instead of the previously planned phase III study for its other candidate, bavdegalutamide.

The deal with ARVN adds another late-stage oncology to NVS’ deep pipeline.

Shares of Novartis have lost 6.6% in the year-to-date period against the industry’s growth of 10.6%.

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Novartis already has Pluvicto in its quiver for prostate cancer. Pluvicto is an intravenous radioligand therapy, combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177). It is approved for adults with prostate-specific membrane antigen-positive mCRPC, a type of advanced cancer that has spread to other parts of the body (metastatic).

With the successful spin-off of the Sandoz business in 2023, Novartis is now a pure-play innovative medicine company with a focus on these core therapeutic areas — cardiovascular, renal and metabolic, immunology, neuroscience and oncology.

Novartis announced that it has commenced tender offer for MorphoSys AG .  Earlier, in February 2024, Novartis announced that it would acquire MOR to expand its oncology portfolio.

The acquisition will add MorphoSys’s late-stage candidate pelabresib (CPI-0610) to NVS’ pipeline. The candidate is being evaluated in combination with Jakafi (ruxolitinib) for patients with myelofibrosis (MF), a rare bone marrow cancer. Pelabresib is also being evaluated in patients with essential thrombocythemia in a mid-stage study.

Novartis will also add tulmimetostat (CPI-0209) to its deep pipeline with MOR’s acquisition. The candidate is an early-stage investigational dual inhibitor of enhancer of zeste homolog 1 and 2 (EZH1 and EZH2) proteins, which are currently being tested in patients with solid tumors or lymphomas.

MorphoSys’ pipeline also includes ianalumab (VAY736), being evaluated across multiple immunological diseases and in hematology in partnership with Novartis. The MorphoSys acquisition will bolster Novartis’ broad oncology portfolio, provided pelabresib wins the FDA approval for MF.

NVS carries a Zacks Rank #3 (Hold) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


 


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