Novartis and Endocyte intend to merge in an announcement made by the global medicines company. Novartis has entered into an agreement and plan of merger with Endocyte, a US-based biopharmaceutical company focused on developing targeted therapeutics for cancer treatment.
Endocyte uses drug conjugation technology to develop targeted therapies with companion imaging agents, including 177Lu-PSMA-617, a potential first-in-class investigational radioligand therapy (RLT) for the treatment of metastatic castration-resistant prostate cancer (mCRPC). 177Lu-PSMA-617 targets the prostate-specific membrane antigen (PSMA), present in the majority of patients with mCRPC, and has shown promising Phase II data. 177Lu-PSMA-617 is currently being investigated in the Phase III global VISION clinical trial in men with mCRPC, a disease with limited treatment options and significant unmet medical need.
If completed, the Endocyte acquisition would expand the Novartis RLT platform with both a potential near-term product launch and early-stage clinical development programmes. The deal would also enable Novartis to harness its research and development expertise to investigate the potential development of 177Lu-PSMA-617 for use in earlier lines of prostate cancer therapy.
In a Phase II study, 50 patients with PSMA-positive mCRPC treated with 177Lu-PSMA-617 showed a median prostate specific antigen (PSA) progression free survival (PFS) of 7.6 months (p<0.0001). Median overall survival for the first cohort of 30 patients enrolled was 13.5 months (p=0.0201).
VISION is a global, prospective, open-label, multi-center, randomized Phase III trial of 177Lu-PSMA-617 in combination with best supportive care versus best supportive care alone. The trial is currently enrolling patients with mCRPC. In September, the US Food and Drug Administration (FDA) agreed to radiographic progression-free survival (rPFS) as an alternative primary endpoint to OS in the trial.
The Endocyte pipeline includes additional investigational RLTs, including 225Ac-PSMA-617 in preclinical studies for the treatment of mCRPC.
Radiopharmaceuticals such as 177Lu-PSMA-617 are innovative medicinal formulations containing radioisotopes that are used clinically for both diagnosis and therapy.
Through the acquisition of Advanced Accelerator Applications (AAA), Novartis acquired Lutathera® (lutetium Lu 177 dotatate / INN: lutetium (177Lu) oxodotreotide) – the first ever approved Peptide Receptor Radionuclide Therapy – for the treatment of somatostatin-receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), an orphan disease.
The transaction would be in the form of a merger of Endocyte and a newly formed Novartis subsidiary. Under the terms of the agreement and plan of merger, upon closing, holders of Endocyte common stock would receive USD 24 in cash per share. This offer values Endocyte’s equity at USD 2.1 billion.
Closing of the transaction is subject to customary closing conditions, including the approval of Endocyte’s stockholders and receipt of regulatory approvals. Until closing, Endocyte will continue to operate as a separate and independent company. The acquisition of Endocyte is planned to be funded through available cash.