Novartis’ purchase agreement came shortly after the US Food and Drug Administration (FDA) gave approval for Endocyte’s testing approach, which will see radiographic progression-free survival (rPFS) be used as an alternative primary endpoint in the drug’s clinical trials.
The drug, known as Lu-PSMA-617, is an investigational radioligand therapy (RLT) that uses pinpoint-radiation. According to Novartis, this occurs when a small molecule is used within the therapy to insert a radioactive drug at a specific target in the body.
In the case of Endocyte, the target is the prostate-specific membrane antigen (PSMA) which is found in high concentration on the diseased cell’s surface.
In a Phase II study of 50 patients, with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), those treated with the therapy showed a progression-free survival rate of 7.6 months.
The acquisition will also include Endocyte’s pipeline of additional RLTs, including Ac-PSMA-617 which is currently in preclinical studies for the treatment of mCRPC.
In addition, Novartis will expand its chimeric antigen-receptor (CAR)-T technology research program as part of the acquisition, with Endocyte expected to submit an investigational new drug application by the end of 2018 for its adaptor-controlled CAR T-cell therapy.
Per the agreement, Endocyte and an undisclosed newly formed Novartis subsidiary will merge.
Novartis’ acquisition of Endocyte will have a $2.1 billion price tag, the company explained the expense by noting that the global market for prostate cancer treatments will reach $11 billion by 2024.
Novartis view Lu-PSMA-617 as having a large market potential, with CEO, Vas Narasimhan, suggesting it has blockbuster potential in a press release.
Neither Novartis nor Endocyte was able to make any further comment at this time.