Dive Brief:
- After a tough year, Endocyte, Inc. shares have more than quadrupled in value over the past two days on news of a licensing deal with private German company ABX GmbH that adds a Phase 3-ready prostate cancer drug to the biotech's pipeline.
- Per the deal, Endocyte secured a worldwide and exclusive license to a radioligand therapeutic that targets the prostate-specific membrane antigen (PSMA), which the company hopes to move into a registrational late-stage study early next year.
- Endocyte said it will focus most of its resources on development of the treatment and — with the exception of a CAR-T program — seek to outlicense the remainder of its R&D programs.
Dive Insight:
In June this year, Endocyte was struggling. The company had shut down its EC1456 targeted cancer therapy program after failures in clinical trials, and refocused to a dual-targeted DNA crosslinker drug called EC2629, which was heading for the clinic in 2017, and a CAR-T project aimed for human studies in 2018. As a result of the restructuring, Endocyte said it would cut 40% of its workforce.
Now, the EC2629 has disappeared from the company's pipeline and the CAR-T project looks like it will be a secondary focus to the newly acquired prostate cancer treatment.
"With the exception of a very targeted effort to generate proof-of-concept data for our CAR T-cell program, we will focus our resources on the development of 177Lu-PSMA-617," said Mike Sherman, president and CEO of Endocyte. "We will explore out-licensing opportunities for all other development programs."
The newly-licensed 177Lu-PSMA-617 is designed to target PMSA on tumor cells specifically and deliver a radioactive isotope to destroy the cells in bone and soft tissue disease.
Endocyte will seek approval from the Food and Drug Administration to begin a Phase 3 study in early 2018 and hopes to complete the registrational trial by 2020.
Shares in the company were up nearly 60% to trade around $5.60 apiece Tuesday, after closing up 157% Monday.