Endocyte expands supply deal for VISION prostate cancer trial
- A subsidiary of German company ITM Isotopen Technologien München has picked up a long-term agreement to supply Endocyte with highly purified, no-carrier-added Lutetium-177 (177Lu) EndolucinBeta, to support clinical and commercial supply of Endocyte's 177Lu-PSMA-617.
- The deal, which will last until 2035, will cover 100% of the 177Lu needed for the Phase 3 VISION trial, and between 50% and 100% of the commercial supply. It extends an existing agreement, signed in February 2018.
- Endocyte will pay ITM's subsidiary Isotope Technologies Garching €5 million (around $5.9 million) upfront to support expansion of worldwide manufacturing capacity for 177Lu. Further financial details have not been disclosed.
177Lu-PSMA-617, in-licensed from private German company ABX in 2017, is in a Phase 3 clinical trial for metastatic castration-resistant prostate cancer (mCRPC). The study, known as VISION, enrolled its first patient last month. The combination of the radioactive isotope and antigen makes its production more complex, which is why Endocyte has gone with a specialist manufacturer. ABX will continue to supply the PSMA-617 component.
"We believe ITM is already well positioned to support the completion of Endocyte’s VISION trial and we are preparing to support the potential global commercialization of this therapy. With multiple manufacturing facilities around the world and an unrivaled logistics network, we are confident we will reliably meet the needs for this significant opportunity," said Steffen Schuster, CEO of ITM.
Endocyte was struggling a year ago. Last June, it shut down two R&D programs and culled 30 jobs, and its share price fell by almost 31% to just $1.76, a 52-week low. Its focus is now on lead candidate 177Lu-PSMA-617, as well as its CAR-T therapy, which is due to go into safety and proof-of-concept human studies in the fourth quarter.
The markets are currently positive about Endocyte. Its stock value has been climbing steadily over the last 12 months, reaching a 52-week high of $16.92 last week. Equity analyst Maury Raycroft of Jefferies said in a company note, "[The supplier agreement] is an important update that further de-risks the stock, providing a reliable supplier through commercial launch as well as flexibility to negotiate [with] other suppliers along the way."
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