Dive Brief:
- Troubled cancer pharma Endocyte has shut down two of its R&D programs, shifting its focus towards CAR-T and dual-targeted DNA crosslinker drug research. It is cutting 30 jobs, leaving it with only 47 employees.
- Development of EC1456, a folate receptor-targeted tubulysin cancer therapy, will be discontinued and the focus of the EC1169 prostate cancer therapy program will be narrowed down to taxane-exposed, metastatic castration-resistant prostate cancer patients. The plan is to bring its CAR-T cell bispecific adaptor molecule to the clinic in 2018, and file an investigational new drug application for EC2629, a dual-targeted DNA crosslinker drug, in mid-2017.
- Endocyte expects one-time charges of around $2.4 million and has reviewed its guidance; the company's share price tumbled by over 25% on the news; by close of markets yesterday the fall was up to almost 31%, closing at just $1.76 and creating a new 52-week low.
Dive Insight:
Endocyte is a personalized medicine company, with each of its drugs paired with a companion imaging agent. It was founded in 1999 to develop folate-targeted cancer agents under a collaboration with the National Cancer Institute. This announcement marks the end of its lead folate receptor targeted drug, EC1456, which did not show sufficient clinical activity across different patient cohorts and different dosing schedules. Patients will still be enrolled into a small ovarian cancer surgical study to inform the ongoing small molecule drug conjugate (SMDC) work ongoing.
EC1169, Endocyte's prostate-specific membrane antigen targeted (PSMA-targeted) tubulysin prostate cancer therapy, was in studies in both taxane-naïve and taxane-exposed, metastatic castration-resistant prostate cancer (mCRPC) patients. Following an interim assessment, Endocyte is continuing the study in taxane-treated patients with more advanced disease, and stopping enrollment of taxane-naïve mCRPC patients in the EC1169 trial.
"Endocyte is a data-driven company, and we are committed to the disciplined management of clinical programs as the science guides us," said Mike Sherman, president and CEO of Endocyte. "Recently gained insight into the safety and efficacy of EC1169 and EC1456, coupled with our commitment to the productive investment of capital, has led us to refocus efforts on our most promising programs, which include our CAR-T cell SMDC adaptor platform, our dual-targeted DNA crosslinker drug EC2629, and the cohort of taxane-exposed patients receiving EC1169."
The development of the CART-T cell bispecific adaptor molecule will continue with Seattle Children's Research Institute. CAR-T immunotherapy has been an area sparking a lot of interest recently, despite a number of setbacks, and could be an interesting comeback for a company currently at difficult point.
In its first quarter 2017 results, Endocyte announced losses of $11.5 million for the first quarter of 2017.