Endocyte said today it will eliminate approximately 40% of its workforce—leaving it with 47 employees—under a restructuring that includes ending patient enrollment in a Phase I trial of one cancer candidate, and narrowing the development focus of a second.
The workforce reduction would amount to approximately 30 jobs, based on the 76 employees that publicly traded Endocyte reported as of December 31, 2016, according to its Form 10-K for last year, filed March 13.
In a regulatory filing today, Endocyte said the layoffs will occur across the organization and are part of a strategic restructuring. The company said it expects to establish a severance program for affected employees, and “substantially” complete the workforce reduction in the third quarter.
“The Company currently anticipates incurring total restructuring costs related to the strategic restructuring of approximately $2.4 million,” Endocyte said in a Form 8-K.
Those costs include approximately $1.1 million in severance, benefits and related costs; $0.3 million in fixed-asset impairment charges; and approximately $1 million in clinical trial termination charges.
Endocyte said it would end patient enrollment in a Phase I trial of its folate receptor-targeted tubulysin solid tumor cancer candidate EC1456, saying in a statement: “A careful assessment in folate receptor-positive (FR-positive) disease across multiple cohorts of patients and multiple dosing schedules did not yield the level of clinical activity necessary to support continued advancement of this agent.”
However, Endocyte added that it will continue enrolling a “small number” of patients in an ovarian cancer surgical study of EC1456, using the results toward the development of its other small-molecule drug conjugate (SMDC) programs.
Preliminary data from that study showed that patients with FR-positive disease were successfully identified with the use of the etarfolatide imaging agent, according to the company, though intratumoral levels of the EC1456 drug payload may be lower than predicted by preclinical models.
Endocyte is also ending enrollment in a Phase I trial of a second cancer candidate, the prostate-specific membrane antigen targeted (PSMA-targeted) tubulysin prostate cancer therapy EC1169. The development focus of EC1169 will be narrowed to taxane-exposed, metastatic castration-resistant prostate cancer (mCRPC) patients, Endocyte said, with a topline efficacy assessment of the trial’s expansion phase expected before the end of this year.
An interim assessment confirmed clinical activity of the drug in the taxane-exposed cohort with a partial response in one patient, stable disease in other patients, and other markers of activity. Endocyte said it believes EC1169 may have benefit in taxane-exposed patients, with more advanced disease, where upregulation of PSMA increases with prior treatments.
“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,” Endocyte president and CEO Mike Sherman stated.
Sherman said these programs include Endocyte’s dual-targeted DNA crosslinker drug EC2629 and its CAR T-cell SMDC adaptor platform, in addition to EC1169 in taxane-exposed mCRPC patients.
Later this year, Endocyte plans to file an IND for EC2629, which includes a potent DNA-targeted warhead with clinically proven activity. By next year, the company plans to advance its CAR T-cell bispecific adaptor molecule, developed with Seattle Children’s Research Institute, into clinical trials.
