June 2, 2017
By Mark Terry, BioSpace.com Breaking News Staff
West Lafayette, Ind. – Endocyte announced that it is cutting 40 percent of its workforce as it recalibrates two clinical programs.
For the company’s EC1169 program, Endocyte indicates it is narrowing its focus to only a cohort of taxane-exposed, metastatic castration-resistant prostate cancer (mCRPC) patients. An interim assessment showed clinical activity in the taxane-exposed cohort with a partial response in a single patient, stable disease in other patients, as well as additional markers of activity. The company believes the drug may benefit taxane-exposed patients with more advanced disease. It otherwise plans to halt enrollment of taxane-naïve mCRPC patients in the trial.
Endocyte will stop enrollment in its EC1456 clinical trial. An evaluation in folate receptor-positive (FR-positive) disease across multiple cohorts and multiple dosing regimens did not show enough clinical activity to continue the trial. But, the company will enroll a small number of patients in the EC1456 ovarian cancer surgical study to support other SMDC programs it has in development. Early data from the ovarian surgical trial indicates patients with FR-positive disease are being identified successfully with the use of the etarfolatide imaging agent. However, intratumoral levels of the EC1456 drug may be lower than predicted in preclinical studies.
“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, Endocyte’s president and chief executive officer, in a statement. “Recently gained insight into the safety and efficacy of EC1169 and EC1456, coupled with our commitment to the product 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 company’s programs for CAR-T therapies will continue with Seattle Children’s Research Institute. It hopes to enter the program into the clinic next year. It also plans to file its Investigational New Drug (IND) application for EC2629 mid-2017. The company states, “To Endocyte’s knowledge, this is the first drug candidate designed to simultaneously target both tumor cells and tumor associated macrophages (TAMs), which contribute to disease progression by interfering with natural anti-tumor immune responses.”
Three years ago, Endocyte had a relationship with Merck over its lead cancer program. After failures in the program, Merck bailed on the partnership. John Carroll, writing for Endpoints News, says, “The once high-flying biotech scored a $1 billion licensing pact with Merck on vintafolide, which also gained a conditional approval in Europe based on positive Phase II data. But the drug subsequently failed to improve progression-free survival for ovarian cancer patients.”
Endocyte took a hit at the news of the job and program cuts. It is currently trading at $2.73, but dropped almost 30 percent in pre-market trading.
Emma Court, for MarketWatch, wrote, “Endocyte stock plummeted 30.4 percent in premarket trade Friday after the company said it plans a ‘strategic restructuring’ that includes an about 40 percent reduction in its workforce and clinical trial changes, including ending enrollment in one trial. The company plans to terminate 47 employees, largely in the third quarter, and said it expects total restructuring costs of about $2.4 million, including severance, clinical trial termination changes and other costs.”
Endocyte indicates it expects to have $105 million in cash at the end of 2017.
