Is the end in sight for Endocyte? The cancer company says it’s still going strong with plans for the future, but today announced it would cull nearly half of its employees and scale back its drug programs as it refocuses.
In an update this morning, Endocyte, which had focused on small molecule drug conjugates (SMDCs) and companion imaging agents, said it would “narrow” its EC1169 development program to focus only on the cohort of taxane-exposed, metastatic castration-resistant prostate cancer (mCRPC) patients; top-line efficacy assessment of the expansion phase of this phase 1 trial is slated in the coming months.
But the company said it would be halting enrollment of taxane-naïve mCRPC patients in the EC1169 trial.
And it will also stop enrollment in a trial for its folate receptor-targeted tubulysin cancer therapy, EC1456.
This is because “it did not yield the clinical activity necessary to support continued advancement of this agent.” In other words, it didn’t work.
“However, enrollment of a small number of patients in the EC1456 ovarian cancer surgical study will continue in order to inform other SMDC programs in development” the company added, although it noted that the effect might not be as big as that shown in preclinical tests.
As it reduces its focus on these meds, Endocyte says it will be “refocusing its efforts” on its CAR-T and dual-targeted DNA crosslinker drug EC2629 programs. Working with Seattle Children’s Research Institute, the biotech says it plans to bring its very early-stage CAR T-cell bi-specific adaptor molecule to the clinic next year.
And there are plans for an IND for EC2629 any week now, which includes a “potent DNA-targeted warhead with clinically proven activity.”
But Endocyte will do all of this so with 40% fewer staff, “in order to better focus its resources on the company’s highest value opportunities, while maintaining key capabilities."
Endocyte will get hit with $2.4 million charge for these terminations as well as the accelerated closure of the EC1456 trial.
But the company is revising its guidance for 2017 and now expects its cash balance at the end of 2017 to be around $105 million, with a more “substantial positive impact from the restructuring.”
“Endocyte is a data-driven company, and we are committed to the disciplined management of clinical programs as the science guides us,” said new chief Mike Sherman.
"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."
Sherman added, “As we refocus our clinical development efforts, we are also aligning our investments and resources to advance our most compelling pipeline programs to key inflection points. We are very grateful for all the contributions over the years from our dedicated, talented team of employees, who have devoted so much of themselves towards helping advance our efforts to bring our innovative, targeted therapies to patients with cancer and other serious diseases. We’ll be working closely with those affected by the restructuring to support them through this difficult but necessary transition.”
It's been a tough road for the biotech, and this latest setback comes after Ron Ellis, a man who spent two decades at the helm, hung up his executive boots a year ago as Sherman took the CEO and president job.
Endocyte, once flying high after securing a deal worth up to $1 billion with Merck a few years back, flew a little too close to the sun and was brought crashing back to earth in 2014 when its much-hyped drug vintafolide flopped a phase 3 test in ovarian cancer.
The study was in fact stopped on the advice of a data and safety monitoring board, which said the biotech’s experimental drug failed to move the needle on progression-free survival. This came just a few months after the EMA gave the drug a conditional approval based on what appeared to be strong midstage results. Cue its shares tanking on the news, which dropped 60% on the day, and later saw Merck backing away from the deal.
The biotech’s shares were hit hard in early trading, down 26% this morning with its market cap under $100 million.