Bellicum Pharmaceuticals' shares are being routed after it announced a full house of horrors: poor data, a paused program and slashing the vast majority of its staff as it looks to save cash.
First up, the data: Its drug BPX-601, part of its so-called GoCAR-T tech, is designed to enhance T-cell proliferation and functional persistence, reignite host immunity and overpower the suppressive tumor microenvironment to deliver the potential to treat solid tumors that traditional CAR-T therapies cannot reach.
The interim data posted after-hours Thursday evening were for a dose-escalation test in patients with relapsed/refractory metastatic pancreatic cancer. As with most of these trials, response evaluation criteria in solid tumors (aka RECIST) were used to assess its efficacy: These are a set of published rules that define when tumors in cancer patients improve, stay the same or worsen during treatment.
But the results were poor: “Clinically meaningful efficacy as measured by RECIST criteria was not observed,” the biotech said simply in its release.
There was also a serious safety issue with one patient who was hit by cytokine release syndrome, a blight that can hit CAR-T trials and can in some instances be life-threatening.
Despite the weak data, Bellicum is doggedly determined to keep going with BPX-601. This will see it begin enrolling patients with metastatic castration-resistant prostate cancer (mCRPC) in the ongoing phase 1/2 test before the end of the year, though it will “review its plans in pancreatic cancer [a typically difficult cancer to treat] upon completion of the current safety cohort.”
It will also continue on with BPX-603, its first dual-switch GoCAR-T candidate, in patients with HER2+ solid tumors in a phase 1/2 clinical trial, also plotting patient enrollment by the end of the year.
But to keep this going with dwindling funds, it will be “pausing development” of its BCMA GoCAR-NK program, an early-stage effort designed as a natural killer cell therapy targeting B-cell maturation antigen in blood cancers.
In the background of all this are swingeing cuts: 79% of its staffers will be axed, dropping from 68 to 14 full-time employees by the end of 2020. It’s also looking to pay down its Oxford Finance debt obligations using cash on hand this month, both moves that should help keep it afloat for a little longer.
Shares in the biotech were down 35% premarket Friday morning on the news.
“The results we have observed in the BPX-601 study are encouraging in terms of safety and GoCAR-T cell activation, proliferation, and persistence. We are eager to investigate our technology further in new tumor types like mCRPC and against established target antigens like HER2,” said Rick Fair, president and CEO of Bellicum.
“We have concluded that Bellicum must reduce spending on preclinical programs and shift its resources to enable achievement of meaningful milestones in the clinic. We regret the impact this unavoidable decision will have on our departing employees and we sincerely thank them for their contributions and dedication.”