Blaming Covid disruption, supply shortages, microcap biotech hits the brakes on cell therapy trial
More than two years into the Covid-19 pandemic, we’re not done seeing its disruption of biotech.
That’s according to Caladrius execs, who cited the pandemic as one reason for suspending its Phase IIb trial of a cell therapy as a treatment for coronary microvascular dysfunction (CMD). The company plans to go ahead on an interim analysis before deciding what to do with the program, which was built on a licensing deal with Shire in 2018.
In retrospect, the writing may have been on the wall last month when Caladrius announced its merger with Cend Therapeutics, a little-known biotech focused on solid tumors. Caladrius had plans to rename itself into Lisata and make Cend’s cancer work the “emphasis” of its R&D group moving forward.
Over its 16-year history — it was founded as NeoStem and already rebranded once, in 2015 — Caladrius has tried and failed to bring forward cell therapies for a number of diseases, and its shares have been languishing in penny stock territory.
Xowna, the drug being tested in its halted trial, comprises an infusion of autologous CD34+ cells.
Caladrius had previously completed a Phase IIa open-label, proof-of-concept study in CMD. The Phase IIb FREEDOM study was meant to confirm those results in a controlled trial — as well as better gauge how big the treatment effect might be, as measured by clinical endpoints the FDA would likely be looking for in a later pivotal trial.
But while the study kicked off as planned in October 2020 and treated the first patient the next January, Caladrius ran into serious trouble enrolling patients. On top of the impact of Covid-19, the biotech said supply chain issues made it tough to get the catheters needed for both the diagnosis and administration of Xowna, as the manufacturer stopped making the equipment originally specified in the trial to qualify patients for the study while a commonly used contrast agent was also in shortage.
Thrown off the original schedule, the company said the revised timeline is simply “not viable for financial and commercial reasons and an alternative development plan must be considered.”
Despite the multiple protocol amendments to address these obstacles, along with an increased number of sites in the study, the FREEDOM trial has only enrolled approximately one third of the targeted 105 patients, and at this rate, more than four years would likely be required to reach the primary endpoint follow-up at 6 months post-treatment for all subjects.
CEO David Mazzo added that pausing enrollment now and taking a look at the interim results is in the “best interest” of the company.
Results of the interim analysis are expected in August.
Editor’s note: This story has been updated to clarify the origin of the Xowna program in CMD. While Caladrius licensed a no-option refractory disabling angina program from Shire, it formulated and owns the IP for CMD.