The cessation of research at MD Anderson Cancer Center has put a stop to production of Bellicum Pharmaceuticals’ clinical development candidates.
Bellicum completed the sale of its cell therapy manufacturing plant to MD Anderson on April 14. Days later, Bellicum told investors MD Anderson has temporarily stopped research, including “activity in the manufacturing facility in which the product candidates for [Bellicum’s] clinical development programs are manufactured.”
As it stands, Bellicum doesn’t expect MD Anderson’s actions to “have a significant impact” on its programs. Bellicum is currently involved in 12 active studies, according to ClinicalTrials.gov, including a phase 1/2 trial of BPX-601 CAR-T cells in advanced solid tumors that express high levels of PSCA.
However, uncertainty about the duration and extent of the disruption caused by COVID-19 means Bellicum is unable to ascertain “exact timing of delays and overall impact to [its] business, preclinical research and clinical trials” at this stage.
Bellicum outlined some of the possible ways the pandemic could impact its operations in an update to the risk factors it provides to investors. In that document, Bellicum said it “may be unable to enroll patients in our ongoing and planned clinical trials until manufacturing resumes at the facility, unless MD Anderson agrees to exceptions to its policy.”
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The biotech is also contending with the impact of an executive order in its home state of Texas that requires people to stay at home for an indefinite period of time. In response to the order, Bellicum has adopted work-from-home policies and temporarily modified its research operations in line with the recommendations on social distancing.
While those actions have enabled Bellicum to continue operating, the biotech thinks the changes are “likely to negatively impact productivity, disrupt [its] business and delay [its] timelines.” Again, the extent of the impact will depend on the length and severity of the restrictions.