Aduro Biotech (ADRO) Announces Partial Clinical Hold of LADD Trials
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Aduro Biotech, Inc. (Nasdaq: ADRO) has received notice from the U.S. Food and Drug Administration (FDA) that trials with investigational agents based on its LADD (Listeria-based immunotherapy construct) platform have been placed on partial clinical hold to pause new patient enrollment. Patients currently receiving a LADD-based agent (except one currently identified patient, due to the presence of a pacemaker) are continuing to receive treatment, with several of these patients having been on study drug for six months or longer. The partial hold was initiated following notification to the FDA that a blood culture sample from an indwelling port of a metastatic pancreatic cancer patient who presented with gastrointestinal symptoms tested positive for Listeria, which is suspected to be CRS-207. The patient was administered intravenous antibiotics, subsequent blood cultures tested negative for Listeria, and the patient was reported to be doing well.
Aduro is working with the FDA to lift the partial hold so as to resume new patient enrollment in its LADD clinical trials. The company is revising study protocols in accordance with feedback from the agency, including the modification of antibiotic administration following treatment, extended patient surveillance, and, as a pre-emptive measure, exclusion of patients who are on or will receive certain immune-suppressive treatments or who have certain prosthetic devices. Aduro will be providing proposed revisions to the protocols, patient consent forms, and investigator brochures to the agency later this week.
This partial hold does not impact any ongoing development of Aduro’s two other distinct platform technologies, STING pathway activators and B-select monoclonal antibodies.
Conference Call with Management Aduro’s management will host a conference call to review this announcement today at 6 a.m. PT. To participate in the conference call, please dial (844) 309-0604 (domestic) or (574) 990-9932 (international) and refer to conference ID 4915023. Live audio of the conference call will be simultaneously webcast and will be available to members of the news media, investors and the general public at http://edge.media-server.com/m/p/rk79zbwm.
The webcast will be archived under the investor section of the company’s website and available for replay for at least one month after the conference call.
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