Aduro gets back on track with CRS-207 after FDA lifts partial clinical hold
Just a month after the FDA forced Aduro to halt enrolling more patients in studies using its cancer vaccine CRS-207, the Berkeley, CA-based biotech says regulators have lifted the partial hold, giving it a green light to resume proceeding on plan.
The partial hold was instituted after a patient tested positive for Listeria. CRS-207 uses reengineered Listeria monocytogenes — removing genes in order to disarm the bacteria — that express mesothelin, sparking an immune response to a protein concentrated on cancer cells.
Shares of Aduro $ADRO edged up 1% in mid-morning traffic.
The case was linked to an indwelling port used in prosthetic devices, and as was speculated at the time, the enrollment is resuming after the agency agreed on dropping any more patients with these devices (provided their port can be removed). And investigators are adding guidance to administer prophylactic antibiotics following LADD-based treatment for patients who may receive immune-suppressive treatments.
“While this removes a modest overhang on the stock, the main upside drivers in our view continue to be ADRO’s STING and B-Select antibody platforms,” noted Leerink’s Seamus Fernandez.
“We are pleased to come to a rapid agreement with the FDA to resume new patient enrollment in our LADD clinical studies,” said Stephen T. Isaacs, chairman, president and CEO of Aduro Biotech. “With slight protocol modifications implemented, we remain on track to initiate a Phase 2 clinical study using our LADD-based therapy CRS-207 in combination with an anti-PD-1 compound for patients with mesothelioma in the first half of 2017. Additionally, we continue to make significant progress with our STING Pathway Activator and B-select Antibody programs and with our three diverse immunotherapy platforms, we believe we are uniquely positioned to bring innovative therapies to patients with late-stage cancers.”