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Aduro Reports Partial Hold Lift on LADD Studies in U.S.

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Aduro Biotech, Inc. (ADRO - Free Report) received encouraging news when the FDA lifted the partial clinical hold on studies evaluating investigational agents based on its LADD (live, attenuated double-deleted) immunotherapy platform. With the partial hold lift, the company has now been able to resume patient enrollment in all Aduro-sponsored studies.

However, the company has had to revise and implement study protocols in accordance with the FDA’s guideline in order to recommence enrollment. These guidelines include extended patient surveillance, exclusion of patients with certain prosthetic devices that are not easily removed, and guidance in the administration of prophylactic antibiotics following LADD-based treatment in patients who may receive immune-suppressive treatments.

In its press release, Aduro stated that it is on track to initiate a phase II study utilizing the LADD-based therapy CRS-207, in combination with an anti-PD-1 compound, for the treatment of mesothelioma in the first half of 2017.

We remind investors that last month, the FDA had placed a partial clinical hold on studies evaluating Aduro’s LADD-based agents, bringing patient enrollment to a halt. The decision came after a blood culture sample taken from an indwelling port of a metastatic pancreatic cancer patient tested positive for Listeria.



Note that Aduro is developing the LADD platform for the treatment of multiple indications, including pancreatic, ovarian, lung and prostate cancers, mesothelioma and glioblastoma. In addition, a personalized form of LADD is being developed utilizing tumor neoantigens that are specific to an individual patient’s tumor.

Several studies utilizing this platform are being conducted, which include a phase I/II study on CRS-207, in combination with Incyte Corporation’s (INCY - Free Report) selective IDO1 inhibitor epacadostat, for the treatment of ovarian cancer; and a phase I lung cancer study on ADU-214, in collaboration with Johnson & Johnson’s (JNJ - Free Report) Janssen Biotech among others.

Meanwhile, Aduro continues to progress with its two other platform technologies – the STING pathway activator and the B-select antibody programs.

Aduro currently has a Zacks Rank #2 (Buy).

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