Aduro Biotech (ADRO) Presenta CRS-207 Safety, Efficacy Data at SITC Annual Meeting

November 14, 2016 6:36 AM EST

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Aduro Biotech, Inc. (NASDAQ: ADRO) announced highlights from a poster presentation at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC) being held in National Harbor, Maryland on the preliminary safety and efficacy of its novel immunotherapy, CRS-207, being evaluated in unresectable malignant pleural mesothelioma. These data were from the second cohort of patients in an ongoing Phase 1b clinical trial of CRS-207 in combination with standard of care chemotherapy and immune-modulating doses of cyclophosphamide (Cy) as a first-line treatment.

Preliminary results as of October 2016 from the 22 patients in the second cohort in the Phase 1b clinical study (Abstract #261) showed that 82 percent (18/22) of patients had disease control, with 55 percent (12/22) of patients achieving a partial response (PR) and 27 percent (6/22) with stable disease. Tumor shrinkage was observed in 77 percent (17/22) of patients. Of these patients, 36 percent (8/22) experienced tumor shrinkage after two doses of immunomodulatory doses of cyclophosphamide combined with CRS-207 (Cy/CRS-207), but prior to initiation of standard of care chemotherapy. Fourteen percent (3/22) of these patients achieved a partial response. No treatment-related serious adverse events or unexpected toxicities were observed. Median duration on study was 9.7 months at the time of data cutoff. Treatment continues, with immune response evaluations and survival follow up ongoing.

Of note, analysis of paired tumor biopsies obtained from two patients showed a marked infiltration of immune effector cells into the tumor microenvironment (TME) following two doses of Cy/CRS-207, as compared to baseline. Post-therapeutic changes included an increase in CD8+ cytotoxic T cells as well as an increase in other immune cell types that are thought to be essential for effective immunotherapy, including dendritic cells and natural killer cells. Together, these data suggest that the Cy/CRS-207 remodeling of the TME may be an important component of the clinical responses observed in this cohort of patients.

“The data from the second cohort, which is a patient population with more advanced disease compared to the first cohort, demonstrate that the addition of immunomodulatory doses of cyclophosphamide, which has been shown to inhibit negative regulatory T cell populations, to the combination of CRS-207 and chemotherapy results in encouraging disease control and tolerability for patients with mesothelioma,” said Dirk G. Brockstedt, Ph.D., executive vice president of research and development of Aduro. “Importantly, we believe these data, together with the results from the first cohort, support further investigation of CRS-207 in mesothelioma, and we intend to initiate a Phase 2 study of CRS-207 used in combination with an anti-PD-1 therapy as an immune-modulator in patients with mesothelioma who have failed at least one prior therapy.”

Additional Data on STING, pLADD Platform Technologies

A poster presentation highlighting preclinical data on the potential mechanism of action of ADU-S100 (also known as MIW315) therapy for treating cancer (Abstract #399) was given yesterday. The data showed that injection of ADU-S100 directly into the tumor microenvironment induces a systemic tumor-specific T cell response that leads to durable anti-tumor immunity. The data demonstrate that TNF-alpha and neutrophil recruitment mediate the primary tumor shrinkage following injection with ADU-S100, while CD8-alpha+ cells and natural killer cells mediate durable anti-tumor immunity. Anti-tumor efficacy was enhanced by combining ADU-S100 with anti-PD-1 or anti-CTLA4 checkpoint inhibitors. An ongoing Phase 1 clinical study is ongoing evaluating the safety and tolerability and possible anti-tumor effects of ADU-S100 in patients with cutaneously-accessible non UV-induced and UV-induced malignancies.

An additional poster presentation highlighting preclinical data on a personalized, live, attenuated double-deleted Listeria monocytogenes (pLADD) immunotherapy (Abstract #366) will be given today at 11:45 a.m. ET. pLADD is a patient-specific immunotherapy based on Aduro’s LADD platform. To design the individualized pLADD immunotherapy, tumor-specific mutations, called neoantigens, are identified through a comparison of tumor and normal tissue sequences. Aduro then constructs a LADD strain encoding patient-specific neoantigens that will be administered to the patient. Preclinical data included in the poster presentation demonstrate that a mouse tumor-specific pLADD induces a robust neoantigen-specific response and survival benefit in two mouse models of cancers when combined with anti-PD-1 checkpoint modulation.

About LADD and CRS-207 LADD is Aduro's proprietary platform of live, attenuated double-deleted Listeria monocytogenes strains that have been engineered to generate a potent innate immune response and to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity.

CRS-207 is one of a family of product candidates based on Aduro's LADD immunotherapy platform that has been engineered to express the tumor-associated antigen mesothelin, which is over-expressed in many cancers including mesothelioma and pancreatic, non-small cell lung, ovarian, endometrial and gastric cancers.

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