Aduro Starts Phase II Combo Study with CRS-207 & Keytruda
Aduro Biotech, Inc. ADRO has announced initiation of a phase II study to evaluate a combination therapy of its lead LADD (live, attenuated double-deleted) based candidate, CRS-207, in combination with Merck & Co., Inc.’s MRK anti-PD-1 therapy, Keytruda (pembrolizumab), for treatment of patients previously nursed for malignant pleural mesothelioma (MPM). Note that, this combination therapy is also being evaluated for treatment of gastric cancer.
Aduro is developing the LADD platform for treating multiple cancer indications, including pancreatic, ovarian, lung and prostate cancers, mesothelioma and glioblastoma. In addition, a personalized form of LADD is being developed utilizing tumor neoantigens, specific to an individual patient’s tumor.
We remind investors that in Oct 2016, the FDA had placed a partial clinical hold on studies evaluating Aduro’s LADD-based agents, thus 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, a serious infection usually caused by eating contaminated food. Subsequently in Nov 2016, the FDA had lifted the partial clinical hold on studies.
However, the company had to revise and implement study protocols in accordance with the FDA’s guideline in order to recommence enrollment.
Shares of Aduro increased almost 2% after the company announced initiation of the combination trial. Moreover, the company’s shares have outperformed the Zacks classified Medical-Biomed/Genetics industry in the last three months. The stock rose 2.8% compared with the broader industry’s advance of 2.2%.
The phase II study is designed to evaluate the safety and efficacy of the combination of CRS-207 with Keytruda in adult patients (n=35), previously treated for MPM. The primary efficacy endpoint of the study is objective response rate, to be based on the proportion of patients with either complete or partial responses.
It is important to remind investors that in June last year, Aduro had presented data from a phase Ib study, evaluating CRS-207 alone and in combination with standard chemotherapy in patients with newly-diagnosed MPM at the American Society of Clinical Oncology. Data from the study has demonstrated encouraging anti-tumor responses.
Note that, several studies utilizing this platform are being conducted, including a phase I/II study on CRS-207 in combination with Incyte Corporation’s INCY selective IDO1 inhibitor epacadostat, for healing ovarian cancer; and a phase I lung cancer study on ADU-214 in collaboration with Johnson & Johnson’s JNJ Janssen Biotech, among others.
Aduro continues to progress with its other two platform technologies – the STING pathway activator and the B-select antibody programs.
Aduro Biotech, Inc. Price
Aduro Biotech, Inc. Price | Aduro Biotech, Inc. Quote
Zacks Rank
Aduro currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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